CN106456681B - Tablet containing saccharomyces sake - Google Patents

Tablet containing saccharomyces sake Download PDF

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Publication number
CN106456681B
CN106456681B CN201580028888.2A CN201580028888A CN106456681B CN 106456681 B CN106456681 B CN 106456681B CN 201580028888 A CN201580028888 A CN 201580028888A CN 106456681 B CN106456681 B CN 106456681B
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coating
tablet
saccharomyces sake
glycerol
mass
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CN106456681A (en
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金岛大辅
五木田智夫
南埜秀明
松野步
菅藤寿裕
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Kao Corp
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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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
    • A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • 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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/282—Organic compounds, e.g. fats

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  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
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Abstract

The present invention can get that a kind of coating property is excellent, the equal coating agent of no problem in terms of appearance, aroma and flavor.The present invention provides a kind of tablet, it is the plain piece containing saccharomyces sake, the plain piece is coated by the coating agent containing hydroxypropyl methyl cellulose and glycerol, wherein, the coating rate (A) of hydroxypropyl methyl cellulose is 2~20 relative to the ratio (A/B) of the coating rate (B) of glycerol, and the content of saccharomyces sake thallus (C) is 15 mass % or more relative to plain piece.

Description

Tablet containing saccharomyces sake
Technical field
The present invention relates to the tablets containing saccharomyces sake.
Background technique
The nutritional ingredients such as vitamins rich in, amino acids, food fiber, mineralogical composition in saccharomyces sake.Cause This, it can be expected that reaching nutritional supplementation, prevention disease and other effects by intake saccharomyces sake.
Tablet containing saccharomyces sake can more easily be taken compared with saccharomyces sake itself.Therefore, containing saccharomyces sake Tablet is as being useful for obtaining the nutritional supplementation effect that saccharomyces sake is played.But above-mentioned nutrition is mended in order to obtain It fills or other effects, needs to absorb the saccharomyces sake of more amount.Therefore, it if the content of saccharomyces sake is few in tablet, absorbs Tablet can become excessively, to go wrong in taking.Therefore, in order to improve the taking of the tablet containing saccharomyces sake, Need to improve the yeast concentration in tablet.But if improving the yeast concentration in tablet, generate the hardship from saccharomyces sake The problem of taste, distinctive smell.
As the technology for inhibiting such bitter taste, smell, there is the technology being coated by coating agent to tablet.Patent text Offer described in 1 with cellulose derivative to the tablet of the dry thallus of the microorganism containing s-adenosyl-L-methionine (SAMe) into Row coating, and describe the preparation example for using hydroxypropyl methyl cellulose as cellulose derivative.
Existing technical literature
Patent document
Patent document 1: International Publication No. 2009/081833
Summary of the invention
Problem to be solved by the invention
But method described in patent document 1, its object is to make stable components contained in yeast, it is difficult to anti- The coating property such as decortication, corrugation, sliver, sticking for only generating is deteriorated.
It is an object of the present invention to obtain that a kind of coating property is excellent, the packet of equal no problem in terms of appearance, aroma and flavor Clothing agent.
The technical solution solved the problems, such as
The present inventor has carried out deep discussion in order to solve the above problems.It is found in the process by hydroxypropyl methyl fibre Dimension element is combined with glycerol to be used as coating agent, can keep good coating.Further, by adjusting hydroxypropyl methyl The balance of both cellulose and glycerol coating rate, can keep good appearance, aroma and flavor.
The present invention provides (1)~(3).
(1) a kind of tablet is the plain piece containing saccharomyces sake, and the plain piece is by containing hydroxypropyl methyl cellulose and glycerol Coating agent be coated, wherein
The coating rate (A) of hydroxypropyl methyl cellulose is 2~20 relative to the ratio (A/B) of the coating rate (B) of glycerol,
The content of saccharomyces sake thallus (C) is relative to plain piece more than 15 mass %.
(2) tablet according to (1), wherein the coating rate (B) of glycerol is 0.025%~2.5%.
(3) tablet according to (1) or (2), wherein the coating rate (A) of hydroxypropyl methyl cellulose be 0.5% with On.
Invention effect
Can provide that a kind of coating property is excellent according to the present invention, appearance, in terms of no problem contain The coated tablet of saccharomyces sake.
Specific embodiment
Contain saccharomyces sake in tablet of the invention.Saccharomyces sake is the yeast used when making pure mellow wine.When making pure mellow wine The yeast used principally falls into saccharomyces cerevisiae (S.cerevisiae).As saccharomyces sake, No. 6 yeast (K- of association can be enumerated 6), No. 7 yeast (K-7) of association, No. 9 yeast (K-9) of association, No. 701 No. 601 yeast (K-601) of association, association yeast (K- 701), No. 1501 No. 901 yeast (K-901) of association, No. 1001 yeast (K-1001) of association, association yeast (K-1501) (are Public good juridical person Japan makes association and promulgates).Saccharomyces sake can be any of raw thallus and dead thallus.
Saccharomyces sake is usually dry thallus.Dry thallus is a part warp of the thallus such as the fragment of thallus and/or thallus It is dried resulting product.As drying process, freeze-drying can be enumerated, be dried under reduced pressure, dry, spray drying of ventilating. Dry thallus is usually powdered.
Relative to the quality of plain piece of the present invention, the content of saccharomyces sake thallus (C) (dry mass) is as in every tablet The content of saccharomyces sake is usually 15 mass % or more relative to plain piece, preferably 20 mass % or more, more preferable 23 mass % with On.Thus, it is possible to which intake the piece number is controlled in the appropriate range, therefore taking can be improved.The upper limit preferably 70 mass % with Under, more preferable 60 mass % is hereinafter, further preferred 50 mass % or less.Thus, it is possible to prevent from saccharomyces sake Bitter taste, distinctive smell, can keep taste and smell.The content of saccharomyces sake thallus (C) is relative to plain piece in every tablet, It is preferred that 15 mass of mass %~70 %, the more preferable 20 mass mass of %~60 %, the further preferred 23 mass mass of %~50 %.
Saccharomyces sake thallus (C) in tablet of the invention is contained in saccharomyces sake.Saccharomyces sake and saccharomyces sake bacterium Body (C) is sometimes identical.In addition, the ingredient other than saccharomyces sake thallus (C) can also be contained in saccharomyces sake.As the pure mellow wine ferment Ingredient other than female thallus (C), such as can enumerate: fermentation liquid, culture supernatant etc..
Tablet of the invention can be coated the plain piece containing saccharomyces sake by coating agent.Coating agent contains hydroxyl Propyl methocel and glycerol.
Viscosity in 20 DEG C of 2 mass % aqueous solutions of hydroxypropyl methyl cellulose (alias: HPMC), preferably 2mm2/ s with On, more preferable 4mm2/ s or more.The preferred 10mm of the upper limit2/ s is hereinafter, more preferable 8mm2/ s or less.Thus, it is possible to realize film formability Good coating.
The degree of substitution of hydroxypropyl methyl cellulose, methoxyl content preferably 15% or more, more preferable 20% or more.The upper limit is excellent It selects 40% hereinafter, more preferable 30% or less.In addition, hydroxypropoxy content preferably 2% or more, more preferable 5% or more.The upper limit is excellent It selects 15% hereinafter, more preferable 12% or less.Thus, it is possible to realize the good coating of film formability.
As hydroxypropyl methyl cellulose, can enumerate: the METOLOSE60SH-03 of Shin-Etsu Chemial Co., Ltd, 60SH-06, SE-06, MCE-4, SB-4, SM-4, TC-5E, TC-5M, TC-5R etc..Wherein, particularly preferred SE-06, TC-5R.
The coating rate (A) of hydroxypropyl methyl cellulose, preferably 0.5% or more, more preferable 1% or more.The upper limit preferably 10% Hereinafter, more preferable 5% hereinafter, further preferred 3% or less.The coating rate preferably 0.5%~10%, more preferable 0.5%~ 5%, further preferred 1%~3%.
If the coating rate (A) of hydroxypropyl methyl cellulose more than preferred lower limit value, can be reduced more from clear The bitter taste of brewer yeast, distinctive smell, if in preferred upper limit value hereinafter, if the more good tablet of disintegration can be obtained.
As glycerol, glycerol specified in Japanese Pharmacopoeia or food additives statutory document can be used.
The coating rate (B) of glycerol, preferably 0.025% or more, more preferable 0.1% or more.The upper limit preferably 2.5% is hereinafter, more It is preferred that 0.8% or less.The coating rate preferably 0.025%~2.5%, more preferable 0.1%~0.8%.
If the coating rate (B) of glycerol can keep more good coating more than preferred lower limit value, if Preferred upper limit value is hereinafter, be then more difficult to that cosmetic variation occurs as time goes by.
Coating rate in the present invention is the numerical value being calculate by the following formula out.
(formula)
Coating rate=(content/plain piece quality of coating constituents) × 100
The coating rate (A) of hydroxypropyl methyl cellulose is relative to the ratio (A/B) of the coating rate (B) of glycerol 2 in tablet More than, preferably 4 or more.The upper limit preferably 20 is hereinafter, it is preferred that 10 or less.The ratio is 2~20, preferably 4~10.
If (A/B) more than preferred lower limit value and upper limit value hereinafter, if can keep more good coating.
Coating agent can contain the ingredient other than ylmethyl cellulose and glycerol.As the ingredient, can enumerate poly- Vinyl alcohol, polyvinylpyrrolidone etc. synthesize macromolecule；The polyalcohols such as polyethylene glycol, propylene glycol, glycerol；Triacetyl glycerine, The synthesizing esters such as triethyl citrate, fatty acid glyceride；Carboxymethyl cellulose, hydroxypropyl cellulose, methylcellulose, ethyl The cellulose families such as cellulose；The natural materials such as shellac, pulullan polysaccharide, gum arabic；Or these combination.In addition, can The pigment such as titanium oxide, iron oxide are added as needed；Any ingredients such as mannitol, cetanol, NaLS.In addition, After film coating, the Brazil wax etc. as gloss agent can be added.
It, can in the amount of degree for not damaging effect of the invention as long as not bringing bad influence to effect of the invention With any ingredient used in the manufacture containing tablets such as other pharmaceuticals, the outer product of medicine, food.As any ingredient, such as Can enumerate: excipient, adhesive, disintegrating agent, enteric polymer, insoluble polymer, lubricant, surfactant, Toner, flavoring agent, adsorbent, antistatic agent, disintegration extension agent, foaming agent etc..
It as excipient, such as can enumerate: starch, cornstarch, granulated sugar, mannitol, avicel cellulose, magnesium carbonate, carbon It is sour calcium, castor sugar, glucose, dextrose hydrate, lactose, silica (alias: silicic acid anhydride, silica particle), low Replace hydroxypropyl cellulose etc..The content of excipient is not particularly limited, preferably 0.1~80 mass % in terms of amounting to, further It is preferred that 10~70 mass %.
It as adhesive, such as can enumerate: sucrose, gelatin, gummi arabicum pulveratum, methylcellulose, hydroxypropyl cellulose, hydroxyl It is propyl methocel, carboxymethyl cellulose, calcium carboxymethylcellulose, polyvinylpyrrolidone, pulullan polysaccharide, dextrin, pre- Gelatinized starch etc..The content of adhesive is not particularly limited, preferably 0.1~10 mass %, further preferred 1~5 mass %.
It as disintegrating agent, such as can enumerate: cross-linked carboxymethyl sodium, insoluble crosslinked polyvinylpyrrolidone, partial gelatinization Starch, crospovidone, calcium carboxymethylcellulose (alias: Carmellose Calcium, CMC-Ca), sodium carboxymethyl starch, Cornstarch etc..The content of disintegrating agent is not particularly limited, preferably 0.1~30 mass %, further preferred 1~20 mass %.
It as enteric polymer, such as can enumerate: hydroxypropyl methyl cellulose phthalic acid, acetate propionate fiber Element, carboxymethylethylcellulose etc..
As insoluble polymer, such as can enumerate: Eudragit E100 (for example, Eudragit E, Eudragit RS etc.), methacrylic acid copolymer (for example, Eudragit L30-55 etc.) etc..
It as lubricant, such as can enumerate: polyethylene glycol, talcum, stearic acid or its salt (for example, calcium stearate), sucrose Aliphatic ester etc..The content of lubricant is not particularly limited, preferably 0.001~5 mass %, further preferred 0.01~3 matter Measure %.As the sucrose fatty ester, such as can enumerate: Surfhope SE Cosme C 1216, Sucrose myristate, sucrose palmitate, Sucrose stearate etc..It as Surfhope SE Cosme C 1216, can enumerate: sucrose monolaurate, sucrose dilaurate, sucrose March Cinnamic acid ester etc.；It as Sucrose myristate, can enumerate: sucrose monomyristate, two myristinate of sucrose, three meat of sucrose Myristate etc.；It as sucrose palmitate, can enumerate: sucrose palmitic acid ester, sucrose dipalmitate, three palmitinic acid of sucrose Ester etc.；It as sucrose stearate, can enumerate: sucrose monostearate, sucrose distearate, sucrose tristearate etc..
It as surfactant, such as can enumerate: the anionic surfactant such as sodium alkyl sulfate, polyoxyethylene Nonionic surface active agent such as Span, polyoxyethylene fatty acid ester and castor oil derivatives etc..
As colorant, such as can enumerate: tar pigment, caramel, kermes, titanium oxide, riboflavin class, green-tea extract, Chlorophyll copper sodium, edible Sunset Yellow FCF, eat Amaranth, eat blue 2 and wait edible pigments, edible color lake pigment etc..
As flavoring agent, such as can enumerate: sweetener (for example, saccharin sodium, dipotassium glycyrrhizinate, Aspartame, stevioside, Artificial sweeteners such as Talin etc.), fragrance is (for example, lemon, lemon bitter orange, orange, L- menthol, peppermint oil, peppermint MICRON X-8277-T, Dry Coat smear tea #421 etc.), acid (for example, citric acid, tartaric acid, malic acid etc.), green tea powder etc..
It as adsorbent, such as can enumerate: special calcium silicates (fluorite) etc..
It as antistatic agent, disintegration extension agent, such as can enumerate: light anhydrous silicic acid etc..
It as foaming agent, such as can enumerate: sodium bicarbonate etc..
The manufacturing method of tablet of the invention is not particularly limited, and is exemplified below an example and is illustrated.Firstly, obtaining element Piece.The methods of wet type granulation, dry type granulation can be used as needed to be granulated plain piece.In addition, can obtain by the following method Plain piece: mixing plain piece raw material and the direct compression method for carrying out tabletting；After dry type particle is made in compression forming, or water is added Carry out being kneaded after mixed solvent/granulation/dry after wet granulate is made, again or by being dissolved in additive in water equal solvent after Carry out spray drying wet granulate is made after, the indirect pressed disc method of compressed tablets is made；Or the method for combining these.It connects , mixing hydroxypropyl methyl cellulose, glycerol and desired any ingredient simultaneously prepare coating solution, by coating solution Direct spraying or The Coating Solution of water will be added to be sprayed in plain piece, form coating membrane on plain piece surface by dry, it is hereby achieved that Tablet of the invention.
[embodiment]
In the following, the present invention is described in more detail referring to embodiment, but embodiments of the present invention are not limited to These embodiments
Embodiment 1~14 and comparative example 1 and 2
(plain piece 1 and 2)
When manufacturing the saccharomyces sake tablet in each embodiment, the plain piece 1 and 2 of coating object is made.The composition of plain piece such as table 1 It is shown.
[table 1]
(footnote in table 1)
The amount (amount=saccharomyces sake amount × 0.7 saccharomyces sake thallus (C)) of saccharomyces sake thallus (C) in ※ saccharomyces sake [dry mass]
The content unit of each ingredient: mg/ piece
The manufacturing method of plain piece is as follows.By saccharomyces sake (dry yeast containing SAMe, Mitsubishi's gas chemistry strain formula Biomass 70% in commercial firm's system, yeast powder) and silica particle (Carplex FPS-500, DSL Amada Co., Ltd. System) mixing after, add and mixed crystallization cellulose (CEOLUS (registered trademark) UF-F711, Asahi Chemical Corp's system) With calcium carboxymethylcellulose (E.C.G-FA, sun wheel chemical industry Co. Ltd. system), then adds and mix calcium stearate (tristearin Sour calcium, peaceful Chemical Industries Co. Ltd. system), tabletting is carried out at 12kgN by direct compression method.Tabletting uses rotary pressure Piece machine (LIBRA2, Kikusui Seisakusho Ltd.'s system).
Coating agent in table 2~4 is dissolved in the water, the coating solution of concentration 5% is configured to.On the other hand, by 200Kg element Piece is fitted into seed-coating machine (DRC-14000S, P Co., Ltd.'s owrex system), with 65 DEG C of feed air temperature, revolution 1rpm, the row of being preheated to After temperature degree is 45 DEG C, spray coating liquid under conditions of revolution 5rpm/ spray liquid speed 300mL/min.After spraying, do It is dry to delivery temperature be 50 DEG C, terminate coating.It is explained, hydroxypropyl methyl cellulose (commodity used in each embodiment Name: METOLOSE SE-06, manufacturer's name: Shin-Etsu Chemial Co., Ltd) have the property that the 2 mass % at 20 DEG C The viscosity of aqueous solution is 5.9mm2/s；Methoxyl content is 28.9%；Hydroxypropoxy content is 9.0%.In addition, glycerol uses Food additives glycerol, by slope this pharmaceutical industries Co. Ltd. system.
The coating of obtained each tablet, appearance, aroma and flavor are evaluated.The evaluation of coating property are as follows: range estimation is seen The case where examining the decortication, corrugation, sliver that are coated in the tablet just produced, and evaluated according to standard as shown below.Piece The ocular estimate of agent is the changing condition that visual observations save outside color in 4 months tablets in 40 DEG C of thermostats, and It is evaluated according to standard as shown below.The evaluation of aroma and flavor is smell/taste of one group of 5 people to the tablet just produced Road is evaluated, and is evaluated according to standard as shown below.
[judgment criteria of coating property]
What be can be seen is coated decortication, wrinkles, the tablet of sliver, if in 100 being 2 or less, then it is assumed that can receive.
◎: being 0 in 100 it can be seen that peeling, wrinkling, the tablet of sliver
Zero: being 1 or more and 2 or less in 100 it can be seen that peeling, wrinkling, the tablet of sliver
Δ: being 3 or more and 5 or less in 100 it can be seen that peeling, wrinkling, the tablet of sliver
×: it is 6 or more in 100 it can be seen that peeling, wrinkling, the tablet of sliver
[judgment criteria of appearance]
4 months preservation product and the preservation condition ratio of shady place (5 DEG C) are saved at 40 DEG C, if appearance color almost without Variation, then it is assumed that can receive.
◎: appearance color is unchanged
Zero: appearance color is almost unchanged
Δ: it can be seen that appearance color variation is less
×: it can be seen that appearance color variation is more
[judgment criteria of aroma and flavor]
If the average mark of one group of 5 people is higher than 4 points, then it is assumed that can receive.
5 points: not feeling smell/taste
4 points: feeling smell/taste slightly
3 points: feeling smell/taste
2 points: feeling apparent smell/taste
1 point: feeling very big smell/taste
<evaluation>
◎: average mark is higher than 4.5 points
Zero: average mark is higher than 4 points and 4.5 points or less
△: average mark is higher than 3 points and 4 points or less
×: average mark is 3 points or less
The type of plain piece, coating conditions and evaluation result are as shown in table 2~4 in each Examples and Comparative Examples.
[table 2]
[table 3]
[table 4]
As clearly shown in table 2~4, the tablet of embodiment 1~14 is evaluated as well in coating property and appearance, smell and taste Road is also within the acceptable range.In contrast, the coating agent of comparative example 1 of the A/B less than 2 coating property, appearance, smell and Taste is poor, A/B be more than 20 comparative example 2 in coating agent, coating property, aroma and flavor are poor.It should be the result shows that this hair The coating of bright tablet is excellent, also no problem in terms of appearance, in terms of smell, taste also without a doubt.
(Formulation Example)
<tablet>
Other than the combined amount of each ingredient, tablet is obtained by method similarly to Example 1.The composition of tablet such as table Shown in 5.
[table 5]
(A): coating rate (the %)=1.333/0.167=8 of coating rate (%)/(B): (b) (a)

Claims (3)

1. a kind of tablet is the plain piece containing saccharomyces sake, the plain piece is by the coating agent packet containing hydroxypropyl methyl cellulose Clothing forms, which is characterized in that
The coating agent also includes glycerol,
Wherein, the coating rate (A) of hydroxypropyl methyl cellulose is 2~20 relative to the ratio (A/B) of the coating rate (B) of glycerol,
The content of saccharomyces sake thallus (C) is 15 mass % or more relative to plain piece.
2. tablet according to claim 1, wherein the coating rate (B) of glycerol is 0.025%~2.5%.
3. tablet according to claim 1 or 2, wherein the coating rate (A) of hydroxypropyl methyl cellulose is 0.5% or more.
CN201580028888.2A 2014-06-10 2015-06-09 Tablet containing saccharomyces sake Active CN106456681B (en)

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