WO2015190452A1 - 清酒酵母含有錠剤 - Google Patents
清酒酵母含有錠剤 Download PDFInfo
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- WO2015190452A1 WO2015190452A1 PCT/JP2015/066545 JP2015066545W WO2015190452A1 WO 2015190452 A1 WO2015190452 A1 WO 2015190452A1 JP 2015066545 W JP2015066545 W JP 2015066545W WO 2015190452 A1 WO2015190452 A1 WO 2015190452A1
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- sake
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/064—Saccharomycetales, e.g. baker's yeast
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
Definitions
- the present invention relates to a tablet containing sake yeast.
- Sake yeast contains abundant nutrients such as vitamins, amino acids, dietary fiber, and minerals. Sake yeast intake is useful for nutritional supplementation. Sake yeast contains a relatively large amount of S-adenosylmethionine (SAMe), and this component is effective for joint pain, liver function improvement, depression, growth hormone secretion promoting action and sleep. It is known that it has an action to improve the quality of the food (Patent Documents 1, 2, etc.), and intake of sake yeast can be expected to have these effects.
- SAMe S-adenosylmethionine
- sake yeast in order to obtain the above effect, it is necessary to ingest a relatively large amount of sake yeast. Therefore, when using sake yeast as a tablet, if the amount of sake yeast contained in one tablet is low, the number of tablets that must be ingested increases, resulting in poor dosage. In order to reduce the number of tablets that must be ingested, it is conceivable to increase the amount of sake yeast contained in one tablet, but if the amount of sake yeast contained in one tablet is increased, the moldability deteriorates, Due to hardness problems such as tablet breakage, it is necessary to add appropriate additives. However, simply increasing the amount of additives such as excipients causes problems with disintegration, and the amount of sake yeast contained in one tablet is relatively small. As it increases, the problem of ingestion reignites.
- the present invention has been made in view of the above problems, and an object of the present invention is to obtain a sake yeast-containing tablet having sufficient tablet physical properties such as hardness and disintegration even if a lot of sake yeast is blended in one tablet. To do.
- the sake yeast (A) is contained in an amount of 15% by mass or more in the tablet, and the amount of crystalline cellulose (B) relative to the content of the sake yeast (A) The tablet whose mass ratio (B / A) of content is 1.3 or more.
- a tablet having good tablet physical properties such as hardness and disintegration can be provided.
- the tablet of the present invention contains sake yeast.
- Sake yeast is yeast used for sake brewing. Yeasts used for sake brewing are mainly classified into S. cerevisiae. As sake yeast, association 6 yeast (K-6), association 7 yeast (K-7), association 9 yeast (K-9), association 601 yeast (K-601), association 701 yeast ( K-701), Association No. 901 yeast (K-901), Association No. 1001 yeast (K-1001), Association No. 1501 yeast (K-1501) (all of which are distributed by the Japan Brewing Association). Sake yeast may be either live cells or dead cells.
- Sake yeast is usually dry cells.
- a dry microbial cell is a result obtained by drying a part of microbial cells, such as a microbial cell and / or a fragment of a microbial cell. Examples of the drying process include freeze drying, reduced pressure drying, aeration drying, and spray drying. Dry cells are usually in powder form.
- the content (dry mass) of the sake yeast cells (A) relative to the mass of the tablet of the present invention is usually 15% by mass or more, preferably 20% by mass or more, as the content per sake yeast tablet. Yes, more preferably 23% by mass or more. Thereby, since the number of ingested tablets can be suppressed to an appropriate range, the dosing property can be improved.
- the upper limit is preferably 70% by mass or less, more preferably 60% by mass or less, and still more preferably 50% by mass or less. Thereby, hardness sufficient as a tablet and favorable disintegration are obtained.
- the content of sake yeast (A) per tablet is preferably 15% by mass to 70% by mass, more preferably 20% by mass to 60% by mass, and 23% by mass to 50% by mass. % Is more preferable.
- Sake yeast cells (A) in the tablet of the present invention are contained in sake yeast.
- the sake yeast and the sake yeast (A) may be the same.
- components other than sake yeast (A) may be contained in sake yeast.
- Examples of components other than the sake yeast (A) include fermentation broth and culture supernatant.
- the tablet of the present invention contains crystalline cellulose (B).
- Crystalline cellulose (B) is cellulose having a crystal structure, and may be microcrystalline cellulose (cellulose having a microcrystalline structure).
- the production conditions of crystalline cellulose are not particularly limited, and may be produced by partially depolymerizing ⁇ -cellulose, or may be produced by hydrolyzing raw materials such as pulp to remove non-crystalline parts. Also good.
- the crystalline cellulose (B) may be what is called microcrystalline cellulose.
- Examples of the crystalline cellulose (B) include Theolas (registered trademark) of grades such as UF, KG, PH, and FD manufactured by Asahi Kasei Chemicals Corporation. Preferable examples include Theolas (registered trademark) FD-101, Theolas (registered trademark) UF-F702, and Theolas (registered trademark) UF-F711.
- the bulk density of crystalline cellulose (B) is preferably from 0.3 g / cm 3 or less, more preferably 0.25 g / cm 3, 0 .1g / cm 3 or more preferably, 0.15 g / cm 3 or more is more preferable.
- the average particle size of the crystalline cellulose (B) is preferably 100 ⁇ m or less, more preferably 80 ⁇ m or less, and further preferably 60 ⁇ m or less, 1 micrometer or more is preferable, 20 micrometer or more is more preferable, and 30 micrometer or more is still more preferable.
- the bulk density can be measured based on the bulk density and tap density measurement method No. 2 in the 16th revised Japanese Pharmacopoeia general test method. Specifically, the sample can be uniformly supplied from above the container through a JIS standard 1.0 mL sieve into a cylindrical container having an inner diameter of 30 mm (measured volume: 25 mL), and the upper surface is ground and weighed. .
- the average particle size is measured when the crystalline cellulose (B) is dispersed in water and measured with a laser diffraction particle size distribution analyzer (refractive index setting; standard, dispersion; 1% Tween 20 solution, ultrasonic dispersion time 2 minutes)
- the content of crystalline cellulose (B) is not particularly limited.
- the content per crystalline cellulose (B) tablet is usually 0.5% by mass or more, preferably 10% by mass or more.
- An upper limit is 85 mass% or less, Preferably it is 75 mass% or less. Thereby, sufficient tablet hardness and good disintegration as a tablet are obtained.
- the content of crystalline cellulose is preferably 0.5% by mass to 85% by mass, and more preferably 10% by mass to 75% by mass.
- the mass ratio (B / A) of the content of crystalline cellulose (B) to the content of sake yeast (A) is 1.3 or more, preferably 2.5 or more. . Thereby, the tablet excellent in both hardness and disintegration can be obtained.
- the upper limit of the mass ratio (B / A) since it is 5.7 at the maximum, this value is preferably the upper limit and is preferably less than 3.7. Thereby, the ingestion property of a tablet can be kept favorable.
- the tablet of the present invention preferably further contains carboxymethylcellulose calcium (also known as carmellose calcium) (C).
- carboxymethylcellulose calcium (C) also known as carmellose calcium
- the blending amount of carboxymethyl cellulose calcium (C) is preferably 0.5% by mass or more, more preferably 1% by mass or more, and further preferably 1.5% by mass or more.
- the upper limit is preferably 30% by mass or less, preferably 20% by mass or less, and more preferably 10% by mass or less.
- the content of carboxymethyl cellulose calcium (C) is preferably 0.5 to 30% by mass, more preferably 1 to 20% by mass, and still more preferably 1.5 to 10% by mass.
- Excipients include, for example, starch, corn starch, granulated sugar, mannitol, magnesium carbonate, calcium carbonate, purified white sugar, glucose, hydrous glucose, lactose, silicon dioxide (also known as silicic anhydride, fine silicon dioxide), low degree of substitution Examples thereof include hydroxypropylcellulose.
- the content of the excipient is not particularly limited, but is preferably 0.1% by mass to 80% by mass, and more preferably 0.3% by mass to 74% by mass.
- binder examples include sucrose, gelatin, gum arabic powder, methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, polyvinylpyrrolidone, pullulan, dextrin, pregelatinized starch and the like.
- the content of the binder is not particularly limited, but is preferably 0.1 to 10% by mass, and more preferably 1 to 5% by mass.
- disintegrant examples include croscarmellose sodium, cross-linked insoluble polyvinylpyrrolidone, partially pregelatinized starch, crospovidone, sodium carboxymethyl starch, and corn starch.
- the content of the disintegrant is not particularly limited, but is preferably 0.1 to 30% by mass in total, and more preferably 1 to 20% by mass.
- enteric polymer examples include hydroxypropyl methylcellulose phthalate, cellulose acetate phthalate, and carboxymethylethyl cellulose.
- water-insoluble polymer examples include aminoalkyl methacrylate copolymers (for example, Eudragit E, Eudragit RS, etc.), methacrylic acid copolymers (for example, Eudragit L30-55, etc.), and the like.
- the lubricant examples include polyethylene glycol, talc, stearic acid or a salt thereof (eg, calcium stearate), sucrose fatty acid ester, and the like.
- the content of the lubricant is not particularly limited, but is preferably 0.001 to 5% by mass, and more preferably 0.01 to 3% by mass.
- the sucrose fatty acid ester examples include sucrose laurate, sucrose myristic ester, sucrose palmitate, sucrose stearate, and the like.
- sucrose laurate sucrose monolaurate, sucrose dilaurate, sucrose trilaurate, etc.
- sucrose myristic acid ester sucrose monomyristate, sucrose dimyristate, sucrose trimyristate
- sucrose palmitate examples include sucrose monopalmitate, sucrose dipalmitate, and sucrose tripalmitate.
- sucrose stearate examples include sucrose monostearate, sucrose distearate, and sucrose tristearate. Is mentioned.
- surfactant examples include anionic surfactants such as sodium alkyl sulfate, nonionic surfactants such as polyoxyethylene sorbitan fatty acid ester, polyoxyethylene fatty acid ester, and polyoxyethylene castor oil derivative. .
- colorant examples include tar dyes, caramel, red pepper, titanium oxide, riboflavin, green tea extract, copper chlorophyllin sodium, edible yellow No. 5, edible red No. 2, edible blue No. 2, etc., and edible lake dyes. Etc.
- corrigent examples include sweeteners (eg, artificial sweeteners such as sodium saccharin, dipotassium glycyrrhizinate, aspartame, stevia, thaumatin), flavors (eg, lemon, lemon lime, orange, l-menthol, peppermint oil, Peppermint Micron X-8277-T, dry coat matcha tea # 421, etc.), acidulants (eg, citric acid, tartaric acid, malic acid, etc.), green tea powder and the like.
- sweeteners eg, artificial sweeteners such as sodium saccharin, dipotassium glycyrrhizinate, aspartame, stevia, thaumatin
- flavors eg, lemon, lemon lime, orange, l-menthol, peppermint oil, Peppermint Micron X-8277-T, dry coat matcha tea # 421, etc.
- acidulants eg, citric acid, tartaric acid, malic acid, etc.
- adsorbent examples include special calcium silicate (florite).
- antistatic agent examples include light anhydrous silicic acid (aerosil).
- foaming agent examples include baking soda.
- the tablet production method is not particularly limited, and may be granulated using a method such as wet granulation or dry granulation, if necessary.
- a method such as wet granulation or dry granulation, if necessary.
- other methods include sake yeast, a direct tableting method in which crystalline cellulose and the above additives are mixed and tableted, dry granulation by compression molding, or kneading by adding a mixed solvent of water. , Granulated and dried into wet granules, or after dissolving additives in a solvent such as water and spray dried into wet granules, an indirect tableting method to produce compressed tablets, or a combination of these Is mentioned.
- the direct tableting method is preferred.
- Coating agents include celluloses such as carmellose, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, and ethylcellulose; synthetic polymers such as polyvinyl alcohol and polyvinylpyrrolidone; polyhydric alcohols such as polyethylene glycol, propylene glycol, and glycerin; triacetin; Examples include synthetic esters such as triethyl acid and glycerin fatty acid ester, natural substances such as shellac and pullulan, or combinations thereof.
- pigments such as a titanium oxide and an iron oxide, mannitol, cetanol, and sodium lauryl sulfate as needed.
- carnauba wax or the like can be added as a brightening agent after film coating.
- a tablet that is excellent in dosing properties and excellent in tablet physical properties such as hardness and disintegration.
- the hardness of the tablet can be measured using a hardness meter (for example, TH-203CP, manufactured by Toyama Sangyo Co., Ltd.).
- production of problems, such as a crack of a tablet and a chip, can be suppressed as hardness is 5 kgf or more.
- the workability during the treatment can be improved if the hardness is 6 kgf or more.
- the disintegration property can be evaluated by measuring the disintegration time using the method described in the Japanese Pharmacopoeia General Test Method.
- the disintegration time is preferably less than 60 minutes, and more preferably less than 40 minutes. It can be evaluated that the shorter the disintegration time, the more excellent the immediate effect.
- Examples 1 to 6 and Comparative Examples 1 to 3 Sake yeast (SAMe-containing dry yeast, manufactured by Mitsubishi Gas Chemical Co., Inc., 70% of the amount of cells in yeast powder), crystalline cellulose, carboxymethylcellulose calcium (ECG-FA, manufactured by Nichirin Chemical Industries, Ltd.) Then, calcium stearate (calcium stearate, manufactured by Taihei Chemical Industrial Co., Ltd.) was added and mixed, and tableting was performed at 5 kN by the direct compression method.
- As the crystalline cellulose Theolas (registered trademark) FD-101 (manufactured by Asahi Kasei Chemicals Corporation) was used.
- the hardness and disintegration time of each tablet obtained were measured.
- the hardness was measured with a hardness meter (TH-203CP, manufactured by Toyama Sangyo Co., Ltd.) and judged according to the following criteria.
- the disintegration time was measured by conducting a disintegration test according to the tablet disintegration test method listed in the 16th revised Japanese Pharmacopoeia and measuring the disintegration time (minutes).
- the disintegration test solution used ion-exchanged water, and the water bath temperature was 37 ° C. An average value of 6 measurements was calculated and judged according to the following criteria.
- Tables 1 and 2 show the components and evaluation of each tablet.
- Example 7 to 9 Tablets were prepared in the same manner as in Example 1 except that the crystalline cellulose described in Table 3 was used as the crystalline cellulose and the tableting pressure was 4 kN. The hardness and disintegration time of each obtained tablet were measured in the same manner as in Example 1. Table 3 shows the components and evaluation of each tablet.
- Carplex FPS-500 manufactured by DSL Japan Co., Ltd.
- Theolas registered trademark
- FD-101, UF-F702, and UF-F711 all Asahi Kasei
- Chemicals Co., Ltd. was used.
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Abstract
Description
〔1〕 清酒酵母と結晶セルロースとを含有する錠剤において、清酒酵母菌体(A)を錠剤中に15質量%以上含有し、清酒酵母菌体(A)の含有量に対する結晶セルロース(B)の含有量の質量比率(B/A)が1.3以上である、錠剤。
〔2〕 カルボキシメチルセルロースカルシウム(C)を更に含有する、〔1〕に記載の錠剤。
〔3〕 清酒酵母菌体(A)を23質量%以上含有する、〔1〕又は〔2〕に記載の錠剤。
〔4〕 結晶セルロース(B)の嵩密度が0.3g/cm3以下である、〔1〕~〔3〕のいずれかに記載の錠剤。
〔5〕 結晶セルロース(B)の平均粒子径が100μm以下である、〔1〕~〔4〕のいずれかに記載の錠剤。
本発明の錠剤は、清酒酵母を含有する。清酒酵母とは、清酒醸造に用いられる酵母である。清酒醸造に用いられる酵母は、主としてサッカロミセス・セレビシエ(S.cerevisiae)に分類される。清酒酵母としては、協会6号酵母(K-6)、協会7号酵母(K-7)、協会9号酵母(K-9)、協会601号酵母(K-601)、協会701号酵母(K-701)、協会901号酵母(K-901)、協会1001号酵母(K-1001)、協会1501号酵母(K-1501)(いずれも公益財団法人日本醸造協会頒布)が例示される。清酒酵母は、生菌体及び死菌体のいずれでもよい。
本発明の錠剤は、結晶セルロース(B)を含有する。結晶セルロース(B)は、結晶構造を有するセルロースであり、微結晶セルロース(微結晶構造を有するセルロース)であってもよい。結晶セルロースの製造条件は特に限定されず、α-セルロースを部分的に解重合して生成したものであってもよいし、パルプ等の原料を加水分解し非結晶部分を除去して製造してもよい。結晶セルロース(B)は、微結晶セルロースと呼ばれているものであってもよい。結晶セルロース(B)としては、例えば、旭化成ケミカルズ株式会社製のUF、KG、PH、FD等のグレードのセオラス(登録商標)が挙げられる。好ましくは、セオラス(登録商標)FD-101、セオラス(登録商標)UF-F702、セオラス(登録商標)UF-F711が挙げられる。
本発明の錠剤において、清酒酵母菌体(A)の含有量に対する結晶セルロース(B)の含有量の質量比率(B/A)が1.3以上であり、2.5以上であることが好ましい。これにより、硬度及び崩壊性の両方に優れた錠剤を得ることができる。
本発明の錠剤は、カルボキシメチルセルロースカルシウム(別名:カルメロースカルシウム)(C)を更に含有することが好ましい。カルボキシメチルセルロースカルシウム(C)を配合することにより、錠剤の崩壊性をさらに向上させることができる。カルボキシメチルセルロースカルシウム(C)の配合量は、0.5質量%以上であることが好ましく、1質量%以上であることがより好ましく、1.5質量%以上であることが更に好ましい。上限は、30質量%以下であることが好ましく、20質量%以下であることが好ましく、10質量%以下であることがより好ましい。カルボキシメチルセルロースカルシウム(C)の含有量は、0.5~30質量%であることが好ましく、より好ましくは1~20質量%であり、更に好ましくは1.5~10質量%である。
清酒酵母(SAMe含有乾燥酵母、三菱ガス化学(株)製、酵母粉末中の菌体量70%)、結晶セルロース、カルボキシメチルセルロースカルシウム(E.C.G-FA、ニチリン化学工業(株)製)を混合した後、ステアリン酸カルシウム(ステアリン酸カルシウム、太平化学産業(株)製)を添加混合し、直打法により5kNで打錠した。なお、結晶セルロースとしてはセオラス(登録商標)FD-101(旭化成ケミカルズ(株)製)を用いた。
硬度が5kgf以上であれば許容と判断した。
☆:8kgf以上
◎:6kgf以上8kgf未満
○:5kgf以上6kgf未満
×:5kgf未満
崩壊時間が60分未満であれば許容と判断した。
◎:40分未満
○:40分以上、60分未満
×:60分以上
※清酒酵母中の清酒酵母菌体(A)としての量(清酒酵母菌体(A)量=清酒酵母量×0.7)〔乾燥質量〕
各成分の含有量の単位:mg/錠
結晶セルロースとして表3に記載された結晶セルロースを用い、打錠圧を4kNとしたほかは、実施例1と同様にして錠剤を作成した。得られた各錠剤の硬度と崩壊時間を実施例1と同様に測定した。各錠剤の成分と評価を表3に示す。なお、微粒二酸化ケイ素としてはカープレックスFPS-500(DSL.ジャパン(株)製)を用い、結晶セルロースとしては、セオラス(登録商標)FD-101、UF-F702、及びUF-F711(いずれも旭化成ケミカルズ(株)製)を用いた。
※清酒酵母中の清酒酵母菌体(A)としての量(清酒酵母菌体(A)量=清酒酵母量×0.7)〔乾燥質量〕
各成分の含有量の単位:mg/錠
Claims (5)
- 清酒酵母と結晶セルロースとを含有する錠剤において、清酒酵母菌体(A)を錠剤中に15質量%以上含有し、清酒酵母菌体(A)の含有量に対する結晶セルロース(B)の含有量の質量比率(B/A)が1.3以上である錠剤。
- カルボキシメチルセルロースカルシウム(C)を更に含有する、請求項1に記載の錠剤。
- 清酒酵母菌体(A)を23質量%以上含有する、請求項1又は2に記載の錠剤。
- 結晶セルロース(B)の嵩密度が0.3g/cm3以下である、請求項1~3のいずれか1項に記載の錠剤。
- 結晶セルロース(B)の平均粒子径が100μm以下である、請求項1~4のいずれか1項に記載の錠剤。
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