Preparation containing a sialic acid derivative-containing agent, and method for producing the preparation containing a sialic acid derivative-containing agent

Abstract

To provide preparations containing a sialic acid derivative-containing agent in which viral inhibitory actions such as a long-lasting viral inhibitory action and / or a viral proliferation-inhibitory action can be expected while they can be used easily, and to provide methods for producing the preparation containing a sialic acid derivative-containing agent.SOLUTION: A base and a sialic acid derivative-containing agent are contained and the sialic acid derivative-containing agent is not contained in the base. The sialic acid derivative-containing agent has functions inhibiting an activity and proliferation of viruses, such as influenza virus, coronavirus, and novel coronavirus as pathogens. As the base, confectionery bases such as chewing gum bases, candy bases and troche bases, or external preparation bases such as ointments, creams, liquids, and the like can be applied.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention relates to a preparation containing a sialic acid derivative-containing agent, and more particularly, to a preparation containing a sialic acid derivative-containing agent that can stay in the oral cavity, adhere to the oral mucosa, adhere to the nasal mucosa, adhere to the human skin, or adhere to an article.

Background Art

[0002] As pathogens that infect humans, various viruses such as influenza virus, coronavirus, adenovirus, herpes virus, hepatitis virus, AIDS virus, Japanese encephalitis virus, etc. are known. For example, influenza virus and coronavirus enter through the mouth or nose, adhere to the mucosa in the oral cavity, nasal cavity, and respiratory tract, and infect and multiply. When infected with influenza or coronavirus, symptoms such as high fever, sore throat, joint pain, and general malaise are shown. In particular, in the elderly, pneumonia and the like caused by secondary infection have been reported to cause death in some cases.

[0003] Conventionally, as a preventive measure for influenza, a method of inoculating a vaccine to prevent virus infection by an antibody reaction to the influenza virus is known.

[0004] In addition, it is known that the influenza virus is infected by droplet infection in a crowd, and a preventive method of wearing a mask to prevent the virus from entering the body is commonly used.

[0005] Furthermore, research and development of preventive or therapeutic methods for influenza are widely carried out. For example, various techniques as follows have been proposed.

[0006] Japanese Patent Application Laid-Open No. 2001-233773 (Patent Document 1) discloses an antiviral agent containing a sphingoglycolipid having a sugar chain containing a virus receptor recognition site (including gangliosides) as an active ingredient. However, since gangliosides are extracted from the brains of minke whales and human erythrocytes, it can be envisioned that it is somewhat difficult to put them into practical use as anti-influenza drugs from the perspective of large-scale preparation.

[0007] Japanese Patent Application Laid-Open No. 2002-68988 (Patent Document 2) discloses a virus infection inhibitor containing, as an active ingredient, an enzyme-treated product obtained by further subjecting a bird's nest water extract extracted from ground bird's nest with water or hot water to enzyme treatment.

[0008] Japanese Patent Application Laid-Open No. 2007-308444 (Patent Document 3) discloses an anti-influenza virus agent which is a sialic acid-containing sugar chain complex in which a compound other than sugar is bound to a terminal other than the sialic acid terminal of a sialic acid-containing sugar chain containing a sialyl group at one end, and which has excellent anti-influenza virus activity. In particular, it is disclosed that a sialic acid-containing sugar chain complex having a 3-sialylgalactose chain (i.e., Neu5Acα2-3Gal) and / or a 6-sialylgalactose chain (i.e., Neu5Acα2-6Gal) has particularly excellent anti-influenza virus activity.

[0009] Japanese Patent Application Laid-Open No. 2015-133943 (Patent Document 4) discloses an extraction method of a bird's nest using pressure and enzyme in combination, which includes a step of mixing a bird's nest, an enzyme, and a certain amount of water and then performing a crushing and homogenization treatment to obtain a crude sample, and a step of performing a high-pressure hydrolysis treatment on the crude sample at a pressure of 50 to 200 MPa to obtain a hydrolyzate, and thereby a technology for obtaining a bird's nest extract with an increased extraction amount of active ingredients such as sialic acid is disclosed.

[0010] In the technical paper "Hirokazu Yagi, NakAo Yasukawa, Shin-Yi Yu, Chao-Tan Guo, Noriko Takahashi, Tadanobu Takahashi, Wakoto Bukawa, Takashi Suzuki, Kay-Hooi Khoo, Yasuo Suzuki, Koichi Kato: The expression of sialylated high-antennary N-glycans in edible bird’s nest. Carbonhydrate Res., 343, 1373-1377(2008)" (Non-Patent Document 1), it is described that in the sialylated sugar chains prepared by extraction from edible bird's nest, (Neu5Ac)α2,3 galactose (Gal) [i.e., (Neu5Acα2,3Gal)] and (Neu5Ac)α2,6 galactose (Gal) [i.e., (Neu5Acα2,6Gal)] are mixed. Also, it is known that (Neu5Acα2,3Gal) is an avian receptor and (Neu5Acα2,6Gal) is a human receptor.

Prior Art Documents

Patent Documents

[0011]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Non-Patent Documents

[0012]

Non-Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0013] Prevention by vaccination as described above has problems such as the preventive effect of the vaccine not lasting long because the antigen structure of the influenza virus frequently mutates, and the inability to respond quickly when the prediction of the epidemic strain is off. An effective preventive method has not yet been established. Also, prevention by wearing a mask is not fully satisfactory as a preventive method because the size of the virus is extremely small and the virus can penetrate through a normal mask. Furthermore, generally, drugs tend to deteriorate in some way, such as alteration or decomposition, as the temperature rises, and production at a temperature at which the drug does not deteriorate is desired. Also, during the storage of the preparation, a preparation in which alteration of the physical properties of the preparation does not occur is desired.

[0014] In view of the above, the preparation containing a sialic acid derivative-containing agent of the present invention is easy to use, and can suppress the activity of the virus, and / or suppress the growth of the virus, and / or suppress infection by the virus, etc. It is an object of the present invention to provide a preparation containing a sialic acid derivative-containing agent that can be expected to have a virus activity inhibitory effect and can be expected to continuously exhibit these virus activity inhibitory effects for a long time.

[0015] The manufacturing method of the preparation containing a sialic acid derivative-containing agent of the present invention aims to provide a manufacturing method of a preparation containing a sialic acid derivative-containing agent that does not cause deterioration of the sialic acid derivative-containing agent during manufacturing.

Means for Solving the Problems

[0016] The preparation containing a sialic acid derivative-containing agent of the present invention comprises a base and a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent is contained in the base, which is characterized by this. Preferably, the sialic acid derivative-containing agent has a virus activity inhibitory function such as suppressing the activity of a virus, and / or suppressing the growth of a virus, and / or suppressing infection with a virus.

[0017] The manufacturing method of the preparation containing a sialic acid derivative-containing agent of the present invention is a manufacturing method of a preparation containing a base and a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent is contained in the base. The method comprises a step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130°C or lower to form a base-sialic acid derivative-containing agent uniformly-containing intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base. Preferably, the sialic acid derivative-containing agent has a virus activity inhibitory function such as suppressing the activity of a virus, and / or suppressing the growth of a virus, and / or suppressing infection with a virus.

Effects of the Invention

[0018] With the preparation containing a sialic acid derivative-containing agent of the present invention, "Formulation effect A: (An effect where easy usability and long-term virus activity inhibition can be expected) It can be easily and simply used, and virus activity inhibitory effects such as suppressing the activity of a virus, and / or suppressing the growth of a virus, and / or suppressing infection with a virus can be expected, and long-term sustained exertion of these virus activity inhibitory effects can be expected. A preparation containing a sialic acid derivative-containing agent" can be obtained.

[0019] According to the method for manufacturing a preparation containing a sialic acid derivative-containing agent of the present invention, "manufacturing effect A: (the effect that the sialic acid derivative-containing agent contained during production does not deteriorate) can be easily and simply used, and a sialic acid derivative-containing agent that can be expected to have a long-term virus activity inhibitory effect can be obtained by a method for manufacturing a preparation containing a sialic acid derivative-containing agent that does not cause deterioration of the sialic acid derivative-containing agent contained during production."

Brief Description of the Drawings

[0020]

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Mode for Carrying Out the Invention

[0021] Hereinafter, the preparation containing the sialic acid derivative-containing agent of the present invention and the method for producing the preparation containing the sialic acid derivative-containing agent will be described in detail.

[0022] The preparation containing the sialic acid derivative-containing agent of the present invention comprises a base and a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent is contained in the base. Preferably, the sialic acid derivative-containing agent has a virus activity inhibitory function such as suppressing the activity of the virus, and / or suppressing the growth of the virus, and / or suppressing the infection with the virus.

[0023] With the preparation containing the sialic acid derivative-containing agent of the present invention, "preparation effect A: (an effect that easy usability and long-term virus activity inhibition can be expected) can be easily and simply used, and suppresses the activity of the virus, and / or suppresses the growth of the virus, and / or suppresses the infection with the virus, etc., and a virus activity inhibitory effect can be expected, and a long-term continuous exertion of these virus activity inhibitory effects can be expected, a preparation containing a sialic acid derivative-containing agent" can be obtained. In the present invention, the "virus activity inhibitory effect of suppressing virus activity" means an effect similar to the "virus growth inhibitory effect of suppressing virus growth" and the "virus infection inhibitory effect of suppressing virus infection", and the "virus activity inhibitory effect of suppressing virus activity" means, in addition to the "virus activity inhibitory effect of suppressing virus activity", an effect further including the "virus growth inhibitory effect of suppressing virus growth" and the "virus infection inhibitory effect of suppressing virus infection".

[0024] In the preparation containing the sialic acid derivative-containing agent, a preparation containing the sialic acid derivative-containing agent having the following configuration can be preferably implemented. · "The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid (NeuAc) and galactose (Gal) are bonded, and in the chemical structural formula, the second carbon of sialic acid and the sixth carbon of galactose are via an oxygen atom bonded to form a 2,6-bond structure, or the second carbon of sialic acid and the third carbon of galactose are via an oxygen atom bonded to form a 2,3-bond structure."

[0025] As described in paragraph 0007 of Japanese Patent Application Laid-Open No. 2007-308444 described in the column of [Background Art] above, "It is generally known that hemagglutinin (HA), which is one of the spike proteins present on the envelope of influenza virus, recognizes a sugar chain containing sialic acid of a complex glycoprotein present on the cell membrane surface of a target cell, binds to the sugar chain, and establishes infection of the target cell. In addition, avian influenza virus specifically recognizes a sugar chain such as [Neu5Ac(α2-3)Gal-], and human influenza virus specifically recognizes a sugar chain such as [Neu5Ac(α2-6)Gal-], and this is considered to be a factor creating the specificity of virus infection. It is known to those skilled in the art that for viruses and bacteria that recognize components of target cells, bind to target cells, and establish infection, if a component having an affinity equal to or stronger than that of the sugar chain of the target cell recognized by the virus or bacteria is added from the outside, it is considered that the infection by the virus or bacteria is inhibited.

[0026] In addition, in the paper by the inventors described in the column of [Background Art] above, "Hirokazu Yagi, NakAo Yasukawa, Shin-Yi Yu, Chao-Tan Guo, Noriko Takahashi, Tadanobu Takahashi, Wakoto Bukawa, Takashi Suzuki, Kay-Hooi Khoo, Yasuo Suzuki, Koichi Kato: The expression of sialylated high-antennary N-glycans in edible bird’s nest. Carbonhydrate Res., 343, 1373-1377 (2008)", it is described that the sialic acid derivative-containing agent extracted and prepared from edible bird's nest contains a mixture of (Neu5Ac)α2,3 galactose (Gal) [i.e., (Neu5Acα2,3Gal)] and (Neu5Ac)α2,6 galactose (Gal) [i.e., (Neu5Acα2,6Gal)].

[0027] FIG. 1 and FIG. 2 are schematic chemical structural formulas for explaining the chemical structure of the sialic acid derivative-containing agent in the preparation containing the sialic acid derivative-containing agent of the present invention. As described in FIG. 1, FIG. 2, Japanese Patent Application Laid-Open No. 2007-308444, and the above paper, "The sialic acid derivative-containing agent has a chemical structure in which sialic acid (NeuAC or Sia) and galactose (Gal) are bonded, and the second carbon of sialic acid and the sixth carbon of galactose are via an oxygen atom bonded in a 2,6-bonded structure (Sia-α2,6-Gal), or the second carbon of sialic acid and the third carbon of galactose are via an oxygen atom"A preparation containing a sialic acid derivative, which is a sialic acid derivative-containing agent having a combined 2,3-linkage structure (Sia-α2,3-Gal)", can be implemented. That is, the sialic acid derivative-containing agent has a chemical structure in which galactose (Gal) and sialic acid (NeuAc, or Sia) are combined.

[0028] On the other hand, many human cells are said to have a structure (α2,6-linkage) in which the α-direction of the second carbon of sialic acid and the sixth carbon of galactose are via an oxygen atom bonded. Also, it is said that cells in the human throat (larynx) have many "α2,6-linkages", and cells in the human lung have many "α2,3-linkages". Many bird cells are said to have a structure (α2,3-linkage) in which the α-direction of the second carbon of sialic acid and the third carbon of galactose are via an oxygen atom bonded.

[0029] The action of the "sialic acid derivative-containing agent" as a sialic acid derivative-containing agent will be described below. Figure 4 is a schematic diagram for explaining that the sialic acid derivative-containing agent has an action of suppressing infection in the preparation containing the sialic acid derivative-containing agent of the present invention. As shown in (A-1) of (A) in Figure 4, the size of the virus has a spherical or elliptical shape under an electron microscope, and the diameter is about 1 / 10,000 mm. One virus has two types of spikes, about 500 hemagglutinins (HA) and about 100 neuraminidases (NA), in its chemical structure. As shown in (B-4) of (B) in Figure 4, a human cell has a chemical structure of a sugar chain "sialoglycan" containing sialic acid. A human cell is composed of a glycoprotein (or glycolipid) having sialic acid, and the cell having the glycoprotein (or glycolipid) has a sugar chain "sialoglycan" containing sialic acid, and has a chemical structure of a "sialoglycan" in which sialic acid is bound to the end of the sialoglycan. That is, a human cell has a "sialoglycan" containing sialic acid at the end, and the "sialoglycan" acts as a host cell receptor that binds to the virus. That is, as shown in (A-2) of FIG. 4(A), when a virus invades the human body, the hemagglutinin (HA) of the virus binds to sialic acid at the terminal of the sialyl sugar chain, which is the receptor of human host cells, and thus, it is said that humans are infected with the virus.

[0030] When the "sialic acid derivative-containing agent" contained in the base, as shown in (B-2) of FIG. 4(B), is taken orally, it can stay or adhere to the oral mucosa. When applied to human skin or the nasal cavity, it can adhere to the skin or nasal mucosa. Or, when applied to an article such as a molded product and can adhere to the surface of the molded product, the sialic acid derivative-containing agent is configured such that when applied to the oral cavity, skin, nasal cavity, or article, as shown in (B-1), when a virus invades the human oral cavity or nasal cavity, when it adheres to human skin, or when it adheres to the surface of an article, the hemagglutinin (HA) of the virus binds to the "sialic acid" of the "sialic acid derivative-containing agent" as shown in (B-3). As a result, the virus is inactivated, and the binding of the virus to the "sialic acid" of human cells is suppressed. That is, the activity of the virus is suppressed and / or the growth of the virus is suppressed, and as a result, the infection of humans by the virus is suppressed.

[0031] The "sialic acid derivative-containing agent" prepared by chemically treating bird's nest (also known as edible bird's nest) contains about 1.4% sialic acid, and the second carbon of sialic acid and the sixth carbon of galactose are via an oxygen atom bonded in a 2,6-linkage structure, and the second carbon of sialic acid and the third carbon of galactose are via an oxygen atom bonded in a 2,3-linkage structure, and it is said to contain a sialic acid derivative-containing agent having both (described in Non-Patent Document 1 mentioned above).

[0032] As the "sialic acid derivative-containing agent", the following "sialic acid derivative-containing agent" derived from natural products or the synthesized "sialic acid derivative-containing agent" can be implemented. (a) A sialic acid derivative-containing agent obtained by enzymatically treating bird's nest. (b) A sialic acid derivative-containing agent obtained by subjecting bird's nest to high-pressure treatment. (c) A sialic acid derivative-containing agent obtained by extracting from egg yolk or egg white. (d) A "sialic acid derivative-containing agent" synthesized chemically (e) A sialic acid derivative-containing agent obtained by extracting from honey.

[0033] Bird's nest contains about 1 to 15% sialic acid compounds, and egg yolk, egg white, and honey contain 0.1 to 1% sialic acid compounds. A sialic acid derivative-containing agent prepared from these sialic acid compounds derived from natural products is feasible.

[0034] In the preparation containing the sialic acid derivative-containing agent of the present invention, the sialic acid derivative-containing agent contained is the sialic acid derivative-containing agent prepared by subjecting bird's nest to enzymatic treatment as shown in FIG. 1, and the sialic acid derivative-containing agent prepared by chemical synthesis as shown in FIGS. 2 and 3. For example, using bird's nests collected in Indonesia, they were crushed, swollen in water, and the treatment solution sterilized at 100 °C was treated with a protease-containing enzyme. Then, in order to inactivate the enzyme, it was heat-treated at about 90 °C, and thereafter, the treatment solution was filtered and the filtrate was freeze-dried. In this way, a solid and powdered sialic acid derivative-containing agent was prepared. Furthermore, the powdered sialic acid derivative-containing agent was passed through a sieve having desired mesh holes to prepare a solid and powdered sialic acid derivative-containing agent having a particle size below a predetermined size. The details of the manufacturing method of the sialic acid derivative-containing agent used in the present invention will also be specifically described in detail in the section of [Examples] described later.

[0035] Preferably, the sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, and the virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection by the virus. For example, the sialic acid derivative-containing agent can be expected to have an infection suppressing effect against the following influenza virus. ·[Narita01, A / Narita / 1 / 2009 (H1N1)]. ·[Y50, A / YoKohama / 50 / 2015 (H1N1)]. ·[F20, A / Fukui / 20 / 2004 (H3N2)]. ·[F45, A / Fukui / 45 / 2004 (H3N2)]. ·[H5N1, A / mallard / Hokkaido / 24 / 09].

[0036] In addition to the above influenza viruses, the preparation containing the sialic acid derivative substance of the present invention can also be expected to have an infection inhibitory effect against the following coronavirus. ·[Coronavirus]. ·[SARS coronavirus (Severe Acute Respiratory Syndrome)]. ·[MERS coronavirus (Middle East Respiratory Syndrome)]. ·[Novel coronavirus (2019nCoV) SARS-Cov-2]. ·[Human coronavirus OC43]. ·[Human coronavirus 229E]. ·[Human coronavirus NL63]. ·[Human coronavirus HKU1].

[0037] The preparation containing the sialic acid derivative substance of the present invention is not limited to the above viruses, and further, in addition to the above viruses, it can also be expected to be applicable to novel viruses of these viruses, mutant viruses of these viruses, etc. That is, for example, it can be expected to be applicable to the following various viruses. ·[Narita01, A / Narita / 1 / 2009 (H1N1)]. ·[Y50, A / YoKohama / 50 / 2015 (H1N1)]. ·[F20, A / Fukui / 20 / 2004 (H3N2)]. ·[F45, A / Fukui / 45 / 2004 (H3N2)]. ·[H5N1, A / mallard / Hokkaido / 24 / 09]. ·[Human, animal influenza virus A (H1 - H16 subtypes, N1 - N9 subtypes, other 144 types)]. ·[Type B (2 strains)]. ·[Human type C]. ·[Animal type D]. ·[Human parainfluenza virus types 1, 2, and 3]. ·[Human mumps virus]. ·[Animal Sendai virus]. ·[Avian Newcastle disease virus]. ·[Picornavirus]. ·[Equine respiratory virus]. ·[Human enterovirus D38]. ·[Human enterovirus D68]. ·[Human enterovirus 70]. ·[Human enterovirus D71]. ·[Human coxsackievirus A24]. ·[Various animal encephalitis viruses]. ·[Calicivirus]. ·[Human norovirus G11 - 3, G11 - 4]. ·[Various animal caliciviruses]. ·[Various animal sapoviruses]. ·[Reovirus]. ·[Various human respiratory reoviruses]. ·[Human and animal severe digestive system reoviruses]. ·[Adenovirus]. ·[Human adenovirus D, G]. ·[Turkey adenovirus A]. ·[Parvovirus (human parvovirus)]. ·[Polyomavirus]. ·[Human respiratory BK polyomavirus]. ·[Human severe nephritis JC (Cunningham) polyomavirus]. · [Human skin cancer polyomavirus]. · [Human nervous system JC virus]. · [Coronavirus]. · [SARS coronavirus (severe acute respiratory syndrome virus)]. · [MERS coronavirus (Middle East respiratory syndrome virus)]. · [Novel coronavirus]. · [Novel coronavirus (2019nCoV) SARS-Cov-2]. · [Human coronavirus OC43]. · [Human coronavirus 229E]. · [Human coronavirus NL63]. · [Human coronavirus HKU1]. · [Mutant viruses of each of the above viruses].

[0038] In the present invention, the term "influenza virus" means influenza virus, novel influenza virus, mutant viruses of these viruses, etc., and the term "coronavirus" also means coronavirus, novel coronavirus, and viruses such as mutant viruses of these viruses. The sialic acid derivative-containing agent of the present invention is expected to exhibit virus activity inhibitory effects such as suppressing the activity of the above all viruses, and / or suppressing the growth of the viruses, and / or suppressing the infection with the viruses.

[0039] The content of the sialic acid derivative-containing agent contained in the preparation containing the sialic acid derivative-containing agent is not particularly limited. For example, it is preferably 0.5 to 30% by weight, more preferably 1 to 20% by weight, and still more preferably 3 to 15% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent. As the content of the sialic acid derivative-containing agent contained in the preparation containing the sialic acid derivative-containing agent increases, the virus activity inhibitory effect tends to increase. In particular, when the content of the sialic acid derivative-containing agent exceeds 30% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, the cost becomes high, and it tends to be difficult to provide economically. In particular, when the preparation containing the sialic acid derivative-containing agent is a confectionery preparation such as a chewing gum preparation, a candy preparation, or a chocolate preparation that is taken orally by a person, when the content of the sialic acid derivative-containing agent exceeds 30% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, there is an unfavorable taste peculiar to the sialic acid derivative-containing agent, and the taste sensation when taken by chewing, licking, or biting tends to be inferior. When the content of the sialic acid derivative-containing agent is less than 0.5% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, the virus activity inhibitory effect tends not to be sufficiently exhibited.

[0040] In the preparation containing the sialic acid derivative-containing agent, the base has a form of a solid agent, an elastic solid agent, a gel-like solid agent, a cream agent, an ointment agent, a lotion agent, a liquid agent, a gel-like fluid agent, or a spray agent, and a preparation containing the sialic acid derivative-containing agent configured to be able to stay in the oral cavity, adhere to the oral mucosa, adhere to the human skin, adhere to the nasal mucosa, or adhere to an article can be preferably implemented.

[0041] The preparation in which the base constitutes a solid agent is not particularly limited. For example, the base is a confectionery base, and the confectionery preparation includes a hard candy preparation, a soft candy preparation, etc. as confectionery, and a chocolate preparation. The elastic solid agent is not particularly limited. For example, it is a chewing gum preparation as a confectionery. The gel-like solid agent is not particularly limited. For example, it is a gummy candy preparation as a confectionery. The ointment preparation in which the base constitutes an ointment agent is a preparation applied to the skin, and is a semi-solid preparation in which the sialic acid derivative-containing agent is dissolved and / or dispersed in the ointment base. The cream preparation in which the base constitutes a cream agent is a preparation applied to the skin, and is a semi-solid preparation in which the sialic acid derivative-containing agent is dissolved and / or dispersed in the ointment base. A lotion preparation in which the base constitutes a lotion agent is a preparation for application to the skin, and is a liquid preparation in which a sialic acid derivative-containing agent is dissolved and / or dispersed in a liquid. A liquid preparation in which the base constitutes a liquid agent is a preparation for application to the skin or a preparation for application to an article, and is a preparation having a liquid state. A spray preparation has a form in which the above-mentioned lotion preparation or liquid preparation is formed so as to be sprayable or applicable in a spray form. A gel-like fluid preparation in which the base constitutes a gel-like fluid agent has a gel-like fluidity and is a preparation for application to the skin or a preparation for application to an article.

[0042] In the preparation containing the sialic acid derivative-containing agent, a preparation containing the sialic acid derivative-containing agent having the following configuration can be preferably implemented. · "The base contains a confectionery base, the confectionery base contains a sweetening agent, the sialic acid derivative-containing agent is dissolved and / or uniformly mixed in the base, and when taken into a person's mouth, the base melts and / or dissolves in saliva in the mouth, and the sialic acid derivative-containing agent is released into the mouth and has the property of staying in the mouth and / or adhering to the oral mucosa." The confectionery base is not particularly limited, and for example, a gum base, a candy base (molasses base), a chocolate base, a jelly base, a yokan base, a steamed bun base, a Japanese confectionery base, a Western confectionery base, etc. can be implemented.

[0043] With this configuration, a preparation containing a sialic acid derivative having [Formulation Effect B: (a confectionery base, capable of being taken in the same feeling as eating confectionery, easy to use, long retention in the oral cavity, and long-term virus activity suppression effect of the sialic acid derivative-containing agent): achieving the aforementioned "Formulation Effect A", and having the effect of being able to stay in the oral cavity for a long time, adhere to the oral mucosa for a long time, and suppress virus activity for a long time by taking it into a person's oral cavity in a feeling similar to that of confectionery] can be obtained. Further, by containing a sweetening agent and having a sweet taste, the unique taste of the sialic acid derivative-containing agent is suppressed, and it is possible to easily take it into a person's oral cavity in a feeling similar to that of confectionery. When taken into the oral cavity, the sialic acid derivative-containing agent is released into the oral cavity together with saliva, and the released sialic acid derivative-containing agent stays in the oral cavity and adheres to cover the oral mucosa, and a preparation containing a sialic acid derivative having the effect of suppressing virus activity for a long time can be obtained. That is, when a preparation containing a sialic acid derivative is taken into the oral cavity, the sialic acid derivative-containing agent is released into the oral cavity together with saliva, and the released sialic acid derivative-containing agent stays in the oral cavity and can adhere to cover the mucosa in the oral cavity. When a virus enters the oral cavity, the virus binds to and is captured by the sialic acid derivative-containing agent retained in the oral cavity and / or adhered to the oral mucosa. As a result, the virus cannot bind to the cells of the oral mucosa, and thus, an effect of suppressing virus infection can be expected.

[0044] In the present invention and this example, "oral cavity" and "oral cavity" have the same meaning, and "oral cavity" or "oral cavity" includes "inside the mouth", "intraoral cavity", "pharynx", "larynx", and "throat", etc. Also, "storage" of the preparation containing the sialic acid derivative has the same meaning as "preservation".

[0045] In the confectionery base containing a sweetener as described above, "the sweetener is at least one sweetener selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and malt syrup, and the sialic acid derivative-containing agent is uniformly contained in the base, and a preparation containing a sialic acid derivative-containing agent" can be preferably implemented.

[0046] With this configuration, [Formulation effect B-a (Effect of obtaining a desired sweet taste from a sweetener): A preparation containing a sialic acid derivative-containing agent having the aforementioned "Formulation effect A" and "Formulation effect B" and having an effect of exhibiting a desired sweet taste due to the contained sweetener is obtained. Furthermore, an unfavorable taste sensation due to the unique taste sensation of the sialic acid derivative-containing agent is suppressed, and a preparation containing a sialic acid derivative-containing agent having a sweet taste is obtained]. When taken in the human oral cavity, an unfavorable taste sensation and / or an unpleasant taste sensation due to the unique taste sensation of the sialic acid derivative-containing agent are masked by the sweet taste exhibited by the sweetener, and as a result, the unfavorable taste sensation and / or the unpleasant taste sensation due to the unique taste sensation of the sialic acid derivative-containing agent are suppressed.

[0047] Sweeteners such as maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and malt syrup are commonly used in foods and confectionery as sweeteners that exhibit a sweet taste. Depending on their type, these sweeteners slightly differ in sweetness intensity, flavor, etc., and have the unique sweetness and flavor of each sweetener.

[0048] Maltitol, also known as reduced maltose, is generally obtained by reducing maltose and is known as a sweetener that exhibits sweetness. It is a crystalline solid mass or powder at normal temperature and has the property of being easily soluble in water. As maltitol, any maltitol can be used without being limited by the manufacturing method, particle size, or other such shapes. Also, maltitol is a type of sugar alcohol, has 80 - 90% of the sweetness of sucrose, is relatively difficult to be absorbed from the intestinal tract, and is known to be usable as a low-calorie sweetener. Further, through preliminary experiments by the inventors, it has been confirmed that maltitol has the property of being excellent in heat resistance, with little occurrence of high-temperature deterioration such as browning reaction (Maillard reaction) even at high temperatures, and no deterioration being observed even at about 190°C.

[0049] Xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol are types of sugar alcohols, have a crystalline solid form at normal temperature, and have water solubility. Sucrose, also called saccharose, is the main component of granulated sugar. Granulated sugar is a type of sucrose, has a crystalline solid form at normal temperature, and has high water solubility. Glucose, also called dextrose, has a crystalline solid form at normal temperature and has high water solubility. Fructose, also called levulose, has a solid form at normal temperature and has water solubility. Maltose, also called maltose, has a solid form at normal temperature and has water solubility. Mizuame is a viscous sweetener made by saccharifying starch with saccharifying enzymes, acids, etc. There are types such as enzyme saccharified mizuame, enzyme mizuame, acid saccharified mizuame, malt mizuame, reduced mizuame, reduced malt mizuame, etc. These mizuames contain about 5 - 30% water. For example, enzyme saccharified mizuame contains about 15% water.

[0050] <Regarding a preparation containing a sialic acid derivative substance having the form of a chewing gum preparation> In the above-mentioned "preparation containing a sialic acid derivative substance comprising a base and a sialic acid derivative substance-containing agent" of the present invention, a preparation containing a sialic acid derivative substance-containing agent having the following configuration can be implemented. · The base contains a confectionery base, and the confectionery base contains a gum base and a sweetening agent. The sweetening agent contains at least one sweetening agent selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup. The sialic acid derivative-containing agent is uniformly contained in the base, has a chewable elastic solid form, is taken into a person's mouth, and when chewed, the sialic acid derivative-containing agent is released into the mouth and is configured to be able to stay in the mouth and / or adhere to the oral mucosa, and is a sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation. In addition, the sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation has the form of an elastic solid agent at normal temperature, is taken into the mouth, and is used by chewing.

[0051] With this configuration, [Formulation effect C (chewing gum formulation containing sialic acid derivative: having the aforementioned "Formulation effect A", "Formulation effect B", and "Formulation effect B-a"), and when taken orally and chewed, the sialic acid derivative-containing agent can stay in the oral cavity for a long time, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time. By making the most of the limited content of the sialic acid derivative-containing agent, the utilization efficiency of the sialic acid derivative-containing agent can be increased. Also, chewing promotes the secretion of saliva, and an effect is obtained where the sialic acid derivative-containing agent dissolves in the saliva and is easily released into the oral cavity. Furthermore, due to the configuration having a synthetic rubber base such as polyisobutylene as the gum base, the sialic acid derivative-containing agent is in a form covered by a synthetic rubber base having hydrophobicity such as polyisobutylene. Therefore, even when stored for a long time in the normal atmosphere of room temperature, humidity, brightness, etc. in a general household, deterioration such as moisture absorption and air oxidation of the sialic acid derivative-containing agent can be prevented, and it has excellent stability in storage, and a sialic acid derivative-containing agent-containing formulation having a form of a chewing gum formulation capable of suppressing virus activity] can be obtained.

[0052] In the sialic acid derivative-containing agent-containing formulation having the form of the chewing gum formulation of the present invention, as the gum base, solid elastomers such as synthetic rubber, natural rubber, and thermoplastic synthetic resin, plasticizers, binders, viscosity modifiers, adhesives, emulsifiers, cooling agents, inorganic powder fillers, reinforcing agents, lubricants, extenders, fillers, colorants, fragrances, sweetening aids, and other additive aids are used. For example, as the solid elastomer, polyisobutylene, butadiene-styrene copolymer, isobutylene-isoprene copolymer, polybutadiene, etc. are used. As the synthetic resin, vinyl acetate resin, polyethylene, etc. are used. As the natural rubber / elastomer, chicle, jelutong, nispero, rodian, gutta-percha, pendare, perillo, sorbagaum, nisperon, niger gutta, masaranduba belta, chikibul, gum arabic, ester gum, crown gum, locust bean gum, xanthan gum, guar gum, etc. are used. As plasticizers, natural wax, microcrystalline wax, polyethylene wax, paraffin wax, microcrystalline wax, etc. are used. As emulsifiers, lecithin, fatty acid monoglyceride, diglyceride, glyceryl stearate, propylene glycol stearate, etc. are used. In addition, glycerin fatty acid ester, stearic acid, calcium stearate, magnesium stearate, glyceryl triacetate, alcohol ester of rosin, cellulose ester of rosin, glycerol ester of rosin, etc. are used. As inorganic powder fillers, powders that do not have an adverse effect on the human body, such as talc powder, silica powder, aluminum hydroxide powder, aluminum silicate powder, calcium silicate powder, diatomaceous earth powder, magnesium oxide powder, calcium carbonate powder, magnesium carbonate, dicalcium phosphate powder, alumina powder, etc. are used. As a cooling agent, menthol (for example, L-menthol) is preferably used.

[0053] Among the above, inorganic powder fillers, reinforcing agents, lubricants, extenders, and fillers may be used for the same purpose. By selecting and combining several types of these components of the gum base, the in-mouth release property, hardness, flexibility, adhesiveness, viscoelasticity of the sialic acid derivative-containing agent when chewed in the mouth, and the change over time of these properties when chewed for a long time, etc., a preparation containing a sialic acid derivative-containing agent having various chewing sensations in the form of a chewing gum preparation can be obtained.

[0054] As sweeteners, at least one sweetener selected from the group consisting of the aforementioned maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup can be used. As a mixing form of the gum base and the sweetener, a chewing gum preparation having a form of (a) a form in which a fine powder sweetener is uniformly dispersed and mixed in the gum base, or (b) a form in which a part of the sweetener is dissolved in the gum base and the other part of the sweetener is uniformly mixed in the gum base is preferably implementable for a preparation containing a sialic acid derivative substance.

[0055] The additive adjuvant is not particularly limited. For example, the following components are implementable. Sweetening aids such as aspartame and acesulfame potassium, synthetic pigments, natural material pigments, coloring agent pigments such as copper chlorophyll and chlorophyll, and flavors such as menthol and mint can be used.

[0056] The above-mentioned base contains a confectionery base. The confectionery base preferably implements a preparation containing a sialic acid derivative substance having the following configuration in a preparation containing a sialic acid derivative substance having a form of a chewing gum preparation containing a gum base and a sweetener. · "The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol, and the second sweetener is at least one second sweetener selected from the group consisting of sucrose, glucose, fructose, maltose, starch syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol, and has a form of a chewing gum preparation, a preparation containing a sialic acid derivative substance".

[0057] As described above, maltitol is a kind of sweetener and is commonly used as a sweetening agent. In addition to this maltitol as a sweetening agent, by further containing other sweeteners (second sweeteners) other than maltitol, when taking the chewing gum preparation, a unique sweet taste sensation caused by each contained sweetener can be obtained. In particular, maltitol has 80 - 90% of the sweetness of sucrose, can be used as a low-calorie sweetening agent, has good mixing and dispersibility with the gum base, and a chewing gum preparation as a preparation containing a sialic acid derivative substance with an excellent chewing feeling with a sweet taste can be obtained.

[0058] With this configuration, [Formulation Effect C-a (Chewing Gum Formulation, Maltitol and Second Sweetener, Desired Sweetness, Healthy Low Calorie)]: having the aforementioned "Formulation Effects A", "Formulation Effect B", "Formulation Effect B-a", "Formulation Effect C", and having an excellent chewing feel due to good mixing and dispersibility with a good gum base, a desired sweetness by selectively containing a desired second sweetener, a healthy low calorie due to low calorie maltitol, etc., a formulation containing a sialic acid derivative-containing agent having the form of a chewing gum formulation is obtained.

[0059] In the above configuration, a formulation containing a sialic acid derivative-containing agent having a configuration in which the content of the maltitol is 5% by weight or more based on the total amount and / or the content of the maltitol is more than the content of the second sweetener can be preferably implemented. With this configuration, a formulation containing a sialic acid derivative-containing agent in which the above "Formulation Effect C-a (Chewing Gum Formulation, Maltitol and Second Sweetener)" can be further significantly exhibited is obtained.

[0060] The above base contains a confectionery base, and the confectionery base has a form of a chewing gum formulation containing a gum base and a sweetener. In a formulation containing a sialic acid derivative-containing agent having the form of a chewing gum formulation, "the sweetener contains at least a first sweetener and a second sweetener, the first sweetener is maltitol, the second sweetener is starch syrup, and a formulation containing a sialic acid derivative-containing agent having the form of a chewing gum formulation" is particularly preferably implementable.

[0061] With this configuration, [Formulation effect C-b (chewing gum formulation, maltitol and starch syrup, smooth and excellent chewing texture): having the aforementioned formulation effect C-a, and the starch syrup contains about 5 to 30% water. On the other hand, the sialic acid derivative-containing agent is water-soluble and poorly soluble in synthetic rubbers such as polyisobutylene. Therefore, in a chewing gum formulation containing a sialic acid derivative-containing agent and starch syrup, at least a part of the sialic acid derivative-containing agent in the form of powder is likely to dissolve in the starch syrup. As a result, when chewing the chewing gum formulation, the gritty feeling caused by the powder form of the sialic acid derivative-containing agent is suppressed, and a smooth and excellent chewing texture is obtained, and at the same time, the efficiency of the release of the sialic acid derivative-containing agent into the oral cavity together with saliva is improved. Also, both the sialic acid derivative-containing agent and maltitol are water-soluble, and in the moisture contained in the starch syrup, at least a part of the maltitol and at least a part of the sialic acid derivative-containing agent in the form of powder are likely to dissolve. As a result, when chewing the chewing gum formulation, the gritty feeling caused by the powder forms of both the sialic acid derivative-containing agent and maltitol is suppressed, and a smooth chewing texture is obtained, and at the same time, the efficiency of the release of the sialic acid derivative-containing agent into the oral cavity together with saliva is improved.

[0062] In a formulation containing a sialic acid derivative-containing agent having the form of a chewing gum formulation containing the above-mentioned maltitol and a second sweetening agent, in particular, a formulation containing a sialic acid derivative-containing agent having a configuration in which the content of the maltitol is 5% by weight or more based on the total amount is particularly preferably practicable. With this configuration, [Formulation effect C-c: (chewing gum formulation, maltitol 5% or more and second sweetening agent, desired sweetness, healthy low calorie, excellent chewing texture) the aforementioned formulation effect C-a "chewing gum formulation, maltitol and second sweetening agent", or a formulation containing a sialic acid derivative-containing agent having the form of a chewing gum formulation in which the formulation effect C-b "chewing gum formulation, maltitol and starch syrup" is further significantly improved] is obtained.

[0063] In a sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation containing the above-mentioned polyol and a second sweetening agent, in particular, a sialic acid derivative-containing agent-containing preparation having a configuration in which the content of the polyol is larger than the content of the second sweetening agent is particularly preferably feasible. With this configuration, [Formulation effect C-d: (chewing gum preparation, polyol is more than the second sweetening agent, desired sweetness, healthy low calorie): the above-mentioned formulation effect C-a "chewing gum preparation, polyol and second sweetening agent", or formulation effect C-b "chewing gum preparation, polyol and starch syrup" is further significantly improved chewing gum preparation] can be obtained. In particular, a sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation in which the above-mentioned formulation effect C-a (chewing gum preparation, polyol and second sweetening agent) is further significantly improved] can be obtained. In the case of a sialic acid derivative-containing agent-containing preparation having a configuration in which the content of the polyol is smaller than the content of the second sweetening agent, the above-mentioned "formulation effect A", "formulation effect B", "formulation effect B-a", and "formulation effect C" can be obtained. However, there is a tendency that the above-mentioned formulation effect C-a (chewing gum preparation, polyol and second sweetening agent) cannot be sufficiently obtained.

[0064] The above-mentioned base contains a confectionery base. In a sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation in which the confectionery base contains a gum base and a sweetening agent, a sialic acid derivative-containing agent-containing preparation having the following configuration is preferably feasible. · "The confectionery base further contains a polyhydric alcohol, and the polyhydric alcohol contains at least one polyhydric alcohol selected from the group consisting of glycerin, butylene glycol, propylene glycol, and dipropylene glycol. The sialic acid derivative-containing agent is uniformly contained in a base containing the confectionery base and the polyhydric alcohol, and has the form of a chewing gum preparation. A sialic acid derivative-containing agent-containing preparation."

[0065] The sialic acid derivative-containing agent has the property of being slightly soluble in a swollen state and / or soluble in a heated state in polyhydric alcohols such as glycerin, butylene glycol, propylene glycol, and dipropylene glycol. For example, in separate experiments, the inventors found that at room temperature of about 25°C, 1 g of the sialic acid derivative-containing agent in powder form was uniformly dispersed and contained in 5 mL of glycerin in a swollen state, and when heated to 60°C, the sialic acid derivative-containing agent in powder form was dissolved to have a transparent liquid state. When it was returned to room temperature of 25°C, it was confirmed that the sialic acid derivative-containing agent had a semi-liquid state with a dissolved transparent viscosity. In experiments using butylene glycol or propylene glycol as the polyhydric alcohol, it was also confirmed that the sialic acid derivative-containing agent had solubility similar to that of glycerin. That is, in a sialic acid derivative-containing agent-containing preparation that contains a gum base as a confectionery base and a sialic acid derivative-containing agent in powder form, and further contains a polyhydric alcohol, at least part of the sialic acid derivative-containing agent in the sialic acid derivative-containing agent in powder form swells and / or dissolves in the polyhydric alcohol, resulting in an effect of suppressing the unpleasant chewing feeling as if chewing powder caused by the sialic acid derivative-containing agent in powder form.

[0066] In addition, polyhydric alcohols such as glycerin, butylene glycol, propylene glycol, and dipropylene glycol have roles such as plasticizers, softeners, and emulsifiers in a gum base composed of synthetic rubber, etc., and greatly contribute to the chewability such as elasticity, hardness, and flexibility of the produced chewing gum preparation. Therefore, by appropriately selecting the types and contents of these polyhydric alcohols, a chewing gum preparation having desired chewability such as elasticity, hardness, and flexibility can be obtained.

[0067] As described above, [Formulation Effect C-e (chewing gum formulation · polyhydric alcohol · excellent chewing feel such as desired elasticity, hardness, softness, etc.): a chewing gum formulation having the above-described "Formulation Effect A", "Formulation Effect B", "Formulation Effect B-a", and "Formulation Effect C", containing a gum base as a confectionery base, a sweetening agent, and a sialic acid derivative-containing agent, and further containing a polyhydric alcohol, and suppressing an unpleasant chewing feel as if chewing powder caused by the sialic acid derivative-containing agent in a powder state, and further having an effect of exhibiting an excellent chewing feel such as desired elasticity, hardness, softness, etc.] can be obtained.

[0068] The content of the polyhydric alcohol is preferably 0.3 to 13% by weight, more preferably 0.5 to 10% by weight, and still more preferably 0.6 to 6% by weight based on the total amount of the sialic acid derivative-containing agent-containing formulation. When the content of the polyhydric alcohol is less than 0.3% by weight, the above-described Formulation Effect C-e tends not to be sufficiently exhibited. When the content of the polyhydric alcohol exceeds 13% by weight, the produced chewing gum formulation becomes too soft, and a comfortable chewing feel tends not to be obtained.

[0069] In the above-described sialic acid derivative-containing agent-containing formulation having the form of a chewing gum formulation containing the base of the present invention and the sialic acid derivative-containing agent, a sialic acid derivative-containing agent-containing formulation having the following configuration can be preferably implemented. · "The base contains a confectionery base, the confectionery base contains a gum base, a sweetener, and further a polyhydric alcohol. The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol, and the second sweetener is at least one selected from the group consisting of sucrose, glucose, fructose, maltose, starch syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol. The polyhydric alcohol contains at least one selected from the group consisting of glycerin, butylene glycol, propylene glycol, and dipropylene glycol. The sialic acid derivative-containing agent is uniformly contained in the base, has a chewable elastic solid form, and when taken into a person's mouth and chewed, the sialic acid derivative-containing agent is released into the mouth, and the sialic acid derivative-containing agent is configured to be able to stay in the mouth and / or adhere to the oral mucosa, and is a preparation containing a sialic acid derivative-containing agent in the form of a chewing gum preparation."

[0070] With this configuration, [Formulation effect C-f (chewing gum preparation, maltitol, second sweetener, polyhydric alcohol, excellent virus activity inhibition, excellent chewing feeling, healthy low calorie): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect C", and at the same time having all the effects of the aforementioned [Formulation effect C-a (chewing gum preparation, maltitol and second sweetener), and the aforementioned [Formulation effect C-e (chewing gum preparation, polyhydric alcohol)], a preparation containing a sialic acid derivative-containing agent in the form of a chewing gum preparation] can be obtained.

[0071] In the preparation containing a sialic acid derivative-containing agent in the form of a chewing gum preparation, in which the above-mentioned base contains a confectionery base, and the confectionery base has a form of a chewing gum preparation containing a gum base and a sweetener, a preparation containing a sialic acid derivative-containing agent having the following configuration can be preferably implemented. · "(i) The sweetener is uniformly contained in the gum base in a powder form, Among the sweeteners contained in the form of powder, the sweetener having a particle size of 300 μm or less contains 90% or more, and the preparation contains a sialic acid derivative-containing agent having the form of a chewing gum preparation.

[0072] , With this configuration, [Formulation effect C-g (chewing gum preparation, sweetener particle size, excellent chewing feel): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect C", and an excellent chewing feel resulting from the improved uniform mixing and dispersibility of the good gum base and sweetener, and a chewing gum preparation form in which the unpleasant chewing feel such as a gritty feeling when chewing due to the powder shape of the sweetener is suppressed] containing a sialic acid derivative-containing agent is obtained. In particular, when the sweetener is maltitol, a preparation containing a sialic acid derivative-containing agent that exhibits healthy low calories due to low-calorie maltitol, etc. is obtained.

[0073] Preferably, the sweetener contains 90% or more of the sweetener having a particle size of 250 μm or less among the sweeteners contained in the form of powder. More preferably, the sweetener contains 90% or more of the sweetener having a particle size of 150 μm or less among the sweeteners contained in the form of powder. More preferably, a preparation containing a sialic acid derivative-containing agent having a configuration in which 90% or more of the sweetener has a particle size of 100 μm or less can be implemented. When the particle size of the sweetener exceeds 300 μm, the effect of suppressing the unpleasant chewing feel such as a gritty feeling when chewing due to the powder shape of the sweetener tends to decrease.

[0074] The above-mentioned base contains a confectionery base, and the confectionery base preferably has the following configuration in a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation containing a gum base and a sweetener. · "(ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powder form, and among the sialic acid derivative-containing agents contained in a powder form, 90% or more of the sialic acid derivative-containing agents having a particle size of 300 μm or less are contained, and it is in the form of a chewing gum preparation, a preparation containing a sialic acid derivative-containing agent."

[0075] With this configuration, [Formulation effect C-h (chewing gum preparation · sialic acid derivative-containing agent particle size · excellent chewing feel): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect C", and an excellent chewing feel resulting from the improved uniform mixing and dispersibility of the good gum base and the sialic acid derivative-containing agent, and the unpleasant chewing feel such as a gritty feeling during chewing due to the powder form of the sialic acid derivative-containing agent is suppressed, and furthermore, a good chewing feeling with the unique taste of the sialic acid derivative-containing agent during chewing being suppressed, etc., a preparation containing a sialic acid derivative-containing agent in the form of a chewing gum preparation] can be obtained.

[0076] Preferably, the sialic acid derivative-containing agent contains 90% or more of the sialic acid derivative-containing agents having a particle size of 250 μm or less among the sialic acid derivative-containing agents contained in a powder form. More preferably, the sialic acid derivative-containing agent contains 90% or more of the sialic acid derivative-containing agents having a particle size of 150 μm or less among the sialic acid derivative-containing agents contained in a powder form. More preferably, a preparation containing a sialic acid derivative-containing agent having a configuration in which 90% or more of the sialic acid derivative-containing agents have a particle size of 100 μm or less is feasible. When the particle size of the sialic acid derivative-containing agent exceeds 300 μm, the effect of suppressing the unpleasant chewing feel such as a gritty feeling during chewing due to the powder form of the sialic acid derivative-containing agent tends to decrease.

[0077] Preferably, the content of the sialic acid derivative-containing agent contained in the preparation containing the sialic acid derivative-containing agent having the form of a chewing gum preparation is not particularly limited. For example, it is preferably 0.5 to 30% by weight, more preferably 1 to 20% by weight, and still more preferably 2 to 15% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent.

[0078] With this configuration, [Formulation effect C-k (chewing gum preparation · content of sialic acid derivative-containing agent · excellent virus activity inhibitory effect): A chewing gum preparation that can be expected to have an effect of suppressing virus activity for a long time when chewed] can be obtained. As the content of the sialic acid derivative-containing agent contained in the preparation containing the sialic acid derivative-containing agent increases, the virus activity inhibitory effect tends to increase. In particular, when the content of the sialic acid derivative-containing agent exceeds 30% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, it tends to be costly and not easily provided economically. Also, particularly in the case of a preparation containing a sialic acid derivative-containing agent, such as a chewing gum preparation, which is taken orally by a person and used as a confectionery preparation, when the content of the sialic acid derivative-containing agent exceeds 30% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, there is an unfavorable taste peculiar to the sialic acid derivative-containing agent, and the taste sensation when chewed and taken tends to be inferior. When the content of the sialic acid derivative-containing agent is less than 0.5% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, the virus activity inhibitory effect tends not to be sufficiently exhibited.

[0079] <Summary of the preparation containing the sialic acid derivative-containing agent having the form of a chewing gum preparation> As described above, it has been found that a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation containing a sialic acid derivative-containing agent, a gum base, and a sweetening agent has an excellent virus activity inhibitory effect. In addition, when taken into a person's mouth and chewed, a chewing gum preparation is obtained in which a sialic acid derivative-containing agent is released in the mouth and the sialic acid derivative-containing agent can remain in the mouth for a long time and / or adhere to the oral mucosa for a long time. Also, by selecting the type of sweetener, an unpleasant taste peculiar to the sialic acid derivative-containing agent is suppressed, and a chewing gum preparation having a desired pleasant taste is obtained. Further, by selectively containing desired components such as a sweetener and a polyhydric alcohol, a chewing gum preparation having each of the above-described desired effects can be obtained.

[0080] The sialic acid derivative-containing agent has the property of dissolving in water and also dissolving and / or swelling in polyhydric alcohols such as glycerin, while having the property of not dissolving in the gum base. Further, in a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation, various basic performances as a chewing gum confectionery are required. Generally, since chewing gum is taken by repeating chewing, the chewing feeling is emphasized, and in particular, a chewing feeling that suppresses the feeling of crunchiness when chewed is required. On the other hand, when at least a part of the sialic acid derivative-containing agent is present in a state of being dispersed in the form of solid powder without dissolving in the gum base, there is an unpleasant chewing feeling such as a feeling of crunchiness when chewed, and the particle size of the sialic acid derivative-containing agent contained in the gum base has an important influence on the chewing feeling. In particular, from this viewpoint, it has been found that a preparation containing a sialic acid derivative-containing agent having a particle size of 300 μm or less and having the form of a chewing gum preparation has a basic feeling of taking as a chewing gum confectionery when taken, and also has an excellent chewing feeling without a feeling of crunchiness.

[0081] Furthermore, by containing a polyhydric alcohol such as glycerin together with the sialic acid derivative-containing agent in the gum base, the used powdered sialic acid derivative-containing agent is contained in the gum base in a state of being dissolved and / or swollen in the polyhydric alcohol, and thereby, it has been found that the feeling of crunchiness caused by the sialic acid derivative-containing agent when chewed is suppressed.

[0082] In the above-mentioned "preparation containing a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent comprises a sialic acid derivative-containing agent", a preparation containing a sialic acid derivative-containing agent having the following constitution can be implemented. · "The base contains a confectionery base, the confectionery base contains a candy base and a sweetening agent, the sweetening agent contains at least one sweetening agent selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup, the sialic acid derivative-containing agent is uniformly contained in the base, is used by licking and / or chewing when taken in a human mouth, the sialic acid derivative-containing agent is released in the mouth, and is configured to be able to stay in the mouth or adhere to the oral mucosa, and has a form of a candy preparation, and is a virus activity inhibitor."

[0083] With this configuration, [Formulation effect D (a preparation containing a candy preparation and a sialic acid derivative: having the aforementioned "Formulation effect A", "Formulation effect B", and "Formulation effect B-a", and enabling the sialic acid derivative-containing agent to stay in the oral cavity for a long time and adhere to the oral mucosa for an even longer time. It is possible to maximize the utilization efficiency of the limited content of the sialic acid derivative-containing agent. Also, by taking and licking or chewing, the secretion of saliva is promoted, and an effect is obtained where the sialic acid derivative-containing agent is dissolved in saliva and is easily released into the oral cavity. Furthermore, due to having a sweetener as the candy base, the sialic acid derivative-containing agent is in a form covered by the sweetener, so even if it is stored and left in the normal atmosphere of a general household room, such as room temperature, humidity, and brightness, deterioration due to moisture absorption, air oxidation, etc. of the sialic acid derivative-containing agent can be prevented, and it has excellent stability in storage and preservation, and a preparation containing a sialic acid derivative-containing agent that can be expected to suppress virus activity] can be obtained.

[0084] The above-mentioned base contains a confectionery base. In a preparation containing a sialic acid derivative-containing agent having a form of a candy preparation containing a candy base and a sweetener, a preparation containing a sialic acid derivative-containing agent having the following configuration is preferably implementable. · "The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol, and the second sweetener is at least one second sweetener selected from the group consisting of sucrose, glucose, fructose, maltose, starch syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol, and is a preparation containing a sialic acid derivative-containing agent having a form of a candy preparation."

[0085] As described above, maltitol is a type of sweetener and is commonly used as a sweetening agent. In addition to this maltitol as a sweetening agent, by further containing other sweetening agents (secondary sweetening agents) other than maltitol, when taking the candy preparation, a unique sweet taste sensation caused by each contained sweetening agent can be obtained. In particular, maltitol has a sweetness of 80 to 90% of sucrose, can be used as a low-calorie sweetening agent, has good mixing and dispersibility with the candy base, and a candy preparation as a sialic acid derivative-containing agent-containing preparation that exhibits an excellent licking feeling with a sweet taste can be obtained.

[0086] With this configuration, [Formulation effect D-a (candy preparation · maltitol and secondary sweetening agent · desired sweetness · healthy low calorie): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect D", and an excellent licking feeling due to good mixability with a candy base, the desired sweetness by selectively containing the desired secondary sweetening agent, a healthy low calorie due to low-calorie maltitol, etc., a candy preparation as a sialic acid derivative-containing agent-containing preparation can be obtained.

[0087] A candy preparation in which the content of the aforementioned maltitol is 5% by weight or more based on the total amount of the sialic acid derivative-containing agent-containing preparation can be preferably implemented. In a sialic acid derivative-containing agent-containing preparation containing a sweetening agent other than maltitol and maltitol, when the content of maltitol is less than 5% by weight based on the total amount of the sialic acid derivative-containing agent-containing preparation, deterioration such as crystallization precipitation of maltitol over time tends to occur.

[0088] The above base contains a confectionery base, In the form of a candy base and a sialic acid derivative-containing agent-containing preparation containing a sweetening agent, the confectionery base is preferably a "sialic acid derivative-containing agent-containing preparation having a form of a candy preparation further containing at least one additive adjuvant selected from the group consisting of an excipient, a gelling agent, an oil and fat, an emulsifier, a pH adjuster, a flavoring agent, a cooling agent, and a sweetening aid."

[0089] With this configuration, a candy preparation as a sialic acid derivative-containing agent-containing preparation having the [formulation effect D-b (candy preparation · desired additive adjuvant): the effect of obtaining a candy preparation having the aforementioned "formulation effect A", "formulation effect B", "formulation effect B-a", "formulation effect D", and further having the desired physical properties exhibited by the contained additive adjuvant] can be obtained.

[0090] Examples of the excipient include gelatin, starch, pregelatinized starch, sodium carboxyalkylcellulose, hydroxyalkylcellulose, polyvinylpyrrolidone, gum arabic powder, dextrin, stearic acid, metal stearates, sodium alkyl sulfate and other anionic surfactants, polyoxyethylene fatty acid esters, polyoxyethylene castor oil derivatives and other nonionic surfactants, corn starch, talc powder, silica powder, magnesium carbonate powder, titanium oxide powder, calcium silicate powder, anhydrous silicic acid (aerosil), chlorophyll pigment, tar pigment, caramel, bengala, riboflavin, food yellow No. 5, food red No. 2, food blue No. 2, etc., and are preferably feasible.

[0091] The gelling agent is not particularly limited, and examples thereof include gelatin, agar, pectin, gellan gum, carrageenan, locust bean gum, xanthan gum, guar gum, tara gum, tragacanth gum, gum arabic, karaya gum, curdlan, sodium alginate, etc., and are preferably feasible.

[0092] The fats and oils are not particularly limited. For example, vegetable fats and oils, palm oil, soybean oil, rapeseed oil, sunflower oil, cottonseed oil, coconut oil, corn oil, sesame oil, shea butter, animal fats and oils, salad oil, rice bran oil, rice bran oil, camellia oil, canola oil, safflower oil, safflower oil, perilla oil, linseed oil, olive oil, peanut oil, almond oil, avocado oil, hazelnut oil, walnut oil, grape seed oil, cocoa butter, peanut butter, lard (pork fat), tallow (beef fat), milk fat, butter, margarine, shortening, fresh cream, etc. can be used.

[0093] The emulsifiers are not particularly limited. For example, sucrose fatty acid esters (e.g., sucrose stearate, sucrose laurate, sucrose myristate, sucrose palmitate), organic acid monoglycerides, glycerin fatty acid esters, polyglycerin fatty acid esters, sorbitan fatty acid esters, propylene glycol fatty acid esters, lecithin, etc. can be used.

[0094] The pH adjusters are not particularly limited. For example, citric acid, lactic acid, tartaric acid, malic acid, phosphoric acid, sodium hydrogen carbonate, sodium hydroxide, and / or salts of the above acids, etc. can be preferably implemented.

[0095] As for spices and coloring agents, extracts of lemon, lime, orange, tangerine, blueberry, grape, strawberry, banana, and other fruits, peppermint, tea powder, tea extract, citrus essential oils such as lime oil, tangerine oil, mandarin oil, allspice, anise seed, basil, mint, laurel, cardamom, celery, clove, cinnamon, cumin, dill, garlic, parsley, mace, mustard, onion, paprika, rosemary, pepper and other known spice essential oils or oleoresins, limonene, linalool, nerol, citronellol, geraniol, citral, eugenol, cinnamic aldehyde, anethole, perilla aldehyde, vanillin, γ-undecalactone, allyl caproate, L-carboxylic acid, maltol and other known isolated or synthetic spices, and citrus mixes mixed at a ratio in line with the purpose of these citrus essential oils, spice essential oils, synthetic spices, and formulated spices expressing various fruits and the like can be used.

[0096] As for cooling agents, powders and oils such as menthol and peppermint are preferably feasible.

[0097] As for sweetening aids, stevia, aspartame, thaumatin, α-glucosyltransferase-treated stevia, acesulfame potassium, alitame, licorice extract (glycyrrhizin), triammonium glycyrrhizinate, tripotassium glycyrrhizinate, trisodium glycyrrhizinate, diammonium glycyrrhizinate, dipotassium glycyrrhizinate, disodium glycyrrhizinate, curcumin, saccharin, sodium saccharin, cyclamate, sucralose, dulcin, thaumatin (thaumatin), tenryocha extract, nigerianberry extract, neotame, neohesperidin dihydrochalcone, fructosyltransferase-treated stevia, brazilian licorice extract, miracle fruit extract, lacanca extract, enzyme-treated licorice, enzyme-decomposed licorice, etc. are preferably feasible.

[0098] The content of these additives is not particularly limited, but for example, a candy formulation with a content of 30% by weight or less of the total amount is preferable. If the content of additives exceeds 30% by weight of the total amount, the desired form of the candy formulation may not be obtained, or there is a concern that some side effects may occur when taken.

[0099] <About the preparation containing a sialic acid inducer in the form of a hard candy> The preparation containing an agent containing a sialic acid inducer in the form of a candy preparation of the present invention preferably has the following components: "Furthermore, the preparation contains water, the base is in the form of a solid formulation, the water content is 7% by weight or less based on the total amount, and the preparation is in the form of a hard candy formulation."

[0100] That is, "the base contains a confectionery base, the confectionery base contains a candy base and a sweetener, the sweetener contains at least one sweetener selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup, the sialic acid inducer-containing agent is uniformly contained in the base, and further contains water, the water content being 7% by weight or less relative to the total amount, and when taken in a person's mouth, it is used by licking and / or chewing, and the sialic acid inducer-containing agent is released in the mouth, and the sialic acid inducer-containing agent is configured to be retained in the mouth or to adhere to the oral mucosa, and a sialic acid inducer-containing agent-containing preparation in the form of a hard candy preparation is possible." The candy formulation having a solid form in the form of a hard candy is not particularly limited, but examples thereof include hard candy formulations, block candy formulations, donut-shaped candy formulations with a hole in the center, and drop formulations.

[0101] Also, in the candy preparation in the form of the above-mentioned hard candy, a candy preparation in which the water content is 7% by weight or less based on the total amount of the sialic acid derivative-containing preparation can be preferably implemented. More preferably, a candy preparation in which the water content is 5% by weight or less based on the total amount can be implemented. Even more preferably, a candy preparation in which the water content is 3% by weight or less based on the total amount can be implemented. As the water content increases, the resulting candy preparation tends to be in a soft and flexible state. When the water content exceeds 7% by weight based on the total amount, a soft-shaped candy preparation can be obtained, and a hard-shaped candy preparation cannot be obtained, and there is also a tendency for a sticky phenomenon to occur on the surface.

[0102] Hard candy is manufactured by heating under relatively high temperature conditions until the water content becomes about 7% or less, preferably 5% by weight or less, and even more preferably 3% by weight or less, and has a relatively hard solid state at normal temperature.

[0103] With this configuration, [Formulation effect D-c (hard candy formulation · prolonged oral retention of sialic acid derivative-containing agent · desired hard candy hardness · desired sweet licking feeling): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect D", and while licking the hard candy in the mouth, the sialic acid derivative-containing agent is released into the mouth and adheres to the oral mucosa, thereby expecting an effect of suppressing virus activity for a long time. Also, it has a licking feeling with a hard hardness having a desired candy form and a desired sweetness due to the type of sweetener contained] A candy preparation as a sialic acid derivative-containing preparation is obtained.

[0104] In the hard candy preparation, the content of the sialic acid derivative-containing agent is preferably 0.5 to 15% by weight based on the total amount of the hard candy preparation. Particularly preferably, it is 1 to 10% by weight, and even more preferably 2 to 7% by weight. When the content of the sialic acid derivative-containing agent is less than 0.5% by weight, it is predicted that the virus activity inhibitory effect is not sufficient. When the content of the sialic acid derivative-containing agent exceeds 15% by weight, in the mixing step of the sialic acid derivative-containing agent and the sweetener, sufficient mixing of these components becomes impossible, and there is a tendency that a solid candy-like candy preparation cannot be obtained.

[0105] The above-mentioned base contains a confectionery base, and the confectionery base preferably has the following configuration in a preparation containing a sialic acid derivative-containing agent having a form of a hard candy preparation containing a candy base and a sweetener. · "Furthermore, it contains water, the base has a solid form, the water content is 7% by weight or less based on the total amount, the sweetener contains at least maltitol as a first sweetener and starch syrup as a second sweetener, and has a form of a hard candy preparation. A preparation containing a sialic acid derivative-containing agent".

[0106] With this configuration, [Formulation effect D-d (hard candy preparation, maltitol and starch syrup, excellent licking and taking feeling): It has the above-mentioned formulation effect D-a, and the starch syrup contains about 5 to 30% water. On the other hand, the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent is water-soluble. Therefore, in a candy preparation containing a sialic acid derivative-containing agent and starch syrup, the sialic acid derivative-containing agent in powder form is likely to dissolve in the moisture of the starch syrup. Also, even when moisture is evaporated and removed during the manufacturing process, the manufactured candy preparation contains about 7% or less (preferably about 1 to 3%) of moisture, and it is presumed that the sialic acid derivative-containing agent is contained in a dissolved and / or swollen state in water. As a result, when taking the candy preparation, the gritty feeling due to the powder form of the sialic acid derivative-containing agent is suppressed, and a smooth licking and taking feeling is obtained, and the effect of improving the efficiency of releasing the sialic acid derivative-containing agent into the mouth together with saliva is obtained. In addition, both the sialic acid derivative-containing agent and maltitol are water-soluble, and it is highly likely that at least a part of the maltitol and at least a part of the sialic acid derivative-containing agent in the form of powder dissolve in the moisture contained in the starch syrup. As a result, when the candy preparation is taken, the gritty feeling caused by the powder forms of both the sialic acid derivative-containing agent and maltitol is suppressed, a smooth feeling when taken is obtained, and the effect of improving the efficiency of the release of the sialic acid derivative-containing agent into the mouth together with saliva is obtained.

[0107] The above-mentioned base contains a confectionery base, and the confectionery base preferably has the following configuration in a sialic acid derivative-containing agent-containing preparation having the form of a hard candy preparation containing a candy base and a sweetening agent. · "Furthermore, it contains water, the base has the form of a solid preparation, the water content is 7% by weight or less based on the total amount, the sweetening agent contains at least maltitol, the confectionery base further contains a polyhydric alcohol, the base has a solid form, the hard candy preparation is suppressed from surface deterioration over time, and a sialic acid derivative-containing preparation having the form of a hard candy preparation".

[0108] With this configuration, a hard candy preparation as a sialic acid derivative-containing agent-containing preparation having [Formulation effect D-e (Appearance deterioration suppression effect of hard candy preparation by maltitol and polyhydric alcohol): having the above-mentioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect D", and suppressing the appearance deterioration of the surface of the candy preparation during storage] is obtained. Particularly, in a hard candy preparation having a solid form containing a sialic acid derivative-containing agent and a sweetener, the sialic acid derivative-containing agent contains at least a sialic acid derivative-containing agent, and the sweetener contains at least maltitol. During storage of the hard candy preparation, depending on the storage environment such as temperature, humidity, and air during storage, appearance changes such as clouding, whitening, or generation of fine bubbles may occur on the surface of the candy preparation. The causes of the clouding and whitening phenomena occurring on the surface of such candy preparations are not clear, but it is thought to be due to partial crystallization of maltitol or some surface appearance change caused by contact with moisture or air in the air. Regarding the appearance change on the surface of this candy preparation, a hard candy preparation containing maltitol as a sweetener and also containing a polyhydric alcohol has been found to have the effect of suppressing the appearance change on the surface of the hard candy preparation during storage of the hard candy preparation.

[0109] The polyhydric alcohol is not particularly limited, but particularly preferably, at least one polyhydric alcohol selected from the group consisting of propylene glycol, dipropylene glycol, butylene glycol, and glycerin can be used. As butylene glycol, 1,3-butylene glycol can be preferably used. At room temperature, maltitol, the sialic acid derivative-containing agent, and the polyhydric alcohol have a homogeneous solid state mixed with each other. The content of the polyhydric alcohol is not particularly limited, but a candy preparation having a content of 1 to 20% by weight based on the total amount is preferably feasible. More preferably, a candy preparation having a content of the polyhydric alcohol of 2 to 15% by weight based on the total amount, and still more preferably 2 to 13% by weight, is feasible. When the content of the polyhydric alcohol is less than 1% by weight based on the total amount, the effect of suppressing appearance changes such as crystal precipitation on the surface of the candy preparation during storage of the candy preparation tends not to be sufficiently obtained. When the content of the polyhydric alcohol exceeds 20% by weight based on the total amount, a formulation that causes stickiness on the surface of the candy formulation (also referred to as "sticky" or "sticking"), a formulation that causes adhesion, or a significantly soft and flexible formulation, etc. may be obtained, and there is a tendency that a candy formulation having a solid shape without surface stickiness and adhesion cannot be obtained.

[0110] The above-mentioned base contains a confectionery base, and the confectionery base has a form of a candy base and a formulation containing a sialic acid derivative-containing agent in a hard candy formulation containing a sweetening agent. A formulation containing a sialic acid derivative-containing agent having the following configuration is preferably feasible. · "The sweetening agent contains at least maltitol, the confectionery base further contains a polyhydric alcohol, contains at least glycerin as the polyhydric alcohol, and a formulation containing a sialic acid derivative-containing agent in which the deterioration of maltitol over time is suppressed" is preferably feasible.

[0111] With this configuration, a candy formulation as a formulation containing a sialic acid derivative-containing agent in which the above-mentioned [formulation effect D-e (effect of suppressing appearance deterioration by hard candy formulation, maltitol and polyhydric alcohol)] is further significantly, optimally and favorably exhibited can be obtained. The content of maltitol is 5% by weight or more based on the total amount of the formulation containing the sialic acid derivative-containing agent, and the content of glycerin is 1% by weight or more based on the total amount of the formulation containing the sialic acid derivative-containing agent, and a formulation containing a sialic acid derivative-containing agent having the form of a candy formulation is preferably feasible. When the content of glycerin is less than 1% by weight, there is a tendency that the appearance deterioration suppressing effect in the above-mentioned formulation effect D-c cannot be sufficiently exhibited.

[0112] The above-mentioned base contains a confectionery base, and the confectionery base has a form of a candy base and a formulation containing a sialic acid derivative-containing agent in a hard candy formulation containing a sweetening agent. A formulation containing a sialic acid derivative-containing agent having the following configuration is preferably feasible. "Furthermore, a preparation containing a sialic acid inducer-containing agent, which further contains water, the base is in the form of a solid preparation, the water content is 7% by weight or less based on the total amount, the sweetener contains at least maltitol as a first sweetener and palatinose reduced as a second sweetener, and has the form of a hard candy preparation" is preferably feasible.

[0113] This composition achieves the following: [Formulation effect Df: (maltitol and reduced palatinose - excellent licking and swallowing sensation) Hard candy formulations containing maltitol have the property of feeling slightly sticky when taken in the mouth and licked. Hard candy formulations containing both maltitol and reduced palatinose as sweeteners have the property of not feeling sticky when taken in the mouth and licked, having a moderate hardness and feeling comfortable when taken in the mouth. Hard candy formulations containing maltitol and reduced palatinose as sweeteners maintain a moderate hardness and have increased stickiness when taken in the mouth, and are less likely to break down into small fragments, maintaining a block shape for a long time. As a result, long-lasting viral activity inhibitory effects can be expected, as well as effects such as an excellent licking and swallowing sensation.]

[0114] The above-mentioned base contains a confectionery base, and the confectionery base is in the form of a hard candy preparation containing a candy base and a sweetener, and a sialic acid inducer-containing agent-containing preparation having the following configuration can be preferably implemented. "Furthermore, water is contained, the base is in the form of a solid preparation, the water content is 7% by weight or less of the total amount, the sweetener contains at least maltitol as a first sweetener and reduced palatinose as a second sweetener, the confectionery base further contains a polyhydric alcohol, deterioration of the maltitol over time is suppressed, and the preparation containing a sialic acid inducer-containing agent is in the form of a hard candy preparation" is preferably feasible.

[0115] With this configuration, [formulation effect D-g: (mannitol, reduced palatinose, and polyhydric alcohol; excellent licking and taking feeling, surface deterioration suppression effect) A hard candy formulation containing mannitol and reduced palatinose tends to have surface deterioration such as cloudiness on the surface when stored in a room temperature atmosphere due to mannitol. In contrast, a hard candy formulation containing polyhydric alcohol in addition to mannitol and reduced palatinose suppresses the sticky feeling that adheres to teeth when taken orally and licked, has a comfortable taking feeling with appropriate hardness, and also does not show surface deterioration such as cloudiness over time even when stored at room temperature, and has the effect of having stable quality over a long period].

[0116] <Regarding a formulation containing a sialic acid derivative-containing agent having the form of a soft candy> In the formulation containing a sialic acid derivative-containing agent having the form of the candy formulation of the present invention, preferably, it has the following configuration. · "Furthermore, it contains water and oil and fat, the base has the form of a solid agent, the water content is 4 to 15% by weight based on the total amount, and / or the oil and fat content is 2 to 15% by weight based on the total amount. When taken into a person's mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released into the mouth and is configured to be able to stay in the mouth or adhere to the oral mucosa, and a formulation containing a sialic acid derivative-containing agent having the form of a soft candy formulation" is feasible. As a candy formulation in the form of a soft candy, candy formulations in the form of soft candies such as caramel, fudge, nougat, taffy, fondant, marshmallow, etc., which have a relatively softer taking feeling than the aforementioned hard candy, are feasible.

[0117] For example, as a sweetening agent, a candy formulation in the form of the following soft candy containing mannitol as a first sweetening agent and also containing a second sweetening agent is feasible. That is, "a solid preparation having the form of a soft candy containing a sialic acid derivative-containing agent and a sweetener, wherein the sweetener contains at least a first sweetener and a second sweetener, the first sweetener is maltitol, and the second sweetener is at least one sweetener selected from the group consisting of sucrose, glucose, fructose, maltose, malt syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol. When taken in a human mouth, it is used by licking and / or chewing in the mouth. The sweetener dissolves in saliva in the mouth to have a sweet taste, and the medicinal ingredient is gradually released into the mouth together with saliva in the mouth, stays in the mouth, and has the property of passing through the throat. The deterioration of the sialic acid derivative-containing agent during storage is suppressed. This is a characteristic candy preparation" is feasible. In particular, a configuration in which the content of maltitol is 5% by weight or more based on the total amount is preferable.

[0118] Also, in the soft candy preparation of the present invention, a candy preparation having the form of a soft candy having a configuration containing maltitol as the first sweetener and not containing a second sweetener is also preferably feasible. That is, "a solid form having the form of a soft candy containing a sialic acid derivative-containing agent and a sweetener, the sweetener contains at least a first sweetener, the first sweetener is maltitol, and the sweetener does not contain at least one sweetener selected from the group consisting of sucrose, glucose, fructose, maltose, malt syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol. When taken in a human mouth, it is used by licking and / or chewing in the mouth. The sweetener dissolves in saliva in the mouth to have a sweet taste, and the sialic acid derivative-containing agent is gradually released into the mouth together with saliva in the mouth, stays in the mouth, and has the property of passing through the throat. A preparation containing a sialic acid derivative-containing agent having a form during storage" is feasible. In particular, a configuration in which the content of maltitol is 5% by weight or more based on the total amount is preferable.

[0119] A configuration in which the water content is 4 to 15% by weight, preferably 5 to 10% by weight, and more preferably 5 to 7% by weight based on the total amount of the sialic acid derivative-containing agent-containing preparation is preferably feasible. Soft candy is manufactured by heating under relatively medium-temperature conditions (lower temperature than hard candy) and boiling down until the desired water content is reached, and has a relatively soft solid state at room temperature compared to hard candy. As the water content in the soft candy increases, the flexibility of the produced soft candy increases, and there is a tendency that a soft texture in the mouthfeel cannot be obtained. When the water content in the soft candy exceeds 15% by weight, there is a tendency to obtain a candy preparation that is too soft and does not have the desired softness or flexibility, or is too soft to maintain a solid shape. As the water content in the soft candy decreases, the hardness of the produced soft candy tends to increase. When it is less than 4% by weight, there is a tendency to obtain a candy preparation that has a hard hardness and does not have the desired softness and flexibility, and does not have a soft texture.

[0120] For example, a configuration in which the oil and fat content is 2 to 15% by weight based on the total amount of the sialic acid derivative-containing agent-containing preparation is preferably feasible. As the oil and fat content increases, the hardness of the produced soft candy tends to become softer and softer. When the oil and fat content exceeds 15% by weight based on the total amount, there is a tendency that the soft candy obtained is too soft and does not have the desired softness. Also, when the oil and fat content is less than 2% by weight based on the total amount, there is a tendency that a relatively hard candy is produced and a soft candy with the desired softness cannot be obtained. The fats and oils used in soft candies are not particularly limited. For example, the above-mentioned fats and oils such as vegetable fats and oils, palm oil, soybean oil, rapeseed oil, sunflower oil, cottonseed oil, coconut oil, corn oil, sesame oil, shea butter, animal fats and oils, salad oil, rice bran oil, bran oil, camellia oil, canola oil, safflower oil, safflower oil, perilla oil, linseed oil, olive oil, peanut oil, almond oil, avocado oil, hazelnut oil, walnut oil, grape seed oil, cocoa butter, peanut butter, lard (pork fat), tallow (beef fat), milk fat, butter, margarine, shortening, fresh cream, etc. can be used. In addition to the above fats and oils, soft candies can also appropriately contain emulsifiers, gum arabic, gelatin, proteins, cellulose, sweeteners, flavors, etc. Also, the soft candies may or may not be coated with a coating such as a sugar coating.

[0121] With this configuration, [Formulation effect D-j (long-term oral release effect of the soft candy sialic acid derivative-containing agent and long-term virus activity suppression can be expected): It has the above-mentioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect D", and during the time of taking it orally, the sialic acid derivative-containing agent is released into the oral cavity together with saliva, and long-term virus activity suppression can be expected. Also, a candy preparation as a soft and flexible hardness sialic acid derivative-containing agent-containing preparation having a desired soft candy form] can be obtained.

[0122] <Regarding the preparation containing a sialic acid derivative-containing agent in the form of gummy candy> In the preparation containing a sialic acid derivative-containing agent having the form of the candy preparation of the present invention, preferably, it has the following configuration. "Furthermore, a sialic acid inducer-containing agent-containing preparation in the form of a gummy candy preparation is possible, which further contains water and a gelling agent, the base has the form of an elastic solid preparation, the water content is 10 to 35 wt % of the total amount, and / or the gelling agent content is 5 to 25 wt % of the total amount, and when taken into a person's mouth, is used by licking and / or by chewing, and the sialic acid inducer-containing agent is released into the mouth, and the sialic acid inducer-containing agent is configured to be retained in the mouth or to be able to adhere to the oral mucosa."

[0123] The gelling agent is not particularly limited, but examples thereof include gelatin, pectin, gum arabic, agar, pectin, gellan gum, carrageenan, locust bean gum, xanthan gum, guar gum, tara gum, tragacanth gum, karaya gum, curdlan, and sodium alginate. Among these, gelatin, pectin, and gum arabic are preferred, and gelatin is more preferred, from the viewpoint of texture. Gelatin may be made from, for example, the skin, bone, tendon, etc. of cows, pigs, chickens, fish, etc., and is not particularly limited, and gelatin obtained by treating with an acid or alkali may be used. The gelling agents can be used alone or in combination of two or more kinds.

[0124] The content of the gelling agent is not particularly limited, but from the viewpoint of obtaining a springy feel when taken, it is preferably 5 to 25% by weight, more preferably 10 to 20% by weight or more, based on the total amount of the sialic acid derivative-containing agent. In particular, when gelatin is used as the gelling agent, the content of gelatin in the gummy candy is preferably 5 to 25% by weight, more preferably 10 to 20% by weight, based on the same viewpoint. As the content of the gelling agent increases, the hardness of the resulting gummy candy tends to become softer while still retaining its springiness. In particular, if the content of the gelling agent is less than 5% by weight based on the total amount, a gummy candy with the desired springiness tends not to be obtained. On the other hand, if the content of the gelling agent is more than 25% by weight based on the total amount, the hardness of the resulting gummy candy tends to be too soft, making it difficult to obtain a gummy candy with the desired springiness.

[0125] The water content contained in the gummy candy is not particularly limited, but it can be 10 to 35% by weight, preferably 15 to 25% by weight, based on the total amount of the sialic acid derivative-containing agent. When the water content contained in the gummy candy is less than 10% by weight, the desired elasticity cannot be obtained and it has a hard property, and there is a tendency to obtain a candy preparation having the desired elasticity and soft texture. When the water content contained in the gummy candy exceeds 35% by weight, the desired elasticity cannot be obtained and it has a soft property, and there is also a tendency to obtain a candy preparation that cannot maintain a solid shape. As the gummy candy, a configuration containing no oil or fat, or a configuration containing oil or fat is feasible, but a gummy candy containing no oil or fat is more preferably feasible.

[0126] With this configuration, [Formulation effect D-k (long-term oral release effect of the gummy candy formulation · sialic acid derivative-containing agent, long-term virus activity suppression can be expected): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect D", and while taking it orally, the sialic acid derivative-containing agent is released into the mouth together with saliva, and long-term virus activity suppression can be expected. Also, a candy preparation having a soft hardness with elasticity having a desired gummy candy form] can be obtained.

[0127] In the sialic acid derivative-containing agent-containing formulation having a form of a candy preparation having the above-mentioned hard candy form, soft candy form, or gummy candy form, as described above, "the sweetener contains at least a second sweetener as the first sweetener, the first sweetener is maltitol, and the second sweetener is at least one second sweetener selected from the group consisting of sucrose, glucose, fructose, maltose, starch syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol" in the sialic acid derivative-containing agent-containing formulation is preferably feasible.

[0128] With this configuration, the aforementioned [Formulation Effect D-a (Candy Formulation·Maltitol and Second Sweetener·Desired Sweetness·Healthy Low Calorie): having the aforementioned "Formulation Effect A", "Formulation Effect B", "Formulation Effect B-a", "Formulation Effect D", and having an excellent licking feeling due to good mixability with a good candy base, the desired sweetness by selectively containing the desired second sweetener, the healthy low calorie due to low calorie maltitol, etc.], a hard candy formulation, a soft candy formulation, or a gummy candy formulation, etc., in the form of a candy formulation containing a sialic acid derivative-containing agent can be obtained.

[0129] <Summary of the Formulation Containing the Sialic Acid Derivative-Containing Agent Having the Form of a Candy Formulation> As described above, it can be expected that the formulation containing the sialic acid derivative-containing agent having the form of a candy formulation containing the sialic acid derivative-containing agent, a candy base, and a sweetener has an excellent virus activity inhibitory effect. Also, when taken into a person's mouth and chewed, a candy formulation can be obtained in which the sialic acid derivative-containing agent is released into the mouth and the sialic acid derivative-containing agent can stay in the mouth for a long time and / or adhere to the oral mucosa for a long time. Also, by selecting the type of sweetener, the peculiar unpleasant taste of the sialic acid derivative-containing agent is suppressed, and a candy formulation having a desired pleasant taste can be obtained. Also, by selectively selecting the contained components such as a sweetener and a polyhydric alcohol as desired, a candy formulation having each of the above effects can be obtained.

[0130] In particular, in the sialic acid derivative-containing agent having the form of a hard candy formulation, in a hard candy formulation containing maltitol as a sweetener, by containing a polyhydric alcohol in combination, an effect of suppressing deterioration such as turbidity over time during long-term storage of the hard candy formulation can be obtained. In addition, since the sialic acid derivative-containing agent having the form of a soft candy preparation and a gummy candy preparation contains a large amount of water compared to a hard candy preparation, the sialic acid derivative-containing agent dissolves in water and also has the property of dissolving and / or swelling in polyhydric alcohols such as glycerin. Therefore, by containing a polyhydric alcohol such as glycerin together with the sialic acid derivative-containing agent, the used powdery sialic acid derivative-containing agent is contained in the confectionery base in a state of being dissolved and / or swollen in the polyhydric alcohol, whereby aggregation of the sialic acid derivative-containing agent is suppressed and a sialic acid derivative-containing agent-containing preparation in which the sialic acid derivative-containing agent is uniformly contained in the confectionery base is obtained.

[0131] <Regarding the sialic acid derivative-containing agent-containing preparation having the form of a chocolate preparation> In the above-mentioned "preparation containing a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is a sialic acid derivative-containing agent-containing preparation containing a sialic acid derivative-containing agent" of the present invention, a sialic acid derivative-containing agent-containing preparation having the following configuration can be implemented. · "The base contains a confectionery base, the confectionery base contains a chocolate base and a sweetening agent, the sweetening agent contains at least one sweetening agent selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup, the sialic acid derivative-containing agent is uniformly contained in the base, and when taken into a person's mouth and used by licking and / or when chewed and used, the sialic acid derivative-containing agent is released into the mouth and is configured to be able to stay in the mouth or adhere to the oral mucosa, and has the form of a chocolate preparation, a sialic acid derivative-containing agent-containing preparation."

[0132] With this configuration, [Formulation effect E (chocolate formulation containing sialic acid derivative: having the aforementioned "Formulation effect A", "Formulation effect B", and "Formulation effect B-a", and the sialic acid derivative-containing agent can stay in the mouth for a long time, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time. By maximizing the use of the limited content of the sialic acid derivative-containing agent, the utilization efficiency of the sialic acid derivative-containing agent can be enhanced. Also, by taking and licking or chewing, the secretion of saliva is promoted, and the sialic acid derivative-containing agent is dissolved in saliva and easily released into the mouth. Furthermore, due to containing a sweetener as the chocolate base, the sialic acid derivative-containing agent is in a form covered by the sweetener, so even if it is stored and left in the normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time, deterioration due to moisture absorption, air oxidation, etc. of the sialic acid derivative-containing agent can be prevented, and it has excellent stability in storage, and a formulation containing a sialic acid derivative-containing agent having a form of a chocolate formulation capable of suppressing virus activity) can be obtained.

[0133] In the formulation containing a sialic acid derivative-containing agent having the form of the chocolate formulation of the present invention, preferably, it has the following configuration. · "The chocolate base contains (i) a cacao-derived raw material and (ii) at least one chocolate additive auxiliary selected from the group consisting of an emulsifier, milk fat, and vegetable oil. The sialic acid derivative-containing agent is uniformly contained in the chocolate base and the sweetener. When taken into a person's mouth and used by licking and / or chewing, the sialic acid derivative-containing agent is released into the mouth together with the cacao-derived raw material, and the cacao-derived raw material and the sialic acid derivative-containing agent are configured to be able to stay in the mouth or adhere to the oral mucosa, and it has the form of a chocolate formulation, a formulation containing a sialic acid derivative-containing agent".

[0134] With this configuration, [Formulation effect E-a: (Bitterness suppression effect caused by cacao-derived raw materials): The effect of the aforementioned "Formulation effect E (chocolate formulation)" is optimally obtained, and (i) by containing both a cacao-derived raw material and a sweetener, a sialic acid derivative-containing agent-containing formulation having a form of a chocolate formulation in which the bitterness caused by the cacao-derived raw material is significantly suppressed] can be obtained.

[0135] Also, [Formulation effect E-b: (Suitable chocolate eating feeling) The effect of the aforementioned "Formulation effect E (chocolate formulation)" is optimally obtained, and (ii) by containing at least one chocolate additive aid selected from the group consisting of an emulsifier, milk fat, and vegetable oil, when taken in a human's mouth, it has a suitable eating feeling as a chocolate confectionery, and the chocolate formulation strongly adheres to the oral mucosa, and a sialic acid derivative-containing agent-containing formulation in which the sialic acid derivative-containing agent easily stays in the mouth for a long time] can be obtained.

[0136] As the cacao-derived raw material, cocoa butter, cocoa cake, cocoa powder, cocoa mass, cocoa nibs, cocoa powder, cocoa butter substitute, etc. can be used. Cocoa nibs are obtained by removing the shell part from cocoa beans. Cocoa mass is obtained by crushing cocoa nibs by a mechanical method. Cocoa cake and cocoa powder are obtained by subjecting cocoa mass or cocoa nibs to a defatting treatment. Cocoa powder is obtained by processing cocoa cake into a powder form. Cocoa butter is the oil contained in cocoa nibs, etc., and usually, the majority of cocoa nibs and cocoa mass are composed of cocoa butter (oil). The content of the cacao-derived raw material is not particularly limited, but for example, it is in the range of 10 to 45% by weight, preferably 15 to 40% by weight, more preferably 15 to 30% by weight, based on the total amount of the formulation. When the content of the cacao-derived raw material is less than 10%, a chocolate formulation with inferior chocolate flavor tends to be obtained.

[0137] The chocolate base contains at least one chocolate additive aid selected from the group consisting of an emulsifier, milk fat, and liquid vegetable oil. Although not particularly limited, examples of vegetable oils include soybean oil, rapeseed oil, rice bran oil, coconut oil, palm kernel oil, palm oil, safflower oil, corn oil, cottonseed oil, sesame oil, peanut oil, olive oil, sunflower oil, macadamia nut oil, almond oil, etc. Usually, it is preferable to blend a plurality of vegetable oils. The content of the vegetable oil is preferably 30% by weight or less based on the total amount of the preparation. The total content of the cacao-derived raw material and the vegetable oil is 15 to 60% by weight, preferably 25 to 55% by weight, and more preferably 35 to 50% by weight.

[0138] Although not particularly limited, examples of milk fat include whole milk powder, skim milk powder, fresh cream, etc. The content of milk fat is not particularly limited, but for example, it is 0 to 40% by weight, preferably 0 to 30% by weight. As the content of milk fat increases, a milk chocolate preparation having a milk flavor can be obtained and can be preferably implemented.

[0139] The emulsifier is mainly contained for the purpose of enhancing the homogeneity and fluidity of the base, and is not particularly limited. For example, lecithin, glycerin fatty acid ester, polyglycerin condensed linoleic acid ester, sucrose fatty acid ester (e.g., sucrose stearate, sucrose laurate, sucrose myristate, sucrose palmitate), etc. can be preferably implemented. The content of the emulsifier is, for example, 0.01 to 10% by weight, particularly preferably 0.1 to 3% by weight based on the total amount of the preparation.

[0140] In the preparation containing a sialic acid derivative-containing agent having the form of the chocolate preparation of the present invention, preferably, it has the following configuration. · "The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol, and the second sweetener is at least one selected from the group consisting of sucrose, glucose, fructose, maltose, starch syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol. It is a preparation containing a sialic acid derivative-containing agent in the form of a chocolate preparation."

[0141] With this configuration, [Formulation effect E-c (chocolate preparation · maltitol and second sweetener · desired sweetness · healthy low calorie): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect E", and an excellent chewing sensation, licking sensation due to good miscibility with a good chocolate base, desired sweetness by selectively containing the desired second sweetener, healthy low calorie due to low-calorie maltitol, etc. A chocolate preparation as a preparation containing a sialic acid derivative-containing agent] can be obtained.

[0142] The form of the chocolate preparation is not particularly limited. For example, solid preparations in the form of plates or lumps, or fluid viscous agents with fluidity and viscosity, gel-like fluid viscous agents, etc. can be implemented.

[0143] In the preparation containing a sialic acid derivative-containing agent having the form of a chocolate preparation of the present invention, preferably, it has the following configuration. · "(i) The maltitol is uniformly contained in the chocolate base in a powdered form, and among the maltitol contained in a powdered form, maltitol having a particle size of 300 μm or less contains 90% or more. It is a preparation containing a sialic acid derivative-containing agent in the form of a chocolate preparation."

[0144] With this configuration, [Pharmaceutical effect E-d (chocolate preparation, maltitol particle size, excellent taste, healthy low calorie): having the aforementioned "Pharmaceutical effect A", "Pharmaceutical effect B", "Pharmaceutical effect B-a", "Pharmaceutical effect E", and excellent taste due to improved uniform mixing and dispersibility of a good chocolate base and maltitol, and suppression of unpleasant taste such as a gritty feeling when taking due to the powder shape of maltitol, and further, a healthy low calorie due to low-calorie maltitol, etc., a preparation containing a sialic acid derivative having the form of a chocolate preparation] can be obtained.

[0145] Preferably, among the maltitol contained in the form of a powder shape, maltitol having a particle size of 250 μm or less contains 90% or more. More preferably, among the maltitol contained in the form of a powder shape, maltitol having a particle size of 150 μm or less contains 90% or more. A preparation containing a sialic acid derivative having such a configuration can be implemented. When the particle size of maltitol exceeds 300 μm, the effect of suppressing unpleasant taste such as a gritty feeling when taking due to the powder shape of maltitol tends to decrease.

[0146] The above-mentioned base contains a confectionery base. In a preparation containing a sialic acid derivative having the form of a chocolate preparation containing a confectionery base and a sweetener, a preparation containing a sialic acid derivative having the following configuration can be preferably implemented. · "(ii) The sialic acid derivative-containing agent is uniformly contained in the chocolate base in the form of a powder shape, and among the sialic acid derivative-containing agents contained in the form of a powder shape, 90% or more of the sialic acid derivative-containing agents having a particle size of 300 μm or less are contained, and a preparation containing a sialic acid derivative having the form of a chocolate preparation."

[0147] With this configuration, [Formulation effect E-e (chocolate formulation·sialic acid derivative-containing agent particle size·good taste when taken): having the aforementioned "Formulation effect A", "Formulation effect B", "Formulation effect B-a", "Formulation effect E", and excellent chewing sensation resulting from improved uniform mixing and dispersibility of a good chocolate base and a sialic acid derivative-containing agent, and suppression of unpleasant taste sensations such as a gritty feeling when taken due to the powder form of the sialic acid derivative-containing agent, and further suppression of the peculiar and uncomfortable taste sensation of the sialic acid derivative-containing agent during ingestion, etc., a sialic acid derivative-containing agent-containing formulation having a form of a chocolate formulation with a good taste sensation, etc.] can be obtained.

[0148] Preferably, the sialic acid derivative-containing agent-containing formulation can be implemented with a configuration in which the sialic acid derivative-containing agent contains 90% or more of the sialic acid derivative-containing agent having a particle size of 250 μm or less among the sialic acid derivative-containing agents contained in powder form, and more preferably, the sialic acid derivative-containing agent contains 90% or more of the sialic acid derivative-containing agent having a particle size of 150 μm or less among the sialic acid derivative-containing agents contained in powder form. When the particle size of the sialic acid derivative-containing agent exceeds 300 μm, the effect of suppressing unpleasant taste sensations such as a gritty feeling when taken due to the powder form of the sialic acid derivative-containing agent tends to decrease.

[0149] <Regarding the configuration where the sialic acid derivative-containing agent-containing formulation is a troche formulation> In the above "sialic acid derivative-containing agent-containing formulation comprising a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent contains a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent is contained in the base" of the present invention, a sialic acid derivative-containing agent-containing formulation having the following configuration can be implemented. · "The base contains a lozenge base, and the sialic acid derivative-containing agent and the base are uniformly contained. When taken in a human's mouth and used by licking, the sialic acid derivative-containing agent is gradually released in the mouth, and the sialic acid derivative-containing agent can stay in the mouth for a long time or adhere to the oral mucosa, and is configured in the form of a lozenge preparation, a sialic acid derivative-containing agent-containing preparation."

[0150] With this configuration, [Formulation effect K (long-term retention of a lozenge preparation and a sialic acid derivative-containing agent in the mouth, long-term virus activity inhibitory effect): It has the aforementioned "Formulation effect A", and the sialic acid derivative-containing agent can stay in the mouth for a long time during licking, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time. By making the most of the limited content of the sialic acid derivative-containing agent, the utilization efficiency of the sialic acid derivative-containing agent can be increased, and an excellent virus activity inhibitory effect can be achieved. Also, by taking and licking or chewing, the secretion of saliva is promoted, and the effect that the sialic acid derivative-containing agent is easily dissolved in saliva and released into the mouth can be obtained. Furthermore, since the sialic acid derivative-containing agent is in a form covered by the base, even if it is stored and left in a normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time, deterioration due to moisture absorption, air oxidation, etc. of the sialic acid derivative-containing agent can be prevented, and a sialic acid derivative-containing agent-containing preparation with excellent stability in storage can be obtained.]

[0151] A lozenge preparation has a solid form made into a desired shape in which a sialic acid derivative-containing agent and a base are uniformly contained. When taken in the mouth, it is gradually dissolved or disintegrated in the mouth, and the sialic acid derivative-containing agent contained in the lozenge preparation is applied to the oral cavity, pharynx, etc. For example, a lozenge preparation is formed by mixing and dispersing a base having a powder shape and a sialic acid derivative-containing agent having a powder shape with each other and solidifying them into a solid state, and has a solid form at room temperature.

[0152] The base or troche base is not particularly limited. For example, sugar alcohols, sweetening aids, starches, starch derivatives, bentonite, lactose, sucrose, maltose, sucrose fatty acid esters, sorbitan fatty acid esters, polyoxyethylene fatty acid esters, phospholipids, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ethers, sodium chloride, aluminum silicate, calcium silicate, silicic anhydride, silicon dioxide, fatty acid salts, organic acids, dicarboxylic acids, calcium sulfate, calcium hydrogen phosphate, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, polyvinyl alcohol, carmellose, carmellose calcium, calcium stearate, magnesium stearate, talc, glucose, galactose, fructose, and other lubricants, excipients, flavoring agents, binders, stabilizers, surfactants, additives, coloring agents, fragrances, and other desired components can be used to form a base or troche base. As sugar alcohols, for example, maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, etc. can be preferably implemented. In addition to the above sugar alcohols, as sweetening agents, sucrose, glucose, fructose, maltose, reduced maltose syrup, powdered reduced maltose syrup, trehalose, etc. can be preferably implemented. The sucrose fatty acid esters are not particularly limited. For example, sucrose myristate, sucrose palmitate, sucrose stearate, sucrose behenate, sucrose oleate, etc. can be preferably implemented. As fatty acid salts, for example, magnesium salts or calcium salts of fatty acids such as lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, pentadecylic acid, etc. can be preferably implemented. As sweetening aids, aspartame, acesulfame potassium, stevia, etc. can be preferably implemented. As organic acids, citric acid, tartaric acid, malic acid, lactic acid, gluconic acid, etc. can be preferably implemented. In the lozenge preparation, flavors such as lemon, lemon-lime, orange, pineapple, mint, menthol, etc., coloring agents, preservatives, etc. may be appropriately blended.

[0153] The preparation containing a sialic acid derivative substance and having the form of the lozenge preparation of the present invention is produced by a conventional method for producing a lozenge preparation. For example, the direct powder compression method, the granule compression method, etc. can be carried out. The lozenge preparation by the direct powder compression method is produced by forming a predetermined solid shape by a compression molding method such as a tableting method for various mixed bases or lozenge bases having a powder shape and a sialic acid derivative substance-containing agent. The lozenge preparation by the granule compression method is produced by granulating and / or drying a desired base or lozenge base and a sialic acid derivative substance-containing agent using a conventional dry granulation method or wet granulation method, and then compression molding the granulated product into a predetermined solid shape. Examples of the machine used for mixing include a V-type mixer, etc. Examples of the machine used for kneading include a pony mixer, a vertical granulator, a universal mixer, etc. Examples of the granulator include a cylindrical granulator, a spherical sizing machine, a pelletable granulator, a basket-type granulator, a crushing granulator such as a speed mill or a power mill, etc. The particle diameter of the granulated product is not particularly limited, but for example, 30 to 1000 μm is preferable. Drying can be carried out by conventional hot air circulation drying, vacuum drying, etc. Examples of the tableting machine include conventional tableting machines such as a single-shot tableting machine, an indirect tableting machine, a rotary tableting machine, etc. The compression molding pressure during tableting by the compression molding method is not particularly limited, but for example, about 10 to about 30 MPa is preferable.

[0154] In the trial production experiment of the preparation containing a sialic acid derivative substance and having the form of a lozenge preparation, a mold having a desired shape made of steel and a conventional experimental press machine are used to compress and mold a predetermined mixed powder or granulated product, whereby a preparation containing a sialic acid derivative substance and having the form of a desired lozenge preparation can be prepared.

[0155] As the shape of the solid-form troche preparation, for example, solid forms such as circular tablet shape, elliptical tablet shape, rectangular tablet shape, square tablet shape, donut-shaped through-hole tablet shape with a hole drilled in the central part, and various other irregular shapes can be preferably implemented. Also, from the viewpoint of ease of administration, a size and shape of about 5 to 15 mm are preferable.

[0156] In the preparation containing a sialic acid derivative-containing agent having the form of the troche preparation of the present invention, preferably, it has the following configuration. · [In addition to the troche base, the base further contains a sweetening agent, and the sweetening agent contains at least one sweetening agent selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and malt syrup, and the sialic acid derivative-containing agent is uniformly contained in the base to form a preparation containing a sialic acid derivative-containing agent].

[0157] With this configuration, [Formulation effect K-b (troche preparation · sweetening agent · excellent sweet taste and feeling of taking medicine): It has the aforementioned "formulation effect A" and "formulation effect K", and while licking the troche preparation in the mouth, the sialic acid derivative-containing agent is released into the mouth and adheres to the oral mucosa, whereby an effect of suppressing viral activity for a long time can be expected. At the same time, the unique taste caused by the sialic acid derivative-containing agent is alleviated, and the desired sweetness caused by the type of sweetening agent contained is obtained, and a troche preparation having an excellent feeling of taking medicine is obtained. Furthermore, while licking the troche preparation in the mouth, due to the sweetening agent, the amount of saliva secreted into the mouth increases, whereby the release of the sialic acid derivative-containing agent contained in the troche preparation into the mouth is promoted by the saliva, and as a result, the viral activity inhibitory effect is more remarkably exhibited] effect is obtained.

[0158] In the preparation containing a sialic acid derivative-containing agent having the form of the troche preparation of the present invention, preferably, it has the following configuration. [The base further contains a sweetener in addition to the troche base, and the sweetener contains at least maltitol and reduced palatinose, the sialic acid inducer-containing agent and the base are uniformly contained, and when taken in a person's mouth and used by licking, the sialic acid inducer-containing agent is released into the mouth, and the sialic acid inducer-containing agent is configured to be retained in the mouth or to be adhered to the oral mucosa, and the sialic acid inducer-containing agent-containing preparation has the form of a troche preparation].

[0159] This composition provides the above-mentioned "Formulation Effect A" and "Formulation Effect K", and while the troche formulation is being licked in the mouth, the sialic acid inducer-containing agent is released into the mouth and adheres to the oral mucosa, which is expected to have a long-lasting effect of suppressing viral activity, while also mitigating the unique taste caused by the sialic acid inducer-containing agent and providing the desired sweetness caused by the type of sweetener contained. Furthermore, a troche formulation having an excellent feeling of being ingested can be obtained, which maintains its solid form while being licked, by suppressing the "solid tablet breaking phenomenon" in which the solid form is broken and broken into small, fragmented chunks when licked. Furthermore, while the lozenge is being sucked in the mouth, the sweetener increases the amount of saliva secreted into the mouth, which in turn promotes the release of the sialic acid inducer-containing agent contained in the lozenge into the mouth, resulting in an even more pronounced effect of suppressing viral activity. Troche preparations containing maltitol as a sweetener have a tendency to be less sticky when taken in the mouth and licked, and the solid form of the troche preparation is broken down and gradually decomposed into small chunks. Troche preparations containing maltitol as a sweetener and reduced palatinose as well as reduced palatinose have an increased sticky property in the solid form, and the tendency to be broken down and broken into small chunks when taken in the mouth and licked is suppressed, and the solid form is maintained for a long time, and as a result, the effect of suppressing virus activity for a long time can be expected to be more significantly exhibited.

[0160] In the preparation containing a sialic acid derivative-containing agent having the form of a troche preparation of the present invention, preferably, it has the following configuration. · [(i) The sweetening agent is uniformly contained in the base in a powdery form, Among the sweetening agents contained in a powdery form, the sweetening agent having a particle size of 300 μm or less contains 90% or more, and / or (ii) the sialic acid derivative-containing agent is uniformly contained in the base in a powdery form, and among the sialic acid derivative-containing agents contained in a powdery form, the sialic acid derivative-containing agent having a particle size of 300 μm or less contains 90% or more, a sialic acid derivative-containing agent-containing preparation].

[0161] In the preparation containing a sialic acid derivative-containing agent having the form of a troche preparation of the present invention, preferably, it has the following configuration. · [(ii) The sialic acid derivative-containing agent is uniformly contained in the base in a powdery form, and among the sialic acid derivative-containing agents contained in a powdery form, the sialic acid derivative-containing agent having a particle size of 300 μm or less contains 90% or more, a sialic acid derivative-containing agent-containing preparation].

[0162] With this configuration, [preparation effect K-d (troche preparation · particle size of sialic acid derivative-containing agent · excellent chewing feeling): having the aforementioned "preparation effect A" and "preparation effect K", and due to the powder shape of the sialic acid derivative-containing agent, the smooth licking feeling, unpleasant taking feelings such as a gritty feeling when licking or chewing in the mouth are suppressed, and furthermore, a good taking feeling in which the unique taste feeling of the sialic acid derivative-containing agent during taking is suppressed, etc., a sialic acid derivative-containing agent-containing preparation having the form of a troche preparation] can be obtained. When the particle size of the sialic acid derivative-containing agent exceeds 300 μm, the effect of suppressing the smooth licking feeling, unpleasant chewing feelings such as a gritty feeling when chewing due to the particle size of the powder shape of the sialic acid derivative-containing agent tends to decrease.

[0163] Preferably, the content of the sialic acid derivative-containing agent contained in the preparation containing the sialic acid derivative-containing agent having the form of a troche preparation is not particularly limited. For example, it is preferably 0.5 to 30% by weight, more preferably 1 to 20% by weight, and still more preferably 2 to 15% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent.

[0164] With this configuration, [Formulation effect K-e (troche preparation · content of sialic acid derivative-containing agent · excellent virus activity inhibitory effect): A troche preparation that can be expected to have an effect of suppressing virus activity for a long time when taken] can be obtained. As the content of the sialic acid derivative-containing agent contained in the preparation containing the sialic acid derivative-containing agent increases, the virus activity inhibitory effect tends to increase. In particular, when the content of the sialic acid derivative-containing agent exceeds 30% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, it tends to be costly and not easily provided economically. In particular, in the preparation containing the sialic acid derivative-containing agent in the form of a troche preparation, when the content of the sialic acid derivative-containing agent exceeds 30% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, there is an unfavorable taste sensation peculiar to the sialic acid derivative-containing agent, and it tends to be inferior in taste sensation when licked or chewed. When the content of the sialic acid derivative-containing agent is less than 0.5% by weight based on the total amount of the preparation containing the sialic acid derivative-containing agent, the virus activity inhibitory effect tends not to be sufficiently exhibited.

[0165] Further, in the preparation containing the sialic acid derivative-containing agent having the form of the troche preparation of the present invention, preferably, it has the following configuration. · [(i) The sweetening agent is uniformly contained in the base in a powdered form, and among the sweetening agents contained in a powdered form, the sweetening agent having a particle size of 300 μm or less contains 90% or more, a preparation containing a sialic acid derivative-containing agent]. With this configuration, [Formulation effect K-f (lozenge formulation, sweetener particle size, excellent taste): having the aforementioned "Formulation effect A" and "Formulation effect K", and being due to the improved uniform mixing and dispersibility with good uniform dispersibility between the base and the sweetener, an excellent licking sensation, biting sensation, and smooth licking sensation when licking or biting, and unpleasant sensations such as a gritty feeling are suppressed, a formulation containing a sialic acid derivative-containing agent having the form of a lozenge formulation] can be obtained. In particular, when the sweetener is maltitol, a formulation containing a sialic acid derivative-containing agent that exhibits healthy low calories due to low-calorie maltitol, etc., can be obtained. When the particle size of the sweetener exceeds 300 μm, the effect of suppressing unpleasant taste sensations such as a smooth licking sensation and a gritty feeling when chewing, which are caused by the powder shape of the sweetener, tends to decrease.

[0166] Also, in the formulation containing a sialic acid derivative-containing agent having the form of the lozenge formulation of the present invention, preferably, it has the following configuration. · [The base contains maltitol and a polyhydric alcohol in addition to the lozenge base, the base has a solid form, the surface deterioration over time is suppressed, and it has the form of a lozenge formulation, a formulation containing a sialic acid derivative-containing agent]. With this configuration, [Formulation effect K-g (lozenge formulation, appearance deterioration suppression effect by maltitol and polyhydric alcohol): having the aforementioned "Formulation effect A" and "Formulation effect K", and an effect of suppressing the appearance deterioration of the surface of the lozenge formulation during storage] a lozenge formulation can be obtained. Particularly, in a troche preparation containing maltitol as a sweetening agent, during the storage of the troche preparation, depending on the storage environment such as temperature, humidity, and air during storage, appearance deterioration such as clouding, whitening, or generation of fine bubbles may occur on the surface of the troche preparation. The cause of such clouding or whitening on the surface of the troche preparation is not clear, but it is thought to be partial crystallization of maltitol or some appearance deterioration of the surface due to contact with moisture or air in the air. Regarding the appearance deterioration of the surface of this troche preparation, it has been found that a troche preparation containing maltitol as a sweetening agent and containing a polyhydric alcohol can obtain an effect of suppressing the appearance deterioration of the surface of the troche preparation during storage of the troche preparation. As the polyhydric alcohol, polyhydric alcohols such as glycerin, butylene glycol, propylene glycol, and dipropylene glycol can be preferably implemented.

[0167] <Regarding the configuration where the preparation containing a sialic acid derivative-containing agent is a chewable base> In the above-mentioned "preparation containing a base and a sialic acid derivative-containing agent, the sialic acid derivative-containing agent contains a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent is contained in the base" of the present invention, a preparation containing a sialic acid derivative-containing agent having the following configuration can be implemented. · "The base contains a chewable base, the sialic acid derivative-containing agent and the base are uniformly contained, and when taken into a person's mouth and chewed and used, the sialic acid derivative-containing agent is gradually released into the mouth and can stay in the mouth for a long time or adhere to the oral mucosa, and has a form of a troche preparation or a chewable preparation. Preparation containing a sialic acid derivative-containing agent".

[0168] With this configuration, [Formulation Effect L (oral long-term retention and long-term virus activity inhibition effect of chewable formulation containing sialic acid derivative): having the aforementioned "Formulation Effect A", while the sialic acid derivative-containing agent can stay in the oral cavity for a long time while being chewed, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time, maximizing the utilization of the limited content of the sialic acid derivative-containing agent, enhancing the utilization efficiency of the sialic acid derivative-containing agent, and achieving an excellent virus activity inhibition effect. Also, by taking and chewing, the secretion of saliva is promoted, and the effect that the sialic acid derivative-containing agent is dissolved in saliva and easily released into the oral cavity can be obtained. Furthermore, since the sialic acid derivative-containing agent is in a form covered by the base, even if it is stored and left in the normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time, deterioration due to moisture absorption, air oxidation, etc. of the sialic acid derivative-containing agent can be prevented, and a sialic acid derivative-containing agent-containing formulation having excellent stability in storage] can be obtained.

[0169] A chewable formulation has a solid form made into a desired shape in which a sialic acid derivative-containing agent and a base are uniformly contained, and when taken orally, it is gradually dissolved or disintegrated in the mouth, and the sialic acid derivative-containing agent contained in the chewable formulation is applied to the oral cavity and the like. For example, a chewable formulation is formed by mixing and dispersing a base having a powder shape and a sialic acid derivative-containing agent having a powder shape with each other and solidifying them into a solid state, and has a solid form at room temperature. It should be noted that a chewable formulation has a solid form similar to the aforementioned troche formulation, and is a formulation formed by mixing and dispersing a base having a powder shape and a sialic acid derivative-containing agent having a powder shape with each other and solidifying them into a solid state, and having a solid form at room temperature. Generally, by chewing in the oral cavity, the active ingredient is absorbed into the blood vessel through the digestive organs such as the stomach and intestines together with saliva. However, in the present invention, by chewing the chewable formulation in the oral cavity, the active ingredient is released into the oral cavity together with saliva and stays in the oral cavity, so that it can be expected to act on the oral mucosa, pharynx, and larynx and achieve a virus activity inhibition effect.

[0170] The base or the chewable base is not particularly limited, and a chewable base similar to the base constituting the above troche preparation can be preferably implemented. For example, sugar alcohols, starches, starch derivatives, bentonite, lactose, sucrose, maltose, sucrose fatty acid esters, sorbitan fatty acid esters, polyoxyethylene fatty acid esters, phospholipids, polyoxyethylene hydrogenated castor oil, polyoxyethylene alkyl ethers, sodium chloride, aluminum silicate, calcium silicate, silicic anhydride, silicon dioxide, fatty acid salts, organic acids, dicarboxylic acids, calcium sulfate, calcium hydrogen phosphate, gelatin, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, polyvinyl alcohol, carmellose, carmellose calcium, calcium stearate, magnesium stearate, talc, glucose, galactose, fructose, etc., lubricants, excipients, flavoring agents, binders, stabilizers, surfactants, additives, coloring agents, fragrances, etc. A base or a chewable base containing desired components can be implemented.

[0171] In the preparation containing a sialic acid derivative substance having the form of the chewable preparation of the present invention, a "preparation containing a sialic acid derivative substance having the form of a chewable preparation" having a configuration with components similar to those of the above-mentioned "preparation containing a sialic acid derivative substance having the form of a troche preparation" can be preferably implemented. Also, due to their respective configurations, an "effect of a preparation containing a sialic acid derivative substance having the form of a chewable preparation" having a preparation effect similar to that of the above-mentioned "preparation containing a sialic acid derivative substance having the form of a troche preparation" can be obtained. That is, the following effects can be obtained. · [Formulation effect L-b (chewable preparation, sweetener, excellent sweet taste feeling): an effect similar to formulation effect K-b]. · [Formulation effect L-c (chewable preparation, maltitol and reduced palatinose sweetener, excellent sweet taste feeling and smooth feeling in taking): an effect similar to formulation effect K-c]. ·[Formulation effect L-d (particle size of chewable formulation and sialic acid derivative-containing agent, excellent chewiness): an effect similar to formulation effect K-d]. ·[Formulation effect L-e (content of sialic acid derivative-containing agent in chewable formulation, excellent virus activity inhibitory effect): an effect similar to formulation effect K-e]. ·[Formulation effect L-f (particle size of sweetener in chewable formulation, excellent taste during administration): an effect similar to formulation effect K-f].

[0172] The formulation containing a sialic acid derivative-containing agent having the form of the chewable formulation of the present invention is produced by the production method of a conventional chewable formulation. For example, it can be carried out by a method similar to the above troche formulation, and direct powder compression method, granule compression method, etc. can be carried out. The chewable formulation by the direct powder compression method is produced by molding various mixed bases or chewable bases in powder form and a sialic acid derivative-containing agent into a predetermined solid shape by a compression molding method such as a tableting method. The chewable formulation by the granule compression method is produced by granulating and / or drying a desired base or chewable base and a sialic acid derivative-containing agent using a conventional dry granulation method or wet granulation method, and then compression molding the granulated product into a predetermined solid shape.

[0173] <Regarding the constitution where the formulation containing a sialic acid derivative-containing agent is a topical formulation> In the above "formulation containing a base and a sialic acid derivative-containing agent, the sialic acid derivative-containing agent contains a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent is contained in the base" of the present invention, a formulation containing a sialic acid derivative-containing agent having the following constitution can be implemented. · "The base contains a topical agent base that can be applied or adhered to human skin, the sialic acid derivative-containing agent is dissolved and / or uniformly dispersed in the topical agent base, and is configured to be attachable to human skin when applied or sprayed on human skin, and has the form of a topical formulation, a formulation containing a sialic acid derivative-containing agent".

[0174] With this configuration, [Formulation effect F (the formulation containing the topical formulation and the sialic acid derivative-containing agent maintains the state of adhering to the skin for a long time): having the aforementioned "Formulation effect A", and a topical formulation in which the sialic acid derivative-containing agent is uniformly contained in the topical agent base is obtained. When the topical formulation is applied or sprayed onto the skin of the human body, the applied or sprayed topical formulation maintains the state of adhering to the skin for a long time. As a result, it is expected that the virus is captured by the topical formulation applied to the skin and the activity of the virus is suppressed while maintaining the adhering state] a formulation containing a sialic acid derivative-containing agent can be obtained. When the topical agent base is a component that is difficult to be removed by evaporation, the sialic acid derivative-containing agent contained in the topical formulation maintains the state of adhering to the skin for a long time, and during that time, it is expected to suppress the activity of the virus. Also, even when the topical agent base is a component that is easily removed by evaporation, a part of the sialic acid derivative-containing agent maintains the state of adhering to the skin, and during that time, it is expected to suppress the activity of the virus. Further, since the sialic acid derivative-containing agent is dissolved and / or dispersed in the topical agent base, the sialic acid derivative-containing agent does not come into contact with oxygen in the air, thereby suppressing the deterioration of the sialic acid derivative-containing agent during storage.

[0175] The form of the topical agent base is not particularly limited. For example, a topical agent base having the form of an ointment, cream, lotion, gel, liquid, spray, solid, elastic solid, gel-like solid, or fluid gel-like agent can be implemented, and each ointment formulation, cream formulation, lotion formulation, gel formulation, liquid formulation, spray formulation, solid formulation, elastic solid formulation, gel-like solid formulation, or fluid gel-like formulation containing these topical agent bases can be implemented.

[0176] An ointment formulation is a formulation applied to the skin, and is a semi-solid formulation in which a sialic acid derivative-containing agent is dissolved and / or dispersed in an ointment base, and there are types of oily ointment formulations and water-soluble ointment formulations. The oily ointment preparation contains hydrocarbon substances such as white petrolatum and liquid paraffin, fatty acid esters such as isopropyl myristate, waxes such as beeswax and lanolin, higher alcohols such as stearyl alcohol and cetyl alcohol, a plastic base, and an oily base such as viscous silicone. A sialic acid derivative-containing agent is uniformly contained in these oily bases in a dispersed state, a swollen fine powder state, and / or a partially dissolved state in a fine powder form. The oily ointment preparation generally has a sticky and viscous property and is difficult to be removed by washing with water. For the water-soluble ointment preparation, for example, an ointment preparation with a water-soluble base such as macrogol can be used. A sialic acid derivative-containing agent is uniformly contained in this water-soluble base in a dissolved state and / or a swollen state.

[0177] The cream preparation is a preparation applied to the skin, and is a semi-solid preparation in which a sialic acid derivative-containing agent is dissolved and / or dispersed in an ointment base. There are oil-in-water (O / W) or water-in-oil (W / O) cream agents. It is a preparation formed in an emulsified state by containing an oily base, an aqueous base, an emulsifier and / or a surfactant. As the aqueous base, polyhydric alcohols such as glycerin, propylene glycol, and butylene glycol, lower alcohols such as ethanol and isopropyl alcohol, and water can be used. As the oily base, the same hydrocarbon substances, waxes, fatty acid esters, higher alcohols, etc. as those described for the above oily ointment can be used. As the emulsifier and surfactant, general-purpose emulsifiers and surfactants can be used. The sialic acid derivative-containing agent is uniformly contained in these aqueous bases and / or oily bases in a dispersed state, a swollen fine powder state, and / or a partially dissolved state in a fine powder form. The cream agent generally has a non-greasy property and is easily removable by washing with water.

[0178] The liquid preparation or lotion preparation is a preparation applied to the skin, has a liquid state, and includes types such as an emulsion lotion, a solution lotion, and a suspension lotion. An emulsion lotion preparation is a lotion preparation formed in an emulsified state by containing an oily base, an aqueous base, an emulsifier and / or a surfactant. A solution lotion preparation is a lotion preparation in which the contained components are dissolved in water. A suspension lotion preparation is a lotion preparation in which some components are dispersed in a suspended state in water. In any lotion preparation, the sialic acid derivative-containing agent is dissolved in water, and in the case of an emulsion lotion preparation and a suspension lotion preparation, some of the sialic acid derivative-containing agent is contained in a dispersed state in the oily component. Note that "lotion preparation" is an expression similar to "liquid preparation", and there is no difference between "lotion preparation" and "liquid preparation", and they have the same meaning.

[0179] A gel preparation is a preparation applied to the skin and has a flowable semi-solid gel-like form. The gel agent is not particularly limited, and for example, water, a water-soluble polymer and / or a polyhydric alcohol can be used. The sialic acid derivative-containing agent is dissolved in water, and the water-soluble polymer and / or the polyhydric alcohol have a gel-like form that is compatible with water without separation from each other.

[0180] A spray preparation has a form in which the above-mentioned lotion preparation or gel preparation is formed into a sprayable or coatable form in a spray shape. In a liquid preparation, a lotion preparation, or a spray preparation containing a sialic acid derivative-containing agent, particularly preferably, a liquid preparation, a lotion preparation, or a spray preparation in which the sialic acid derivative-containing agent is dissolved in an aqueous base is preferred. Thereby, separation of the sialic acid derivative-containing agent during storage of the liquid preparation, lotion preparation, or spray preparation is suppressed, and a preparation in which the sialic acid derivative-containing agent is uniformly contained in the aqueous base even after storage can be obtained.

[0181] As described above, the sialic acid derivative-containing agent has the property of being easily dissolved in water and being hardly dissolved in ethanol or propyl alcohol. On the one hand, as an external preparation, a preparation containing a sialic acid derivative in the form of a liquid preparation obtained by dissolving a sialic acid derivative-containing agent in water has a tendency that when applied to the skin, water is difficult to evaporate and a wet feeling on the skin surface continues for a long time. On the other hand, a liquid preparation containing a lower alcohol such as ethanol tends to quickly evaporate the lower alcohol when applied to the skin, suppressing the wet feeling on the skin surface.

[0182] From these viewpoints, a preparation containing a sialic acid derivative in the form of a liquid preparation or a spray preparation obtained by dissolving a sialic acid derivative-containing agent in a mixed solvent of water and a lower alcohol (ethanol, propyl alcohol) can be easily and simply applied to the skin and used. With this configuration, [Formulation effect F-a (Improved solubility of the sialic acid derivative-containing agent by the mixed solvent of water and a lower alcohol): The above-mentioned "Formulation effect A (Easy usability and an effect of suppressing virus activity for a long time) and Formulation effect F (The external preparation - the preparation containing the sialic acid derivative-containing agent can maintain the adhered state to the skin for a long time), and the sialic acid derivative-containing agent is well dissolved without separating from the mixed solvent, there is no sedimentation separation of the sialic acid derivative-containing agent during storage, and when adhered to the skin, the preparation containing the sialic acid derivative-containing agent can maintain the adhered state to the skin for a long time] effect can be obtained.

[0183] For example, in the mixing ratio of water and ethanol, it has been found that a mixed solvent having a water content equal to or more than the ethanol content, preferably a mixed solvent having a water content 2 times or more the ethanol content, more preferably a mixed solvent having a water content 2.5 times or more the ethanol content, and even more preferably a mixed solvent having a water content 3 times or more the ethanol content can dissolve the sialic acid derivative-containing agent. That is, a liquid preparation, a lotion preparation, or a spray preparation in which a sialic acid derivative-containing agent is contained in a mixed solvent having a water content 1 time or more the ethanol content is preferably feasible.

[0184] In addition to water and ethanol, a mixed solvent is further constituted by mixing polyhydric alcohols such as propylene glycol, 1,3 - butylene glycol, glycerin, etc., and a liquid preparation, lotion preparation, or spray preparation in which a sialic acid derivative substance - containing agent is dissolved in the mixed solvent is preferably practicable. By forming a mixed solvent containing polyhydric alcohol in addition to water and ethanol, the solubility of the sialic acid derivative substance - containing agent is further improved. Moreover, when it adheres to the human skin, the desorption of the sialic acid derivative substance - containing agent from the skin is suppressed, and the effect of being able to adhere to the skin for a long time can be obtained. That is, [Formulation effect F - b (Improvement in solubility of sialic acid derivative substance - containing agent and suppression of desorption of sialic acid derivative substance - containing agent by a mixed solvent of water, lower alcohol, and polyhydric alcohol): The above - mentioned "Formulation effect F - a (Improvement in solubility of sialic acid derivative substance - containing agent by a mixed solvent of water and lower alcohol)" is further significantly improved, and a liquid preparation, lotion preparation, or spray preparation in which the desorption of the sialic acid derivative substance - containing agent from the skin is suppressed can be obtained] effect can be obtained.

[0185] The sialic acid derivative substance - containing agent - containing preparation having the form of an external preparation containing an external preparation base having the form of an ointment preparation, cream preparation, lotion preparation, gel preparation, liquid preparation, spray preparation, solid preparation, elastic solid preparation, gel - like solid preparation, or fluid gel - like preparation is formed to be applicable and adherable to the exposed parts of the human body such as the face, head, neck, hands, and feet, or the nasal cavity.

[0186] In the sialic acid derivative substance - containing agent - containing preparation having the form of an external preparation of the present invention, preferably, it has the following constitution. · "The base contains an external preparation base that can be applied or adhered to the inside of a person's nasal cavity and / or skin. The external preparation base has the form of an ointment, cream, gel, liquid, or spray. The sialic acid derivative substance - containing agent is dissolved and / or uniformly dispersed in the external preparation base, and when applied or sprayed into a person's nasal cavity and / or skin, it is configured to be adherable to the mucous membrane inside the nasal cavity and / or skin, and has the form of an external preparation, a sialic acid derivative substance - containing agent - containing preparation."

[0187] With this configuration, [Formulation effect G (topical formulation for nasal use, containing a sialic acid derivative-containing agent, maintaining an adherent state in the nasal cavity for a long time): having the aforementioned "Formulation effect A", a topical formulation in which the sialic acid derivative-containing agent is uniformly contained in the topical agent base can be obtained. When the topical formulation is applied to the nasal cavity and / or skin of the human body, the applied topical formulation maintains an adherent state to the nasal mucosa and / or skin for a long time. As a result, a virus is captured by the topical formulation applied to the nasal cavity and / or skin, and it is expected that the activity of the virus can be suppressed while maintaining the adherent state] a sialic acid derivative-containing agent-containing formulation can be obtained. When the topical agent base is a component that is difficult to be removed by evaporation, the sialic acid derivative-containing agent contained in the topical formulation maintains an adherent state in the nasal cavity and / or on the skin for a long time, and during that time, it is expected to suppress the activity of the virus. Also, even when the topical agent base is a component that is easily removed by evaporation, a part of the sialic acid derivative-containing agent maintains an adherent state to the nasal mucosa, and during that time, it is expected to suppress the activity of the virus. In addition, since the sialic acid derivative-containing agent is dissolved and / or dispersed in the topical agent base, the sialic acid derivative-containing agent does not come into contact with oxygen in the air, thereby suppressing the deterioration of the sialic acid derivative-containing agent during storage.

[0188] In the sialic acid derivative-containing agent-containing formulation having the form of the topical formulation of the present invention, preferably, it has the following configuration. · "The base contains a topical agent base that can be applied or adhered to the human nasal cavity and / or skin. (i) The base contains an oily base, and the sialic acid derivative-containing agent is contained in the oily base in a dissolved state, a powdered state dispersed therein, and / or a swollen state, having the form of an ointment formulation, and is configured to be able to adhere to the nasal cavity and / or the mucosa of the skin when applied to the human nasal cavity and / or skin, and has the form of a topical formulation" a sialic acid derivative-containing agent-containing formulation.

[0189] With this configuration, [Formulation effect G-a (a formulation containing a sialic acid derivative-containing agent in a topical formulation, nasal preparation, skin preparation, ointment formulation, which can adhere to the nasal cavity or skin for a long time and is expected to capture viruses that have invaded from the outside): having the aforementioned "Formulation effect A", and a topical formulation in which the sialic acid derivative-containing agent is uniformly contained in the topical agent base is obtained. When the topical formulation is applied to the nasal cavity and / or skin of the human body, the applied topical formulation maintains an adherent state to the nasal mucosa and / or skin for a long time. As a result, a formulation containing a sialic acid derivative-containing agent can be obtained, in which viruses are captured by the topical formulation applied to the nasal cavity and / or skin, and the activity of the viruses can be suppressed while maintaining the adherent state. When the topical agent base is a component that is difficult to be removed by evaporation, the sialic acid derivative-containing agent contained in the topical formulation maintains an adherent state to the nasal cavity and / or skin for a long time, and during that time, it can be expected to suppress the activity of the virus. In addition, since the sialic acid derivative-containing agent is dissolved and / or dispersed in the topical agent base and is covered by the topical agent base, the sialic acid derivative-containing agent does not come into contact with oxygen in the air. As a result, deterioration during storage of the sialic acid derivative-containing agent is suppressed. Furthermore, because the topical formulation is oily, it is insoluble in water and difficult to be removed by washing with water, enabling it to maintain adhesion for a long time. Additionally, due to the generally sticky and viscous nature of ointment formulations, it can be expected to obtain the effect of being able to efficiently capture viruses that have invaded from the outside.

[0190] In the formulation containing a sialic acid derivative-containing agent having the form of the topical formulation of the present invention, preferably, it has the following configuration. · "The base contains an external preparation base that can be applied or adhered to the human nasal cavity and / or skin, (ii) has an emulsified state containing an oily base, an aqueous base, an emulsifier and / or a surfactant, and the sialic acid derivative-containing agent is contained in a dissolved state, a powdered state dispersed, and / or a swollen state in the oily base and the aqueous base, has the form of a cream preparation, and is configured to be attachable to the mucous membrane of the nasal cavity and / or skin when applied to the human nasal cavity and / or skin, and has the form of an external preparation, a sialic acid derivative-containing agent-containing preparation."

[0191] With this configuration, [Formulation effect G-b (Effect that an external preparation (nasal cavity use, skin use, cream preparation, sialic acid derivative-containing agent-containing preparation) can adhere to the nasal cavity and skin for a long time and capture viruses that have invaded from the outside): It has the aforementioned "Formulation effect A", and an external preparation in which the sialic acid derivative-containing agent is uniformly contained in the external preparation base is obtained. When the external preparation is applied to the nasal cavity and / or skin of the human body, the applied external preparation maintains an adherent state to the mucous membrane in the nasal cavity and / or skin for a long time. As a result, a sialic acid derivative-containing agent-containing preparation can be obtained in which viruses are captured by the external preparation applied to the nasal cavity and / or skin, and the activity of the viruses can be expected to be suppressed while maintaining the adherent state.] When the external preparation base is a component that is difficult to be removed by evaporation, the sialic acid derivative-containing agent contained in the external preparation maintains an adherent state to the nasal cavity and / or skin for a long time, and during that time, it can be expected to suppress the activity of the virus. Also, since the sialic acid derivative-containing agent is dissolved and / or dispersed in the external preparation base and is covered by the external preparation base, the sialic acid derivative-containing agent does not come into contact with oxygen in the air, thereby suppressing the deterioration of the sialic acid derivative-containing agent during storage. Furthermore, cream preparations generally have no stickiness and can be easily removed with water. Therefore, when application is no longer required, the effect of being able to be easily removed by washing with water can be obtained. As described above, since the ointment preparation and the cream preparation have different textures, they can be supplied and provided in the desired form.

[0192] <Regarding the constitution that the preparation containing a sialic acid derivative-containing agent is a preparation for attaching to an article> In the above-mentioned "preparation containing a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent contains a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent is contained in the base", a preparation containing a sialic acid derivative-containing agent having the following constitution can be implemented. · "The base contains a base for attaching to an article that can be applied or attached to an article, and the base for attaching to an article has a form of a gel-like fluid preparation, a liquid preparation, or a spray preparation, and is configured to be attachable to an article, and is characterized by having a form of a preparation for attaching to an article."

[0193] With this constitution, [Formulation effect H (Effect that the preparation for attaching to an article containing a sialic acid derivative-containing agent can be attached to an article for a long time and capture of the attached virus can be expected): It has the above-mentioned "Formulation effect A", and a preparation for attaching to an article in which the sialic acid derivative-containing agent is uniformly contained in the base for attaching to an article is obtained. When the preparation for attaching to an article is attached to an article by coating, spray coating, etc., the attached preparation for attaching to an article maintains the attached state to the article for a long time. As a result, a virus is captured by the preparation for attaching to an article attached to the article, and it is expected that the activity of the virus can be suppressed while maintaining the attached state. A preparation containing a sialic acid derivative-containing agent] can be obtained. When the base for attaching to an article is a component that is difficult to be removed by evaporation, the sialic acid derivative-containing agent contained in the preparation for attaching to an article maintains the state of being attached to the article for a long time, and during that time, it is expected to suppress the activity of the virus. In addition, since the sialic acid derivative-containing agent is dissolved and / or dispersed in the article-adhering base and is covered with the article-adhering base, the sialic acid derivative-containing agent does not come into contact with oxygen in the air, thereby obtaining the effect of suppressing the deterioration of the sialic acid derivative-containing agent during storage.

[0194] Also, in the same manner as the above-mentioned "preparation containing a sialic acid derivative-containing agent having a form of an external preparation and having a form of a liquid preparation or a spray preparation", a preparation containing a sialic acid derivative-containing agent in a liquid form or a spray form dissolved in a mixed solvent of water and a lower alcohol (ethanol, propyl alcohol) can be easily and simply applied to an article and used. With this configuration, [Formulation effect H-a (Improvement in the solubility of the sialic acid derivative-containing agent by a mixed solvent of an article-adhering preparation, water and a lower alcohol): The above-mentioned "Formulation effect A (Effect that easy usability and long-term virus activity suppression can be expected) and Formulation effect H (Article-adhering preparation, the preparation containing the sialic acid derivative-containing agent maintains the adhering state to the article for a long time), and the sialic acid derivative-containing agent is well dissolved without separating from the mixed solvent, and there is no sedimentation separation of the sialic acid derivative-containing agent during storage, and when adhered to the article, the preparation containing the sialic acid derivative-containing agent maintains the adhering state to the article for a long time] effect is obtained.

[0195] In addition to water and ethanol, a mixed solvent composed of further mixing polyhydric alcohols such as propylene glycol, 1,3-butylene glycol, glycerin, etc. is preferably used, and a liquid preparation, a lotion preparation, or a spray preparation in which the sialic acid derivative-containing agent is dissolved in the mixed solvent can be preferably implemented. The configuration of the mixed solvent containing polyhydric alcohol in addition to water and ethanol further improves the solubility of the sialic acid derivative-containing agent, and further suppresses the desorption of the sialic acid derivative-containing agent from the article when adhered to the article, and the effect of maintaining the adhesion to the article for a long time can be obtained. That is, [Formulation effect H-b (Improvement in solubility of sialic acid derivative-containing agent and suppression of desorption of sialic acid derivative-containing agent by a mixed solvent of water, lower alcohol, and polyhydric alcohol for article adhesion): The above-mentioned "Formulation effect H-a (Improvement in solubility of sialic acid derivative-containing agent by a mixed solvent of water and lower alcohol)" is further significantly improved, and a liquid formulation, lotion formulation, or spray formulation in which the desorption of the sialic acid derivative-containing agent from the article is suppressed can be obtained] is obtained.

[0196] The method for producing a formulation containing a sialic acid derivative-containing agent of the present invention is "a method for producing a formulation containing a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, and the method comprises mixing the base and the sialic acid derivative-containing agent at a temperature of 130°C or lower to form a base-sialic acid derivative-containing agent uniformly-containing intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base". Preferably, the sialic acid derivative-containing agent has a function of suppressing the activity of a virus and / or a function of suppressing the growth of a virus, etc.

[0197] Generally, drugs tend to deteriorate, such as drug alteration and decomposition, as the temperature increases, and it is desired to manufacture drugs at a temperature at which the drugs do not deteriorate. The inventors have confirmed that the sialic acid derivative-containing agent, which is a drug, tends to gradually deteriorate as the temperature rises at about 150°C or higher, and at 150°C, the sialic acid derivative-containing agent changes color and some kind of deterioration such as chemical and / or physical deterioration occurs. Also, it has been found that a formulation containing a sialic acid derivative-containing agent produced by mixing a base and an alic acid derivative at a temperature of 130°C or lower does not cause discoloration and the sialic acid derivative-containing agent does not deteriorate. That is, it has been found that the method for producing a formulation containing a sialic acid derivative-containing agent of the present invention described above has the following effects. "Manufacturing method effect A: (Effect of preventing degradation of the sialic acid derivative-containing agent during production) An easily and simply usable sialic acid derivative-containing agent with an expected long-term virus activity inhibitory effect can be obtained by a manufacturing method of a sialic acid derivative-containing agent-containing preparation that does not cause degradation of the sialic acid derivative-containing agent contained during production."

[0198] Particularly, in the manufacturing method of a sialic acid derivative-containing agent-containing preparation having a configuration in which the base is a confectionery base, the following effects can be obtained." [Manufacturing method effect A-a: (Effect of preventing degradation of the sialic acid derivative-containing agent in the confectionery base during production) A sialic acid derivative-containing agent-containing preparation can be obtained that can be easily and simply used by a person at a desired time, and in a configuration with a confectionery base where the base is a solid agent, elastic solid agent, or gel-like solid agent, can be taken into a person's oral cavity in a sensation similar to that of a confectionery, can stay in the oral cavity for a long time, can adhere to the oral mucosa for a long time, and is expected to have a long-term virus activity inhibitory effect. At the same time, any degradation of the sialic acid derivative-containing agent contained during production can be suppressed, enabling the production of a sialic acid derivative-containing agent-containing preparation capable of suppressing good virus activity.] A manufacturing method of a sialic acid derivative-containing agent-containing preparation having this effect can be obtained."

[0199] Also, in the manufacturing method of a sialic acid derivative-containing agent-containing preparation having a configuration in which the base is a topical agent base, the following effects can be obtained. [Manufacturing method effect A-b: (Effect of preventing degradation of the sialic acid derivative-containing agent in the topical agent base during production) A sialic acid derivative-containing agent-containing preparation can be obtained that can be easily and simply used by a person at a desired time, and in a configuration with a topical agent base having a form of an ointment, cream, lotion, gel, liquid, or spray. By applying it to a person's skin or nasal cavity, it can adhere to the skin or nasal mucosa for a long time and has a long-term virus activity inhibitory effect. At the same time, any degradation of the sialic acid derivative-containing agent contained during production can be suppressed, enabling the production of a sialic acid derivative-containing agent-containing preparation capable of suppressing good virus activity.] A manufacturing method of a sialic acid derivative-containing agent-containing preparation having this effect can be obtained."

[0200] When the temperature in the step of forming a base and sialic acid derivative-containing agent uniformly-containing intermediate material by mixing a base and a sialic acid derivative-containing agent so that the sialic acid derivative-containing agent is uniformly contained in the base exceeds 130°C, the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent tends to chemically deteriorate due to heat, or deteriorate due to oxidation, etc.

[0201] <Regarding the method for producing a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation> In the above-mentioned "method for producing a preparation containing a sialic acid derivative-containing agent, which comprises a base and a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent comprises a sialic acid derivative-containing agent" of the present invention, a preparation containing a sialic acid derivative-containing agent having the following configuration can be implemented. · "A method for producing a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum, wherein the base contains a confectionery base, and the confectionery base has the form of a chewing gum containing a gum base and a sweetening agent, comprising: (A) mixing a gum base, a sweetening agent, and a powdery sialic acid derivative-containing agent at a temperature of 20 to 90°C to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base, the sweetening agent, and the powdery sialic acid derivative-containing agent are uniformly mixed; (B) dividing the chewing gum intermediate mixture into a predetermined shape at a temperature lowered to 45°C or lower and molding it into a predetermined shape having the form of a chewing gum. When taken into a person's mouth and chewed, the sialic acid derivative-containing agent is released into the mouth, and the sialic acid derivative-containing agent is configured to be able to stay in the mouth and / or adhere to the oral mucosa, and has the form of a chewing gum preparation. A method for producing a preparation containing a sialic acid derivative-containing agent."

[0202] With this configuration, [Manufacturing method effect C (Suppressing the deterioration of the sialic acid derivative-containing agent during the manufacture of chewing gum formulations): As described above, “Formulation effect C: The sialic acid derivative-containing agent can stay in the oral cavity for a long time, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time. By maximizing the use of the limited content of the sialic acid derivative-containing agent, the utilization efficiency of the sialic acid derivative-containing agent can be increased. In addition, chewing promotes the secretion of saliva, and the effect of making the sialic acid derivative-containing agent dissolve in saliva and be easily released into the oral cavity can also be obtained.” etc. can be obtained, and at the same time, deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative-containing agent contained during manufacture can be suppressed, and it becomes possible to manufacture a sialic acid derivative-containing agent-containing formulation that can effectively suppress good virus activity with an effect]. A manufacturing method of a sialic acid derivative-containing agent-containing formulation having this is obtained.

[0203] (A) In the step, by mixing a gum base, a sweetening agent, and a powdery sialic acid derivative-containing agent at a temperature of 20 to 90 °C, a chewing gum intermediate mixture in which the sweetening agent and the powdery sialic acid derivative-containing agent are uniformly contained and mixed in the gum base is obtained. In particular, the sialic acid derivative-containing agent has a property of being easily deteriorated by heat, but no deterioration was observed even when mixed at a temperature of 20 to 90 °C. Also, even when the sweetening agent has a powdery form, a chewing gum intermediate mixture in which the powdery sialic acid derivative-containing agent and the powdery sweetening agent are uniformly mixed and dispersed in the gum base, or in which some of the sialic acid derivative-containing agent and the sweetening agent are dissolved and / or swollen in the gum base is obtained.

[0204] (A) The temperature at the time of mixing the gum base, the sweetening agent, and the sialic acid derivative-containing agent in the step is preferably 20 to 90 °C, more preferably 30 to 80 °C, and even more preferably 40 to 65 °C. When the mixing temperature exceeds 90 °C, the gum base tends to become soft as the temperature increases, and a chewing gum intermediate mixture having the desired viscosity cannot be obtained. When it exceeds 130 °C, the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent tends to deteriorate. When the mixing temperature is less than 20°C, the gum base is in a hard state, and it tends to be difficult to uniformly mix the sialic acid derivative-containing agent. In the forming step of step (B), the temperature is preferably 45°C or lower, more preferably 25°C to 40°C. When the forming step exceeds 45°C, the chewing gum intermediate mixture tends to become soft, and it tends not to obtain a sialic acid derivative-containing agent-containing preparation having a desired elasticity.

[0205] The gum base is not particularly limited. For example, solid elastomers such as polyisobutylene and vinyl acetate resin, plasticizers such as microcrystalline wax and paraffin wax, emulsifiers such as glycerin fatty acid esters, powders such as talc powder, and cooling agents such as menthol described in the section of the above-mentioned "chewing gum preparation" can be used. In addition, in step (B), after molding the chewing gum intermediate mixture into a predetermined shape, it is also possible to add a sugar coating step of coating a coating agent.

[0206] As the step of mixing the gum base, the sweetening agent, and the sialic acid derivative-containing agent in the step (A), a known production process used in the production of chewing gum for confectionery can be used. For example, a batch-type screw kneader, a batch-type paddle kneader, a batch-type roll kneader, or a batch-type pressure kneader that kneads while applying air pressure or weights to such kneaders, etc. are used. In particular, it is kneaded within a temperature range in which the sialic acid derivative-containing agent to be used does not deteriorate and within a temperature range in which the gum base to be used has viscosity and the gum base and the sialic acid derivative-containing agent can be kneaded with each other. In order to prevent the deterioration of the sialic acid derivative-containing agent, generally, a temperature range of 20°C to 90°C is desirable as the desirable temperature range. Also, it is desirable to knead in an atmosphere of an inert gas such as nitrogen. Or, by kneading while applying pressure using a pressure kneader, an effect of shortening the kneading time can be obtained. Also, the pressure kneader can obtain an effect of kneading while blocking air. Thereby, a chewing gum intermediate mixture in which the sialic acid derivative-containing agent and the sweetener are uniformly mixed in the gum component is obtained.

[0207] As the step of shaping the chewing gum intermediate mixture in the step (B) into a predetermined shape to prepare a sialic acid derivative-containing agent-containing preparation, it is not particularly limited. For example, generally, a known extrusion molding machine used in the production of thin plate-shaped confectionery chewing gum is used to obtain a sialic acid derivative-containing agent-containing preparation in a thin plate shape, a disc shape, or any other arbitrary shape. However, compared with the production method of confectionery chewing gum, it is desirable to perform molding within a temperature range in which the medicinal ingredient used does not deteriorate and within a temperature range in which the gum base to be used has viscosity and can be processed into a predetermined shape. The desirable temperature range varies depending on the types of the gum base and the sialic acid derivative-containing agent to be used. In order to prevent the deterioration of the sialic acid derivative-containing agent, for example, a temperature range of 20°C to 90°C is desirable. Also, it is desirable to perform molding in an atmosphere of an inert gas such as nitrogen.

[0208] In the step (B), the step of coating with a coating agent is not particularly limited, but a sugar coating agent having a moisture-proof effect for preventing the deterioration of the sialic acid derivative-containing preparation due to humidity during the storage of the sialic acid derivative-containing preparation can be used. As the coating agent, for example, a coating agent containing powdery maltitol, starch syrup, honey containing gum arabic, a coloring agent, a wax agent, a component that exhibits a fruit flavor similar to the flavors of sweets and fruits, etc. to moderate the taste peculiar to the medicinal ingredient, and a cooling flavor for producing a cooling sensation can be used.

[0209] In the above-mentioned "method for producing a sialic acid derivative-containing preparation having a chewing gum preparation form" of the present invention, a method for producing a sialic acid derivative-containing preparation having the following configuration can be preferably implemented. · "The sweetener contains at least one sweetener selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup. The sweetener is uniformly contained in the gum base in a powdery state. The step (A) is a step of mixing a gum base, the sweetener, and a powdery sialic acid derivative-containing preparation at a temperature of 20 to 90°C to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing preparation uniformly containing intermediate material in which the gum base, the sweetener, and the powdery sialic acid derivative-containing preparation are uniformly mixed. The method for producing a sialic acid derivative-containing preparation having a chewing gum preparation form in which the sialic acid derivative-containing preparation is uniformly contained in the base." Each of these sweeteners has a unique sweetness without having the same sweetness. Therefore, a sialic acid derivative-containing preparation having a desired sweetness can be obtained by appropriately selecting the type of sweetener.

[0210] In the above-mentioned "method for producing a sialic acid derivative-containing preparation having a chewing gum preparation form" of the present invention, a method for producing a sialic acid derivative-containing preparation having the following configuration can be preferably implemented. · The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol, and the second sweetener is at least one second sweetener selected from the group consisting of sucrose, glucose, fructose, maltose, malt syrup, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, and lactitol. The step (A) is to mix a gum base, the sweetener, and a powdery sialic acid derivative-containing agent at a temperature of 20 to 90°C to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly containing intermediate material in which the gum base, the sweetener, and the powdery sialic acid derivative-containing agent are uniformly mixed. The method for producing a sialic acid derivative-containing agent-containing preparation having a form of a chewing gum preparation in which the sialic acid derivative-containing agent is uniformly contained in the base.

[0211] With this configuration, [Manufacturing method effect C-a (chewing gum preparation, maltitol and second sweetener, desired sweetness, low calorie, good dispersibility): having the aforementioned "Manufacturing method effect C", and excellent chewing feeling due to good mixing and dispersibility with the gum base, desired sweetness by selectively containing the desired second sweetener, healthy low calorie due to low calorie maltitol, etc., an effect of obtaining a sialic acid derivative-containing agent-containing preparation having a form of a chewing gum preparation] is obtained.

[0212] In the above-mentioned "method for producing a sialic acid derivative-containing agent-containing preparation having a form of a chewing gum preparation" of the present invention, a method for producing a sialic acid derivative-containing agent-containing preparation having the following configuration can be preferably implemented. · "The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol, the second sweetener is starch syrup, and (A) is a step of mixing a gum base, the sweetener, and a powdery sialic acid derivative-containing agent at a temperature of 20 to 90 °C to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base, the sweetener, and the powdery sialic acid derivative-containing agent are uniformly mixed. A method for producing a sialic acid derivative-containing agent-containing preparation, which has the form of a chewing gum preparation in which the sialic acid derivative-containing agent is uniformly contained in the base."

[0213] With this configuration, [Manufacturing method effect C-b (chewing gum preparation · uniform containing of maltitol, starch syrup, sialic acid derivative-containing agent, and maltitol): A sialic acid derivative-containing agent-containing preparation having the aforementioned manufacturing method effect C and the aforementioned "preparation effect C-b" can be obtained. Furthermore, due to the fact that starch syrup contains about 5 to 30% water and maltitol is also water-soluble, in step (A), at least a part of at least a part of maltitol and at least a part of the sialic acid derivative-containing agent in the form of a powdery sialic acid derivative-containing agent are dissolved and / or swollen. As a result, an effect of being able to manufacture a sialic acid derivative-containing agent-containing preparation in which at least a part of the sialic acid derivative-containing agent is contained in a dissolved and / or swollen state and is uniformly contained] can be obtained.

[0214] In the above-mentioned "method for producing a sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation" of the present invention, a method for producing a sialic acid derivative-containing agent-containing preparation having the following configuration is preferably feasible. · "(i) The sweetener is uniformly contained in the gum base in at least a powdery form, and among the sweeteners contained in a powdery form, those having a particle size of 300 μm or less contain 90% or more. A method for producing a sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation in which the sialic acid derivative-containing agent is uniformly contained in the base."

[0215] With this configuration, [Manufacturing method effect C-g (chewing gum preparation, sweetener particle size, excellent chewiness, excellent uniform mixing and dispersibility): The above-mentioned "C-g (chewing gum preparation, sweetener particle size) has an excellent taste due to the improved uniform mixing and dispersibility resulting from the improved uniform dispersibility of the good gum base and the sweetener, and the unpleasant taste such as a gritty feeling when taking the medicine caused by the powder shape of the sweetener is suppressed. Furthermore, a preparation containing a sialic acid derivative substance having the form of a chewing gum preparation that exhibits healthy low calories due to low-calorie maltitol, etc.] can be obtained. Furthermore, a method for producing a preparation containing a sialic acid derivative substance, which has the effect of suppressing deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative substance-containing agent contained during production and enabling the production of a preparation containing a sialic acid derivative substance that can be expected to have good virus activity suppression, can be obtained. In particular, when the sweetener is low-calorie maltitol, the effect of exhibiting healthy low calories, etc. can be obtained.

[0216] Preferably, the sweetener contains 90% or more of the sweetener having a particle size of 250 μm or less among the sweeteners contained in the form of a powder shape. More preferably, the preparation containing a sialic acid derivative substance having a configuration in which 90% or more of the sweetener having a particle size of 150 μm or less is contained among the sweeteners contained in the form of a powder shape can be implemented. When the particle size of the sweetener contained in the form of a powder shape exceeds 300 μm, the effect of suppressing the unpleasant chewing feeling such as a gritty feeling when chewing due to the powder-shaped sweetener tends to decrease.

[0217] The above-mentioned base contains a confectionery base. The confectionery base preferably has the following configuration in a preparation containing a sialic acid derivative substance having the form of a chewing gum preparation containing a gum base and a sweetener. · "The sialic acid derivative-containing agent is uniformly contained in the gum base agent in a powdery form, and among the sialic acid derivative-containing agents contained in a powdery form, the sialic acid derivative-containing agent having a particle size of 300 μm or less contains 90% or more, and has a chewing gum preparation form. A method for producing a preparation containing a sialic acid derivative-containing agent."

[0218] With this configuration, [Manufacturing method effect C-h (chewing gum preparation · sialic acid derivative-containing agent particle size · excellent uniform mixing and dispersibility): the above-mentioned "preparation effect C-h (chewing gum preparation · sialic acid derivative-containing agent particle size: excellent taste due to improved uniform mixing and dispersibility of a good gum base agent and a sialic acid derivative-containing agent, and suppression of unpleasant taste such as a gritty feeling when taking the preparation due to the powder shape of the sialic acid derivative-containing agent), and a preparation containing a sialic acid derivative-containing agent having such an effect can be obtained. Furthermore, it is possible to suppress deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative-containing agent contained during production, and to produce a preparation containing a sialic acid derivative-containing agent that can be expected to have good suppression of virus activity.] A method for producing a preparation containing a sialic acid derivative-containing agent having such an effect is obtained.

[0219] Preferably, the sialic acid derivative-containing agent contains 90% or more of the sialic acid derivative-containing agent having a particle size of 250 μm or less among the sialic acid derivative-containing agents contained in a powdery form. More preferably, the sialic acid derivative-containing agent contains 90% or more of the sialic acid derivative-containing agent having a particle size of 150 μm or less among the sialic acid derivative-containing agents contained in a powdery form. A preparation containing a sialic acid derivative-containing agent having such a configuration can be implemented. When the particle size of the sialic acid derivative-containing agent exceeds 300 μm, the effect of suppressing unpleasant chewing sensations such as a gritty feeling when chewing, which is caused by the powder shape of the sialic acid derivative-containing agent, tends to decrease.

[0220] In the above-mentioned "method for producing a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation" of the present invention, a method for producing a preparation containing a sialic acid derivative-containing agent having the following configuration is preferably feasible. · "In the step (A), the powdery sialic acid derivative-containing agent and the sweetening agent are uniformly mixed to prepare a sialic acid derivative-containing agent / sweetening agent mixture, and the sialic acid derivative-containing agent / sweetening agent mixture and the gum base are mixed to prepare a chewing gum intermediate mixture. A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by this."

[0221] With this configuration, [Production method effect C-j: (Uniform mixing with suppression of localization of the sialic acid derivative-containing agent): An effect is obtained in which a preparation containing a sialic acid derivative-containing agent in which the sialic acid derivative-containing agent is uniformly dispersed and contained without being locally localized in the chewing gum preparation is obtained. For example, when the content of the sialic acid derivative-containing agent is small, when only the sialic acid derivative-containing agent is added to and mixed with the gum base, a phenomenon occurs in which a chewing gum intermediate mixture that is locally localized in the chewing gum preparation is obtained. Thus, in the step (B), when divided into a predetermined shape and formed into a predetermined shape having the form of a chewing gum, there is a tendency to obtain chewing gum preparations having different contents of the sialic acid derivative-containing agent. On the other hand, by uniformly mixing the powdery sialic acid derivative-containing agent and the sweetening agent to prepare a sialic acid derivative-containing agent / sweetening agent mixture, and mixing the sialic acid derivative-containing agent / sweetening agent mixture and the gum base to prepare a chewing gum intermediate mixture, an effect] is obtained in which it becomes possible to easily produce chewing gum preparations having the same content of the sialic acid derivative-containing agent.

[0222] In the above-mentioned "method for producing a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation" of the present invention, a method for producing a preparation containing a sialic acid derivative-containing agent having the following configuration is preferably feasible. · The base contains, in addition to the confectionery base, a polyhydric alcohol, and the polyhydric alcohol contains at least one polyhydric alcohol selected from the group consisting of propylene glycol, dipropylene glycol, butylene glycol, and glycerin. The step (A) is to mix a gum base, a polyhydric alcohol, a sweetener, and a powdery sialic acid derivative-containing agent at a temperature of 20 to 90 °C to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base, the polyhydric alcohol, the sweetener, and the powdery sialic acid derivative-containing agent are uniformly mixed. The method for producing a sialic acid derivative-containing agent-containing preparation has a form of a chewing gum preparation in which the sialic acid derivative-containing agent is uniformly contained in the gum base and the polyhydric alcohol.

[0223] With this configuration, [Manufacturing method effect C-e (Chewing gum preparation · Polyhydric alcohol · Sialic acid derivative-containing agent is uniformly mixed by swelling and / or dissolving in polyhydric alcohol · Excellent homogeneous mixing property): A sialic acid derivative-containing agent-containing preparation having the aforementioned "preparation effect C-e" can be obtained. In the step (A), the sialic acid derivative-containing agent swells and / or dissolves in the polyhydric alcohol, thereby further improving the effect that the sialic acid derivative-containing agent is uniformly contained in the base containing the gum base and the polyhydric alcohol. An effect of being able to manufacture a sialic acid derivative-containing agent-containing preparation having a form of a chewing gum preparation] is obtained.

[0224] <Regarding the manufacturing method of a sialic acid derivative-containing agent-containing preparation having a form of a hard candy preparation> The manufacturing method of the sialic acid derivative-containing agent-containing preparation of the present invention preferably has the following configuration. The manufacturing method of the preparation containing a sialic acid derivative-containing agent of the present invention is as follows: "It comprises a base and a sialic acid derivative-containing agent, the sialic acid derivative-containing agent contains a sialic acid derivative-containing agent, the base contains a confectionery base, the confectionery base has the form of hard candy containing a hard candy base and a sweetening agent, when taken in a human mouth, it is used by licking and / or chewing in the mouth, the sweetening agent dissolves in saliva in the mouth and has a sweet taste, and the sialic acid derivative-containing agent has the property of being released into the oral cavity, staying in the oral cavity and passing through the throat. A manufacturing method of a preparation containing a sialic acid derivative-containing agent, comprising: (A) mixing a sweetening agent and water to prepare a sweetening agent solution in which the sweetening agent is dissolved, and heating the sweetening agent solution to a first predetermined temperature to evaporate and remove water to prepare a heated flowing sweetening agent containing a water content of 7% by weight or less and having a heated flowing state, wherein the heated flowing sweetening agent containing the sweetening agent maintains the first predetermined temperature; (B) mixing the heated flowing sweetening agent containing the sweetening agent with a powdery sialic acid derivative-containing agent while maintaining the flowing state at a second predetermined temperature lower than the first predetermined temperature to prepare a heated multiitol-containing flowing preparation containing a sialic acid derivative-containing agent, wherein the heated flowing preparation containing the sialic acid derivative-containing agent and the sweetening agent maintains the second predetermined temperature; and (C) shaping the heated flowing preparation containing the sialic acid derivative-containing agent and the sweetening agent into a predetermined shape while maintaining the temperature at a third predetermined temperature lower than the second predetermined temperature to prepare a shaped preparation containing a sialic acid derivative-containing agent and a sweetening agent. The first predetermined temperature is 120°C or higher, the second predetermined temperature is lower than the first predetermined temperature and is 70 to 150°C, the third predetermined temperature is lower than 70°C, and the sialic acid derivative-containing agent is uniformly contained in the base in the form of a hard candy preparation."

[0225] For example, when the first predetermined temperature exceeds 150°C, the second predetermined temperature can be 70 - 150°C; when the first predetermined temperature is 150°C or lower, the second predetermined temperature can be 70 - 150°C; when the first predetermined temperature is 130°C, the second predetermined temperature can be 70 - 130°C; when the first predetermined temperature is 121°C, the second predetermined temperature can be 70 - 121°C.

[0226] By the above manufacturing method, [Manufacturing method effect D-e (Deterioration suppression of sialic acid derivative-containing agent during hard candy preparation): The effect of suppressing chemical deterioration of the sialic acid derivative-containing agent due to its temperature during production] can be obtained.

[0227] In the step (B), as the temperature of the sweetener-containing heated and flowing sweetener increases, there is a tendency for chemical deterioration of the sialic acid derivative-containing agent to occur. In particular, when the temperature of the sweetener-containing heated and flowing sweetener exceeds 150°C, deterioration of the sialic acid derivative-containing agent tends to occur in the step of mixing the sweetener and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent. As the temperature of the sweetener-containing heated and flowing sweetener decreases, the viscosity of the sweetener-containing heated and flowing sweetener increases. In particular, when the second predetermined temperature is less than 70°C, the viscosity of the maltitol-containing heated and flowing sweetener becomes extremely high, and there is a tendency that the mixing of the sweetener-containing heated and flowing sweetener and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent cannot be sufficiently performed, and there is a tendency that a desired candy preparation in which the sialic acid derivative-containing agent is uniformly contained in the sweetener cannot be obtained.

[0228] As the second predetermined temperature, it is a temperature lower than the first predetermined temperature, preferably 70 - 140°C, more preferably 70 - 120°C. For example, when the first predetermined temperature exceeds 150°C, the second predetermined temperature can preferably be 70 - 140°C; when the first predetermined temperature is 120°C - 150°C, the second predetermined temperature can preferably be 70 - 120°C.

[0229] The mixing ratio of the sweetener and water in the step (A) is not particularly limited. For example, "a step of mixing 50 to 90% by weight of (A) sweetener and 50 to 10% by weight of water to prepare a sweetener solution in which the sweetener is dissolved", more preferably, "a step of mixing 60 to 90% by weight of (A) sweetener and 40 to 10% by weight of water to prepare a sweetener solution in which maltitol is dissolved", even more preferably, "a step of mixing 70 to 90% by weight of (A) sweetener and 30 to 10% by weight of water to prepare a sweetener solution in which maltitol is dissolved" is feasible.

[0230] Also, in the step (A), "a step of heating the sweetener solution to a temperature of 120°C or higher, evaporating and removing water, and preparing a heated flowing sweetener containing sweetener having a heated flowing state with a water content of 7% by weight or less", more preferably, "heating the sweetener solution to a temperature of 120°C to 200°C", even more preferably, "heating the maltitol solution to a temperature of 120°C to 190°C" to prepare a heated flowing sweetener containing sweetener having a heated flowing state with a water content of 7% by weight or less is feasible. There is an advantage that the time for evaporating and removing water becomes shorter as the heating temperature increases. However, as the heating temperature increases, deterioration such as browning reaction (Maillard reaction) of the sweetener containing sweetener tends to occur. As the temperature for heating the sweetener solution to 120°C or higher and evaporating and removing water, preferably, a temperature of 120°C to 200°C is preferred, and more preferably, 120°C to 190°C is preferred.

[0231] Also, more preferably, in the step (A), "a step of heating the sweetener solution to a temperature of 120°C or higher, evaporating and removing water, and preparing a heated flowing sweetener containing sweetener having a heated flowing state with a water content of 7% by weight or less", a step of preparing a heated flowing sweetener containing sweetener having a heated flowing state with a water content of "5% by weight or less", more preferably, "3% by weight or less" is feasible. As the water content in the candy preparation increases, at room temperature of about 25°C immediately after production and during storage, the candy preparation tends to become a sticky and soft-shaped preparation such as a slime phenomenon. When the water content exceeds 7% by weight based on the total amount, at room temperature of about 25°C immediately after production and / or during storage, the candy preparation tends to have a sticky and soft shape such as a slime phenomenon, or the surface of the candy preparation tends to have a sticky phenomenon. In such a candy preparation having such a phenomenon, it is dealt with in the form of individual packaging or sealed packaging having high airtightness, resulting in the problems that the packaging material cost becomes high and the packaging process becomes complicated.

[0232] The step of "heating the sweetener solution to a temperature of 120°C or higher, evaporating and removing water, and preparing a heated fluid sweetener containing a sweetener having a water content of 7% by weight or less and having a heated fluid state" is not particularly limited. For example, a method of heating the sweetener solution to a temperature of 120°C or higher in a reduced-pressure atmosphere or a method of heating the sweetener solution to a temperature of 120°C or higher in an air atmosphere can be implemented. By evaporating water in a reduced-pressure atmosphere, there are advantages that thermal degradation of the sweetener is suppressed and the time required for water evaporation can be shortened.

[0233] The third predetermined temperature is preferably less than 70°C. When the third predetermined temperature is 70°C or higher, the multiitol-containing molded preparation containing the sialic acid derivative-containing agent tends to maintain a fluid state and cannot be molded into a predetermined shape.

[0234] <Regarding the manufacturing method of a preparation containing a sialic acid derivative-containing agent having the form of a soft candy preparation> The manufacturing method of the preparation containing the sialic acid derivative-containing agent of the present invention preferably has the following configuration. The manufacturing method of a preparation containing a sialic acid derivative-containing agent of the present invention is as follows: "It comprises a base and a sialic acid derivative-containing agent, the sialic acid derivative-containing agent contains a sialic acid derivative-containing agent, the base contains a confectionery base, the confectionery base has the form of a soft candy containing a soft candy base and a sweetener, when taken in a human mouth, it is used by licking and / or chewing in the mouth, the sweetener dissolves in saliva in the mouth and has a sweet taste, and the sialic acid derivative-containing agent has the property of being released into the mouth, remaining in the mouth and passing through the throat. A manufacturing method of a preparation containing a sialic acid derivative-containing agent, comprising: (A) a step of mixing a sweetener and water to prepare a sweetener solution in which the sweetener is dissolved, and heating the sweetener solution to a first predetermined temperature to evaporate and remove water to prepare a heated flowable sweetener-containing agent having a water content of 4% to 15% by weight, where the heated flowable sweetener-containing agent maintains the first predetermined temperature; (B) a step of mixing the heated flowable sweetener-containing agent with a sialic acid derivative-containing agent while lowering the temperature to a second predetermined temperature that maintains a flowable state to prepare a heated flowable preparation containing a sialic acid derivative-containing agent and a heated sweetener-containing agent, where the heated flowable preparation containing a sialic acid derivative-containing agent and a heated sweetener-containing agent maintains the second predetermined temperature; and (C) a step of shaping the heated flowable preparation containing a sialic acid derivative-containing agent and a heated sweetener-containing agent into a predetermined shape at a third predetermined temperature lower than the second predetermined temperature to prepare a shaped preparation containing a sialic acid derivative-containing agent and a sweetener. The first predetermined temperature is 100 °C or higher, the second predetermined temperature is lower than the first predetermined temperature and is 70 to 150 °C, the third predetermined temperature is lower than 70 °C, and the sialic acid derivative-containing agent is uniformly contained in the base in the form of a soft candy."

[0235] For example, when the first predetermined temperature exceeds 150°C, the second predetermined temperature can be 70 - 150°C; when the first predetermined temperature is 150°C or lower, the second predetermined temperature can be 70 - 150°C; when the first predetermined temperature is 130°C, the second predetermined temperature can be 70 - 130°C; when the first predetermined temperature is 101°C, the second predetermined temperature can be 70 - 101°C.

[0236] In the above manufacturing method, [Manufacturing method effect D-f (Effect of suppressing deterioration of sialic acid derivative-containing agent during production of soft candy preparation): In step (A), the effect that the sweetener can be easily dissolved and a predetermined amount of moisture can be efficiently evaporated and removed is obtained. Further, when the water content is 4 wt% - 15 wt% of the total amount, the stickiness phenomenon caused by the moisture on the surface of the candy preparation immediately after production and during storage is suppressed, and a desired soft and smooth feeling in taking the medicine is obtained when taking the medicine. Also, in step (B), it becomes possible to easily prepare a heated sweetener-containing heated flowable preparation containing a sialic acid derivative-containing agent, and the effect of suppressing the chemical deterioration of the sialic acid derivative-containing agent due to temperature can be obtained.

[0237] In step (B), when the second predetermined temperature exceeds 150°C, in the step of mixing the sweetener and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent, the sialic acid derivative-containing agent tends to deteriorate due to chemical changes, and there is a risk that the medicinal effect of the sialic acid derivative-containing agent cannot be fully exerted. When the second predetermined temperature is less than 70°C, the viscosity of the sweetener is high, and the sweetener becomes a form without fluidity. Therefore, there is a tendency that the sweetener and the sialic acid derivative-containing agent cannot be mixed, and there is a tendency that a desired candy preparation in which the sialic acid derivative-containing agent is uniformly contained in the sweetener cannot be obtained.

[0238] (A) In the process, as the first predetermined temperature, it is 100 °C or higher, preferably heated to a temperature of 100 °C to 150 °C, more preferably 110 °C to 130 °C, to evaporate and remove the water contained in the sweetener solution to prepare a sweetener-containing heated flowing sweetener having a flowing state, and this process can be preferably carried out. Also, in the (A) process, the content of water contained in the sweetener-containing heated flowing sweetener is preferably boiled down until it becomes preferably 5 to 10% by weight, more preferably 5 to 7%, and this process can be preferably carried out.

[0239] (B) In the process, as the second predetermined temperature, it is a temperature lower than the first predetermined temperature, and a temperature of 70 °C to 150 °C can be preferably carried out, and more preferably, a temperature of 70 °C to 120 °C can be preferably carried out. For example, when the first predetermined temperature exceeds 150 °C, the second predetermined temperature can be preferably 70 to 150 °C. When the first predetermined temperature is 150 °C or lower, the second predetermined temperature can be preferably 70 to 150 °C. When the first predetermined temperature is 130 °C, the second predetermined temperature can be preferably 70 to 120 °C. When the first predetermined temperature is 101 °C, the second predetermined temperature can be preferably 70 to 101 °C.

[0240] As the water content in the soft candy increases, the flexibility of the produced soft candy increases, and there is a tendency that a soft texture in the mouthfeel cannot be obtained. When the water content in the soft candy exceeds 15% by weight, there is a tendency to obtain a candy preparation that is too soft, loses the desired softness and flexibility, or becomes too soft to maintain a solid shape. As the water content in the soft candy decreases, the hardness of the produced soft candy tends to increase. When it is less than 4% by weight, there is a tendency to obtain a candy preparation that has a hard hardness and does not have the desired softness and flexibility, and does not have a soft texture. A candy preparation with a water content exceeding 15% by weight tends to become too soft to maintain a solid shape.

[0241] When the third predetermined temperature is 70°C or higher, the sweetener-containing molded preparation containing the sialic acid derivative-containing agent is in a state where it maintains fluidity and tends not to be molded into a predetermined shape.

[0242] <Regarding the method for producing a preparation containing a sialic acid derivative-containing agent having the form of a gummy candy preparation> The method for producing a preparation containing a sialic acid derivative-containing agent of the present invention preferably comprises the following configuration. The manufacturing method of a preparation containing a sialic acid derivative-containing agent of the present invention is "a preparation comprising a base and a sialic acid derivative-containing agent, the sialic acid derivative-containing agent containing a sialic acid derivative-containing agent, the base containing a confectionery base, the confectionery base having the form of gummy candy containing a gummy candy base and a sweetening agent, and when taken in a human mouth, being used by licking and / or chewing in the mouth, the sweetening agent dissolving in the oral saliva to have a sweet taste, and the sialic acid derivative-containing agent having the property of being released into the oral cavity, remaining in the oral cavity, and passing through the throat. A manufacturing method of a preparation containing a sialic acid derivative-containing agent, comprising: (A) a step of mixing a sweetening agent and water to prepare a sweetening agent solution in which the sweetening agent is dissolved, and heating the sweetening agent solution to a first predetermined temperature to prepare a heated flowing sweetening agent containing 10% to 35% by weight of water and having a heated flowing state, wherein the heated flowing sweetening agent containing the sweetening agent maintains the first predetermined temperature; (B) a step of mixing the heated flowing sweetening agent containing the sweetening agent with a sialic acid derivative-containing agent while maintaining the flowing state at a second predetermined temperature to prepare a heated flowing preparation containing a sialic acid derivative-containing agent and a heated sweetening agent containing the sialic acid derivative-containing agent, wherein the heated flowing preparation containing the sialic acid derivative-containing agent and the heated sweetening agent maintains the second predetermined temperature; and (C) a step of shaping the heated flowing preparation containing the sialic acid derivative-containing agent and the heated sweetening agent into a predetermined shape while lowering the temperature to a third predetermined temperature to prepare a shaped preparation containing a sialic acid derivative-containing agent and a sweetening agent, and the first predetermined temperature is 100°C or higher, and the sialic acid derivative-containing agent is uniformly contained in the base in the form of gummy candy".

[0243] In the above manufacturing method, [Manufacturing method effect D-g (Effect of suppressing deterioration of sialic acid derivative-containing agent during manufacturing of gummy candy preparation): In step (A), the sweetener can be easily dissolved, contains a predetermined amount of water, and further, when the water content is 10% to 35% by weight based on the total amount, the stickiness phenomenon caused by the moisture on the surface of the candy preparation immediately after manufacturing and during storage is suppressed, and it has a comfortable elasticity and soft texture when taken. In step (B), it becomes possible to easily prepare a heated sweetener-containing heated flowable preparation containing a sialic acid derivative-containing agent, and the chemical deterioration of the sialic acid derivative-containing agent due to temperature can be suppressed.] is obtained.

[0244] (B) In the step, when the second predetermined temperature exceeds 150°C, in the step of mixing the sweetener and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent, the sialic acid derivative-containing agent tends to deteriorate due to chemical changes, and there is a risk that the medicinal effect of the sialic acid derivative-containing agent cannot be fully exerted. When the second predetermined temperature is less than 70°C, the viscosity of the sweetener is high, and the sweetener becomes a form without fluidity. Therefore, there is a tendency that the sweetener and the sialic acid derivative-containing agent containing the sialic acid derivative-containing agent cannot be mixed, and there is a tendency that a desired candy preparation in which the sialic acid derivative-containing agent is uniformly contained in the sweetener cannot be obtained.

[0245] (A) In the step, as the first predetermined temperature, it is preferably heated to 100°C or higher, preferably a temperature of 100°C to 150°C, more preferably a temperature of 110°C to 130°C, to prepare a sweetener-containing heated flowable sweetener having a fluid state, and this step can be preferably carried out.

[0246] (B) In the step, as the second predetermined temperature, it is a temperature lower than the first predetermined temperature, and a temperature of 70°C to 150°C can be preferably carried out, more preferably a temperature of 70°C to 120°C, and even more preferably 70 to 100°C can be preferably carried out.

[0247] When the water content in gummy candy is less than 10% by weight, it has a hard property and cannot obtain the desired elasticity, and there is a tendency to obtain a candy preparation having the desired elasticity and soft texture. When the water content in gummy candy exceeds 35% by weight, it has a soft property and cannot obtain the desired elasticity, and there is a tendency to obtain a candy preparation that cannot maintain a solid shape.

[0248] When the third predetermined temperature is 70 °C or higher, the sweetener-containing molded preparation containing the sialic acid derivative substance-containing agent is in a state of maintaining fluidity and tends not to be molded into a predetermined shape.

[0249] <Regarding another preferred production method in the production method of a candy preparation as a preparation containing a sialic acid derivative substance-containing agent>

[0250] In the production method of a candy preparation as the above-mentioned preparation containing a sialic acid derivative substance-containing agent, preferably, it has the following configuration. · "In the step (A) or the step (B), at least one additive auxiliary agent selected from the group consisting of an excipient, a gelling agent, an oil and fat, an emulsifier, a pH adjuster, a fragrance, a cooling agent, and a sweetening aid is mixed to prepare a sialic acid derivative substance-containing maltitol-containing heated fluid preparation in which the sialic acid derivative substance-containing agent is dissolved." As specific substances of additive auxiliary agents such as excipients, gelling agents, oils and fats, emulsifiers, pH adjusters, fragrances, cooling agents, and sweetening aids, the use of each of the above-mentioned additive auxiliary agents is feasible. With this configuration, a candy preparation having [Production method effect D-h (Effect of containing an additive auxiliary agent in a candy preparation): having the above-mentioned (production method effect D, suppressing thermal degradation of the additive auxiliary agent during and / or at the time of production, and further, an action effect corresponding to the action of the contained additive auxiliary agent)] can be obtained.

[0251] In the production method of a candy preparation as the above-mentioned preparation containing a sialic acid derivative substance-containing agent, preferably, it has the following configuration. · "The base contains a confectionery base, the confectionery base contains a candy base and a sweetening agent, the sweetening agent contains the maltitol, the confectionery base further contains a polyhydric alcohol, and the step (B) is to lower the maltitol-containing heated fluid sweetening agent to a second predetermined temperature that maintains a fluid state, and mix the maltitol-containing heated fluid sweetening agent, a sialic acid derivative-containing agent, and further a polyhydric alcohol to prepare a heated maltitol-containing heated fluid preparation containing a sialic acid derivative-containing agent. Here, the heated maltitol-containing heated fluid preparation containing a sialic acid derivative-containing agent is a step of maintaining the second predetermined temperature. Thereby, a preparation containing a sialic acid derivative-containing agent having a candy form in which the deterioration of maltitol over time is suppressed is prepared, and it has a form of a candy preparation in which the sialic acid derivative-containing agent is uniformly contained in the base. A method for producing a candy preparation as a preparation containing a sialic acid derivative-containing agent, characterized in that."

[0252] For example, "in the step (A) or in the step (B), further, a step of mixing a polyhydric alcohol to prepare a heated maltitol-containing heated fluid preparation containing a sialic acid derivative-containing agent in which the sialic acid derivative-containing agent is dissolved is provided, and the second predetermined temperature having a fluid state is 60 to 120 °C, which is lower than 70 to 150 °C. The deterioration of the sialic acid derivative-containing agent during the manufacturing process and storage is suppressed, and the surface deterioration during storage is suppressed. A method for producing a candy preparation, characterized in that" is preferably practicable.

[0253] With this configuration, [Manufacturing method effect D-c (candy preparation, polyhydric alcohol, effect of suppressing deterioration of sialic acid derivative-containing agent during production): The temperature as the second predetermined temperature having a fluid state can maintain a fluid state even at a lower temperature compared to a configuration not containing a polyhydric alcohol. As a result, compared to a configuration not containing a polyhydric alcohol, at a lower temperature, it becomes possible to mix a sialic acid derivative-containing agent without causing deterioration of the sialic acid derivative-containing agent, and it is possible to prepare a sialic acid derivative-containing agent-containing maltitol-containing heated fluid preparation in which the deterioration of the sialic acid derivative-containing agent is suppressed. Further, the appearance change of the surface of the candy preparation during storage described in the above preparation effect D-c (candy preparation, appearance change suppression effect by maltitol and polyhydric alcohol) is suppressed.] A candy preparation as a sialic acid derivative-containing agent-containing preparation having the effect is obtained.

[0254] The polyhydric alcohol is not particularly limited, but particularly preferably, at least one polyhydric alcohol selected from the group consisting of propylene glycol, dipropylene glycol, butylene glycol, and glycerin can be used. The above polyhydric alcohol has a liquid state at a temperature of about 190°C or lower, and can be mixed with a sialic acid derivative-containing agent, maltitol, and a sweetening agent to form a homogeneous mixture. Also, at normal temperature, maltitol, a sialic acid derivative-containing agent, and a polyhydric alcohol have a homogeneous solid state in which they are mixed with each other. In addition, as the polyhydric alcohol, glycerin is particularly preferably applicable. In a configuration containing glycerin, a candy preparation as a sialic acid derivative-containing agent-containing preparation that can maximally and significantly exhibit the above [Manufacturing method effect D-c (candy preparation, glycerin)] and the above-mentioned [Preparation effect D-c (candy preparation, appearance change suppression effect by maltitol and polyhydric alcohol)] is obtained.

[0255] <Regarding the manufacturing method of a sialic acid derivative-containing agent-containing preparation having the form of a chocolate preparation> The method for manufacturing a preparation containing a sialic acid derivative-containing agent of the present invention preferably has the following configuration. · "The base contains a confectionery base, the confectionery base has a form of chocolate containing a chocolate base and a sweetening agent, and when taken in a human mouth, used by licking, and / or used by chewing, the sialic acid derivative-containing agent is released into the mouth together with the confectionery base, and the confectionery base and the sialic acid derivative-containing agent are configured to be able to stay in the mouth or adhere to the oral mucosa. A method for manufacturing a preparation containing a sialic acid derivative-containing agent, comprising: (A) mixing a chocolate base, a sweetening agent, an additive aid, and a powdery sialic acid derivative-containing agent at a temperature of 45°C to 90°C to prepare a chocolate intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the chocolate base, the sweetening agent, the additive aid, and the powdery sialic acid derivative-containing agent are uniformly mixed; (B) dividing the chocolate intermediate mixture into a predetermined shape at a temperature state lowered to 40°C or lower and molding it into a predetermined shape having a form of chocolate. The method for manufacturing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent has a form of a chocolate preparation uniformly contained in the base."

[0256] In the above chocolate manufacturing process, preferably, the step (A) is as follows: "(A-1) At a temperature of about 45°C to 90°C, a predetermined amount of chocolate base, a predetermined amount of sweetener, and an additive aid are mixed to prepare a chocolate base sweetener-containing mixture in which the chocolate base, the sweetener, and the additive aid are uniformly mixed; (A-2) The prepared chocolate base sweetener-containing mixture is subjected to conching at about 60 to about 80°C for about 20 to 24 hours to prepare a conching mixture; (A-3) The prepared conching mixture is maintained at about 50 to 55°C for a predetermined time, then the temperature is lowered to about 25 to 29°C and maintained for a predetermined time, and then maintained at about 31 to 33°C for a predetermined time to perform tempering to prepare a tempered mixture; and (A-4) At a temperature of about 28 to 33°C, a predetermined amount of a powdery sialic acid derivative-containing agent is added to the prepared tempered mixture and mixed to prepare a chocolate intermediate mixture containing the sialic acid derivative-containing agent." Also preferably, the step (B) is as follows: "(B) The prepared chocolate intermediate mixture containing the sialic acid derivative-containing agent is put into a mold container and cooled to about 20°C to form a plate-like shape having the form of chocolate."

[0257] "Conching" is a process of further kneading cacao beans that have been pulverized from a bean state into a clay state with a stronger force for a long time (for example, 10 to 24 hours) using a stirrer, so that the cocoa butter originally contained in the cacao becomes uniform, moisture and acidity are released by frictional heat, resulting in a smoother and more chocolate-like flavor. This is a conventional technique in the chocolate confectionery industry.

[0258] "Tempering" is the temperature adjustment operation to make the crystals of cocoa butter, the main component of chocolate, in the most stable state. Once the chocolate is heated to about 50 °C and melted, the temperature is lowered to 26 - 29 °C, and then raised to 28 - 32 °C again to adjust and stabilize the crystals. This results in shiny, smooth-melting and delicious chocolate. Specifically, in the case of general sweet chocolate, the preferred temperatures are: the melting temperature is 50 - 55 °C, the lowering temperature is 27 - 29 °C, and the holding temperature is 31 - 32 °C. In the case of milk chocolate, the preferred temperatures are: the melting temperature is 45 - 50 °C, the lowering temperature is 26 - 28 °C, and the holding temperature is 29 - 30 °C. In the case of white chocolate, the preferred temperatures are: the melting temperature is 40 - 45 °C, the lowering temperature is 26 - 27 °C, and the holding temperature is 28 - 29 °C.

[0259] With this configuration, [Manufacturing method effect E (Effect that the chocolate preparation and the sialic acid derivative-containing agent can adhere to the oral mucosa for a long time, during manufacturing, effect of suppressing the deterioration of the sialic acid derivative-containing agent): The above-mentioned "Preparation effect E: The sialic acid derivative-containing agent can stay in the mouth for a long time, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time. By making the most of the limited content of the sialic acid derivative-containing agent, the utilization efficiency of the sialic acid derivative-containing agent can be increased. Also, the secretion of saliva is promoted by taking it, and the effect that the sialic acid derivative-containing agent is dissolved in saliva and is easily released into the mouth can be obtained", etc. can be obtained, and at the same time, the deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative-containing agent contained during manufacturing is suppressed, and it becomes possible to manufacture a sialic acid derivative-containing agent-containing preparation capable of suppressing good virus activity. The manufacturing method of the sialic acid derivative-containing agent-containing preparation having the effect] is obtained.

[0260] In the manufacturing method of the sialic acid derivative-containing agent-containing preparation having the form of the above chocolate preparation, preferably, it has the following configuration. · "The chocolate base contains (i) a cacao-derived raw material and (ii) at least one chocolate additive aid selected from the group consisting of an emulsifier, milk fat, and liquid vegetable oil, and the sweetener contains at least one sweetener selected from the group consisting of maltitol, xylitol, reduced palatinose, sorbitol, erythritol, mannitol, lactitol, sucrose, glucose, fructose, maltose, and starch syrup, and has a form of a chocolate preparation in which the sialic acid derivative-containing agent is uniformly contained in the base, a method for producing a preparation containing a sialic acid derivative-containing agent".

[0261] With this configuration, [Production method effect E-a (taste suppression effect of the chocolate preparation and the sialic acid derivative-containing agent, anti-caking suppression effect during production): The above-mentioned "Preparation effect E-a: By containing both the cacao-derived raw material and the sweetener, a preparation containing a sialic acid derivative-containing agent having a form of a chocolate preparation with a sweet taste in which the inherent taste of the sialic acid derivative-containing agent is suppressed and the bitterness caused by the cacao-derived raw material is significantly suppressed is obtained, and deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative-containing agent contained during production is suppressed, and it becomes possible to produce a preparation containing a sialic acid derivative-containing agent that can be expected to suppress good virus activity" effect], a method for producing a preparation containing a sialic acid derivative-containing agent is obtained.

[0262] Also, [Manufacturing method effect E-b (long-term oral adhesion effect of chocolate preparation and sialic acid derivative-containing agent): By containing at least one chocolate additive selected from the group consisting of the above-mentioned "formulation effect E-b: (b) emulsifier, milk fat, and vegetable oil", when taken into a human mouth, it has a suitable taste sensation as a chocolate confectionery, and the chocolate preparation strongly adheres to the oral mucosa, and a sialic acid derivative-containing agent-containing formulation in which the sialic acid derivative-containing agent is likely to stay in the mouth for a long time] can be obtained, and it is possible to suppress deterioration such as thermal degradation and oxidative degradation of the sialic acid derivative-containing agent contained during production, and a manufacturing method of a sialic acid derivative-containing agent-containing formulation capable of suppressing good virus activity is obtained.

[0263] In the manufacturing method of a sialic acid derivative-containing agent-containing formulation having the form of the above-mentioned chocolate preparation, preferably, it has the following configuration. · "(i) The sweetener contains at least maltitol, the maltitol is uniformly contained in the chocolate base in a powdered form, and among the maltitol contained in a powdered form, maltitol having a particle size of 300 μm or less contains 90% or more, and / or (ii) the sialic acid derivative-containing agent is uniformly contained in the chocolate base in a powdered form, and among the sialic acid derivative-containing agent contained in a powdered form, the sialic acid derivative-containing agent having a particle size of 300 μm or less contains 90% or more, and the sialic acid derivative-containing agent-containing formulation having the form of a chocolate preparation in which the sialic acid derivative-containing agent is uniformly contained in the base".

[0264] With this configuration, [Manufacturing method effect E-g (chocolate preparation, maltitol particle size, excellent taste): having the aforementioned "preparation effect E-g", excellent taste due to improved uniform mixing and dispersibility with good uniform dispersibility between the chocolate base and maltitol, and unpleasant taste such as a gritty feeling when taking due to the powder form of maltitol being suppressed, and further having healthy low calories due to low-calorie maltitol, etc., a sialic acid derivative-containing agent-containing preparation having the form of a chocolate preparation] is obtained, and further, deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative-containing agent contained during production is suppressed, and it becomes possible to produce a sialic acid derivative-containing agent-containing preparation capable of suppressing good virus activity] is obtained. A method for producing a sialic acid derivative-containing agent-containing preparation having an effect is obtained.

[0265] Also, with this configuration, [Manufacturing method effect E-h (chocolate preparation, sialic acid derivative-containing agent particle size, excellent taste): having the aforementioned "preparation effect E-h", excellent chewing feeling due to improved uniform mixing and dispersibility between the good chocolate base and the sialic acid derivative-containing agent, and unpleasant taste such as a gritty feeling when taking due to the powder form of virus activity suppression being suppressed, and further, the unique and uncomfortable taste of the sialic acid derivative-containing agent during taking is suppressed, and a sialic acid derivative-containing agent-containing preparation having the form of a chocolate preparation with an excellent taste feeling, etc.] is obtained, and further, deterioration such as thermal deterioration and oxidative deterioration of the sialic acid derivative-containing agent contained during production is suppressed, and it becomes possible to produce a sialic acid derivative-containing agent-containing preparation capable of suppressing good virus activity] is obtained. A method for producing a sialic acid derivative-containing agent-containing preparation having an effect is obtained.

[0266] <Method for producing a sialic acid derivative-containing agent-containing preparation having the form of a troche preparation or chewable preparation> In the method for producing a sialic acid derivative-containing agent-containing preparation in which the above sialic acid derivative-containing agent is contained in a base, preferably, it has the following configuration. · A method for producing a preparation containing a sialic acid derivative-containing agent having a form of a troche preparation or a chewable preparation containing a troche base or a chewable base and a sweetening agent, comprising: (A) mixing a troche base or a chewable base, a sweetening agent, and a powdery sialic acid derivative-containing agent at a temperature of 130 °C or lower to prepare a powdery or granular intermediate mixture in which the troche base or chewable base, the sweetening agent, and the powdery sialic acid derivative-containing agent are uniformly mixed; (B) compressing and molding the intermediate mixture containing the sialic acid derivative-containing agent uniformly into a predetermined shape at a temperature of 35 °C or lower to form a preparation having a form of a troche preparation or a chewable preparation. The preparation is used by licking and / or chewing when taken in a human mouth, and the sialic acid derivative-containing agent is configured to be released into the mouth and to be retained in the mouth or adhered to the oral mucosa, and has a form of a troche preparation or a chewable preparation.

[0267] In the method for producing a preparation containing a sialic acid derivative-containing agent contained in a base, preferably, it has the following configuration. ·A method for producing a preparation containing a sialic acid derivative-containing agent having a form of a troche preparation or a chewable preparation containing a troche base or a chewable base and a sweetening agent, comprising: (A-1) mixing a troche base or a chewable base and a sweetening agent at a temperature of 130°C or lower to prepare a powdery or granular troche base intermediate mixture or chewable base intermediate mixture in which the troche base or chewable base and the sweetening agent are uniformly mixed; (A-2) mixing the troche base intermediate mixture or chewable base intermediate mixture and a powdery sialic acid derivative-containing agent at a temperature of 35°C or lower to prepare a sialic acid derivative-containing agent uniformly-containing intermediate material in which the troche base or chewable base, the sweetening agent, and the sialic acid derivative-containing agent are uniformly mixed; and (B) compressing and molding the sialic acid derivative-containing agent uniformly-containing intermediate material into a predetermined shape at a temperature of 35°C or lower to form a preparation having a form of a troche preparation or a chewable preparation. When taken in a human mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released into the mouth and is configured to be able to stay in the mouth or adhere to the oral mucosa, and has a form of a troche preparation or a chewable preparation. A method for producing a preparation containing a sialic acid derivative-containing agent]。

[0268] With this configuration, [Manufacturing method effect K (Effect of suppressing deterioration of sialic acid derivative-containing agent in troche preparation, chewable preparation): having the aforementioned "Manufacturing method effect A (Effect of preventing deterioration of sialic acid derivative-containing agent contained during manufacturing)", and the sialic acid derivative-containing agent can stay in the mouth for a long time while being licked, and the sialic acid derivative-containing agent can adhere to the oral mucosa for an even longer time. By making the most of the limited content of the sialic acid derivative-containing agent, the utilization efficiency of the sialic acid derivative-containing agent can be increased, and an excellent virus activity inhibitory effect can be achieved. Also, by taking and licking or chewing, the secretion of saliva is promoted, and the effect that the sialic acid derivative-containing agent is easily dissolved in saliva and released into the mouth can be obtained. Furthermore, since the sialic acid derivative-containing agent is in a form covered by the base, even if it is stored and left in the normal atmosphere such as room temperature, humidity, and brightness in a general household for a long time, deterioration such as moisture absorption and air oxidation of the sialic acid derivative-containing agent can be prevented, and a manufacturing method of a troche preparation or a chewable preparation having excellent stability in storage] can be obtained. The compression pressure during compression molding is not particularly limited. For example, 10 MPa or more is preferable, and more preferably about 10 to about 30 MPa is preferably applicable.

Example

[0269] Hereinafter, examples of the preparation containing a sialic acid derivative-containing agent and the manufacturing method of the preparation containing a sialic acid derivative-containing agent of the present invention will be described.

Example

[0270] A sialic acid derivative-containing agent was prepared by the following method.

Example

[0271] This powdered bird's nest extract enzyme-treated powder was ground in a mortar to prepare each sialic acid derivative-containing agent having the following particle diameters. (a) Sialic acid derivative-containing agent (passing through a 35-mesh sieve, particle diameter of about 500 μm or less). (b) A sialic acid derivative-containing agent having a particle diameter of about 500 μm or less and further passing through a 50-mesh sieve, having a particle diameter of about 300 μm or less. (c) A sialic acid derivative-containing agent having a particle diameter of about 500 μm or less and further sieved through a 50-mesh sieve, having a particle diameter of about 300 - 500 μm remaining on the sieve. (d) A sialic acid derivative-containing agent having a particle diameter of about 500 μm or less and further passing through a 100-mesh sieve, having a particle diameter of about 150 μm or less. (e) A sialic acid derivative-containing agent having a particle diameter of about 500 μm or less and further passing through a 170-mesh sieve, having a particle diameter of about 90 μm or less.

[0272] The sialic acid derivative-containing agent prepared above, having a particle size of about 150 μm or less, had a light tea-yellow color. Also, when taken orally and licked, it had an unpleasant taste with a peculiar sense of discomfort. When this sialic acid derivative-containing agent was left in an air atmosphere at 140 °C for 1 hour, no change in appearance was observed at all. However, when this sialic acid derivative-containing agent was left in an air atmosphere at about 160 °C for 1 hour, the appearance changed slightly to brown. Furthermore, when left in an air atmosphere at 180 °C for 1 hour, the appearance changed to dark brown. This brown coloring is thought to be due to some kind of deterioration.

[0273] The edible bird's nest enzyme-treated powder prepared in this way contains a sialic acid derivative-containing agent, and the sialic acid derivative-containing agent has a chemical structure in which sialic acid (SA) and galactose (Gal) are bonded, and the second carbon of sialic acid and the sixth carbon of galactose are via an oxygen atom bonded in a 2,6-bond structure, and the second carbon of sialic acid and the third carbon of galactose are via an oxygen atom bonded in a 2,3-bond structure, and it is confirmed as described in the following paper by the inventors to be a sialic acid derivative-containing agent having such a structure. [Hirokazu Yagi, Nakao Yasukawa, Shin-Yi Yu, Chao-Tan Guo, Noriko Takahashi, Tadanobu Takahashi, Wakoto Bukawa, Takashi Suzuki, Kay-Hooi, Yasuo Suzuki, Koichi Kato: The expression of sialylated high-antennary N-glycans in edible bird’s nest. Carbhydrate Res., 313, 1373-1377(2008)].

Examples

[0274] The "Neu5Acα(2-6)Galβ(1-4)GlcNAcon PGA" (sugar chain introduction rate: 5%) as the sialic acid derivative-containing agent of the present invention was produced by the following method. The synthesis scheme is shown below. In addition, Fig. 3 shows a schematic diagram of the production method of "Neu5Acα(2-6)Galβ(1-4)GlcNAcon PGA".

[0275] Compound 1 (450 mg, 0.627 mmol, manufactured by Tokyo Chemical Industry Co., Ltd.) and Compound 2 (750 mg, 0.987 mmol, manufactured by Tokyo Chemical Industry Co., Ltd.) shown in Fig. 3 were dissolved in DMF / MeOH (1 / 1, 60 ml) and stirred for 18 hours. After confirming the completion of the reaction by TLC (AcOEt / MeOH / H2O / AcOH = 4 / 2 / 1 / 0.5), it was concentrated under reduced pressure. The obtained residue was subjected to column chromatography (CHCl3 / MeOH = 3 / 1 → 2 / 1 → 1 / 1) to obtain the above Compound 3 (273 mg, 32%).

[0276] Compound 3 (260 mg, 0.191 mmol) was dissolved in MeOH (12 ml), Et3N (0.6 ml) was added, and the mixture was stirred for 20 hours. After confirming the completion of the reaction by TLC (AcOEt / MeOH / H2O / AcOH = 4 / 2 / 1 / 0.5), it was concentrated under reduced pressure. The obtained residue was subjected to gel filtration column chromatography (LH-20, MeOH) to obtain Compound 4 (211 mg, 97%).

[0277] Compound 4 (158 mg, 0.139 mmol) and sodium polyglutamate (average molecular weight 84,600, 419 mg, 2.77 mmol (as sodium glutamate)) were dissolved in H2O (100 ml), THF (50 ml) and DMTMM: 4-(4,6-Dimethoxy-1,3,5-triazin-2-yl)-4-methylmorpholinium Chloride (385 mg, 1.39 mmol) were added, and the mixture was stirred for 2 hours. After confirming the completion of the reaction by TLC (AcOEt / MeOH / H2O / AcOH = 4 / 2 / 1 / 0.5), EtOH was added and the mixture was concentrated under reduced pressure. The obtained residue was dissolved in 5% aqueous NaHCO3 solution (80 ml) and subjected to gel filtration column chromatography (G-25, MeOH) to obtain Compound 5 (530 mg, 92%), and a polymeric compound containing 5% sugar chain of the present invention (hereinafter, also referred to as "polyglutamic acid compound with 5% sugar chain introduction rate") was obtained. In the same manner, by using 0.0278 mmol of Compound 4, a polymeric compound containing 1% sugar chain of the present invention was obtained, and by using 0.278 mmol of Compound 4, a polymeric compound containing 10% sugar chain was obtained.

[0278] The polyglutamic acid (polymeric) compounds with 1%, 5%, and 10% sugar chain introduction rates synthesized in the above examples were confirmed by NMR and capillary electrophoresis. From the capillary electrophoresis results of the polyglutamic acid compound with 1% sugar chain introduction and polyglutamic acid, and the 1H-NMR results of the polyglutamic acid compound with 1% sugar chain introduction and polyglutamic acid, it was confirmed that the sugar chain introduction rate was 1%. The characteristics of the polyglutamic acid with 1% sugar chain introduction rate are shown below. · Sugar chain introduction amount: 5.8 per molecule (= 560 Glu × 5%). · Average molecular weight: 116,520 (= 84,600 + (1140 × 28)). · Number of sugar chain moles per 1 μg: 1 [μg] / 116,520 × 5.6 [Glu] = 6.15 × 10-5 [μmol]. In this way, "Neu5Acα(2-6)Galβ(1-4)GlcNAc on PGA" as a sialic acid derivative-containing agent was synthesized.

Example

[0279] A sialic acid derivative-containing agent having a NeuAc-Gal bond with a 2,6-linkage structure between sialic acid and galactose was produced by the following method. · Preparation of defatted egg yolk by defatting process of egg yolk: 200 mL of ethanol was added to the egg yolk (5 eggs) contained in a glass beaker, and the mixture was sufficiently stirred and mixed. The mixture was transferred to a glass centrifuge container and centrifuged at 5000 rpm for 30 minutes to obtain a supernatant layer and a precipitate layer. The supernatant layer was removed to obtain a precipitate. 200 mL of ethanol was added to the obtained precipitate, and the mixture was sufficiently stirred and mixed. The mixture was centrifuged by the same operation as above to obtain a supernatant layer and a precipitate layer. The supernatant layer was removed to obtain a precipitate. This operation was repeated 5 times to obtain 70 g of defatted egg yolk as a precipitate.

[0280] · Preparation of a crudely purified extract containing a sialic acid derivative-containing agent by water extraction process: 100 mL of water was added to the obtained 70 g of defatted egg yolk, and the mixture was sufficiently stirred and mixed. The mixture was centrifuged at 5000 rpm for 30 minutes to separate into a supernatant layer and a precipitate layer, and the supernatant layer was recovered. On the other hand, 100 mL of water was added to the precipitate, and the mixture was sufficiently stirred and mixed. The mixture was centrifuged at 5000 rpm for 30 minutes to separate into a supernatant layer and a precipitate layer, and the supernatant layer was recovered. The operation of recovering this supernatant layer was repeated 3 times to obtain a crudely purified extract containing a sialic acid derivative-containing agent.

[0281] · Preparation of a crudely purified precipitate containing a sialic acid derivative-containing agent by alcohol precipitation process: Each of the supernatant layers recovered as described above was filtered through a glass filter, and the filtrate was concentrated by evaporating water under reduced pressure to obtain a concentrated solution of about 50 mL. Thereafter, the obtained concentrated solution was poured into 400 mL of ethanol, and the generated precipitate was centrifuged at 5000 rpm for 30 minutes to separate into a supernatant layer and a precipitate layer. The generated supernatant layer was removed to recover the precipitate. The obtained precipitate was put into water and stirred well, and the mixture was then put into a large amount of ethanol again. The formed precipitate was centrifuged at 5000 rpm for 30 minutes to separate into a supernatant layer and a precipitate layer. The formed supernatant layer was removed to recover the precipitate. This operation was repeated three times. These precipitates were recovered to prepare 0.7 g of a crude purified precipitate containing a sialic acid derivative-containing agent.

[0282] · Preparation of a crude purified product containing a sialic acid derivative-containing agent by a desalting step: A glass column was filled with 20 g of ODS resin prepared by reacting dimethyloctadecylchlorosilane with porous silica gel. After washing the resin with methanol and then further washing with water, a methanol / water-washed ODS resin was prepared. 0.7 g of the crude purified precipitate containing a sialic acid derivative-containing agent prepared as described above was dissolved in 5 mL of water, added to the methanol / water-washed ODS resin, and then further washed by adding 100 mL of water. Thus, a "crude purified product containing a sialic acid derivative-containing agent retained by the resin" was obtained.

[0283] · Preparation of a purified product containing a sialic acid derivative-containing agent by an elution step and a drying step: The "crude purified product containing a sialic acid derivative-containing agent retained by the resin" prepared as described above was eluted with a 2% aqueous acetonitrile solution by a conventional method to elute the sialic acid derivative-containing agent into the aqueous acetonitrile solution. By freeze-drying the eluate by a conventional method, about 50 mg of a purified product containing a sialic acid derivative-containing agent was obtained. The obtained purified product containing a sialic acid derivative-containing agent was confirmed to contain a sialic acid derivative-containing agent having a NeuAc-Gal bond with a 2,6-bond structure between sialic acid and galactose as shown in Fig. 1(A) by comparison with a standard product (a sialic acid derivative-containing agent manufactured by Tokyo Chemical Industry) according to the measurement result by HPLC (high-performance liquid chromatography analysis) using an HPLC measuring device manufactured by GL Sciences Inc. In this way, a sialic acid derivative-containing agent was prepared from the egg yolk of a chicken egg.

Example

[0284] The sialic acid derivative-containing agent of the present invention was produced by the following high-pressure extraction method using bird's nest. Commercially available bird's nest was dried at 70 °C for 16 hours, pulverized, passed through a 30-mesh (pore size 600 μm) sieve to remove external foreign matters such as feathers, and bird's nest powder having a size of 600 μm or less was prepared. 25 g of this bird's nest powder was mixed with 1000 mL of distilled water, and the mixture was pressurized and heat-treated in a high-pressure vessel at a pressure of about 100 MPa and a temperature of about 40 °C for about 10 hours to prepare a bird's nest extraction suspension. This bird's nest extraction suspension was reacted at 45 °C for 4 hours using about 1 g of protease-containing enzyme (trade name "Pancreatin F" manufactured by Amano Enzyme Inc.). Thereafter, the reaction-treated solution was adjusted to pH 6.5 to pH 8.5, heat-treated at 90 °C for 5 minutes to inactivate the enzyme, then filtered through filter paper (ADVANTEC filter paper no. 2), and the filtrate was recovered. Evaporation treatment of water was performed on the recovered filtrate to obtain a concentrate. Thereafter, the concentrate was freeze-dried. In this way, a powdered bird's nest extract enzyme-treated powder obtained by enzyme-treating the extract from bird's nest was prepared.

[0285] <Regarding the embodiment of the sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation>

Example

Example

[0286] A sialic acid derivative-containing agent-containing preparation having a form of a chewing gum preparation containing 5% by weight of a sialic acid derivative-containing agent with respect to the total amount was prepared by the following method. First, the step of preparing a gum base will be described. Into a kneader heated to about 100 to 130°C, 300 g of polyisobutylene, 250 g of vinyl acetate resin, 50 g of ester gum, 200 g of microcrystalline wax, and 50 g of glycerin fatty acid ester were weighed and added, and kneaded until each component melted and became uniform. Then, 150 g of fine talc powder was added into the kneader, and further kneaded until these components became uniform. Then, it was taken out from the kneader and cooled at room temperature. In this way, a gum base was prepared. The obtained gum base had a viscous solid that could be easily deformed by pressure at normal temperature.

[0287] Separately, at a room temperature of about 25°C, in a beaker, maltose syrup (reduced maltose syrup containing about 15% water: 27 g), glycerin (3 g), and the sialic acid derivative-containing agent (15 g) having a predetermined particle size (150 μm or less or 90 μm or less) prepared in the aforementioned "Example 1-a" were mixed to prepare a sialic acid derivative-containing agent sweetener mixture. In this example, the sialic acid derivative-containing agent sweetener mixture had a form in which the sialic acid derivative-containing agent was uniformly mixed in a swollen state. (A) Step: Next, the prepared gum base (120 g) was weighed and put into a kneader heated to about 50 - 60°C, and further, maltitol powder (132 g) having a predetermined particle size (150 μm or less or 90 μm or less) was put in and kneaded until the maltitol powder became uniform. Then, 2.5 g of aspartame (manufactured by Ajinomoto Co., Inc.) as a sweetening aid, an additive aid such as 0.5 g of green pigment (manufactured by Nippon Chlorophyll Co., Ltd.) as a colorant, and the above-prepared sialic acid derivative-containing agent sweetener mixture (45 g) were put in and kneading was continued until all components were uniformly mixed. The total of these kneading times was about 20 minutes. Then, it was taken out from the kneader and left on a fluororesin sheet at a room temperature of about 25°C. In this way, a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base, polyhydric alcohol, sweetener, additive aid, and powdery sialic acid derivative-containing agent were uniformly mixed was prepared.

[0288] (B) Step: Next, 45 g of the chewing gum intermediate mixture prepared above was spread into a plate shape with a thickness of 4 mm, and further cut and divided into a length with a vertical width of about 7 mm and a horizontal width of 7 mm to prepare a sialic acid derivative-containing agent-containing preparation having a form of a chewing gum preparation with a weight of 2 g per substantially rectangular parallelepiped shape. In this way, a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation is prepared, which contains 120 g of a gum base, 132 g of maltitol powder, 2.5 g of aspartame, 0.5 g of green dye, 27 g of starch syrup (reduced maltose starch syrup containing about 15% water), 3 g of glycerin, and 15 g of a sialic acid derivative-containing agent. Note that aspartame and green dye are additive aids. That is, the chewing gum preparation thus prepared contains a sialic acid derivative-containing agent at 5% by weight based on the total preparation.

[0289] The preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation thus prepared had a good chewing feeling without any discomfort similar to that of ordinary chewing gum when taken orally and chewed, and had a good sweetness peculiar to maltitol and starch syrup. Also, when chewed, the gritty feeling due to the powder forms of both the sialic acid derivative-containing agent and maltitol was suppressed, and a smooth chewing feeling was obtained. Also, when the chewing gum preparation containing this sialic acid derivative-containing agent was chewed, a unique taste due to the sialic acid derivative-containing agent was slightly felt. That is, when chewed, it was confirmed that the sialic acid derivative-containing agent contained in the chewing gum preparation was released into the oral cavity together with saliva and adhered to the oral mucosa for a long time. Also, in a separate experiment, no change in appearance was observed even when stored in an atmosphere of about 20 - 30°C and 40 - 90% RH for 30 days.

Example

[0290] In a method similar to Example 2-1a above, a preparation containing a sialic acid derivative-containing agent having the form of a chewing gum preparation containing a sialic acid derivative-containing agent at 10% by weight based on the total amount was prepared. Example 2-1b differed from Example 2-1a in the content ratio of the sialic acid derivative-containing agent. Example 2b contained a 10% by weight sialic acid derivative-containing agent relative to the total amount, and Example 2a above contained a 5% by weight sialic acid derivative-containing agent relative to the total amount. That is, in step (A) of the production method described in the aforementioned "Example 2-1a", Instead of 15 g of the sialic acid derivative-containing agent containing the sialic acid sugar chain substance, a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly containing 30 g of the sialic acid derivative-containing agent containing the sialic acid sugar chain substance was prepared. The other steps were produced by the same method as the production method described in the aforementioned "Example 2-1a".

[0291] The sialic acid derivative-containing agent-containing preparation having the form of a chewing gum preparation containing the sialic acid derivative-containing agent prepared in this way had a good chewing feeling without a sense of incongruity similar to that of a normal chewing gum confectionery when taken orally and chewed, and had a good sweetness peculiar to maltitol and starch syrup. Also, when chewed, the gritty feeling due to the powder form of both the sialic acid derivative-containing agent and maltitol was suppressed, and a smooth chewing feeling was obtained. Also, when the chewing gum preparation containing this sialic acid derivative-containing agent was chewed, a unique taste due to the sialic acid derivative-containing agent was slightly felt. Compared with the chewing gum preparation of the above "Example 2-1b", a unique taste due to the sialic acid derivative-containing agent was strongly felt. That is, when chewed, it was confirmed that the sialic acid derivative-containing agent contained in the chewing gum preparation was released into the oral cavity together with saliva and adhered to the oral mucosa for a long time. Also, in a separate experiment, even when stored in an atmosphere of about 20 to 30 °C and 40 to 90% RH for 30 days, no change in appearance was observed.

[0292] [Reference Example 2-1c] A chewing gum preparation containing only a gum base and 5% by weight of a sialic acid derivative-containing agent and not containing a sweetening agent, glycerin, an additive aid, etc. was prepared by the following method. The gum base was prepared in the same manner as in Example 2-1a described above. The obtained gum base had a viscous solid that could be easily deformed by pressure at room temperature. Next, 190 g of the prepared gum base was weighed and put into a kneader heated to about 50 to 60 °C, and further, 10 g of the sialic acid derivative-containing agent containing the sialic acid sugar chain substance prepared in the above "Example 1-a" was mixed, and kneading was continued until all the components were uniformly mixed. The total of these kneading times was about 20 minutes. Then, it was taken out from the kneader and left on a fluororesin sheet at room temperature of about 25 °C. In this way, a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly containing intermediate material in which the gum base and the powdery sialic acid derivative-containing agent were uniformly mixed was prepared. Next, 45 g of the chewing gum intermediate mixture prepared above was spread into a plate shape with a thickness of 4 mm, and further cut and divided into a length with a vertical width of about 7 mm and a horizontal width of about 7 mm to form a chewing gum preparation having a weight of 2 g per substantially rectangular parallelepiped shape and containing a sialic acid derivative-containing agent.

[0293] When the obtained chewing gum preparation containing the sialic acid derivative-containing agent was taken orally and chewed, a unique taste due to the sialic acid derivative-containing agent was felt. Also, when the obtained chewing gum preparation was taken orally, it had a slightly harder chewing feeling compared to the chewing gum preparation obtained in Example 1-a, had no sweetness at all, and tended to be inferior in the feeling of taking as a chewing gum confectionery.

[0294] [Reference Example 2-1d] A chewing gum preparation containing only a gum base and not containing a sialic acid derivative-containing agent, a sweetening agent, glycerin, an additive adjuvant, etc. was prepared by the following method. The gum base was prepared in a method similar to Example 2a above. The obtained gum base had a viscous solid that could be easily deformed by pressure at room temperature. This gum base was spread into a plate shape with a thickness of 4 mm, and further cut and divided into a length of about 7 mm in the vertical direction and about 7 mm in the horizontal direction to prepare a chewing gum preparation in the shape of a substantially rectangular parallelepiped with a weight of 2 g per piece.

[0295] When the chewing gum preparation containing only the obtained gum base was taken into the mouth and chewed, there was no sweetness and no taste as a confectionery was felt at all.

[0296] [Reference Example 2-1e] By the following method, a chewing gum preparation containing a gum base, a sweetener, glycerin, and an additive adjuvant and not containing a sialic acid derivative substance was prepared. In the step (A) of Example 2-1a above, a chewing gum intermediate mixture not containing a sialic acid derivative substance was prepared. This chewing gum preparation was spread into a plate shape with a thickness of 4 mm, and further cut and divided into a length of about 7 mm in the vertical direction and about 7 mm in the horizontal direction to prepare a chewing gum preparation in the shape of a substantially rectangular parallelepiped with a weight of 2 g per piece.

[0297] When the obtained chewing gum preparation containing no sialic acid derivative substance and containing each body agent was taken into the mouth and chewed, it had a good chewing feeling without a sense of incongruity and a good sweetness similar to that of a normal chewing gum confectionery. Also, compared with the above "Example 2-1a" and "Example 2-1b", no taste peculiar to the sialic acid derivative substance was felt at all.

Example

[0298] By the following method, for the "chewing gum preparation containing a sialic acid derivative substance", "chewing gum preparation not containing a sialic acid derivative substance", and "sialic acid derivative substance only" prepared according to the above "Example 2-1a" to "Reference Example 2-1e", a measurement experiment was conducted on the presence or absence of a virus activity inhibitory effect against influenza virus.

[0299] [Example 2-2 - Experiment 2a: Preparation of chewing gum formulations containing sialic acid derivative-containing agents, or chewing gum formulations not containing sialic acid derivative-containing agents, or aqueous extraction samples such as aqueous solutions of sialic acid derivative-containing agents] The sialic acid derivative-containing agent has the property of being soluble in water and insoluble in hexane. On the other hand, the gum base has the property of being insoluble in water and soluble in hexane. Note that water and hexane do not mix with each other and have the property of separating. Utilizing this property, for each chewing gum formulation prepared in "Example 2-1a" to "Reference Example 2-1e" by the following method, using a liquid of water and hexane, the sialic acid derivative-containing agent contained in the chewing gum formulation was dissolved in water, and water extraction samples "Sample 21" to "Sample 28" were prepared by extraction with water. Note that for the chewing gum formulations, chewing gum formulations left standing at room temperature of about 25°C for 30 to 50 days after production were used.

[0300] Each accurately weighed predetermined amount of chewing gum formulation was cut into approximately 1 mm square shapes to create chewing gum formulation cut pieces. These chewing gum formulation cut pieces were put into a separating funnel into which water and hexane had been poured. The separating funnel containing these chewing gum formulation cut pieces, water, and hexane was shaken vigorously up, down, left, and right, and then, after allowing it to stand, the state of separation into two layers, an aqueous phase and a hexane layer, was confirmed, and then the aqueous layer was taken out into a beaker. Next, the hexane layer was put back into the separating funnel, more water was added, the separating funnel was shaken vigorously up, down, left, and right, and then, after allowing it to stand and separating into two layers, an aqueous phase and a hexane layer, the aqueous layer was taken out into a beaker. This operation was repeated three times to take out the aqueous layer. After that, the total aqueous layer was filtered, the filtrate was taken out, and this filtrate was prepared as an aqueous extraction sample containing a sialic acid derivative-containing agent. On the premise that all sialic acid derivative-containing agents contained in the chewing gum preparation are dissolved in water and extracted into the aqueous layer, the weight of the chewing gum preparation used and the total amount of water used were accurately weighed and used so that the content of the sialic acid derivative-containing agent in the water extraction sample containing the sialic acid derivative-containing agent would reach the desired content.

[0301] In this way, the following water extraction samples were prepared for each chewing gum preparation. · Sample 21: For the chewing gum preparation of "Example 2-1a", a water extraction sample containing 10 mg of sialic acid derivative-containing agent per 1 mL of water was prepared (sialic acid derivative-containing agent concentration in water: 10 mg / mL). · Sample 22: For the chewing gum preparation of "Example 2-1b", a water extraction sample containing 20 mg of sialic acid derivative-containing agent per 1 mL of water was prepared (sialic acid derivative-containing agent concentration in water: 20 mg / mL). · Sample 27: For the chewing gum preparation of "Reference Example 2-1c", a water extraction sample containing 10 mg of sialic acid derivative-containing agent per 1 mL of water was prepared (sialic acid derivative-containing agent concentration in water: 10 mg / mL). · Sample 23: A water extraction sample was prepared for the gum base preparation prepared only from the gum preparation without containing the sialic acid derivative-containing agent and the sweetening agent of "Reference Example 2-1d" (without the content of sialic acid derivative-containing agent in water, 0 mg / mL). · Sample 26: For the chewing gum preparation of "Reference Example 2-1e", a water extraction sample not containing the sialic acid derivative-containing agent was prepared (without the content of sialic acid derivative-containing agent, 0 mg / mL in water). Regarding the water extraction samples prepared as above, the presence or absence of the components contained in the chewing gum preparation, the concentration of the sialic acid derivative-containing agent in the water extraction sample, etc. are shown in Table 1.

[0302] As reference samples, Samples 24, 25, and 28 containing only the following sialic acid derivative-containing agents without having the form of a chewing gum preparation were prepared. · Sample 24: A predetermined amount of a sialic acid derivative-containing agent was dissolved in a predetermined amount of water to prepare an aqueous solution of the sialic acid derivative-containing agent (sialic acid derivative-containing agent concentration: about 5 mg / mL, about 0.5% aqueous solution). · Sample 25: Using a predetermined amount of the sialic acid derivative-containing agent powder of the above "Sample 24", an extraction experiment was carried out with a mixed solution of water and hexane to prepare an aqueous solution of the sialic acid derivative-containing agent (sialic acid derivative-containing agent concentration: 5 mg / mL, 0.5% aqueous solution). · Sample 28: A predetermined amount of a sialic acid derivative-containing agent was dissolved in a predetermined amount of water to prepare an aqueous solution of the sialic acid derivative-containing agent (sialic acid derivative-containing agent concentration: about 250 mg / mL, about 25% aqueous solution).

[0303] Regarding the aqueous solution containing the sialic acid derivative-containing agent and the water extraction sample prepared as described above, the concentration of the sialic acid derivative-containing agent in the aqueous solution or the water extraction sample, etc. is shown in Table 1.

[0304]

Table 1

[0305] [Example 2-2 - Experiment 2b: Experiment to confirm the effect of inhibiting influenza virus activity] Regarding the water extraction sample of the chewing gum preparation prepared above and "Samples 21" to "Samples 28" such as the aqueous solution containing the sialic acid derivative-containing agent, a measurement experiment was carried out on the presence or absence of the effect of inhibiting influenza virus activity against "avian influenza virus A (A / mallard / Hokkaido / 24 / 09 (H5N1))".

[0306] Measurement experiments on the presence or absence of the effect of influenza virus activity inhibition were carried out as follows to measure the presence or absence of the effect of influenza virus activity inhibition in accordance with the measurement methods described in the known papers "Sriwilaijaroen N, Suzuki K, Takashita E, Hiramitsu H, Kanie O, Suzuki Y, J Antimicrob Chemother. 2015;70(10):2797-2809" and "Sriwilaijaroen N, Nakakita SI, Kondo S, Yagi H, Kato K, Murata T, Hiramatsu H, Kawahara T, Watanabe Y, Kanai Y, Ono T, Hirabayashi J, Suzuki Y. FEBSJ. 2018;285(9):1611-1634".

[0307] MDCK ATCC cells were monolayered in a flat-bottom 96-well plastic plate, and the cell count was measured. Each sample prepared in the above "Experiment 2a" was aliquoted, and "Sample 21" to "Sample 28" for measurement, each serially diluted to various concentrations with PBS from each sample, were prepared. Each of the prepared samples was mixed with the virus (0.06 PFU / cell) and left at 4°C for 1.5 hours in the presence of 4 μg / mL of acetylated trypsin. This mixture was added to pre-cultured serum-free MDCK ATCC cells (monolayer cultured cells), and after culturing in a carbon dioxide incubator for 23 hours, methanol was added and fixed for 1 minute. In this process, holes are opened through which antibodies can penetrate the viral membrane. Subsequently, a primary antibody against influenza virus nucleoprotein (anti-nucleoprotein mouse IgG, 4E6, an antibody that reacts with all of the influenza A viruses) was added, and further, an antibody against the primary antibody (β-galactosidase enzyme-labeled mouse IgG secondary antibody, Calbiochem, San Diego, Ca, USA) was added. After reacting at 37°C for 45 minutes, 4-methylumbelliferyl β-D-galactoside (MU-Gal, Wako, Osaka), a fluorescent substrate for β-galactosidase, was added. Since the fluorescence of MU released by the enzyme becomes stronger in proportion to the amount of virus, the amount of influenza virus antigen in each sample was measured by measuring the fluorescence intensity (excitation: 355 nm; emission: 460 nm).

[0308] The content of each of the prepared samples is shown in Table 1 above. Also, for each sample, the measurement results of the remaining virus amount measured corresponding to the content of the sialic acid derivative-containing agent (μg / mL) in the diluted sialic acid derivative-containing agent are shown in FIG. 5. FIG. 5 is a graph in an example showing the relationship between the content of the sialic acid derivative-containing agent and the remaining virus amount in the sialic acid derivative-containing agent-containing preparation against "avian influenza A virus (A / mallard / Hokkaido / 24 / 09(H5N1))". In FIG. 5, the content of the sialic acid derivative-containing agent is the content of the sialic acid derivative-containing agent in 1 mL of the sample, indicated by "μg / mL", and the amount of virus at each concentration was evaluated by measuring the "fluorescence intensity (excitation: 355 nm; emission: 460 nm)" described in the above "Experiment 3b".

[0309] [Example 2-2 - Experiment 2c: Visualization experiment on the effect of suppressing influenza virus activity] Furthermore, with respect to the water extraction sample of the chewing gum preparation prepared above and the aqueous solution containing the sialic acid derivative-containing agent, a visualization experiment was conducted on the presence or absence of the effect of suppressing influenza virus activity against "avian influenza A virus (A / mallard / Hokkaido / 24 / 09 (H5N1))". In order to visualize the expression of viral antigens in virus-infected cells, experiments were conducted according to the experimental methods described in the aforementioned known papers "J Antimicrob Chemother. 2015;70(10):2797-2809" and "FEBS J. 2018;285(9):1611-1634".

[0310] That is, infection suppression was confirmed by visualizing in the following manner, scanning the color development, and recording it. In cells infected with influenza A virus, after a certain period of infection, nucleoprotein, which is an important antigen common to all influenza viruses, appears. Therefore, an antibody against influenza A virus nucleoprotein, "horseradish peroxidase (HRP)-conjugated goat anti-mouse IgG antibody", was added to the infected cells, and a blue color was developed using a reagent containing H202, N,N-diethyl-p-phenylenediamine dihydrochloride, and 4-chloro-1-naphthol, which are substrates of HRP. Since the blue color becomes darker in proportion to the amount of virus, the amount of virus in the infected cells was confirmed thereby. The results of this method were recorded by scanning the colored plate. The experimental results are shown in Fig. 6. Fig. 6 is a simplified photograph showing visualization in an example indicating the relationship between the content of the sialic acid derivative-containing agent in the preparation containing the sialic acid derivative-containing agent and the remaining virus amount against the influenza virus.

[0311] [Example 2-2 - Summary: Summary of experimental results on the virus activity suppression effect of the chewing gum preparation containing the sialic acid derivative-containing agent] The following findings were confirmed from the experimental results of Figs. 5 and 6 above. · Finding a: A chewing gum preparation containing a sialic acid derivative-containing agent, a gum base, a sweetener, and a polyhydric alcohol has an effect of suppressing viral activity against avian influenza virus A. (Sample 21, Sample 22). · Finding b: A chewing gum preparation containing a gum base, a sweetener, and a polyhydric alcohol but not containing a sialic acid derivative-containing agent has no effect of suppressing viral activity against avian influenza virus A. (Sample 26). · Finding c: A chewing gum preparation containing only a sialic acid derivative-containing agent and a gum base and not containing a sweetener and a polyhydric alcohol has an effect of suppressing viral activity against avian influenza virus A. (Sample 27). · Finding d: A prepared chewing gum consisting only of a gum base and not containing a sialic acid derivative-containing agent, a sweetener, and a polyhydric alcohol has no effect of suppressing viral activity against avian influenza virus A. (Sample 23). · Finding e: Only the sialic acid derivative-containing agent has an effect of suppressing viral activity against avian influenza virus A. (Sample 24, Sample 28). · Finding f: A sample obtained by extracting only the sialic acid derivative-containing agent with water and hexane has an effect of suppressing viral activity against avian influenza virus A. (Sample 25).

[0312] · Finding g: From the results of "a chewing gum preparation containing a gum base, a sweetener, and a polyhydric alcohol but not containing a sialic acid derivative-containing agent (Sample 26)" and "a chewing gum preparation containing only a gum base and not containing a sialic acid derivative-containing agent (Sample 23) having no effect of suppressing viral activity", it can be seen that "the gum base, sweetener, and / or polyhydric alcohol have no effect of suppressing viral activity. That is, other components contained in the chewing gum preparation other than the sialic acid derivative-containing agent have no effect of suppressing viral activity against influenza virus. · Finding h: Chewing gum preparations (Sample 21, Sample 22, Sample 27) containing at least a gum base and a sialic acid derivative-containing agent have an effect of s...

Claims

1. It comprises a base and a sialic acid derivative-containing agent, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a virus activity inhibitory function against influenza virus or coronavirus, The virus activity inhibitory function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The base contains a confectionery base, The confectionery base contains a gum base, a sweetening agent, and further a polyhydric alcohol, The sweetening agent contains at least maltitol, The polyhydric alcohol contains glycerin or butylene glycol, (i) The sweetening agent is uniformly contained in the gum base in a powdery form, and the sweetening agent contained in a powdery form has a particle size of 150 μm or less, (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in a powdery form has a particle size of 150 μm or less, The sialic acid derivative-containing agent is uniformly contained in the base, It has a chewable elastic solid form, It has the form of a chewing gum preparation, When taken into a person's mouth and chewed, The discomfort of chewing powder caused by the sialic acid derivative-containing agent contained in a powdery form is suppressed, The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa, A preparation containing a sialic acid derivative-containing agent, characterized by the above.

2. It comprises a base and a sialic acid derivative-containing agent, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are linked via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are linked via an oxygen atom, The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The base contains a confectionery base, The confectionery base contains a gum base, a sweetening agent, and further a polyhydric alcohol, The sweetening agent contains at least a first sweetening agent and a second sweetening agent, The first sweetening agent is maltitol, The second sweetening agent is xylitol, The polyhydric alcohol contains glycerin, (i) The sweetening agent is uniformly contained in the gum base in a powdery form, and the sweetening agent contained in a powdery form has a particle size of 150 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in a powdery form has a particle size of 150 μm or less. The sialic acid derivative-containing agent is uniformly contained in the base, It has a chewable elastic solid form, It has the form of a chewing gum preparation, When taken and chewed in a person's mouth, The discomfort such as chewing the powder caused by the sialic acid derivative-containing agent contained in a powdery form is suppressed, The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa, A preparation containing a sialic acid derivative-containing agent, characterized in that.

3. It contains a base and a sialic acid derivative-containing agent, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are linked via an oxygen atom in a chemical structural formula, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are linked via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are linked via an oxygen atom, The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The base contains a confectionery base, The confectionery base contains a gum base, a sweetening agent, and further a polyhydric alcohol, The sweetening agent contains at least a first sweetening agent and a second sweetening agent, The first sweetening agent is maltitol, The second sweetening agent is starch syrup, The polyhydric alcohol contains glycerin, (i) The sweetening agent is uniformly contained in the gum base in a powdered form, and the sweetening agent contained in a powdered form has a particle size of 300 μm or less, (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdered form, and the sialic acid derivative-containing agent contained in a powdered form has a particle size of 300 μm or less, The sialic acid derivative-containing agent is uniformly contained in the base, It has a chewable elastic solid form, It has the form of a chewing gum preparation, When taken into a person's mouth and chewed, The discomfort of chewing powder caused by the sialic acid derivative-containing agent contained in a powdered form is suppressed, The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa, A preparation containing a sialic acid derivative-containing agent, characterized by this.

4. It contains a base and a sialic acid derivative-containing agent, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in a chemical structural formula, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The base contains a confectionery base. The confectionery base contains a gum base, a sweetening agent, and further a polyhydric alcohol. The sweetening agent, the polyhydric alcohol, and the sialic acid derivative-containing agent (a) The sweetening agent contains reduced palatinose, and the polyhydric alcohol contains glycerin. (i) The sweetening agent is uniformly contained in the gum base in a powdery form, and the sweetening agent contained in the powdery form has a particle size of 90 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 90 μm or less. Or (b) The sweetening agent contains xylitol, and the polyhydric alcohol contains butylene glycol. (i) The sweetening agent is uniformly contained in the gum base in a powdery form, and the sweetening agent contained in the powdery form has a particle size of 150 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 150 μm or less. Or (c) The sweetening agent contains sorbitol, and the polyhydric alcohol contains isopropyl glycol. (i) The sweetening agent is uniformly contained in the gum base in a powdery form, and the sweetening agent contained in the powdery form has a particle size of 90 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 90 μm or less. The sialic acid derivative-containing agent is uniformly contained in the base. It has a chewable elastic solid form. It has the form of a chewing gum preparation. When taken into a person's mouth and chewed, The discomfort such as chewing the powder caused by the sialic acid derivative-containing agent contained in the powdery form is suppressed. The substance-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa. A preparation containing a sialic acid derivative-containing agent, characterized in that.

5. The content of the sialic acid derivative-containing agent is 5 to 25% by weight based on the total amount. A preparation containing the sialic acid derivative-containing agent according to any one of claims 1 to 4, characterized in that...

6. Comprising a base, a sialic acid derivative-containing agent, and further water, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The sialic acid derivative-containing agent has a particle size of 150 μm or less, The base contains a confectionery base, The confectionery base contains a candy base, a sweetening agent, and further a polyhydric alcohol, The content of the water is 7% by weight or less based on the total amount, The sweetening agent contains at least maltitol as a first sweetening agent, The polyhydric alcohol contains glycerin or butylene glycol, It has a solid form, It has the form of a hard candy preparation, The change in the surface over time is suppressed, The sialic acid derivative-containing agent is uniformly contained in the base, When taken in a person's mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released into the mouth and is configured to be able to stay in the mouth or adhere to the oral mucosa, A preparation containing a sialic acid derivative-containing agent, characterized in that...

7. Comprising a base, a sialic acid derivative-containing agent, and further water, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a virus activity inhibitory function against influenza virus or coronavirus, The virus activity inhibitory function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The sialic acid derivative-containing agent has a particle size of 150 μm or less, The base contains a confectionery base, The confectionery base contains a candy base, a sweetening agent, and further a polyhydric alcohol, The water content is 7% by weight or less based on the total amount, The sweetening agent contains at least maltitol as a first sweetening agent and reduced palatinose as a second sweetening agent, The polyhydric alcohol contains glycerin, It has a solid form, It has the form of a hard candy preparation, The change in the surface over time is suppressed, The sialic acid derivative-containing agent is uniformly contained in the base, When taken in a person's mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released into the mouth, and the sialic acid derivative-containing agent is configured to be able to stay in the mouth or adhere to the oral mucosa, A preparation containing a sialic acid derivative-containing agent, characterized by the above.

8. It contains a base, a sialic acid derivative-containing agent, and further water, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula, The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a virus activity inhibitory function against influenza virus or coronavirus, The virus activity inhibitory function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The sialic acid derivative-containing agent has a particle size of 150 μm or less, The base contains a confectionery base, The confectionery base contains a candy base, a sweetening agent, and further a polyhydric alcohol, The water content is 7% by weight or less based on the total amount, The sweetener contains at least maltitol as a first sweetener and starch syrup as a second sweetener, The polyhydric alcohol contains glycerin, has a solid form, has the form of a hard candy preparation, is suppressed from surface deterioration over time, the sialic acid derivative-containing agent is uniformly contained in the base, when taken in a human mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released in the mouth and is configured to be able to stay in the mouth or adhere to the oral mucosa, A preparation containing a sialic acid derivative-containing agent, characterized by the above.

9. The content of the sialic acid derivative-containing agent is 1 to 10% by weight based on the total amount, and / or the content of the polyhydric alcohol is 1 to 20% by weight based on the total amount, The preparation containing a sialic acid derivative-containing agent according to any one of claims 6 to 8, characterized by the above.

10. It contains a base and a sialic acid derivative-containing agent, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The sialic acid derivative-containing agent has a particle size of 150 μm or less, The base contains a confectionery base, The confectionery base contains a troche base, a sweetener, and further a polyhydric alcohol, The sweetener contains maltitol, The maltitol has a particle size of 150 μm or less, The polyhydric alcohol contains glycerin, has a solid form, has the form of a troche preparation, is suppressed from surface deterioration over time, the sialic acid derivative-containing agent and the base are uniformly contained, When taken into a person's mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released into the mouth, and the sialic acid derivative-containing agent is configured to be able to stay in the mouth or adhere to the oral mucosa. A preparation containing a sialic acid derivative-containing agent, characterized by the above.

11. Comprising a base and a sialic acid derivative-containing agent, A method for producing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, Comprising a step of mixing a base and a sialic acid derivative-containing agent at a temperature of 130 °C or lower to form a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base. The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in a chemical structural formula. The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom. The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus. The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus. The base contains a confectionery base. The confectionery base has the form of chewing gum containing a gum base, a sweetening agent, and further a polyhydric alcohol. The sweetening agent contains maltitol. The polyhydric alcohol contains butylene glycol or glycerin. (i) The sweetening agent is uniformly contained in the gum base in a powdery form. The sweetening agent contained in a powdery form has a particle size of 150 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in a powdery form has a particle size of 150 μm or less. Step of preparing a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material by mixing the gum base, the sweetener, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent at a temperature of 20 to 90 °C, so that the gum base, the sweetener, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent are uniformly mixed. Here, the sialic acid derivative-containing agent is uniformly contained in the gum base and the polyhydric alcohol in a powdery form. The sweetener is uniformly contained in the gum base and the polyhydric alcohol in a powdery form. And Step of dividing the chewing gum intermediate mixture into a predetermined shape and forming it into a predetermined shape having the form of chewing gum in a temperature state where the temperature of the chewing gum intermediate mixture is lowered to 45 °C or lower. Comprising Having the form of a chewing gum preparation When taken into a person's mouth and chewed The discomfort of chewing powder caused by the powdery sialic acid derivative-containing agent contained in a powdery form is suppressed. The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa. A method for manufacturing a preparation containing a sialic acid derivative-containing agent, characterized in that.

12. Comprising a base and a sialic acid derivative-containing agent, A method for manufacturing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, Comprising a step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130 °C or lower to form an intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base. The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in a chemical structural formula. The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom. The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus. The virus activity inhibitory function has a function of inhibiting the activity of a virus, and / or a function of inhibiting the growth of a virus, and / or a function of inhibiting infection by a virus. The base contains a confectionery base. The confectionery base has a form of chewing gum containing a gum base, a sweetener, and further a polyhydric alcohol. The sweetener contains at least a first sweetener and a second sweetener. The first sweetener is maltitol. The second sweetener is xylitol. The polyhydric alcohol contains glycerin. (i) The sweetener is uniformly contained in the gum base in a powdery form. The sweetener contained in a powdery form has a particle size of 150 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in a powdery form has a particle size of 150 μm or less. (A) A step of mixing the gum base, the sweetener, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent at a temperature of 20 to 90°C to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base, the sweetener, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent are uniformly mixed. Here, the sialic acid derivative-containing agent is uniformly contained in the gum base and the polyhydric alcohol in a powdery form. The sweetener is uniformly contained in the gum base and the polyhydric alcohol in a powdery form. And (B) A step of dividing the chewing gum intermediate mixture into a predetermined shape in a temperature state lowered to a temperature of 45°C or less and molding it into a predetermined shape having a form of chewing gum. It comprises It has a form of a chewing gum preparation. When taken into a person's mouth and chewed, The discomfort such as chewing powder caused by the sialic acid derivative-containing agent contained in a powdery form is suppressed. The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa. A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

13. A method for producing a preparation containing a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base. A step of mixing a base agent and a sialic acid derivative-containing agent at a temperature of 130°C or lower to form an intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base agent, namely, a base agent-sialic acid derivative-containing agent uniformly-containing intermediate material, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in a chemical structural formula, The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a virus activity suppression function against influenza virus or coronavirus, The virus activity suppression function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The base agent contains a confectionery base agent, The confectionery base agent has the form of chewing gum containing a gum base agent, a sweetening agent, and further a polyhydric alcohol, The sweetening agent contains at least a first sweetening agent and a second sweetening agent, The first sweetening agent is maltitol, The second sweetening agent is starch syrup, The polyhydric alcohol contains glycerin, (i) The sweetening agent is uniformly contained in the gum base agent in a powdery form, The sweetening agent contained in a powdery form has a particle size of 300 μm or less, (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base agent in a powdery form, and the sialic acid derivative-containing agent contained in a powdery form has a particle size of 300 μm or less, (A) A step of mixing the gum base agent, the sweetening agent, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent at a temperature of 20 to 90°C to prepare a chewing gum intermediate mixture as a base agent-sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base agent, the sweetening agent, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent are uniformly mixed, Here, the sialic acid derivative-containing agent is uniformly contained in the gum base agent and the polyhydric alcohol in a powdery form, The sweetening agent is uniformly contained in the gum base agent and the polyhydric alcohol in a powdery form, And, Step of dividing the chewing gum intermediate mixture into a predetermined shape and forming it into a predetermined shape having the form of chewing gum while maintaining a temperature state where the temperature is lowered to 45°C or lower. Comprising: Having the form of a chewing gum preparation. When taken into a person's mouth and chewed, The discomfort of chewing powder caused by the sialic acid derivative-containing agent contained in powder form is suppressed. The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa. A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

14. Comprising a base and a sialic acid derivative-containing agent, A method for producing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, Comprising a step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130°C or lower to form an intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base. The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom. The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom. The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus. The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus. The base contains a confectionery base. The confectionery base has the form of chewing gum containing a gum base, a sweetening agent, and further a polyhydric alcohol. The sweetening agent, the polyhydric alcohol, and the sialic acid derivative-containing agent (A) The sweetening agent contains reduced palatinose, and The polyhydric alcohol contains glycerin. (i) The sweetening agent is uniformly contained in the gum base in powder form, and the sweetening agent contained in powder form has a particle size of 90 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 90 μm or less. Or, (b) The sweetener contains xylitol, The polyhydric alcohol contains butylene glycol, (i) The sweetener is uniformly contained in the gum base in a powdery form, and the sweetener contained in the powdery form has a particle size of 150 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 150 μm or less. Or, (c) The sweetener contains sorbitol, The polyhydric alcohol contains isopropyl glycol, (i) The sweetener is uniformly contained in the gum base in a powdery form, and the sweetener contained in the powdery form has a particle size of 90 μm or less. (ii) The sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 90 μm or less. (A) At a temperature of 20 to 90°C, the gum base, the sweetener, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent are mixed to prepare a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly containing intermediate material in which the gum base, the sweetener, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent are uniformly mixed. Here, the sialic acid derivative-containing agent is uniformly contained in the gum base and the polyhydric alcohol in a powdery form. The sweetener is uniformly contained in the gum base and the polyhydric alcohol in a powdery form. And, (B) A step of dividing the chewing gum intermediate mixture into a predetermined shape and forming it into a predetermined shape having the form of chewing gum in a temperature state where the temperature of the chewing gum intermediate mixture is lowered to 45°C or less. comprising having the form of a chewing gum preparation, when taken into a person's mouth and chewed, the discomfort of chewing powder caused by the sialic acid derivative-containing agent contained in the powdery form is suppressed. The sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa. A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

15. The content of the sialic acid derivative-containing agent is 5 to 25% by weight based on the total amount. A method for producing a preparation containing a sialic acid derivative-containing agent according to any one of claims 11 to 14, characterized by the above.

16. It contains a base, a sialic acid derivative-containing agent, and further water. A method for producing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, A step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130 ° C or lower to form a base-sialic acid derivative-containing agent uniformly-containing intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base. The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula. The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom. The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus. The virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus. The base contains a confectionery base. The confectionery base has the form of a hard candy containing a hard candy base, a sweetening agent, and further a polyhydric alcohol. The sweetening agent contains maltitol. The polyhydric alcohol contains glycerin or butylene glycol. The sialic acid derivative-containing agent contains a sialic acid derivative-containing agent having a particle size of 150 μm or less. (A) A step of mixing a sweetener and water to prepare a sweetener solution in which the sweetener is dissolved, and a step of heating the sweetener solution to a first predetermined temperature to evaporate and remove water to prepare a heated sweetener-containing heated fluid sweetener having a water content of 7% by weight or less. Here, the heated sweetener-containing heated fluid sweetener maintains the first predetermined temperature, (B) A step of mixing the heated sweetener-containing heated fluid sweetener with a powdery sialic acid derivative-containing agent in a state where the temperature is lowered to a second predetermined temperature that maintains the fluid state to prepare a heated multiitol-containing heated fluid preparation containing a sialic acid derivative-containing agent. Here, the heated sweetener-containing heated fluid preparation containing a sialic acid derivative-containing agent maintains the second predetermined temperature, and, (C) A step of shaping the heated sweetener-containing heated fluid preparation containing a sialic acid derivative-containing agent to a predetermined shape at a third predetermined temperature to prepare a shaped preparation containing a sweetener and a sialic acid derivative-containing agent. comprising: The first predetermined temperature is 120° C. or higher, The second predetermined temperature is lower than the first predetermined temperature and is 70 to 120° C., The third predetermined temperature is less than 70° C., The sialic acid derivative-containing agent has the form of a hard candy preparation uniformly contained in the base, In the step (B), the heated multiitol-containing fluid sweetener is mixed with a sialic acid derivative-containing agent and a polyhydric alcohol in a state where the temperature is lowered to a second predetermined temperature that maintains the fluid state to prepare a heated multiitol-containing heated fluid preparation containing a sialic acid derivative-containing agent. Here, the heated multiitol-containing heated fluid preparation containing a sialic acid derivative-containing agent maintains the second predetermined temperature. Thereby, a preparation containing a sialic acid derivative-containing agent having the form of a candy preparation in which surface deterioration over time is suppressed is prepared. The sialic acid derivative-containing agent has the form of a candy preparation uniformly contained in the base, When taken into a person's mouth, it is used by licking and / or chewing in the mouth. The sweetener dissolves in saliva in the mouth, has a sweet taste, and the medicinal ingredient is released into the mouth and stays in the mouth and passes through the throat. A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

17. It comprises a base, a sialic acid derivative-containing agent, and further water. A method for producing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, comprising the step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130°C or lower to form an intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula. The sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom. The sialic acid derivative-containing agent has a virus activity suppression function against influenza virus or coronavirus. The virus activity suppression function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus. The base contains a confectionery base. The confectionery base has the form of hard candy containing a hard candy base, a sweetening agent, and further a polyhydric alcohol. The sweetening agent contains maltitol as the first sweetening agent and reduced palatinose as the second sweetening agent. The polyhydric alcohol contains glycerin. The sialic acid derivative-containing agent contains a sialic acid derivative-containing agent having a particle size of 150 μm or less. (A) A step of mixing a sweetening agent and water to prepare a sweetening agent solution in which the sweetening agent is dissolved, and a step of heating the sweetening agent solution to a first predetermined temperature to evaporate and remove water to prepare a heated flowing sweetening agent containing a water content of 7% by weight or less and having a heated flowing state, where the heated flowing sweetening agent containing the sweetening agent maintains the first predetermined temperature. (B) The step of mixing the heat-flowable sweetener containing the sweetener with the powdery sialic acid derivative-containing agent in a state where the heat-flowable sweetener containing the sweetener is lowered to a second predetermined temperature at which the flow state is maintained, to prepare a heat-mannitol-containing heat-flowable preparation containing a sialic acid derivative-containing agent, wherein the heat-flowable preparation containing the sweetener and the sialic acid derivative-containing agent maintains the second predetermined temperature, and, (C) The step of shaping the heat-flowable preparation containing the sweetener and the sialic acid derivative-containing agent into a predetermined shape in a state where the temperature is lowered to a third predetermined temperature, to prepare a shaped preparation containing the sweetener and the sialic acid derivative-containing agent, , comprising: The first predetermined temperature is 120°C or higher, The second predetermined temperature is lower than the first predetermined temperature and is 70 to 120°C, The third predetermined temperature is lower than 70°C, The sialic acid derivative-containing agent has the form of a hard candy preparation in which the sialic acid derivative-containing agent is uniformly contained in the base, In the step (B), the heat-flowable mannitol-containing sweetener is mixed with the sialic acid derivative-containing agent and further polyhydric alcohol in a state where the heat-flowable mannitol-containing sweetener is lowered to a second predetermined temperature at which the flow state is maintained, to prepare a heat-mannitol-containing heat-flowable preparation containing a sialic acid derivative-containing agent, wherein the heat-flowable preparation containing the sialic acid derivative-containing agent and the heat-mannitol maintains the second predetermined temperature, Thereby, a preparation containing a sialic acid derivative-containing agent having the form of a candy preparation in which surface deterioration over time is suppressed is prepared, The sialic acid derivative-containing agent has the form of a candy preparation in which the sialic acid derivative-containing agent is uniformly contained in the base, When taken into a person's mouth, it is used by licking and / or chewing in the mouth. The sweetener dissolves in saliva in the mouth, has a sweet taste, and the medicinal ingredient is released into the mouth and stays in the mouth and passes through the throat. A method for producing a preparation containing a sialic acid derivative-containing agent, characterized in that.

18. A method for producing a preparation containing a sialic acid derivative-containing agent, comprising a base, a sialic acid derivative-containing agent, and further water, wherein the sialic acid derivative-containing agent is contained in the base. A step of mixing a base agent and a sialic acid derivative-containing agent at a temperature of 130°C or lower to form a base agent-sialic acid derivative-containing agent uniformly-containing intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base agent. The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in a chemical structural formula. The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom. The sialic acid derivative-containing agent has a virus activity inhibitory function against influenza virus or coronavirus. The virus activity inhibitory function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus. The base agent contains a confectionery base agent. The confectionery base agent has the form of hard candy containing a hard candy base agent, a sweetening agent, and further a polyhydric alcohol. The sweetening agent contains maltitol as a first sweetening agent and starch syrup as a second sweetening agent. The polyhydric alcohol contains glycerin. The sialic acid derivative-containing agent contains a sialic acid derivative-containing agent having a particle size of 150 μm or less. (A) A step of mixing a sweetening agent and water to prepare a sweetening agent solution in which the sweetening agent is dissolved, and heating the sweetening agent solution to a first predetermined temperature to evaporate and remove water to prepare a heated flowing sweetening agent-containing heated flowing sweetening agent having a water content of 7% by weight or less. Here, the heated flowing sweetening agent-containing heated flowing sweetening agent maintains the first predetermined temperature. (B) A step of mixing the heated flowing sweetening agent-containing heated flowing sweetening agent with a powdery sialic acid derivative-containing agent while lowering the temperature to a second predetermined temperature that maintains a flowing state to prepare a sialic acid derivative-containing agent-containing heated maltitol-containing heated flowing preparation containing the sialic acid derivative-containing agent. Here, the sialic acid derivative-containing agent-containing heated sweetening agent-containing heated flowing preparation maintains the second predetermined temperature. And (C) A step of shaping the sialic acid derivative-containing agent-containing heated sweetening agent-containing heated flowing preparation into a predetermined shape at a third predetermined temperature to prepare a sialic acid derivative-containing agent-containing sweetening agent-containing shaped preparation. comprising; the first predetermined temperature is 120° C. or higher; the second predetermined temperature is lower than the first predetermined temperature and is 70 to 120° C.; the third predetermined temperature is lower than 70° C.; the sialic acid derivative-containing agent is uniformly contained in the base in the form of a hard candy preparation; the step (B) is a step of mixing the maltitol-containing heated fluid sweetener, a sialic acid derivative-containing agent, and a polyhydric alcohol in a state where the maltitol-containing heated fluid sweetener is lowered to a second predetermined temperature that maintains a fluid state, to prepare a heated maltitol-containing heated fluid preparation containing a sialic acid derivative-containing agent, wherein the heated maltitol-containing heated fluid preparation containing a sialic acid derivative-containing agent maintains the second predetermined temperature; thereby, a preparation containing a sialic acid derivative-containing agent having the form of a candy preparation in which surface alteration over time is suppressed is prepared; the sialic acid derivative-containing agent is uniformly contained in the base in the form of a candy preparation; when taken into a human mouth, it is used by licking and / or chewing in the mouth, the sweetener dissolves in saliva in the mouth, has a sweet taste, and the medicinal ingredient is released into the mouth and stays in the mouth and passes through the throat; A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

19. the content of the sialic acid derivative-containing agent is 1 to 10% by weight based on the total amount; and / or the content of the polyhydric alcohol is 1 to 20% by weight based on the total amount, A method for producing a preparation containing a sialic acid derivative-containing agent according to any one of claims 16 to 18, characterized by the above.

20. comprising a base and a sialic acid derivative-containing agent; A method for producing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, comprising a base and a sialic acid derivative-containing agent; the sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom; the sialic acid derivative has a 2,6-linkage structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-linkage structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom; The sialic acid derivative-containing agent has a virus activity inhibitory function against influenza virus or coronavirus, The virus activity inhibitory function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus, The sialic acid derivative-containing agent has a particle size of 150 μm or less, The base contains a confectionery base, The confectionery base contains a troche base, a sweetening agent, and further a polyhydric alcohol, The sweetening agent contains maltitol, The maltitol has a particle size of 150 μm or less, The polyhydric alcohol contains glycerin, (A-1) A step of mixing a troche base and a sweetening agent at a temperature of 130° C. or lower to prepare a powdery or granular intermediate mixture of the troche base in which the troche base and the sweetening agent are uniformly mixed, (A-2) A step of mixing the intermediate mixture of the troche base and the powdery sialic acid derivative-containing agent at a temperature of 35° C. or lower to prepare a uniformly mixed intermediate material containing the sialic acid derivative-containing agent in which the troche base, the sweetening agent, and the sialic acid derivative-containing agent are uniformly mixed, And, (B-1) A step of compression molding the intermediate material uniformly containing the sialic acid derivative-containing agent into a predetermined shape at a temperature of 20 to 35° C. to form a predetermined shape having the form of a troche preparation, It has the form of a troche preparation, The deterioration of the surface over time is suppressed, When taken in a human mouth, it is used by licking and / or chewing, and the sialic acid derivative-containing agent is released into the mouth, and the sialic acid derivative-containing agent is configured to be able to stay in the mouth or adhere to the oral mucosa, A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

21. The sialic acid derivative-containing agent is a sialic acid derivative-containing agent obtained by enzymatically treating edible bird's nest, A method for producing a preparation containing a sialic acid derivative-containing agent according to any one of claims 11 to 20, characterized by the above.

22. The sialic acid derivative-containing agent is a sialic acid derivative-containing agent extracted from the egg yolk of a chicken egg, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in the chemical structural formula. The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid is bonded to the sixth carbon of galactose via an oxygen atom. A method for producing a preparation containing a sialic acid derivative-containing agent according to any one of claims 11 to 20, characterized by the above.

23. A method for producing a preparation containing a base and a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, and the method comprises: a step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130 ° C or lower to form an intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base; wherein the sialic acid derivative-containing agent is (a) a sialic acid derivative-containing agent obtained by subjecting edible bird's nest to enzymatic treatment; wherein the sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom; wherein the sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid is bonded to the sixth carbon of galactose via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid is bonded to the third carbon of galactose via an oxygen atom; wherein the sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus; wherein the virus activity suppressing function has a function of suppressing the activity of the virus, and / or a function of suppressing the growth of the virus, and / or a function of suppressing infection with the virus; wherein the base contains a confectionery base; wherein the confectionery base has a form of chewing gum containing a gum base, a sweetener, and further a polyhydric alcohol; wherein the sweetener contains maltitol; wherein the polyhydric alcohol contains butylene glycol or glycerin; (i) the sweetener is uniformly contained in the gum base in a powdery form, and the sweetener contained in the powdery form has a particle size of 150 μm or less; (ii) the sialic acid derivative-containing agent is uniformly contained in the gum base in a powdery form, and the sialic acid derivative-containing agent contained in the powdery form has a particle size of 150 μm or less; wherein the content of the sialic acid derivative-containing agent is 5 to 25% by weight based on the total amount. Step of preparing a chewing gum intermediate mixture as a base sialic acid derivative-containing agent uniformly-containing intermediate material in which the gum base, the sweetening agent, the polyhydric alcohol, and the powdery sialic acid derivative-containing agent are mixed at a temperature of 20 to 90 °C, wherein the sialic acid derivative-containing agent is uniformly contained in the gum base and the polyhydric alcohol in a powdery form, the sweetening agent is uniformly contained in the gum base and the polyhydric alcohol in a powdery form, and, Step of dividing the chewing gum intermediate mixture into a predetermined shape and molding it into a predetermined shape having the form of chewing gum in a temperature state where the temperature of the chewing gum intermediate mixture is lowered to 45 °C or lower, comprising, having the form of a chewing gum preparation, when taken into a person's mouth and chewed, the discomfort of chewing powder caused by the powdery sialic acid derivative-containing agent contained in a powdery form is suppressed, the sialic acid derivative-containing agent is released into the oral cavity, and the sialic acid derivative-containing agent is configured to be able to stay in the oral cavity and / or adhere to the oral mucosa, A method for producing a preparation containing a sialic acid derivative-containing agent, characterized by the above.

24. Comprising a base, a sialic acid derivative-containing agent, and further water, A method for producing a preparation containing a sialic acid derivative-containing agent, wherein the sialic acid derivative-containing agent is contained in the base, Comprising a step of mixing the base and the sialic acid derivative-containing agent at a temperature of 130 °C or lower to form an intermediate material in which the sialic acid derivative-containing agent is uniformly contained in the base, The sialic acid derivative-containing agent is (a) a sialic acid derivative-containing agent obtained by enzymatically treating bird's nest, The sialic acid derivative-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom in a chemical structural formula, The sialic acid derivative has a 2,6-bond structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom, or a 2,3-bond structure in which the second carbon of sialic acid and the third carbon of galactose are bonded via an oxygen atom, The sialic acid derivative-containing agent has a function of suppressing virus activity against influenza virus or coronavirus, The virus activity suppression function has a function of suppressing the activity of a virus, and / or a function of suppressing the growth of a virus, and / or a function of suppressing infection by a virus. The base contains a confectionery base. The confectionery base has the form of a hard candy containing a hard candy base, a sweetener, and further a polyhydric alcohol. The sweetener contains maltitol. The polyhydric alcohol contains glycerin or butylene glycol. The sialic acid derivative-containing agent contains a sialic acid derivative-containing agent having a particle size of 150 μm or less. The content of the sialic acid derivative-containing agent is 1 to 10% by weight based on the total amount. And / or The content of the polyhydric alcohol is 1 to 20% by weight based on the total amount. (A) A step of mixing a sweetener and water to prepare a sweetener solution in which the sweetener is dissolved, and heating the sweetener solution to a first predetermined temperature to evaporate and remove water to prepare a heated flowing sweetener-containing heated flowing sweetener having a water content of 7% by weight or less. Here, the heated flowing sweetener-containing heated flowing sweetener maintains the first predetermined temperature. (B) A step of mixing the heated flowing sweetener-containing heated flowing sweetener with a powdery sialic acid derivative-containing agent in a state where the temperature is lowered to a second predetermined temperature that maintains the flowing state to prepare a heated flowing preparation containing a sialic acid derivative-containing agent, a sweetener, and maltitol. Here, the heated flowing preparation containing the sialic acid derivative-containing agent and the sweetener maintains the second predetermined temperature. And (C) A step of shaping the heated flowing preparation containing the sialic acid derivative-containing agent and the sweetener into a predetermined shape at a third predetermined temperature to prepare a shaped preparation containing the sialic acid derivative-containing agent and the sweetener. It comprises: The first predetermined temperature is 120°C or higher. The second predetermined temperature is lower than the first predetermined temperature and is 70 to 120°C. The third predetermined temperature is less than 70°C. The sialic acid derivative-containing agent is in the form of a hard candy preparation uniformly contained in the base. The step (B) is a step of preparing a heated multiitol-containing flowable preparation containing a sialic acid derivative agent, in which the multiitol-containing heated flowable sweetener is mixed with a sialic acid derivative agent and further a polyhydric alcohol while being lowered to a second predetermined temperature at which the flowable state is maintained, and the heated multiitol-containing flowable preparation containing the sialic acid derivative agent is maintained at the second predetermined temperature. Thereby, a preparation containing a sialic acid derivative agent having a form of a candy preparation in which deterioration of the surface over time is suppressed is prepared. The preparation containing the sialic acid derivative agent has a form of a candy preparation in which the sialic acid derivative agent is uniformly contained in the base. When taken into a human mouth, it is used by licking and / or chewing in the mouth. The sweetener dissolves in saliva in the mouth, has a sweet taste, and the medicinal ingredient is released into the mouth and stays in the mouth and passes through the throat. A method for producing a preparation containing a sialic acid derivative agent, characterized by the above.

25. The sialic acid derivative agent-containing agent is replaced with a sialic acid derivative agent-containing agent obtained by enzymatically treating the above (a) edible bird's nest. The sialic acid derivative agent-containing agent is (c) a sialic acid derivative agent-containing agent extracted from the egg yolk of a chicken egg, and the sialic acid derivative agent-containing agent contains a sialic acid derivative having a chemical structure in which sialic acid and galactose are bonded via an oxygen atom. The sialic acid derivative has a 2,6-bonding structure in which the second carbon of sialic acid and the sixth carbon of galactose are bonded via an oxygen atom in the chemical structural formula. A method for producing a preparation containing a sialic acid derivative agent according to claim 23 or 24, characterized by the above.

26. The sialic acid derivative agent-containing agent obtained by extracting from the egg yolk of the above (c) chicken egg is (i) Ethanol is added to the egg yolk of a chicken egg to prepare a mixed egg yolk-ethanol mixture, and defatted egg yolk is prepared from the precipitate of the egg yolk-ethanol mixture. (ii) Water is added to the defatted egg yolk to prepare a mixed defatted egg yolk-ethanol mixture, and the defatted egg yolk-ethanol mixture is separated into a liquid layer and a precipitate layer, and the liquid layer is recovered to prepare a crudely purified extract containing a sialic acid derivative agent. (c) Filter the crude extract containing the sialic acid derivative-containing agent, evaporate the water in the filtered filtrate to prepare a concentrated solution, add the concentrated solution into ethanol, collect the generated precipitate, and prepare a crude precipitate containing the sialic acid derivative-containing agent. (d) Add the crude precipitate containing the sialic acid derivative-containing agent to a column filled with an ODS resin prepared by reacting dimethyloctadecylchlorosilane with porous silica gel, and prepare a crude product containing the sialic acid derivative-containing agent retained by the ODS resin. and (e) Use an aqueous acetonitrile solution to elute the sialic acid derivative-containing agent in the aqueous acetonitrile solution from the crude product containing the sialic acid derivative-containing agent retained by the ODS resin, and lyophilize the eluate. Thereby, a preparation containing the sialic acid derivative-containing agent obtained by lyophilization is prepared. The preparation is prepared by a process including The method for producing a preparation containing a sialic acid derivative-containing agent according to claim 22 or 25, characterized in that.

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