External drug containing beneficial element and / or hydrotalcite-like compound

Abstract

The present invention provides a novel medicinal composition capable of exhibiting a preventive or remedial effect on type-I allergic diseases by a new mechanism different from those of conventional external drugs.　The present invention specifically provides an external drug in which the beneficial element is at least one element selected from the group consisting of titanium, manganese, copper, zinc, and silicon.

Description

Topical medications containing beneficial elements and / or hydrotalcite-like compounds

[0001] The present invention relates to topical preparations containing beneficial elements and / or hydrotalcite-like compounds.

[0002] Type I allergic diseases are allergic diseases primarily characterized by anaphylactic reactions. Known types of type I allergic diseases include allergic rhinitis and asthma. Allergic rhinitis is considered an international health issue due to its high prevalence (10% to 30%). In Japan, the prevalence of Japanese cedar pollinosis (JCP) has reached approximately 50%, and JCP is now referred to as a national disease of Japan (Non-Patent Document 1). Non-Patent Document 2 reports Cry j1 as a representative antigen of JCP. Meanwhile, asthma attacks can be fatal due to phlegm clogging the bronchi. However, the full picture of type I allergic diseases has yet to be fully elucidated, and the development of effective preventive or therapeutic agents is needed.

[0003] Hydrotalcite is a layered double hydroxide with anion exchange function. Hydrotalcite compounds are known to adsorb anions through intercalation, and this property is utilized for their use as cleaning agents and neutralizing agents. In the pharmaceutical field, where hydrotalcite compounds are most widely consumed, they are used in stomach medicines as a neutralizer for stomach acid, and in the industrial materials field as a neutralizer for catalysts and a thermal stabilizer for resins.

[0004] Journal of Allergy and Clinical Immunology 2014, 133, 632-639.The Journal of Immunology 2008, 180, 5680-5688.

[0005] An object of the present invention is to provide a novel pharmaceutical composition that can exert a preventive or therapeutic effect on type I allergic diseases based on a mechanism of action different from that of conventional topical medications.

[0006] The present inventors have conducted extensive research to achieve the above-mentioned object. As a result, they have found that certain elements can affect the exacerbation or remission of symptoms of type I allergic diseases. Furthermore, they have also found that type I allergic diseases can be prevented or treated by controlling the amounts of these regulators of allergic symptoms. Based on these findings, the present inventors have conducted further research and completed the present invention. That is, the present invention includes the following features.

[0007] Item 1. An external medicine containing a beneficial element, wherein the beneficial element is at least one element selected from the group consisting of titanium, manganese, copper, zinc, and silicon.

[0008] Item 2. The topical medicine according to Item 1, which contains a hydrotalcite-like compound containing the beneficial elements.

[0009] Item 3. The topical preparation according to Item 1 or 2, which is used for the prevention or treatment of type I allergic diseases.

[0010] Item 4. An external medicine containing a hydrotalcite-like compound.

[0011] Item 5. The topical medication according to Item 4, which does not contain harmful elements such as lead, tin, and vanadium.

[0012] Item 6. The topical preparation according to Item 4 or 5, which is used for the prevention or treatment of type I allergic diseases.

[0013] Item 7. A fiber structure comprising a beneficial element, wherein the beneficial element is at least one element selected from the group consisting of titanium, manganese, copper, zinc, and silicon.

[0014] Item 8. The fiber structure according to Item 7, comprising a hydrotalcite-like compound containing the beneficial elements.

[0015] Item 9. The fiber structure according to Item 7 or 8, which is for preventing or treating type I allergic diseases.

[0016] According to the present invention, a novel pharmaceutical composition can be provided which can exert preventive and / or therapeutic effects on type I allergic diseases based on a mechanism of action different from that of conventional topical medications.

[0017] 1 is a diagram showing an outline of the animal verification experiment of Reference Example 1. In particular, an example is shown for the case where the element is lead (Pb). FIG. 2 is a diagram showing the results of a clinical observation study of Reference Example 1. For each element (from left, lead (Pb), tin (Sn), and vanadium (V)), the correlation between the element level in the nasal lavage fluid and nasal allergy symptoms is shown as an odds ratio. FIG. 3 is a diagram showing the results of the animal verification experiment of Reference Example 1. For each element (from left, lead (Pb), tin (Sn), and vanadium (V)), the number of sneezes (upper row) and the number of nose rubs (lower row) in 10 minutes are shown. FIG. 4 is a diagram showing an outline of the animal verification experiments of Examples 1 and 2. FIG. 5 is a diagram showing the results of an animal verification experiment using the hydrotalcite (Mg—Al—HT) of Example 1. (a) shows the number of sneezes, (b) shows the number of nose rubs, (c) shows the lead (Pb) level in the supernatant of the nasal wash, and (d) shows the lead (Pb) level in the precipitate of the nasal wash.

[0034] Figure 1 shows the results of an animal verification experiment using the hydrotalcite-like compound (Mg-Fe-HT) of Example 2.

[0035] Figure 2 shows the results of a clinical observation study of Example 3.

[0036] In particular, the case where the elements are titanium (Ti), manganese (Mn), and silicon (Si) is illustrated.

[0037] Figure 3 shows the results of an animal verification experiment of Example 3. From left to right, the results for titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn), and silicon (Si) are shown.

[0038] Figure 4 shows the results of powder XRD analysis of the hydrotalcite-like compound (Zn-Ti-HT) of Production Example 2.

[0039] Figure 5 shows an adsorption isotherm for the adsorption of lead (Pb) by the hydrotalcite-like compound (Zn-Ti-HT) of Production Example 2. 1 is a Langmuir plot of the adsorption of lead (Pb) by the hydrotalcite-like compound (Zn—Ti-HT) of Production Example 2. 2 is the result of powder XRD analysis of the hydrotalcite-like compound (Cu—Al-HT) of Production Example 4. 3 is an adsorption isotherm of the adsorption of lead (Pb) by the hydrotalcite-like compound (Cu—Al-HT) of Production Example 4. 4 is a Langmuir plot of the adsorption of lead (Pb) by the hydrotalcite-like compound (Cu—Al-HT) of Production Example 4. 5 is a diagram showing the results of an animal verification experiment using the hydrotalcite-like compound (Zn—Ti-HT) of Example 4. 6 is a conceptual diagram illustrating the adsorption of exacerbating factors and the release of ameliorating factors using the hydrotalcite-like compound (Zn—Ti-HT) of Example 4.1 is a diagram showing the results of an animal verification experiment using the hydrotalcite-like compound (Mn—Cu—Ti-HT) of Example 5. FIG. 2 is a diagram showing the results of an animal verification experiment using the hydrotalcite-like compound (Cu—Al-HT) of Example 6.

[0018] In this specification, the term "containing" is a concept that encompasses all of "comprise," "consist essentially of," and "consist only of."

[0019] In this specification, the expression "A to B" indicating a range of values ​​means "greater than or equal to A and less than or equal to B."

[0020] In this specification, the term "element" may refer to "ion" as well as "atom." For example, when describing an element (atom) that exists in the form of ions in biological tissue, "removing an element" means removing the ions, as will be clear to those skilled in the art.

[0021] In this specification, the term "hydrotalcite" generally refers to an Mg / Al-based carbonate layered double hydroxide, typified by naturally occurring hydrotalcite, but is not limited to the carbonate type, and other anions may be inserted, or the carbonate ions may be replaced by other anions.

[0022] In this specification, the term "hydrotalcite-like compound" refers to a compound having a structure similar to that of hydrotalcite, which is obtained by substituting some or all of the elements (atoms or ions) that constitute hydrotalcite with other elements (atoms or ions). In this specification, the term "hydrotalcite-like compound" is a concept that includes hydrotalcite.

[0023] In this specification, "removal" means removing part or all of the substance to be removed, preferably means removing almost all of the substance to be removed, and more preferably means removing all of the substance to be removed.

[0024] In this specification, the term "topical medication" refers to all medications that are directly applied to the human body, excluding oral medications and injectable medications, and is a comprehensive concept that includes nasal drops, eye drops, ear drops, suppositories, inhalants, sprays, gargles, nasal rinses, eyewashes, etc. In this specification, examples of eyewashes include cup-type eyewashes and drop-type eyewashes.

[0025] As used herein, "type I allergic disease" refers to immediate-type allergies, and is a comprehensive concept that includes allergic rhinitis, hay fever, atopic dermatitis, keratoconjunctivitis, bronchial asthma, otitis externa, urticaria, anaphylaxis, and the like.

[0026] 1. Beneficial Elements In the present invention, type I allergic diseases can be prevented or treated by delivering elements (herein, such elements may be referred to as "beneficial elements" or "alleviation factors") that alleviate symptoms of type I allergic diseases (particularly symptoms of allergic rhinitis) to biological tissues such as the skin, nose, eyes, and ears and / or to the interior or surface of substances that can come into contact with biological tissues.

[0027] The beneficial elements that can be used in the present invention are not particularly limited as long as they alleviate the symptoms of type I allergic diseases. However, from the viewpoint of effectively preventing or treating type I allergic diseases, titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn) and silicon (Si) are preferred, with copper (Cu) and zinc (Zn) being more preferred. The present inventors were the first to discover that these elements alleviate the symptoms of type I allergic diseases. Therefore, the present invention can provide a novel pharmaceutical composition that can exert the effect of preventing or treating type I allergic diseases.

[0028] The method for evaluating the preventive or therapeutic effect on type I allergic diseases (particularly allergic rhinitis) is not particularly limited, and can be evaluated, for example, based on the severity or frequency of allergic symptoms such as sneezing, runny nose, nasal congestion, and nose rubbing.

[0029] 2. Bad Elements Furthermore, in the present invention, type I allergic diseases can be prevented or treated by removing elements (herein, such elements may be referred to as "bad elements" or "aggravating factors") that exacerbate symptoms of type I allergic diseases (particularly allergic rhinitis symptoms, asthma symptoms, etc.) from the inside or surface of the living tissue itself and / or substances that may come into contact with the living tissue.

[0030] The harmful elements that can be removed by the present invention are not particularly limited as long as they exacerbate the symptoms of type I allergic diseases. However, from the viewpoint of effectively preventing or treating type I allergic diseases, lead (Pb), tin (Sn), and vanadium (V) are preferred, with lead (Pb) being more preferred. The present inventors were the first to discover that these elements exacerbate the symptoms of type I allergic diseases. Therefore, the present invention can provide a novel pharmaceutical composition that can exert an effect of preventing or treating type I allergic diseases.

[0031] The above-mentioned harmful elements can exacerbate symptoms of type I allergic diseases (particularly allergic rhinitis symptoms, asthma, etc.) when the concentrations in nasal epithelial lining fluid (ELF) are as follows: Pb: usually 5.0 μg / L to 180 μg / L, preferably 10 μg / L to 180 μg / L, and more preferably 50 μg / L to 180 μg / L; Sn: usually 0.30 μg / L to 60 μg / L, preferably 3.0 μg / L to 60 μg / L, and more preferably 10 μg / L to 60 μg / L; or V: usually 0.030 μg / L to 10 μg / L, preferably 0.30 μg / L to 10 μg / L, and more preferably 1.0 μg / L to 10 μg / L. For secretions other than nasal epithelial lining fluid (e.g., oral secretions such as saliva, upper and lower respiratory tract secretions such as sputum, ocular secretions such as tears, and aural secretions), the following concentrations of harmful elements in the secretions may exacerbate type I allergic disease symptoms: Pb: usually 5.0 μg / L to 180 μg / L, preferably 10 μg / L to 180 μg / L, and more preferably 50 μg / L to 180 μg / L; Sn: usually 0.30 μg / L to 60 μg / L, preferably 3.0 μg / L to 60 μg / L, and more preferably 10 μg / L to 60 μg / L; V: usually 0.030 μg / L to 10 μg / L, preferably 0.30 μg / L to 10 μg / L, and more preferably 1.0 μg / L to 10 μg / L.

[0032] 3. Hydrotalcite-Like Compounds The hydrotalcite-like compounds that can be used in the present invention are not particularly limited, and a wide variety of compounds can be used. The hydrotalcite-like compounds can remove harmful elements from a target by contacting them with the target. From the viewpoint of the preventive or therapeutic effect on type I allergic diseases, it is preferable that the hydrotalcite-like compounds that can be used in the present invention do not contain harmful elements, but they may contain small amounts of harmful elements as long as the object of the present invention is not impaired.

[0033] By virtue of this action, the hydrotalcite-like compound can remove harmful elements from the interior or surface of biological tissue itself and / or from materials that may come into contact with biological tissue. Therefore, the hydrotalcite-like compound can provide a novel pharmaceutical composition that can exhibit a preventive or therapeutic effect against type I allergic diseases. The subject to be contacted with the hydrotalcite-like compound is not particularly limited, and examples thereof include gases such as air, oral secretions such as saliva, upper and lower respiratory tract secretions such as nasal discharge, ocular secretions such as tears, aural secretions, liquids such as droplets, and aerosols. When the subject is secretions derived from an animal, the animal may be a human or a non-human mammal (e.g., a rodent such as a mouse, a dog, a cat, a monkey, etc.).

[0034] Furthermore, from the viewpoint of alleviating allergic symptoms, the hydrotalcite-like compound usable in the present invention preferably contains beneficial elements, more preferably at least one selected from the group consisting of titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn) and silicon (Si), and even more preferably at least two selected from the group consisting of titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn) and silicon (Si). In this case, the hydrotalcite-like compound can release beneficial elements into the interior or surface of biological tissues such as the skin, nose, eyes and ears, thereby enhancing the preventive or therapeutic effect of type I allergic diseases.

[0035] The hydrotalcite-like compound that can be used in the present invention is a compound represented by the general formula (1): [M1 ２＋ １－ｘ M2 ３＋ ｘ (OH) ２ ][A ｎ－ ｘ／ｎ ・mH ２ O] (1) [wherein, M1 ２＋ represents a divalent cation, M2 ３＋ represents a trivalent cation, and A ｎ－ represents an anion, x represents 0.2 to 0.7, n represents 1 or 2, and m represents an integer greater than 0 (for example, an integer of 1 to 10).

[0036] This hydrotalcite-like compound is M1 ２＋ １－ｘ M2 ３＋ ｘ (OH) ２ The host layer is composed of a positively charged octahedral layer, and the anions that compensate for the positive charge and interlayer water are composed of A ｎ－ ｘ／ｎ ・mH ２ It is preferable that the hydrotalcite structure has a guest layer represented by O and a guest layer represented by .O. alternately laminated.

[0037] In general formula (1), M1 ２＋ As the divalent cation represented by the formula, magnesium ion (Mg ２＋ ), cobalt ions (Co ２＋ ), iron ions (Fe ２＋ ), nickel ions (Ni ２＋ ), zinc ions (Zn ２＋ ), manganese ions (Mn ２＋ ), calcium ions (Ca ２＋ ), barium ions (Ba ２＋ ), copper ions (Cu ２＋ ), silicon ions (Si ２＋ ) and the like, and zinc ions (Zn ２＋ ), manganese ions (Mn ２＋ ), copper ions (Cu ２＋ ), silicon ions (Si ２＋ ), and zinc ions (Zn ２＋ ), copper ions (Cu ２＋ ) is more preferred.

[0038] In general formula (1), M2 ３＋ As the trivalent cation represented by the formula (I), titanium ion (Ti ３＋ ), iron ions (Fe ３＋ ), aluminum ions (Al ３＋ ), cobalt ions (Co ３＋ ), chromium ions (Cr ３＋ ), gallium ions (Ga ３＋ ), indium ions (In ３＋) and the like, and titanium ions (Ti ３＋ ) is more preferable.

[0039] In general formula (1), a combination of a divalent cation and a trivalent cation (M1 ２＋ , M2 ３＋ ) as (Mg ２＋ , Al ３＋ ), (Mn ２＋ , Al ３＋ ), (Cu ２＋ , Al ３＋ ), (Zn ２＋ , Al ３＋ ), (Si ２＋ , Al ３＋ ), (Mg ２＋ , Fe ３＋ ), (Mn ２＋ , Fe ３＋ ), (Cu ２＋ , Fe ３＋ ), (Zn ２＋ , Fe ３＋ ), (Si ２＋ , Fe ３＋ ), (Mg ２＋ , Ti ３＋ ), (Mn ２＋ , Ti ３＋ ), (Cu ２＋ , Ti ３＋ ), (Zn ２＋ , Ti ３＋ ), (Si ２＋ , Ti ３＋ ) is preferred.

[0040] In general formula (1), the molar ratio of divalent cations to trivalent cations (M ２＋ / M2 ３＋ ) is preferably 0.5 to 4, more preferably 0.7 to 3, from the viewpoints of machinability, element adsorption and removal performance, etc.

[0041] In the general formula (1), the anion A of the guest layer ｎ－ Any anion can be used, for example, OH － , NO ３ － , F － , Cl － , S.O. ４ ２－ , CO３ ２－ , SiO ３ ２－ , Si ２ O ５ ２－ etc. can be adopted.

[0042] The hydrotalcite-like compound can be prepared using an aqueous sodium carbonate solution as a precipitant. ｎ－ Carbonate ions CO ３ ２－ In this case, the hydrotalcite-like compound is represented by the general formula (2): [M1 ２＋ １－ｘ M2 ３＋ ｘ (OH) ２ ][(A ｎ－ ) ｙ ・(CO ３ ２－ ) ｚ ・mH ２ O] (2) [wherein yn + 2z = x, and other symbols are the same as above.] and the guest layer is represented by (A ｎ－ ) ｙ ・(CO ３ ２－ ) ｚ ・mH ２ It can be O.

[0043] The hydrotalcite-like compound that can be used in the present invention can remove ions containing at least one element selected from the group consisting of Fe, Ba, Cr, U, Sr, Al, Ca, V, Co, Ni, Ga, Se, Zr, Ag, Cd, Sn, W, Hg, Pb, Bi, Ge, Sb, and Tl from biological tissue itself and / or substances that may come into contact with biological tissue.

[0044] As such hydrotalcite and hydrotalcite-like compounds, known or commercially available products can be used. In addition, when producing a hydrotalcite-like compound, first, a cation M1 ２＋ and anion A ｎ－ and an aqueous solution of a salt consisting of cation M2 ３＋ and anion A ｎ－It is preferable to prepare an aqueous solution of a salt consisting of an anion A and an anion B, and then mix and prepare the solution in a predetermined composition ratio. ｎ－ As NO ３ ２－ When the salt is used, for example, an aqueous solution of nitric acid can be used. Here, the respective salts can be mixed together to prepare a mixed aqueous solution.

[0045] Next, a basic aqueous solution (aqueous sodium carbonate solution, aqueous sodium hydroxide solution, potassium carbonate, potassium hydroxide, lithium carbonate, lithium hydroxide, etc.) is prepared as a precipitant, and the temperature can be raised to a predetermined temperature for hydrothermal synthesis, for example, room temperature to 100°C.

[0046] Next, the precipitant is stirred while being maintained at the above-mentioned predetermined temperature, and the prepared mixed aqueous solution is added dropwise. The stirring speed and time can be set appropriately. After the dropwise addition is completed, the precipitant temperature can be maintained and stirring can be continued to allow maturation.

[0047] Subsequently, the precipitate in the precipitant is collected by suction filtration, washed, and then dried to obtain a hydrotalcite-like compound. Thus, the hydrotalcite-like compound can be produced using a simple process with low raw material costs. The compound can then be classified or crushed in a mortar or the like to a predetermined particle size. It can also be prepared in various forms, such as a slurry or granulated by adding a binder or the like.

[0048] When the precipitant contains a precipitant containing hydroxide ions (such as a sodium hydroxide aqueous solution), the hydrotalcite-like compound can be made dense. On the other hand, when a precipitant containing carbonate ions (such as a sodium carbonate aqueous solution) is used, the hydrotalcite-like compound can be made porous. For example, the water absorption rate can be set to 50% to 90%. Thus, from the viewpoint of increasing the specific surface area and more efficiently adsorbing and removing elements, it is preferable to use a precipitant containing carbonate ions (such as a sodium carbonate aqueous solution), and from the viewpoint of durability, it is preferable to use a precipitant containing hydroxide ions (such as a sodium hydroxide aqueous solution).

[0049] 4. External Medications The external medications (particularly nasal drops) of the present invention according to the first aspect contain the above-mentioned beneficial elements as active ingredients. External medications with such characteristics can deliver beneficial elements to areas where they are needed. In particular, nasal drops with such characteristics can deliver beneficial elements into the nasal cavity when administered intranasally. Therefore, the external medications (particularly nasal drops) of the present invention are suitable for use in the prevention or treatment of type I allergic diseases (particularly allergic rhinitis, asthma, etc.).

[0050] From the viewpoint of preventing or treating type I allergic diseases, the topical preparation of the present invention preferably contains beneficial elements in the form of ions.

[0051] The above-mentioned topical medication (particularly, nasal drops) preferably contains the above-mentioned hydrotalcite-like compound containing beneficial elements as an active ingredient. A topical medication having these characteristics can remove harmful elements from areas contaminated with harmful elements while delivering (sustained release) beneficial elements. In particular, a nasal drop having these characteristics, when administered intranasally, can remove harmful elements from the nasal cavity while delivering (sustained release) beneficial elements into the nasal cavity. Therefore, the preventive or therapeutic effect of type I allergic diseases (particularly, allergic rhinitis, asthma, etc.) can be enhanced.

[0052] The topical preparation (particularly, nasal drops) of the present invention according to the second aspect contains the above-mentioned hydrotalcite-like compound as an active ingredient. A topical preparation having such characteristics can remove harmful elements from areas contaminated with harmful elements. In particular, a nasal drop having such characteristics can remove harmful elements from the nasal cavity when administered intranasally. Therefore, the topical preparation (particularly, nasal drops) of the present invention is suitable for use in the prevention or treatment of type I allergic diseases (particularly, allergic rhinitis, asthma, etc.).

[0053] It is preferable that the above-mentioned topical medication (particularly, nasal drops) is substantially free of harmful elements. In this specification, "topical medication substantially free of harmful elements" means a topical medication in which the concentration of each harmful element is less than 0.01 μg / L. A topical medication having these characteristics can more reliably remove harmful elements from areas contaminated with harmful elements. Therefore, it is possible to enhance the preventive or therapeutic effects of type I allergic diseases (particularly, allergic rhinitis, asthma, etc.).

[0054] When the topical medication of the present invention is in the form of a nasal drop, from the viewpoint of preventing or treating type I allergic diseases, the concentrations in nasal epithelial lining fluid (ELF) are as follows: Pb: preferably less than 50 μg / L, more preferably less than 10 μg / L, and even more preferably less than 5.0 μg / L; Sn: preferably less than 10 μg / L, more preferably less than 3.0 μg / L, and even more preferably less than 0.30 μg / L; and V: preferably less than 1.0 μg / L, more preferably less than 0.30 μg / L, and even more preferably less than 0.030 μg / L. Similarly, for topical medications other than nasal drops, from the viewpoint of preventing or treating type I allergic diseases, the concentrations of Pb in secretions other than nasal epithelial lining fluid (e.g., oral secretions such as saliva, upper and lower respiratory tract secretions such as sputum, ocular secretions such as tears, and otic secretions) are preferably less than 50 μg / L, more preferably less than 10 μg / L, and even more preferably less than 5.0 μg / L; Sn: preferably less than 10 μg / L, more preferably less than 3.0 μg / L, and even more preferably less than 0.30 μg / L; and V: preferably less than 1.0 μg / L, more preferably less than 0.30 μg / L, and even more preferably less than 0.030 μg / L.

[0055] When the topical medication of the present invention is a nasal spray, the amounts of beneficial and harmful elements in the nasal cavity, i.e., the amounts of these elements released and removed, can be evaluated based on the amounts of the elements present in the nasal wash. In particular, the amount of harmful elements removed is preferably evaluated by evaluating the precipitate obtained by centrifuging the nasal wash, and the amount of beneficial elements released is preferably evaluated by evaluating the supernatant obtained by centrifuging the nasal wash. In these evaluations, the amount of the elements present in the nasal wash is preferably normalized (standardized) by, for example, the amount of urea present in serum. Similarly, for topical medications other than nasal sprays, the amounts of beneficial and harmful elements in the corresponding biological tissues can be evaluated based on the amounts of the elements present in the wash obtained after washing the tissue.

[0056] The form of the topical medication (particularly, nasal drops) is not particularly limited, and a wide variety of forms that known topical medications can take can be adopted. Examples of such forms include liquid, gel, paste, powder, ointment, cream, etc. When the topical medication is a nasal drop and is used to prevent or treat type I allergic diseases, it may be sprayed into the nasal cavity in liquid form, instilled into the eyes like eye drops in liquid form, or sprayed into the nasal cavity in powder form.

[0057] The method for producing the topical drug (particularly, nasal drops) of the present invention is not particularly limited, and examples thereof include a method in which a beneficial element is mixed with a solvent and stirred until homogeneous to obtain a solution, and a method in which a hydrotalcite-like compound is mixed with a solvent and stirred until homogeneous to obtain a dispersion (suspension).

[0058] Examples of solvents for the above-mentioned solutions and dispersions (suspensions) include purified water, sterilized water, natural water, tap water, water for injection, etc., buffer solutions such as PBS (phosphate buffered saline), ethanol, absolute ethanol, various denatured ethanols, alcohols such as n-propanol, i-propanol, n-butanol, i-butanol, etc. The solvents can be used alone or in combination of two or more.

[0059] In the topical medicine (particularly, nasal drops) of the present invention, the concentration of the beneficial element in the solution or dispersion (suspension) is, from the viewpoint of preventing or treating type I allergic diseases, preferably 500 μg / L to 30,000 μg / L, more preferably 3,000 μg / L to 30,000 μg / L, and even more preferably 6,000 μg / L to 30,000 μg / L when the beneficial element is Ti; preferably 8,000 μg / L to 200,000 μg / L, more preferably 16,000 μg / L to 200,000 μg / L, and even more preferably 40,000 μg / L to 450,000 μg / L when the beneficial element is Mn; and preferably 15,000 μg / L to 450,000 μg / L when the beneficial element is Cu. L is preferred, 40,000 μg / L to 450,000 μg / L is more preferred, and 90,000 μg / L to 450,000 μg / L is even more preferred; when the good element is Zn, 10,000 μg / L to 1,500,000 μg / L is preferred, 50,000 μg / L to 1,500,000 μg / L is more preferred, and 100, When the good element is Si, the concentration is preferably 500,000 μg / L to 15,000,000 μg / L, more preferably 1,500,000 μg / L to 15,000,000 μg / L, and even more preferably 3,000,000 μg / L to 15,000,000 μg / L.

[0060] In the dispersion (suspension), the concentration of the hydrotalcite-like compound is preferably 0.01% by mass to 50% by mass, more preferably 0.1% by mass to 10% by mass, and even more preferably 1% by mass to 5% by mass, from the viewpoint of preventing or treating type I allergic diseases.

[0061] The above-mentioned topical medications (particularly nasal drops) may contain various pharmaceutically acceptable ingredients, such as surfactants, thickeners, oily components, isotonicity agents, pH adjusters, buffers, chelating agents, fragrances / fresheners, antioxidants, preservatives, absorption enhancers, and suspending agents, within the scope of the object of the present invention.

[0062] In the case of liquid nasal drops, the amounts of these ingredients are preferably adjusted to approximate the physiological state of the nose (isotonicity with nasal secretions), for example, 100 mOsm / kg to 1200 mOsm / kg, more preferably 200 mOsm / kg to 900 mOsm / kg, and even more preferably 250 mOsm / kg to 350 mOsm / kg. The pH of the nasal drops is not particularly limited and is adjusted to within the pH range used for known nasal drops, and from the viewpoint of mucosal irritation, it is preferably adjusted to between pH 5 and 9. Similarly, for topical medications other than nasal drops, it is preferable to approximate the physiological state of the corresponding biological tissue.

[0063] Alternatively, a method for producing the topical agent (particularly, a nasal spray) of the present invention may involve pulverizing a hydrotalcite-like compound to obtain a powder. The size of the powder is not particularly limited, but is preferably, for example, 1 nm to 1000 μm, and more preferably 10 μm to 300 μm. Here, in this specification, the size of the powder refers to the diameter when the powder is spherical, and refers to the major axis when the powder is non-spherical.

[0064] When the topical medication (particularly, nasal drops) is sprayed, it is preferable to spray it as an aerosol, regardless of whether the topical medication is in liquid or powder form. The aerosol can be generated using a known aerosol generator. The size of the droplets or particles of the aerosol can be set to the same range as the size of the powder of the hydrotalcite-like compound.

[0065] 5. Fiber Structure The fiber structure of the first aspect of the present invention contains the above-mentioned beneficial elements as active ingredients. The fiber structure of the present invention is not particularly limited, and may, for example, have beneficial elements on its surface or inside. A fiber structure with such characteristics can deliver beneficial elements to the interior or surface of living tissue itself and / or a substance that may come into contact with living tissue. Therefore, the fiber structure of the present invention is suitable for use in the prevention or treatment of type I allergic diseases (particularly allergic rhinitis, asthma, etc.).

[0066] The above-mentioned fiber structure preferably contains the above-mentioned hydrotalcite-like compound containing beneficial elements as an active ingredient. A fiber structure having such characteristics can deliver (sustainedly release) beneficial elements into the nasal cavity while removing harmful elements from the nasal cavity, thereby enhancing the preventive or therapeutic effects of type I allergic diseases.

[0067] The fiber structure of the present invention according to a second aspect contains the above-mentioned hydrotalcite-like compound as an active ingredient. The fiber structure of the present invention is not particularly limited, and may, for example, have a hydrotalcite-like compound on its surface or inside. A fiber structure (e.g., a mask, a filter) having such characteristics can remove harmful elements from biological tissues themselves (e.g., skin, nose, eyes, ears, oral cavity, etc.) and / or substances that may come into contact with biological tissues (e.g., gases, liquids, etc.). Therefore, the fiber structure of the present invention (particularly, a mask) is suitable for use in the prevention or treatment of type I allergic diseases (particularly, allergic rhinitis, asthma, etc.).

[0068] It is preferable that the above-mentioned fiber structure is substantially free of harmful elements. In this specification, the term "fiber structure substantially free of harmful elements" means a fiber structure in which the amount of each harmful element carried is 0.01 mg / m ２ A fiber structure having these characteristics can more reliably remove harmful elements from living tissue, thereby enhancing the effectiveness of preventing or treating type I allergic diseases.

[0069] In this specification, the term "fibrous structure" refers to a structure made of fibers, and may be any of a fabric, nonwoven fabric, or sewn textile product in the form of yarn, woven fabric, or knitted fabric. Examples of the fiber structure include, but are not limited to, general clothing, sanitary products such as disposable diapers, sanitary napkins, incontinence pads, and masks, armpit pads, stockings, gloves, caps, dishcloths, wipers, cooking sheets, drip sheets, wet tissues, bedding (bed sheets, pillowcases, and the like), tote bags, slippers, tissue paper, nursing care products, towels, oral care sheets, food retention sheets, dust collection filters, filtration filters, mops, foot mats, and clothing for hospitals and nursing facilities. Among these, as the fiber structure, masks, dust collection filters, and filtration filters are preferred, and masks are more preferred, from the viewpoint of preventing or treating type I allergic diseases.

[0070] The fibers constituting the fiber structure of the present invention are not particularly limited, but examples thereof include natural fibers such as cotton, linen, silk, and wool; regenerated and semi-synthetic fibers such as rayon, cupra, acetate, and triacetate; synthetic fibers such as nylon, polyester, acrylic, and polyurethane; inorganic fibers such as glass, carbon, and metal; and mixtures thereof.

[0071] The method for producing the fiber structure of the present invention is not particularly limited, and examples thereof include a method of adhering beneficial elements and / or hydrotalcite-like compounds to the fiber surface of the fiber structure. Specifically, the fiber structure of the present invention can be obtained, for example, by adhering a beneficial element solution or a dispersion containing a hydrotalcite-like compound to the fiber surface according to a conventional method, and then drying off any unnecessary solvent. Here, methods for adhering the beneficial element solution or the dispersion containing a hydrotalcite-like compound to the fiber surface include, in addition to the immersion method, a roller touch method, a spray method, a shower method, an impregnation method, etc.

[0072] In the above-described production method, the solids concentration of the solution or dispersion to be adhered to the fiber surface is preferably less than 50% by mass, more preferably 0.00001% by mass to 40% by mass, and even more preferably 0.001% by mass to 5% by mass, from the viewpoint of the supporting efficiency of the hydrotalcite-like compound and the like.

[0073] In the above-mentioned fiber structure, the amount of beneficial elements or hydrotalcite-like compounds supported on the fibers is 0.001 mg / m in terms of solid content from the viewpoint of preventing or treating type I allergic diseases. ２ ~5000mg / m ２ is preferred, and 0.01 mg / m ２ ~1000mg / m ２ More preferably, 0.1 mg / m ２ ~100 mg / m ２ is more preferable.

[0074] 6. Pharmaceutical Compositions The administration method, dosage form, and dosage of pharmaceuticals (including the topical agents and fiber structures) containing the above-mentioned beneficial elements and / or the above-mentioned hydrotalcite-like compounds as active ingredients can be appropriately determined depending on the intended use. For example, pharmaceuticals containing the elements and / or compounds of the present invention as active ingredients may be administered orally or parenterally. Examples of dosage forms include oral preparations such as tablets, powders, inhalants, capsules, enteric-coated preparations, granules, extracts, and syrups, as well as parenteral preparations such as injections, patches, topical preparations, ointments, infusions, ear drops, nasal drops, eye drops, and suppositories. These preparations can be produced as pharmaceutical compositions containing the above-mentioned hydrotalcite-like compounds and pharmaceutically acceptable excipients.

[0075] The effective amount of a drug or pharmaceutical composition containing the above-mentioned beneficial elements and / or the above-mentioned hydrotalcite-like compound as an active ingredient is not particularly limited, but for example, an appropriate daily dose for an adult is about 0.1 mg to 5000 mg for oral administration, and about 0.01 mg to 300 mg for parenteral administration, and this is administered once or multiple times a day. The dosage varies depending on various conditions, so an amount smaller than the above dosage range may be sufficient in some cases.

[0076] The following Reference Examples and Examples will further clarify the features of the present invention, but the present invention is not limited to these Examples. To simplify the description of the specification, the following abbreviations may be used in the Reference Examples and Examples. Abbreviations: OVA: ovalbumin, HT: hydrotalcite, ELF: nasal epithelial lining fluid, NLF: nasal lavage fluid, JCP: cedar pollinosis, PBS: phosphate buffered saline, ICP-MS: inductively coupled plasma mass spectrometry, OR: odds ratio, 95% CI: 95% confidence interval.

[0077] Reference Example 1: Exacerbating Factors of Type I Allergic Diseases The following clinical observational study and animal verification experiment were carried out to evaluate the effects of each element (lead (Pb), tin (Sn), and vanadium (V)) on Type I allergic diseases (particularly allergic rhinitis).

[0078] (Clinical Observational Study) The clinical trial was conducted under conditions of natural allergen exposure. A total of 103 subjects were followed from January (preseason) to April (season). At baseline, information on demographic characteristics, including age, gender, smoking, and medical history, was collected. All subjects were free of other respiratory diseases, immune disorders, or other serious illnesses during the study period. After excluding two subjects due to incomplete follow-up questionnaires, subjects were divided into a 57-person control group and a 44-person patient group with a history of JCP and positive anti-cedar pollen-specific IgE (≥0.35 IU / mL) using ImmunoCAP. Subjective symptoms, including sneezing, runny nose, and nasal congestion, were scored using a method previously validated in Non-Patent Document 1.

[0079] Nasal wash fluid (NLF), serum, saliva, and urine samples were collected from JCP patients (n = 44) and control subjects (n = 57) without JCP during the preseason and in-season and stored at -80°C until analysis. The elemental concentrations in each sample were measured using an ICP-MS (7500cx; Agilent Technologies, Inc., California). It has been reported that urea concentrations in serum and nasal secretions are constant regardless of the presence or absence of an allergic response (Kaulbach HC et al., J Allergy Clin Immunol 92:457-465, 1993). Therefore, the epithelial lining fluid (ELF) in the nasal cavity can be calculated using the following formula, using urea as an internal standard:

[0080]

[0081] Differences in continuous variables between controls and patients were compared using Student's t test or Mann-Whitney U test. Differences in categorical variables were compared using χ ２ The difference in elemental concentrations between pre-season and in-season samples was assessed using a paired Wilcoxon test. A generalized estimating equation (GEE) model was applied to examine the difference in changes in elemental concentrations between pre-season and in-season samples. Individual differences were controlled by incorporating individual characteristics (age, sex, body mass index (BMI), and smoking status) as fixed effects.

[0082] After logarithmic transformation of element concentrations, the association between element concentrations in human samples and the incidence of each patient's nasal symptom was estimated using a generalized linear model including the same covariates as in the GEE model to calculate odds ratios (ORs) and 95% confidence intervals (95% CIs). Because physical activity and sleep duration have been proposed to affect the symptoms of type I allergic diseases, sleep duration and number of physical exercise days (≦2 days / week and >2 days / week) were also included in each statistical model for nasal symptoms.

[0083] Statistical analysis was performed using IBM SPSS Statistics (version 26.0, IBM Corp., New York) and R Programming Language (version 4.0.5, R Foundation for Statistical Computing, Austria). P < 0.05 in a two-tailed test was considered statistically significant.

[0084] The odds ratios of element concentrations in nasal washings (NLF) and type I allergic disease, i.e., the correlation between the two, are shown in Figure 2A. The results confirmed a significant positive correlation between the concentrations of lead (Pb), tin (Sn), and vanadium (V) in NLF and allergic symptoms.

[0085] (Animal Verification Experiment) A mouse model of type I allergic disease was generated according to the method described in Non-Patent Document 2 (Figure 1). BALB / c mice (female, 6 weeks old) were purchased from Japan SLC (Hamamatsu City), randomly bred, and housed under specific pathogen-free (SPF) conditions. The antigens, OVA and aluminum hydroxide, were purchased from Fujifilm Wako Pure Chemical Industries, Ltd. (Osaka). Antigen sensitization was performed by intraperitoneally injecting 200 μL of saline containing 25 μg of antigen and 1.5 mg of aluminum hydroxide once daily on days 0, 7, and 14 (a total of three injections). From days 21 to 27, 500 μg of antigen and / or 20 μL of saline with or without added elements were intranasally administered to the mice once daily (a total of seven injections). The element concentrations in the nasally administered nasal drops were Pb: 90,000 μg / L, Sn: 25,000 μg / L, and V: 4,000 μg / L. Naive control mice and sensitized mice were divided into four groups: (1) naive mice treated with saline (control group), (2) naive mice treated with elements (element group), (3) sensitized mice challenged with antigen (antigen group), and (4) sensitized mice treated with antigen and elements (antigen + element group). After the final induction on day 27, the number of nose rubs and sneezes was counted over a 10-minute period. Then, on day 28, nasal washes and serum were collected from the naive control mice and sensitized mice and stored at -80°C. The element concentrations and their NLF-to-ELF conversions were measured using the same methods as in the clinical study described above. In statistical analysis, the results in different groups of mice were compared by one-way ANOVA followed by the LSD test.

[0086] The number of sneezing and nose-rubbing events in the mice is shown in Figure 2B. As a result, unsensitized mice did not show allergic symptoms even when treated with each element, whereas sensitized mice treated with saline containing lead (Pb), tin (Sn), and vanadium (V) together with the antigen showed significantly increased numbers of sneezing and nose-rubbing events compared to the group without added elements.

[0087] Therefore, taking into consideration the results of the above-mentioned clinical observation studies, lead (Pb), tin (Sn), and vanadium (V) are factors that aggravate type I allergic diseases (particularly allergic rhinitis, asthma, etc.).

[0088] [Production Example 1: Production of Mg—Fe-HT] The hydrotalcite-like compound used in this example was produced in accordance with the methods described in the examples of JP-A Nos. 2013-146660 and 2020-93252.

[0089] The hydrotalcite-like compound Mg—Fe-HT has (M1, M2) as (Mg, Fe), Mg:Fe in a molar ratio of 2:1, and A of the guest layer ｎ－ But NO ３ － or CO ３ ２－ It was manufactured by adjusting it so that

[0090] Example 1: Nasal spray containing Mg—Al—HT Hydrotalcite (Mg—Al—HT) was purchased from Fujifilm Wako Pure Chemical Industries, Ltd. Hydrotalcite (Mg—Al—HT, 10 mg) was added to 1 mL of saline and mixed until homogenous to prepare a hydrotalcite-containing nasal spray (1% HT).

[0091] The effects of the nasal spray on the symptoms of type I allergic disease were examined using a modified procedure ( FIG. 3 ) from the animal validation experiment in Reference Example 1. Specifically, to prepare a nasal allergy mouse model, BALB / c mice (female, 6 weeks old) were intraperitoneally injected once daily with 200 μL of saline containing 25 μg of antigen and 1.5 mg of aluminum hydroxide on days 0, 7, and 14 (a total of three injections). Then, from days 21 to 27, the mice were intranasally administered 20 μL of saline or the above 1% HT once daily, and 15 minutes later, the mice were intranasally administered 20 μL of saline containing 500 μg of antigen, with or without 1.75 μg of lead (Pb), for a total of seven injections. Sensitized and exacerbated mice were divided into four groups (including a group of naive mice treated with saline alone (control)): (5) sensitized mice challenged with antigen (antigen group), (6) sensitized mice treated with hydrotalcite (antigen + HT group), (7) exacerbated mice exacerbated with lead (Pb) (antigen + Pb group), and (8) exacerbated mice treated with HT (antigen + Pb + HT group). After the final treatment on day 27, the number of nose rubs and sneezes was counted over a 10-minute period. Nasal washes and serum were then collected from naive control and sensitized mice on day 28 and stored at -80°C. The nasal washes were separated into supernatant and precipitate by centrifugation. The concentrations of each element and their NLF-to-ELF conversions were measured using the same methods as in the clinical study described above. In statistical analysis, the results in different groups of mice were compared by one-way ANOVA followed by the LSD test.

[0092] The number of sneezes and nose rubs of the mice is shown in Figures 4(a) and (b). As with Reference Example 1, the antigen + Pb group showed a worsening of allergic symptoms due to lead (Pb) compared to the antigen group, as with Reference Example 1. In contrast, although no significant alleviation of allergic symptoms was observed in the antigen + HT group, the number of sneezes and nose rubs in the antigen + Pb + HT group was significantly reduced compared to the exacerbated mouse group (antigen + Pb group) and was comparable to that of the antigen group (and antigen + HT group). From the results in Figures 4(c) and (d), it can be easily understood that in the antigen + Pb + HT group, nasal administration of Mg-Al-HT adsorbed and removed the exacerbating factor (lead (Pb)) in the nasal cavity. From the above, Mg-Al-HT reduced the aggravating effect of lead (Pb) on type I allergic diseases (particularly allergic rhinitis) by adsorbing and removing allergy aggravating factors in the nasal cavity.

[0093] Example 2 Nasal Drops Containing Mg—Fe—HT An animal verification experiment was carried out in the same manner as in Example 1, except that the hydrotalcite-like compound (Mg—Fe—HT) of Production Example 1 was used instead of the hydrotalcite (Mg—Al—HT).

[0094] The results are shown in Figure 5. As in Example 1, Mg-Fe-HT adsorbed and removed lead (Pb) from the nasal cavity, thereby reducing the exacerbating effect of lead (Pb) on type I allergic diseases (particularly allergic rhinitis).

[0095] Example 3: Relief Factors for Type I Allergic Disease The effects of titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn), and silicon (Si) on Type I allergic disease were evaluated using the same method as in Reference Example 1. The element concentrations used in the nasally administered nasal drops were Ti: 500 μg / L, Mn: 10,000 μg / L, Cu: 450,000 μg / L, Zn: 50,000 μg / L, and Si: 1,500,000 μg / L.

[0096] (Clinical Observation Study) The results of a clinical observation study using titanium (Ti), manganese (Mn), and silicon (Si) are shown in Figure 6A. As is clear from the results, unlike the elements in Reference Example 1, the elements used in Example 3 tended to show a negative correlation between their concentrations in ELF and allergic symptoms.

[0097] (Animal Verification Experiment) Figure 6B shows the results of a verification experiment using mice. While each element had little effect on naive mice, it alleviated allergic symptoms in sensitized mice. In particular, the number of sneezes and nose-rubbing events in sensitized mice treated with copper (Cu) was comparable to that of naive mice.

[0098] From the above, titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn) and silicon (Si) are ameliorating factors for type I allergic diseases (particularly allergic rhinitis, asthma, etc.).

[0099] [Production Example 2: Production of Zn—Ti-HT] A hydrotalcite-like compound Zn—Ti-HT was produced in the same manner as in Production Example 1, except that (M1, M2) was (Zn, Ti) and the molar ratio of Zn:Ti was adjusted to 2:1.

[0100] The powder XRD analysis results shown in Figure 7A confirmed that the obtained Zn-Ti-HT had a structure specific to hydrotalcite. Furthermore, the adsorption isotherm (Figure 7B) and its linearized Langmuir plot (Figure 7C) for the adsorption of lead (Pb) by Zn-Ti-HT indicated the saturated adsorption amount Q ｍａｘ was calculated to be 161.29 mg / g.

[0101] [Production Example 3: Production of Mn—Cu—Ti-HT] A hydrotalcite-like compound Mn—Cu—Ti-HT was produced in the same manner as in Production Example 1, except that (M1, M2) was (Mn and Cu, Ti), the molar ratio of Mn:Cu:Ti was adjusted to 1:1:1, and the concentration of the hydrotalcite-like compound in the nasal drops was changed to 1 mass%.

[0102] [Production Example 4: Production of Cu—Al—HT] A hydrotalcite-like compound Cu—Al—HT was produced in the same manner as in Production Example 1, except that (M1, M2) was (Cu, Al) and the molar ratio of Cu:Al was adjusted to 2:1.

[0103] The powder XRD analysis results shown in Figure 8A confirmed that the obtained Cu-Al-HT had a structure specific to hydrotalcite. Furthermore, the adsorption isotherm (Figure 8B) and its linearized Langmuir plot (Figure 8C) for the adsorption of lead (Pb) by Cu-Al-HT showed that the saturated adsorption amount Q ｍａｘ was calculated to be 263.16 mg / g.

[0104] Example 4 Nasal Drops Containing Zn—Ti—HT An animal verification experiment was carried out in the same manner as in Example 1, except that the hydrotalcite-like compound (Zn—Ti—HT) of Production Example 2 was used instead of hydrotalcite (Mg—Al—HT).

[0105] The number of sneezes and nose rubs of the mice is shown in Figures 9(a) and (b). The number of sneezes and nose rubs in the antigen + HT group was comparable to that in the naive mouse group. Furthermore, the number of sneezes and nose rubs in the antigen + Pb + HT group was not only significantly reduced compared to the exacerbated mouse group (antigen + Pb group), but also reduced to the same level as the naive mouse group. From the results in Figures 9(c), (d), and (e), it is easy to see that in the antigen + Pb + HT group, intranasal administration of Zn-Ti-HT adsorbed and removed exacerbation factors (lead (Pb)) in the nasal cavity and released (sustained release) amelioration factors (titanium (Ti) and zinc (Zn)). From the above, Zn-Ti-HT not only reduced the exacerbating effect of lead (Pb) on type I allergic diseases (especially allergic rhinitis) but also alleviated allergic symptoms by adsorbing and removing allergy aggravating factors in the nasal cavity while simultaneously releasing alleviating factors (Figure 10).

[0106] Example 5 Nasal Drops Containing Mn—Cu—Ti—HT An animal verification experiment was carried out in the same manner as in Example 1, except that the hydrotalcite-like compound (Mn—Cu—Ti—HT) of Production Example 3 was used instead of the hydrotalcite (Mg—Al—HT).

[0107] The results are shown in Figure 11. As in Example 4, Mn-Cu-Ti-HT adsorbed and removed lead (Pb) from the nasal cavity, thereby reducing the exacerbating effect of lead (Pb) on type I allergic diseases (particularly allergic rhinitis) and alleviating allergic symptoms.

[0108] Example 6 Nasal Drops Containing Cu—Al—HT An animal verification experiment was carried out in the same manner as in Example 1, except that the hydrotalcite-like compound (Cu—Al—HT) of Production Example 4 was used instead of the hydrotalcite (Mg—Al—HT).

[0109] The results are shown in Figure 12. As in Example 4, Cu-Al-HT adsorbed and removed lead (Pb) from the nasal cavity, thereby reducing the exacerbating effect of lead (Pb) on type I allergic diseases (particularly allergic rhinitis) and alleviating allergic symptoms.

[0110] Example 7: Mask containing Zn—Ti-HT A commercially available mask containing a hydrotalcite-like compound (Zn—Ti-HT) can be obtained by immersing the mask in an aqueous suspension of the hydrotalcite-like compound (Zn—Ti-HT) of Production Example 2 and then drying it. Gas that has passed through the mask containing the hydrotalcite-like compound (Zn—Ti-HT) may contain fewer harmful elements (e.g., lead (Pb), tin (Sn), and vanadium (V)) and more beneficial elements (e.g., titanium (Ti), manganese (Mn), copper (Cu), zinc (Zn), and silicon (Si)) compared to the gas before passing through the mask. Thus, the mask of the present invention can prevent or treat type I allergic diseases (particularly allergic rhinitis, asthma, etc.) by removing harmful elements and / or releasing beneficial elements.

Claims

1. An external medication containing a beneficial element, the beneficial element being at least one element selected from the group consisting of titanium, manganese, copper, zinc and silicon.

2. The topical medication according to claim 1, comprising a hydrotalcite-like compound containing said beneficial elements.

3. The topical medication according to claim 1 or 2, which is for the prevention or treatment of type I allergic diseases.

4. Topical preparations containing hydrotalcite-like compounds.

5. The topical medication according to claim 4, which does not contain the harmful elements lead, tin and vanadium.

6. The topical medication according to claim 4 or 5, which is for the prevention or treatment of type I allergic diseases.

7. A fiber structure comprising a beneficial element, the beneficial element being at least one element selected from the group consisting of titanium, manganese, copper, zinc and silicon.

8. The fiber structure of claim 7, comprising a hydrotalcite-like compound containing said beneficial elements.

9. The fiber structure according to claim 7 or 8, which is for the prevention or treatment of type I allergic diseases.

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