Oral composition, method for masking bitterness in oral composition, and method for producing oral composition

Abstract

To readily provide an oral composition containing Agrimol B with its bitterness masked.SOLUTION: In order to solve the problem, the present invention provides an oral composition containing a powder containing component (a) below, and at least one powder selected from components (B1) to (C) below. (a) Agrimol B. (B1) A cellulose derivative for which a 2% aqueous solution has a viscosity at a shear rate at 20°C of 2-800 mPa s. (B2) 0.5-40 mass% of carrageenan. (B3) 1-40 mass% of pregelatinized starch. (B4) 1-30 mass% of disaccharide sugar alcohol. (B5) 1-40 mass% of linear dextrin or branched dextrin with a dextrol equivalent (DE) of 2-20. (C) 0.5-10 mass% of a higher fatty acid metal salt or sucrose fatty acid ester.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to an oral composition, a method for masking the bitterness of an oral composition, and a method for producing an oral composition. More specifically, the present invention relates to an oral composition with a masked bitterness, a method for masking the bitterness of an oral composition, and a method for producing an oral composition with a masked bitterness, which are used in the fields of medicines, health foods, etc. [Background technology]

[0002] Some ingredients contained in foods, medicines, and quasi-drugs that are taken orally have unpleasant tastes. Although sourness, bitterness, saltiness, sweetness, etc. are fundamentally important tastes, if these tastes are too strong, they can sometimes reduce consumer preference. Agrimole B has been attracting attention in recent years as an active ingredient in food, pharmaceuticals, and quasi-drugs. It has been shown to have the effect of activating SIRT1, known as the longevity gene, which prevents aging and extends the lifespan of living organisms, as well as a variety of other pharmacological actions, such as a whitening effect due to its inhibitory activity against melanin production, an effect of improving type I allergies, and an inhibitory effect against muscle atrophy. Although research is being conducted into various uses of this ingredient, when used orally as a food or medicine, Agrimole B has a strong bitter taste, which can affect consumer preference, reduce its market value, and make it difficult to take as a medicine.

[0003] Regarding methods for suppressing unpleasant tastes such as strong bitterness in foods and medicines, for example, Patent Document 1 discloses an oil-containing food in which the bitterness, astringency, and harshness of flavonoids are significantly reduced by including an oil phase containing diacylglycerol and an aqueous phase containing flavonoid glycosides. Patent Document 2 also discloses a method for suppressing the astringency or astringent taste of naringin by adding 0.001 to 2 parts by weight of sucralose to 1 part by weight of naringin. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] JP 2007-129983 A [Patent Document 2] Patent No. 5259149 Summary of the Invention [Problem to be solved by the invention]

[0005] Generally, when an active ingredient with a very strong bitter taste is formulated for oral use, a separate formulation design is assumed, such as making tablets into sugar-coated or coated tablets, or coating granulation into granules, in order to mask the bitter taste. However, such an increase in manufacturing processes causes problems in terms of cost. On the other hand, a simple and low-cost method for suppressing the excessive bitterness of foods and oral medicines containing Agrimole B has not been established. Therefore, a simple and low-cost method for suppressing the strong bitterness of agents containing Agrimole B, which exhibits such a strong bitter taste, is desired. Therefore, an object of the present invention is to easily provide an oral composition which contains Agrimole B and has its bitterness masked. [Means for solving the problem]

[0006] As a result of intensive research into the above-mentioned problems, the inventors discovered that by combining a powder containing Agrimole B with powders of specific commonly used excipients and additives, the strong bitterness of Agrimole B can be masked easily and at low cost without going through the coating or granulation processes, and thus completed the present invention.

[0007] That is, the present invention provides the following [1] to [6]. [1] A composition for oral administration, comprising a powder containing the following component (a) and one or more powders selected from the following components (B1) to (C): (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1-40% by mass (B4) Disaccharide sugar alcohol 1 to 30% by mass (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) 0.5 to 10% by mass of a metal salt of a higher fatty acid or a sucrose fatty acid ester According to this oral composition, even if it contains Agrimole B, which has a strong bitter taste, by further containing specific commonly used excipients and additive powders, it is possible to create an oral composition in which the unpleasant taste caused by the bitterness is masked. [2] The oral composition according to [1], characterized in that component (a) is derived from component (A) an extract of agrimony. According to this characteristic, since Agrimole B is derived from an extract of the natural product, agrimony, it meets the needs of consumers who prefer natural products, and by selecting the extraction and purification methods, it is possible to create an oral composition that allows the purity and content of Agrimole B to be easily adjusted and costs to be reduced to suit needs. [3] The oral composition according to [1] or [2], characterized in that the composition contains both one or more types of powder selected from components (B1) to (B5) and a powder of component (C). According to this feature, by containing one or more types of powder selected from components (B1) to (B5) together with component (C), an oral composition can be obtained which synergistically exerts the effect of masking the bitterness of both components (B1) to (B5) and component (C). [4] The oral composition according to any one of [1] to [3], wherein the ratio of the content of components (B1) to (C) to the content of component (a) is one or more of the following: the ratio (B1 / a) of the content of the component (B1) to the content of the component (a) is 1 to 450; the ratio (B2 / a) of the content of the component (B2) to the content of the component (a) is 2 to 450; the ratio (B3 / a) of the content of the component (B3) to the content of the component (a) is 10 to 450; the ratio (B4 / a) of the content of the component (B4) to the content of the component (a) is 10 to 450; the ratio (B5 / a) of the content of the component (B5) to the content of the component (a) is 5 to 450; The ratio (C / a) of the content of the component (C) to the content of the component (a) is 5 to 100. According to this feature, by specifying the content ratio of bitterness-masking components, components (B1) to (B5) or component (C), to the bitter component (a) Agrimole B, an oral composition can be made that more reliably exerts a bitterness-masking effect. [5] A method for masking the bitterness of an oral composition which is a powder containing the following component (a), characterized in that the composition contains one or more types of powder selected from the following components (B1) to (C): (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1-40% by mass (B4) Disaccharide sugar alcohol 1 to 30% by mass (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) 0.5 to 10% by mass of a metal salt of a higher fatty acid or a sucrose fatty acid ester According to this method of masking the bitterness of an oral composition, even if the composition contains Agrimole B, which has a strong bitter taste, the unpleasant taste caused by the bitterness can be masked by further containing specific commonly used excipients and additives. [6] A method for producing the oral composition according to any one of [1] to [4], comprising the step of stirring and mixing the following component (a) with one or more selected from components (B1) to (C): (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1-40% by mass (B4) Disaccharide sugar alcohol 1 to 30% by mass (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) 0.5 to 10% by mass of a metal salt of a higher fatty acid or a sucrose fatty acid ester Effect of the Invention

[0008] According to the present invention, it is possible to easily provide an oral composition which contains Agrimole B and in which the bitterness of the same is masked. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] The oral composition of the present invention and the method for masking the bitterness of the oral composition will be described below. The oral compositions and the methods for masking the bitterness of oral compositions described in the embodiments are merely exemplified to explain the present invention, and the present invention is not limited thereto.

[0010] [Oral Composition] The oral composition of the present invention is an oral composition characterized by containing a powder containing the following component (a) and one or more types of powder selected from the following components (B1) to (C). (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1-40% by mass (B4) Disaccharide sugar alcohol 1 to 30% by mass (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) 0.5 to 10% by mass of a metal salt of a higher fatty acid or a sucrose fatty acid ester First, each component constituting the oral composition of the present invention will be described in detail. Note that the content of each component refers to the content in the oral composition unless otherwise specified.

[0011] <(a) Agrimor B> The oral composition of the present invention contains, as a main component that exhibits a bitter taste, Agrimole B. By containing Agrimole B, which exhibits a strong bitter taste, a strong bitter taste is felt when the oral composition is orally ingested. Agrimole B has been attracting attention in recent years as an active ingredient in medicines and foods, and has been reported to have the effect of activating SIRT1, which is called the longevity gene, because it prevents the aging of organisms and extends their lifespan. In addition, various studies have been conducted on the physiological effects of Agrimole B, and it has been disclosed that it has various pharmacological effects such as whitening effect due to melanin production inhibitory activity (JP Patent Publication No. 11-335256), improvement effect of type I allergy (JP Patent Publication No. 2022-93893), and muscle atrophy inhibitory effect (JP Patent Publication No. 2022-167403), and is attracting great attention for its use in the fields of food, medicine, etc.

[0012] Agrimole B is a compound represented by the following chemical formula 1 (MW: 682.75). The Agrimole B of the present invention is not particularly limited as long as it is acceptable for use in pharmaceuticals, foods, veterinary medicines, feed, etc., and can be used by chemical synthesis or by extraction, separation, and purification from natural products such as plants. Agrimole B may also be contained as a plant extract of a plant containing Agrimole B. Furthermore, it is also possible to purchase and use a commercially available product available on the market. [ka]

[0013] Agrimol B can be chemically synthesized using phloroglucinol or the like as a starting material, for example, by the method described in Acta Pharmaceutica Sinica 1989, 24(6): pp. 431-437, or the method disclosed in JP-A-11-335256.

[0014] In addition, there are two types of Agrimol B that can be obtained by synthesis: (S)-(+)-Agrimol B and its optical isomer, (R)-(-)-Agrimol B. In this specification, "Agrimol B" may refer to a single compound consisting of one of these types, or a mixture consisting of two types.

[0015] The content of component (a) Agrimole B in the oral composition of the present invention is not particularly limited and can be changed depending on the purity and origin of Agrimole B, the subject and purpose of administration, etc., but is, for example, 0.001 to 2% by mass based on the entire oral composition. The lower limit is more preferably 0.01% by mass or more, and even more preferably 0.02% by mass or more. On the other hand, the upper limit is more preferably 1% by mass or less, even more preferably 0.6% by mass or less, and most preferably 0.3% by mass or less. By setting the content within the above range, the effect of Agrimole B as an active ingredient can be reliably exhibited, and at the same time, the effect of masking the bitterness of Agrimole B by mixing it with components (B1) to (C) described later can be more reliably exhibited.

[0016] <Plant extract> The oral composition of the present invention may contain Agrimonia B as a plant extract, as described above. Such a plant extract is not particularly limited as long as it contains Agrimonia B, but an Agrimonia extract (A) derived from Agrimonia can be preferably used. Agrimonia (scientific name: Agrimonia pilosa) is a perennial plant of the genus Agrimonia in the family Rosaceae, and grows wild on forest edges, fields, and roadsides in Honshu, Shikoku, Kyushu, and other places. It is also known as Dragon's Tooth. In the present invention, the whole plant, which is wild or cultivated, can be collected and naturally dried or heat-dried, and dried Agrimonia that is commercially available as a raw material for Chinese herbal medicines, folk remedies, and health foods (herbal tea), can also be used. The dried whole plant of Agrimonia is commercially available under the herbal name Senkakuso.

[0017] The plant extract in the present invention may be an extract with water or various organic solvents, a distillate obtained by steam distillation, a dry powder, a grated product, or juice squeezed from the grated product, etc. From the viewpoint of the yield and purity of the agrimony extract, an extract with water or various organic solvents is preferred, and an extract with ethyl alcohol or hydrous ethyl alcohol containing water is more preferred. Extraction with water or various organic solvents can be carried out by a known extraction method using various organic solvents and mixtures thereof in addition to water as the solvent. Before the extraction operation, the raw material, or the material roughly chopped, may be washed with a hydrophobic or hydrophilic solvent alone or a mixture of organic solvents to remove unnecessary substances such as pigments. Examples of hydrophobic solvents include chloroform, ether, hexane, cyclohexane, toluene, dichloromethane, petroleum ether, and benzene, while examples of hydrophilic solvents include lower alcohols (e.g., methyl, ethyl, n-propyl, isobutyl, or butyl alcohol), ethyl acetate, acetone, isopropyl alcohol, and acetonitrile. If desired, water may be appropriately added to the raw material to moisten the raw material.

[0018] To perform extraction with water, for example, 0.5 to 10 parts by mass of water is added to 1 part by mass of the raw material, and extraction is performed at 40 to 120°C for 5 minutes to 2 hours, preferably 10 to 60 minutes, and more preferably 10 to 20 minutes. At this time, the extraction efficiency can be improved by stirring. Extraction can also be performed by heating under reflux. After extraction, filtration or squeezing is performed using a filter cloth, a filter, or a mesh wire screen. In this case, pressure may be applied to improve the work efficiency. Alternatively, the extract can be obtained by centrifugation (1000 to 20000 rpm). To increase the recovery rate, this extraction and filtration process can be repeated 1 to 5 times.

[0019] To perform extraction with an organic solvent, for example, 0.5 to 10 parts by mass of the solvent is added to 1 part by mass of the raw material, and an extract can be obtained in the same manner as extraction with water. The above-mentioned hydrophobic and hydrophilic solvents can be used alone or in combination of two or more kinds as the solvent to be used, and water-containing solvents can also be used. In particular, when the raw material is washed with a hydrophobic solvent before extraction as described above to remove unnecessary substances such as pigments, and when the crude extract after extraction is washed with a hydrophobic solvent as described below, the solvent used for extraction is preferably water, lower alcohol, or 50 to 80% (v / v) water-containing lower alcohol. Examples of these lower alcohols include the same as those described above. The removal of the solvent can be performed according to a conventional method such as filtration, centrifugation, and distillation.

[0020] A particularly preferred method for extracting a plant extract, in particular an extract of agrimony (A), can be, for example, as follows. The whole plant, either naturally grown or cultivated, is collected and naturally or heat-dried for use. It is then cut into strips and immersed in about 10 times the amount of water or 0-99.5% (v / v) ethyl alcohol, preferably 1-50% ethyl alcohol, particularly preferably 5-10% ethyl alcohol, for 3-5 days for extraction at room temperature, or for 5-24 hours at 50-80°C using a reflux condenser, and then filtered to recover the extract. Water and ethyl alcohol are removed from this extract using a reduced pressure vacuum drying device such as a rotary evaporator, or a freeze-drying device, to obtain a plant extract (solid matter).

[0021] Next, a step of concentrating the plant extract is carried out, in which the plant extract is concentrated by washing with 0 to 40% ethyl alcohol to remove 0 to 40% ethyl alcohol soluble components. Specifically, this plant extract (solid matter) is washed with 0-40% ethyl alcohol, particularly preferably 10-30% ethyl alcohol, and 0-40% ethyl alcohol, particularly preferably 10-30% ethyl alcohol soluble components are removed by means of filtration or the like, and then the filtration residue is subjected to a reduced pressure vacuum drying apparatus such as a rotary evaporator or a freeze-drying apparatus to remove water and ethyl alcohol, thereby obtaining a more concentrated plant extract. The concentrated plant extract is redissolved in 50-99.5% ethyl alcohol, particularly preferably 70-90% ethyl alcohol, and an excipient to be used in formulation is added and freeze-dried to obtain a concentrated plant extract of a desired concentration. In addition, a sieving process may be performed so that the extract can be easily mixed with other powders.

[0022] The content of the component (A) agrimony extract in the oral composition of the present invention is not particularly limited and can be changed depending on its purity, the degree of purification, the subject of administration, the purpose, etc., and is, for example, 0.5 to 70% by mass based on the entire oral composition. The lower limit is more preferably 2% by mass or more, and even more preferably 5% by mass or more. On the other hand, the upper limit is more preferably 50% by mass or less, even more preferably 40% by mass or less, and most preferably 30% by mass or less. By setting the content within the above range, the effect of the agrimony extract as an active ingredient can be reliably exhibited, and at the same time, the effect of masking the bitterness of the agrimony extract by mixing it with the components (B1) to (C) described later can be more reliably exhibited.

[0023] The oral composition of the present invention may contain the following components (B1) to (B5) as component (B). By mixing the powders (B1) to (B5) with a powder containing Agrimole B, an oral composition in which the strong bitterness of Agrimole B is masked can be easily obtained. Each of these components will be described in detail below.

[0024] <(B1) Cellulose derivatives> The cellulose derivative usable in the oral composition of the present invention is a cellulose derivative having a viscosity of 2 to 800 mPa·s at 20°C and a shear rate of 10 / s for 1 min when made into a 2% aqueous solution. Cellulose is a polymeric compound having a structure in which a large number of β-glucose molecules are linearly polymerized through glycosidic bonds, and the cellulose derivative is a derivative of this cellulose. The cellulose derivative usable in the present invention is not particularly limited as long as it is acceptable for use in pharmaceuticals, foods, veterinary medicines, feeds, and the like. The cellulose derivative may be, for example, the following cellulose derivatives or salts thereof. Specific examples of cellulose derivatives include hydroxyalkylcelluloses such as hydroxypropyl cellulose (HPC), hydroxyethyl cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl methylcellulose (HPMC), hydroxyethyl methylcellulose, hydroxypropyl methylcellulose acetate succinate, and hydroxypropyl methylcellulose phthalate; alkylcelluloses such as methylcellulose and ethylcellulose; and carboxyalkylcelluloses such as carboxymethylcellulose, potassium carboxymethylcellulose, calcium carboxymethylcellulose, sodium carboxymethylcellulose, carboxymethylethylcellulose, croscarmellose sodium, and croscarmellose. The upper limit of the viscosity of the cellulose derivative is not particularly limited, but is more preferably 400 mPa·s or less.

[0025] Among them, from the viewpoint of the bitterness masking effect of the present invention, hydroxyalkyl cellulose is preferred, and hydroxypropyl cellulose (HPC) and hydroxypropyl methyl cellulose (HPMC) are more preferably usable. In addition, the upper limit of the viscosity of these hydroxypropyl celluloses is not particularly limited, but is more preferably 400 mPa·s or less, and even more preferably 300 mPa·s or less. On the other hand, the lower limit of hydroxypropyl methyl cellulose is not particularly limited, but is more preferably 4 mPa·s or more. The upper limit is more preferably 150 mPa·s or less, more preferably 100 mPa·s or less, and particularly preferably 60 mPa·s or less. These cellulose derivatives may be blended alone or in combination of two or more kinds. In addition, the method for producing the cellulose derivative of the present invention is not particularly limited, and it can be produced using a known method. In addition, commercially available products can also be used as the cellulose derivative.

[0026] The content of the cellulose derivative (B1) is not particularly limited, but is, for example, 0.05 to 60% by mass. The lower limit is preferably 0.1% by mass or more, more preferably 0.2% by mass or more, even more preferably 1% by mass or more, and most preferably 5% by mass or more. On the other hand, the upper limit is not particularly limited, but is preferably 50% by mass or less, more preferably 30% by mass or less. By setting the content of the cellulose derivative within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the cellulose derivative itself can be minimized, and at the same time, freedom of formulation design can be ensured.

[0027] The ratio (B1 / a) of the content of the cellulose derivative (B1) to the component (a) Agrimol B is not particularly limited, but is, for example, 1 to 450. The lower limit is more preferably 1.5 or more, even more preferably 7 or more, and most preferably 40 or more. On the other hand, the upper limit is not particularly limited, but is more preferably 200 or less, and even more preferably 150 or less. By setting the content ratio of component (B1) cellulose derivative to component (a) Agrimole B within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the cellulose derivative itself can be minimized, and at the same time, freedom of formulation design can be ensured. Furthermore, the ratio (B1 / A) of the content of the cellulose derivative (B1) to the agrimony extract (A) is not particularly limited, but is, for example, 0.005 to 2. The lower limit is preferably 0.01 or more, more preferably 0.03 or more, even more preferably 0.1 or more, and most preferably 0.2 or more. On the other hand, the upper limit is preferably 1 or less, more preferably 0.7 or less. By setting the content ratio of component (B1) cellulose derivative to component (A) agrimony extract within the above range, the bitterness masking effect of the present invention can be fully exerted while minimizing the influence of the taste of the cellulose derivative itself, thereby ensuring freedom in formulation design.

[0028] <(B2) Carrageenan> Carrageenan is a polysaccharide having a main chain with a linear structure in which D-galactose is alternately linked by α-1,3 bonds and β-1,4 bonds. The carrageenan that can be used in the present invention is not particularly limited as long as it is acceptable for use in pharmaceuticals, foods, veterinary medicines, feeds, etc., and examples thereof include kappa carrageenan, iota carrageenan, and lambda carrageenan, all of which can be suitably used in the present invention. In addition, the origin of the carrageenan is not particularly limited, and those derived from seaweeds such as Eucheuma cottonii and Eucheuma spinosum may be used. In addition, these carrageenans may be blended alone or in combination of two or more types. In addition, commercially available products may be used as the carrageenan.

[0029] The content of component (B2) carrageenan is 0.5 to 40% by mass based on the entire oral composition. The lower limit is more preferably 1% by mass or more, and even more preferably 5% by mass or more. On the other hand, the upper limit is not particularly limited, but is more preferably 30% by mass or less, and even more preferably 20% by mass or less. By setting the carrageenan content within the above range, the bitterness masking effect of the present invention can be fully exerted, while the influence of the taste of the carrageenan itself can be minimized, and it is expected that the carrageenan will exert a separate effect on the oral composition (e.g., a thickening effect).

[0030] The ratio (B2 / a) of the content of component (B2) carrageenan to component (a) Agrimol B is not particularly limited, but is, for example, 2 to 450. The lower limit is more preferably 7 or more, and even more preferably 30 or more. On the other hand, the upper limit is more preferably 200 or less, and even more preferably 150 or less. By setting the content ratio of component (B2) carrageenan to component (a) Agrimole B within the above range, the bitterness masking improvement effect of the present invention can be fully exerted while minimizing the influence of the taste of the carrageenan itself, and it is also expected that carrageenan will exert a separate effect on oral compositions (e.g., a thickening effect). Furthermore, the ratio of the content of the component (B2) carrageenan to the component (A) agrimony extract ((B2) / (A)) is not particularly limited, but is, for example, 0.01 to 2. The lower limit is more preferably 0.03 or more, even more preferably 0.05 or more, and most preferably 0.1 or more. On the other hand, the upper limit is more preferably 1 or less, and even more preferably 0.7 or less. By setting the ratio of the carrageenan content to the agrimony extract of component (A) within the above range, the bitterness masking effect of the present invention can be fully exerted while minimizing the influence of the taste of the carrageenan itself, and it is also expected that the carrageenan will exert a separate effect on the oral composition (e.g., a thickening effect).

[0031] <(B3) Pregelatinized starch> Pregelatinized starch is obtained by gelatinization and drying, for example, by heating a water suspension of starch by spray drying, drum drying, extrusion granulation, or the like. The method of gelatinization and drying is not particularly limited, and any method may be used as long as it results in a state in which part or all of the starch is soluble in cold water. Pregelatinized starch that can be used in the present invention is not particularly limited as long as it is acceptable for use in pharmaceuticals, foods, veterinary medicines, feed, and the like, and any degree of pregelatinization can be used. In addition, the type of starch that is the raw material for pregelatinized starch is not particularly limited, and examples thereof include corn starch, wheat starch, rice starch, potato starch, tapioca starch, high amylose starch, hydroxypropyl starch, starch hydrolysate, starch acetate, starch phosphate, starch octenyl succinate, carboxymethyl starch, phosphate crosslinked starch, oxidized starch, dialdehyde starch, acid-treated starch, sweet potato starch, sago starch, pea starch, and the like. Furthermore, processed starches obtained by carrying out chemical treatments such as esterification, etherification, oxidation and crosslinking in addition to the gelatinization treatment can also be used.

[0032] Among them, from the viewpoint of the bitterness masking effect of the present invention, pregelatinized corn starch, pregelatinized tapioca starch, and partially pregelatinized corn starch are preferably usable. Moreover, these pregelatinized starches may be blended alone or in combination of two or more. Moreover, the method for producing the pregelatinized starch of the present invention is not particularly limited, and it can be produced using a known method. Moreover, commercially available products can be used as the pregelatinized starch.

[0033] The content of component (B3) pregelatinized starch is 1 to 40% by mass based on the entire oral composition. The lower limit is more preferably 1% by mass or more. Meanwhile, the upper limit is more preferably 30% by mass or less, and even more preferably 20% by mass or less. By setting the content of pregelatinized starch within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the pregelatinized starch itself can be minimized, and a separate effect that the pregelatinized starch has on the oral composition (e.g., effect as a binder) can be expected to be exerted.

[0034] The ratio (B3 / a) of the content of component (B3) pregelatinized starch to component (a) Agrimol B is not particularly limited, but is, for example, 10 to 450. The lower limit is more preferably 20 or more, and even more preferably 40 or more. On the other hand, the upper limit is more preferably 200 or less, and even more preferably 150 or less. By setting the content ratio of (B3) pregelatinized starch to component (a) Agrimole B within the above range, the bitterness masking improvement effect of the present invention can be fully exerted, the influence of the taste of the pregelatinized starch itself can be minimized, and it is also expected that the pregelatinized starch will exert a separate effect on the oral composition (e.g., effect as a binder). Furthermore, the ratio (B3 / A) of the content of (B3) pregelatinized starch to the plant extract (A) is not particularly limited, but is, for example, 0.05 to 2. The lower limit is more preferably 0.1 or more, and even more preferably 0.2 or more. On the other hand, the upper limit is more preferably 1 or less, and even more preferably 0.7 or less. By setting the content ratio of component (B3) pregelatinized starch to component (A) agrimony extract within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the pregelatinized starch itself can be minimized, and a separate effect of the pregelatinized starch on the oral composition (e.g., as a binder) can be expected to be exerted.

[0035] <(B4) Disaccharide sugar alcohol> Sugar alcohols are sugars obtained by adding hydrogen to sugar molecules, and are used as indigestible, low-calorie sweeteners, and are also widely used in the fields of food quality improvers, such as for improving the shelf life of foods, retaining moisture, and suppressing coloring, as well as in the fields of foods for sick people, cosmetics, and medicines. The disaccharide sugar alcohols that can be used in the present invention are not particularly limited as long as they are acceptable for use in medicines, foods, animal medicines, feed, and the like, and examples thereof include maltitol (reduced maltose), lactitol (reduced lactose), and reduced palatinose (isomaltulose reduction product). Among these, maltitol and reduced palatinose are more preferably used from the viewpoint of the bitterness masking effect of the present invention. In addition, these disaccharide sugar alcohols may be blended alone or in combination of two or more kinds. In addition, the method for producing the disaccharide sugar alcohol of the present invention is not particularly limited, and can be produced using a known method. In addition, commercially available products can be used as the disaccharide sugar alcohol of the present invention.

[0036] The sugar alcohol content of the (B4) disaccharide is 1 to 30% by mass. The lower limit is more preferably 5% by mass or more. On the other hand, the upper limit is more preferably 20% by mass or less. By setting the content of disaccharide sugar alcohol within the above range, the bitterness masking effect of the present invention can be fully exerted, while the influence of the taste of the sugar alcohol itself can be minimized. In addition, it is expected that the sugar alcohol will exert additional effects as a food quality improver, such as retaining moisture in oral compositions and suppressing coloration.

[0037] The ratio (B4 / a) of the content of sugar alcohol of disaccharide of component (B4) to component (a) Agrimol B is not particularly limited, but is, for example, 10 to 450. The lower limit is more preferably 20 or more, and even more preferably 40 or more. On the other hand, the upper limit is more preferably 200 or less, even more preferably 150 or less, and most preferably 100 or less. By setting the ratio of the sugar alcohol content of component (B4) disaccharide to component (a) Agrimole B within the above range, the bitterness masking improvement effect of the present invention can be fully exerted while minimizing the influence of the taste of the sugar alcohol itself.In addition, it is expected that the sugar alcohol will exert additional effects as a food quality improver, such as retaining moisture in oral compositions and suppressing coloration. Furthermore, the ratio (B4 / A) of the content of sugar alcohol of disaccharide of component (B4) to component (A) agrimony extract is not particularly limited, but is, for example, 0.05 to 2. The lower limit is more preferably 0.1 or more, and even more preferably 0.2 or more. On the other hand, the upper limit is more preferably 0.7 or less, and even more preferably 0.5 or less. By setting the ratio of the sugar alcohol content to the agrimony extract of component (A) within the above range, the bitterness masking effect of the present invention can be fully exerted while minimizing the influence of the taste of the sugar alcohol itself. It is also expected that the sugar alcohol will exert additional effects as a food quality improver, such as retaining moisture in the oral composition and suppressing coloration.

[0038] <(B5) Linear dextrin or branched dextrin> Dextrin is a product obtained by decomposing starch, which is a raw material, with an enzyme or acid. The dextrin that can be used in the oral composition of the present invention is linear dextrin or branched dextrin having a DE (dextrose equivalent) of 2 to 20. Linear dextrin means dextrin in which glucose is bonded in a linear chain, and branched dextrin (sometimes called branched dextrin) means dextrin in which glucose is bonded in a chain while having a branched chain. The dextrin of the present invention may be a mixture of these linear dextrins and branched dextrins. The linear dextrin or branched dextrin having a DE of 2 to 20 that can be used in the present invention is not particularly limited as long as it is acceptable for use in pharmaceuticals, foods, veterinary drugs, feed, etc. For example, the glycosidic bond of the sugar may be any of α-1,4 bond, α-1,6 bond, β-1,2 bond, β-1,3 bond, β-1,4 bond, β-1,6 bond, or a combination thereof.

[0039] The lower limit of the DE is more preferably 4, and the upper limit of the DE is more preferably 18. The DE value can be analyzed by a known method for measuring dextrose, such as the Wilstetter-Schudel method. These dextrins may be blended alone or in combination of two or more kinds. The method for producing the dextrin of the present invention is not particularly limited, and the dextrin may be produced by a known method. Furthermore, commercially available products may be used as the dextrin of the present invention.

[0040] The content of the component (B5) linear dextrin or branched dextrin having a DE of 2 to 20 is 1 to 40% by mass based on the entire oral composition. The lower limit is more preferably 2% by mass or more, even more preferably 5% by mass or more, and most preferably 10% by mass or more. On the other hand, the upper limit is not particularly limited, but is more preferably 30% by mass or less. By setting the content of linear dextrin or branched dextrin within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the dextrin itself can be minimized, and at the same time, freedom of formulation design can be ensured. In addition, dextrin having a cyclic structure such as cyclodextrin may be contained within a range that does not impair the effects of the present invention. The content of dextrin having a cyclic structure is not particularly limited, and can be changed depending on the content of Agrimole B or (B5) linear dextrin or branched dextrin, but is, for example, 2% by mass or less based on the oral composition. More preferably, it is 0.5% by mass or less, even more preferably 0.1% by mass or less, and particularly preferably 0.01% by mass or less, and it is most preferable that the composition does not substantially contain dextrin having a cyclic structure. Here, "substantially" means that it is unavoidably contained.

[0041] The content ratio (B5 / a) of linear dextrin or branched dextrin having a DE of 2 to 20 of component (B5) to component (a) Agrimol B is not particularly limited, but is, for example, 5 to 450. The lower limit is more preferably 30 or more, and even more preferably 70 or more. On the other hand, the upper limit is more preferably 200 or less, and even more preferably 150 or less. By setting the ratio of dextrin content to component (a) Agrimole B within the above range, the bitterness masking improvement effect of the present invention can be fully exerted, the influence of the taste of dextrin itself can be minimized, and at the same time freedom of formulation design can be ensured. Furthermore, the content ratio (B5 / A) of the linear dextrin or branched dextrin having a DE of 2 to 20 of the component (B5) to the component (A) agrimony extract is not particularly limited, but is, for example, 0.03 to 2. The lower limit is more preferably 0.15 or more, and even more preferably 0.3 or more. On the other hand, the upper limit is more preferably 1 or less, and even more preferably 0.7 or less. By setting the content ratio of (B5) linear dextrin or branched dextrin having a DE of 2 to 20 to component (A) agrimony extract within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the dextrin itself can be minimized, and at the same time, freedom of formulation design can be ensured.

[0042] Furthermore, the oral composition of the present invention may contain the following component (C). By mixing the powder component (C) with a powder containing Agrimole B, an oral composition in which the strong bitterness of Agrimole B is masked can be easily obtained. This component (C) is described in detail below.

[0043] <(C) Metal salt of higher fatty acid or sucrose fatty acid ester> The metal salt of a higher fatty acid or sucrose fatty acid ester that can be used in the oral composition of the present invention is not particularly limited. As the metal salt of a higher fatty acid, a metal salt of a higher aliphatic carboxylic acid having 10 to 22 carbon atoms can be preferably used, and examples thereof include capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid, oleic acid, and erucic acid. In addition, the metal salt is not particularly limited, and examples thereof include sodium salt, lithium salt, calcium salt, magnesium salt, zinc salt, and aluminum salt. Among these metal salts of higher fatty acids, from the viewpoint of the bitterness masking effect of the present invention, a metal salt of stearic acid can be preferably used, and calcium stearate and magnesium stearate can be more preferably used. In addition, these metal salts of higher fatty acids may be blended alone or in combination of two or more.

[0044] The sucrose fatty acid ester is not particularly limited, and any sucrose fatty acid ester in which a fatty acid is ester-bonded to sucrose can be used regardless of HLB, the number of carbon atoms of the fatty acid, the degree of esterification, etc. The fatty acid ester-bonded to sucrose is not particularly limited, and examples thereof include lauric acid, myristic acid, palmitic acid, stearic acid, behenic acid, erucic acid, etc. The metal salts of these higher fatty acids or sucrose fatty acid esters may be blended alone or in combination of two or more kinds.

[0045] The content of the component (C) higher fatty acid metal salt or sucrose fatty acid ester is 0.5 to 10% by mass based on the entire oral composition. The lower limit of the content of the higher fatty acid metal salt or sucrose fatty acid ester is preferably 1% by mass or more, more preferably 2% by mass or more. On the other hand, the upper limit is preferably 7% by mass or less, more preferably 5% by mass or less. By setting the content of the component (C) higher fatty acid metal salt or sucrose fatty acid ester within the above range, the masking effect against the bitterness of the present invention can be fully exerted, the influence of the taste of the higher fatty acid metal salt or sucrose fatty acid ester itself can be minimized, and a separate effect of the higher fatty acid metal salt or sucrose fatty acid ester on the oral composition (for example, an effect as a lubricant) can be expected to be imparted.

[0046] The ratio (C / a) of the content of component (C) metal salt of higher fatty acid or sucrose fatty acid ester to component (a) Agrimol B is not particularly limited, but is, for example, 5 to 100. The lower limit is more preferably 10 or more. On the other hand, the upper limit is more preferably 60 or less. By setting the content ratio of component (C) metal salt of higher fatty acid or sucrose fatty acid ester to component (a) Agrimole B within the above range, the bitterness masking improvement effect of the present invention can be fully exerted, the influence of the taste of the metal salt of higher fatty acid or sucrose fatty acid ester itself can be minimized, and it is also expected that the higher fatty acid metal salt or sucrose fatty acid ester can impart an additional effect to the oral composition (e.g., effect as a lubricant). Furthermore, the ratio (C / A) of the content of the component (C) metal salt of a higher fatty acid or sucrose fatty acid ester to the component (A) agrimony extract is not particularly limited, but is, for example, 0.02 to 0.5. The lower limit is preferably 0.05 or more. Meanwhile, the upper limit is preferably 0.3 or less, more preferably 0.25 or less. By setting the content ratio of component (C) metal salt of a higher fatty acid or sucrose fatty acid ester to component (A) agrimony extract within the above range, the bitterness masking effect of the present invention can be fully exerted, the influence of the taste of the metal salt of a higher fatty acid or sucrose fatty acid ester itself can be minimized, and it is also expected that the higher fatty acid metal salt or sucrose fatty acid ester can impart a separate effect to the oral composition (e.g., effect as a lubricant).

[0047] <Ingredient (C) / Ingredient (B)> The mass ratio (C / B) of the content of the metal salt of a higher fatty acid or the sucrose fatty acid ester as component (C) to the content of components (B1) to (B5) as component (B) is not particularly limited and is, for example, 0.025 to 1. The lower limit is more preferably 0.05 or more, and even more preferably 0.1 or more. On the other hand, the upper limit is more preferably 0.5 or less, and even more preferably 0.25 or less. By setting the content of the metal salt of a higher fatty acid or sucrose fatty acid ester as component (C) relative to the content of components (B1) to (B5) as component (B) within the above range, the effect on taste can be minimized and it can be expected that the components (B1) to (B5) and the metal salt of a higher fatty acid or the sucrose fatty acid ester of component (C) will provide a separate effect to the oral composition.

[0048] The oral composition of the present invention may contain any combination of two or more of the components (B1) to (B5) or (C) in any proportion, as long as the effects of the present invention are achieved. It is more preferable that any one or more of the components (B1) to (B5) or (C) satisfy the above-mentioned content and / or content ratio. It is even more preferable that any one or more of the components (B1) to (B5) or (C) satisfy both the above-mentioned content and content ratio.

[0049] (Other Ingredients) The oral composition of the present invention may contain active ingredients and additives as necessary, in addition to Agrimole B and a plant extract containing Agrimole B. Specific examples of additives include excipients, binders, disintegrants, lubricants, stabilizers, preservatives, colorants, flavorings, sweeteners, etc. In addition, the composition may contain Agrimoles (Agrimol A to Agrimole G or Agrimofol) other than Agrimole B, which are ingredients contained in the Agrimole extract.

[0050] The active ingredient is not particularly limited as long as it exhibits efficacy and effect and is acceptable for use in medicines, foods, veterinary medicines, feed, etc., and examples include medicinal ingredients and functional ingredients used in medicines, quasi-drugs, OTC medicines, Chinese herbal medicines, herbal medicines, cosmetics, cosmetic materials, health foods, supplements, veterinary medicines, feed, etc. Specific examples of medicinal ingredients and functional ingredients include vitamin A, vitamin D, vitamin E, vitamin B1, vitamin B2, vitamin B6, vitamin B12, folic acid, biotin, niacin, niacinamide, pantothenic acid, iron, copper, zinc, manganese, selenium, chromium, molybdenum, polyglutamic acid, wisteria tea polyphenols, lipid regulators, antidiabetic agents, antihypertensive agents, vasodilators, β-adrenergic receptor blockers, cardiac ion channel agents, arrhythmia treatments, anticoagulants, central nervous system function improvers, sympathomimetics, parasympathomimetics, antimuscarinic agonists, dopaminergic agents, tranquilizers, antidepressants, and anti-anxiety agents. Examples of the active ingredient include drugs, hypnotics, animal-derived substances, plant-derived substances, lapidin, nobiletin, sulforaphane, ampelopsin, curcumins, resveratrols, geraniol, osajin, isoliquiritigenin, hydroxytyrosol, 25-hydroxycholecalciferol, S-adenosylmethionine, anthocyanin, proteoglycan, N-acetylglucosamine, collagen, bilberry extract, carrot powder, malt extract, lotus germ extract powder, gokahi, licorice, peony root, cinnamon bark, fennel, scutellaria, bifidobacteria, lactic acid bacteria, yeast, and dietary fibers such as polydextrose. Among them, it is preferable to use an active ingredient that has an anti-aging effect and a synergistic effect, which is expected as the effect of the essential ingredient of the present invention. In addition, these medicinal ingredients and functional ingredients may be formulated alone or in combination of two or more.

[0051] <Form of oral composition> The form of the oral composition of the present invention is not particularly limited as long as it is acceptable for use in medicines, foods, animal medicines, feeds, etc. For example, in addition to powders as they are, the composition may be in the form of powders or fine granules, or in the form of tablets such as plain tablets, sugar-coated tablets, buccal tablets, coated tablets, chewable tablets, pills, soft capsules, hard capsules, granules, liquids such as suspensions, emulsions, syrups, elixirs, and lozenges. Among these, from the viewpoint of realizing low cost, a powder form is preferable, and a powder mixture in which the powders of each component are mixed is more preferable. These preparations can be prepared by known means in preparation. Furthermore, these preparations can be used for processed foods, health foods (nutritional supplements, nutritional functional foods, foods for the sick, foods for specified health uses, functional foods, etc.), supplements, foods for the sick (hospital foods, foods for sick people, foods for nursing care, etc.), confectionery, oils and fats, dairy products, retort foods, microwave foods, frozen foods, seasonings, health supplements, beverages, nutritional drinks, etc., depending on the purpose. Among these, it is preferable to use it for the purpose of oral administration for anti-aging purposes.

[0052] [Method of manufacturing oral composition] The method for producing the composition for oral administration of the present invention is not particularly limited, and it can be produced by a known method. For example, in addition to the step of stirring and mixing each component (a) or (A) with one or more of the components (B1) to (C), steps such as heating, drying, pulverization, and sieving may be added as necessary, and the order and conditions of these steps are also not particularly limited.

[0053] Due to the above characteristics, the oral composition of the present invention can exert the effect of masking the bitterness in the oral composition due to the inclusion of component (a) Agrimole B, through the action of the specific components (B1) to (C).

[0054] [Method for masking the bitterness of an oral composition] The method for reducing the taste of an oral composition of the present invention is a method in which one or more powders selected from components (B1) to (C) are added to a powder oral composition containing component (a) Agrimole B or component (A) Agrimole extract containing component (a) Agrimole B. In addition, the Agrimole B, agrimony extract, cellulose derivatives, carrageenan, alpha-starch, disaccharide sugar alcohols, linear dextrin or branched dextrin, and metal salts of higher fatty acids or sucrose fatty acid esters that constitute the bitterness masking method of the oral composition may be the same as those of the oral composition of the present invention.

[0055] Similarly, the amounts of these cellulose derivatives, carrageenan, alpha-starch, sugar alcohols of disaccharides, linear dextrin or branched dextrin, and metal salts of higher fatty acids or sucrose fatty acid esters added are not particularly limited, and may be, for example, any amounts that satisfy the description of the cellulose derivatives, carrageenan, alpha-starch, sugar alcohols of disaccharides, linear dextrin or branched dextrin, and metal salts of higher fatty acids or sucrose fatty acid esters in the oral composition.

[0056] Due to the above characteristics, the method for masking the bitterness of an oral composition of the present invention can exert the effect of masking the bitterness of an oral composition containing Agrimole B through the action of components (B1) to (C). EXAMPLES

[0057] Although examples of the present invention will be described below, the present invention is not limited to these examples, and various modifications are possible within the technical concept of the present invention.

[0058] [Test Example 1: Bitterness-masking effect of oral composition containing Agrimole B] A test was conducted on the bitterness masking effect of an oral composition containing Agrimole B. More specifically, the bitterness masking effect was evaluated when an Agrimole B-containing Agrimole B extract was mixed with a powder of cellulose derivative, carrageenan, alpha-starch, disaccharide sugar alcohol, linear or branched dextrin, metal salt of higher fatty acid, or sucrose fatty acid ester. The Agrimole B extract used in the examples contains 0.452% by mass of Agrimole B.

[0059] <Preparation of test samples> Each sample was prepared by weighing each raw material in the composition shown in Tables 1 to 14, mixing the raw materials in a mixer (see-through mixer S-3, Tsutsui Rikagaku Kikai Co., Ltd.), and sieving through a 30-mesh sieve to obtain specimens of oral compositions of Reference Example 1, Comparative Examples 1 to 29, and Examples 1 to 82. Unless otherwise specified, the numerical values ​​in each table indicate the composition of each component as mass% relative to the entire oral composition. Details of the raw materials used in this test example are shown in Table 1 below.

[0060] [Table 1]

[0061] <Sensory evaluation> The oral compositions obtained as samples were placed in the mouth, and the bitterness was evaluated according to the following evaluation criteria. The evaluation was determined by consensus of three expert panelists.

[0062] (Evaluation Criteria) The panelists decided and evaluated the bitterness of each product compared to the raw material apricot alone according to the following criteria: ◯ and ◎ were considered to have a high bitterness masking effect and were therefore considered to be acceptable (examples), and the results are shown in each table. ◎ No bitterness 〇: Slightly bitter taste (not unpleasant) △...Has an unpleasant bitter taste. ×...Same bitterness as when using agrimony alone

[0063] <(B1) Cellulose derivatives> Cellulose derivatives with different viscosities were evaluated for their bitterness masking effect on the agrimony extract in the formulations shown in Table 2 below. The results of the sensory evaluation are also shown in Table 2. Note that Reference Example 1 and Comparative Examples 1 to 4 show the results for samples containing only agrimony extract and excipient (cellulose).

[0064] [Table 2]

[0065] (result) The results of Reference Example 1 and Comparative Examples 1 to 4 reveal that when the content of the agrimony extract is 2.5% by mass or more, an unpleasant bitter taste is felt. In addition, the results of Comparative Examples 5 and 6 show that the bitterness-masking effect of cellulose derivatives having viscosities outside the range of the present invention did not meet the standards. On the other hand, the results of Examples 1 to 13 show that the cellulose derivatives having viscosities within the range of the present invention can provide a sufficient bitterness-masking effect.

[0066] <(B2) Carrageenan> The bitterness-masking effect of the agrimony extract was evaluated for carrageenan and other thickening polysaccharides in the formulations shown in Table 3 below. The results of the sensory evaluation are also shown in Table 3.

[0067] [Table 3]

[0068] (result) From the results of Examples 14 to 24, it is clear that kappa carrageenan, iota carrageenan, and lambda carrageenan all exhibit their bitterness masking effect sufficiently and meet the standard. On the other hand, as shown by the results of Comparative Examples 7 to 14, thickening polysaccharides other than carrageenan do not obtain the bitterness masking effect and do not meet the standard. In addition, as shown by the results of Comparative Example 14 and the above Examples 14 to 24, it is clear that a certain amount or more of carrageenan is required to obtain a sufficient bitterness masking effect of carrageenan.

[0069] <(B3) Pregelatinized starch> (B3) Examination of types of pregelatinized starch The bitterness-masking effect of the agrimony extract was evaluated for pregelatinized starch and other starches in the formulations shown in Table 4 below. The results of the sensory evaluation are also shown in Table 4.

[0070] [Table 4]

[0071] (B3) Examination of the amount of pregelatinized starch Next, the effect of masking the bitterness of the agrimony extract was evaluated for the effective contents of pregelatinized starch in the formulations shown in Table 5 below. The results of this sensory evaluation are also shown in Table 5.

[0072] [Table 5]

[0073] (result) As shown by the results of Comparative Examples 15 to 17 in Table 4, β-starch did not provide a masking effect on the bitterness of the agrimony extract, whereas the results of Examples 25 to 27 show that in the case of at least partially gelatinized starch, the unpleasant bitterness disappeared and a sufficient bitterness masking effect that met the criteria was obtained. Furthermore, as shown in Table 5, it was revealed that in order to obtain the masking effect of pregelatinized starch, a certain amount or more of pregelatinized starch is required.

[0074] <(B4) Disaccharide sugar alcohol> Various sugar alcohols were evaluated for their bitterness-masking effect on the agrimony extract in the formulations shown in Table 6. The results of the sensory evaluation are also shown in Table 6.

[0075] [Table 6]

[0076] (result) From the results of Comparative Example 23 and Examples 37 to 44, it was revealed that an oral composition containing only a disaccharide sugar alcohol as component (B) can mask the bitterness of an agrimony extract, and that a certain amount of disaccharide sugar alcohol is required to obtain a sufficient masking effect. On the other hand, as shown by the results of Comparative Examples 19 to 22, the unpleasant bitterness could not be sufficiently masked with other sugars, and the criteria could not be met.

[0077] <(B5) Linear dextrin or branched dextrin> The bitterness-masking effect of each dextrin in the composition shown in Table 7 was evaluated for the agrimony extract. The results of the sensory evaluation are also shown in Table 7.

[0078] [Table 7]

[0079] (result) From the results of Comparative Example 27 and Examples 46 to 53, it was revealed that a powder oral composition containing only linear dextrin or branched dextrin with DE within a specific range as component (B) can mask the bitterness of the agrimony extract, and that a certain amount of component (B5) is required to obtain a sufficient masking effect. On the other hand, when gamma cyclodextrin having a cyclic structure in the molecule is contained alone, or when linear dextrin or branched dextrin with DE outside the range of the present invention is contained alone, the unpleasant bitterness cannot be sufficiently masked and the standard cannot be met, as shown by the results of Comparative Examples 24 to 26.

[0080] <(C) Metal salt of higher fatty acid or sucrose fatty acid ester> The metallic salts of higher fatty acids or sucrose fatty acid esters were evaluated for their bitterness-masking effect on the agrimony extract in the formulations shown in Table 8. The results of the sensory evaluation are also shown in Table 8.

[0081] [Table 8]

[0082] (result) The results of Examples 54 to 61 show that oral compositions containing only a metal salt of a higher fatty acid or a sucrose fatty acid ester as component (C) were able to provide a sufficient masking effect on the bitterness of agrimony extract, whereas the other fatty acid esters in Comparative Example 28 were unable to sufficiently mask the unpleasant bitterness and failed to meet the standards. Furthermore, the results of Comparative Example 29 showed that when the ratio (C / a) of component (C) calcium stearate to Agrimole was 1.11, the unpleasant bitterness could not be sufficiently masked.

[0083] [Test Example 2: Synergistic effect of component (B) and component (C)] An oral composition containing component (A) agrimony and a powder oral composition containing components (B1) to (B5) were further mixed with component (C) to evaluate the bitterness-masking effect of the oral composition.

[0084] <(B1) Cellulose derivatives and components (C)> In the formulations shown in Table 9 below, a powder mixture containing both the cellulose derivative (B1) and component (C), the effectiveness of which was confirmed, was evaluated for its synergistic effect in masking the bitterness of the agrimony extract. The results of this sensory evaluation are also shown in Table 9.

[0085] [Table 9]

[0086] <(B2) Carrageenan and ingredients (C)> In the formulation shown in Table 10 below, a powder mixture containing both (B2) carrageenan, whose effectiveness was confirmed, and component (C) was evaluated for its synergistic effect in masking the bitterness of the agrimony extract. The results of this sensory evaluation are also shown in Table 10.

[0087] [Table 10]

[0088] <(B3) Pregelatinized starch and its components (C)> In the formulations shown in the following Table 11, a powder mixture containing both (B3) pregelatinized starch, the effectiveness of which has been confirmed, and component (C) was evaluated for its synergistic effect in masking the bitterness of agrimony extract. The results of this sensory evaluation are also shown in Table 11.

[0089] [Table 11]

[0090] <(B4) Disaccharide sugar alcohols and their components (C)> In the formulation shown in Table 12 below, a powder mixture containing both the sugar alcohol of disaccharide (B4) and component (C), the effectiveness of which was confirmed, was evaluated for its synergistic effect in masking the bitterness of the agrimony extract. The results of this sensory evaluation are also shown in Table 12.

[0091] [Table 12]

[0092] <(B5) Linear dextrin or branched dextrin and component (C)> In the formulations shown in Table 13 below, a powder mixture containing both linear or branched dextrin with a DE of 2 to 20 (B5) and component (C), which have been confirmed to have a bitterness-masking effect, was evaluated for its synergistic effect in masking the bitterness of an agrimony extract. The results of this sensory evaluation are also shown in Table 13.

[0093] [Table 13]

[0094] (result) As shown in Tables 9 to 13, by forming a powder oral composition containing both component (B) and component (C), the results of the sensory evaluation showed a masking effect to the extent that no bitterness was felt, and the results were given the highest rating of "◎". Thus, a synergistic effect between component (B) and component (C) in masking the bitterness of the agrimony extract was confirmed.

[0095] [Test Example 3: Confirmation of manufacturability and bitterness masking effect in tablets] <Preparation of tablets> The raw materials were mixed according to the composition shown in Table 14, sieved through a 30 mesh screen, and then mixed using a mixer. The resulting mixture was compressed into tablets using a single punch tablet press (Okada Seiko Co., Ltd., N-30E) to obtain tablets of Examples 81 and 82. The tableting conditions were as follows: tablet diameter 9 mm, R12, tablet weight 300 mg / pill, and compression pressure 1000 kgf.

[0096] <Sensory evaluation and tableting evaluation> The compressed tablets were placed in the mouth and the bitterness was evaluated in the same manner as above. The tableting properties were also evaluated. The tableting properties were evaluated as "no problem" if no tableting problems such as capping or sticking occurred. These evaluations are also shown in Table 14.

[0097] [Table 14]

[0098] (result) As shown in Table 14, the results of the sensory evaluation were also the highest for tablets prepared by compressing the powdered oral composition containing the agrimony extract, component (B3), pregelatinized starch, and component (C). Therefore, it was revealed that even when formulated into tablets, the bitterness masking effect of components (B) and (C) on the agrimony extract can be obtained, similar to that of the powder mixture described above. At the same time, it was also revealed that the product has satisfactory tableting properties.

[0099] As described above, it was confirmed that by adding components (B1) to (C) to an oral composition containing Agrimole B, its bitterness can be masked and it can be formulated into tablets. [Industrial Applicability]

[0100] The present invention makes it possible to easily prepare oral compositions that contain Agrimole B while masking its bitterness, thereby making it possible to provide pharmaceuticals, quasi-drugs, drinkable cosmetics, drinkable cosmetics, health foods (nutritional supplements, nutritional functional foods, foods for the sick, foods for specified health uses, foods with functional claims, etc.), supplements, feed, etc. that utilize the beneficial effects of Agrimole B as an active ingredient.

Claims

1. A composition for oral administration, comprising a powder containing the following component (a) and one or more powders selected from the following components (B1) to (C): (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa·s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1 to 40% by mass (B4) 1 to 30% by mass of disaccharide sugar alcohol (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) Metal salt of higher fatty acid or sucrose fatty acid ester 0.5 to 10% by mass

2. The composition for oral administration according to claim 1 , characterized in that component (a) is derived from component (A) an extract of agrimony.

3. The composition for oral administration according to claim 1 or 2, characterized in that the composition contains one or more types of powder selected from components (B1) to (B5) and a powder of component (C).

4. The oral composition according to claim 1 or 2, characterized in that the ratio of the content of the components (B1) to (C) to the content of the component (a) is one or more of the following: the ratio (B1 / a) of the content of the component (B1) to the content of the component (a) is 1 to 450; the ratio (B2 / a) of the content of the component (B2) to the content of the component (a) is 2 to 450; the ratio (B3 / a) of the content of the component (B3) to the content of the component (a) is 10 to 450; the ratio (B4 / a) of the content of the component (B4) to the content of the component (a) is 10 to 450; the ratio (B5 / a) of the content of the component (B5) to the content of the component (a) is 5 to 450; The ratio (C / a) of the content of the component (C) to the content of the component (a) is 5 to 100.

5. A method for masking the bitterness of a powder oral composition containing the following component (a), characterized in that the method contains one or more types of powder selected from the following components (B1) to (C). (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa·s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1 to 40% by mass (B4) 1 to 30% by mass of disaccharide sugar alcohol (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) Metal salt of higher fatty acid or sucrose fatty acid ester 0.5 to 10% by mass

6. A method for producing an oral composition containing the following component (a) and one or more types of powder selected from components (B1) to (C), the method comprising a step of stirring and mixing component (a) and one or more types of powder selected from components (B1) to (C). (a) Agrimor B (B1) A cellulose derivative having a viscosity of 2 to 800 mPa·s at a shear rate of 20°C in a 2% aqueous solution. (B2) Carrageenan 0.5 to 40% by mass (B3) Pregelatinized starch 1 to 40% by mass (B4) 1 to 30% by mass of disaccharide sugar alcohol (B5) 1 to 40% by mass of linear dextrin or branched dextrin having a dextrol equivalent (DE) of 2 to 20 (C) Metal salt of higher fatty acid or sucrose fatty acid ester 0.5 to 10% by mass

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