TW200950820A - Film coating composition - Google Patents

Abstract

To provide a film-coated preparation having a highly glossy surface, even when a sugar coating is not applied. ; This film coating composition is characterized by comprising (A) hydroxypropyl methyl cellulose, (B) polyethylene glycol, and (C) talc, wherein the mass ratio (A:B) of the components (A) to (B) is 1:0.22 to 1.25; and the mass ratio (A:C) of the components (A) to (C) is 1:0.8 to 3.8.

Description

200950820 IX. Description of the invention: [Technical field to which the invention pertains] The composition is used more finely. The present invention relates to a coating composition, an envelope which can be used as a coating agent for a solid preparation. [Prior Art]

The envelope or the sugar coating is wrapped on the tablet to improve the stability of the raw material to light or rabbit, or to prevent bitterness, odor, irritation, etc., or to prevent the generation of t to increase the money as a product. As the mouth is beautiful, especially; ^ the surface of the luster or moist, cut the envelope is not good: sugar coating. On the other hand, although the surface of the tablet coated with sugar coating has a relatively bright luster, since the sugar coating step takes a long time, not only the manufacturing cost rises, but also the preparation becomes large and heavy due to the sugar coating, and thus the carrier is poor. In the 'further' sugar coating step, the high temperature and high humidity state lasts for a long time, and thus sometimes affects the stability of the active ingredient. Therefore, attempts have been made to impart a high gloss to a surface of a coated sheet such as a sugar-coated sheet. For example, a film for glazing using a mixture of a sweet component and a glazing wax has been proposed (Patent Document 丨); a dry powder composition using gum arabic (Patent Document 2); and hydroxypropylcellulose and carboxymethylcellulose are formulated. A coating composition of sodium sodium (Patent Document 3) or the like. However, the gloss obtained from such compositions is not sufficient. [Patent Document 1] Japanese Patent Laid-Open Publication No. 2001-89361 [Patent Document 2] International Publication No. 2002/01998*7 pamphlet [Patent Document 3] Japanese Patent Laid-Open Publication No. 2002-534373 [Summary of Invention] 132034. Doc 200950820 [Problem to be Solved by the Invention] An object of the present invention is to provide a coating preparation which has a high gloss surface even if it is not coated with a sugar coating. [Means for Solving the Problems] The inventors of the present invention conducted intensive studies in order to achieve the above object, and as a result, unexpectedly found that hydroxypropyl hydrazine having a coating agent component previously used as a solid preparation was formulated at a specific ratio. The composition of cellulose, polyethylene glycol and talc can impart a high gloss to the surface of the preparation, thereby completing the present invention. That is, the present invention provides a composition for a coating comprising: (4) hydroxypropylmethylcellulose, (poly)polyethylene glycol, and (c) a mass ratio of the talc component (VIII) to (8) (A:_1: 0.22 to (3), and the mass ratio (A: C) of the components (4) to (C) is 1: 〇§ to 3.8. Further, the present invention provides a coating preparation in which the composition is wrapped with a thickness of 20 μm. [The effect of the invention] When the tablet is coated with the composition for a coating of the present invention, a film having a beautiful gloss can be formed, and a coating preparation having improved appearance quality can be obtained. According to the present invention, since the sugar coating step is not required, not only can the weight of the agent be reduced or miniaturized, but also the manufacturing cost can be reduced, and further, the moisture of the final preparation can be controlled to maintain the stability of the active ingredient 14 and can also be prevented. The formulation of the present invention contains (4) propylmethylcellulose (8) 132034.doc 200950820 polyethylene glycol and (c) talc. As component used herein (A) hydroxy Propyl methyl cellulose is not particularly limited, but From the viewpoint of high gloss, it is preferred that the degree of substitution of the methoxy group is 16.5 to 30.0, particularly preferably 28 〇 to 3 〇〇, and the degree of substitution of the hydroxypropoxy group is 4.0 to 32'0. Especially good is 7 〇~12 〇. Also, hydroxypropyl A. The viscosity of cellulose is, based on the viscosity of 2% aqueous solution at 2 ° C, preferably 3 to 10,000 mPa.s, especially Preferably, it is 3 to 15 mPa.s. As a commercial product of hydroxypropylmethylcellulose, hydroxypropylmethylcellulose ❹ 2208, hydroxypropylmethylcellulose 2906, hydroxypropylmethylcellulose 2910, etc. are mentioned. These may be used singly or in combination of two or more kinds. The content of the hydroxypropylmethylcellulose in the composition relative to the total solid content of the composition for a coating of the present invention is the film strength and coating. From the viewpoint of the rate of attachment and high gloss, it is preferably 5 to 8 % by mass, particularly preferably 10 to 60% by mass, more preferably 15 to 35 % by mass. The component (B) used in the polyethylene glycol is not particularly limited, and it is preferably a solid at 25, and the weight average molecular weight is preferably 190 to 42, 〇〇〇 Particularly preferably, it is 7 3 〇〇 to 9 3 〇〇. Further, the weight average molecular weight of the polyethylene glycol is a value converted by polystyrene measured by Gpc. As a commercial product of polyethylene glycol, it is exemplified Polyethylene glycol 2 〇〇, polyethylene glycol 4 〇〇 'polyethylene glycol 600, polyethylene glycol 1000, polyethylene glycol 1500, polyethylene glycol 1540, polyethylene glycol 4 〇〇〇, poly Ethylene glycol 6 oxime, polyethylene glycol 200 oxime, polyethylene glycol 35 hydrazine, etc. may be used alone or in combination of two or more. With respect to 1 part by mass of hydroxypropylmethylcellulose, The content of the polyethylene glycol in the group 132034.doc 200950820 of the present invention is 0.22 to 125 parts by mass, preferably 〇·25~1·〇 part by mass, particularly preferably 〇4~ 〇 8 parts by mass. If the content of the polyethylene glycol is small, the gloss is poor. On the other hand, if a large amount of polyethylene glycol is blended, the adhesion rate at the time of coating is lowered, and the smoothness of the surface is lost. The component (c) used in the present invention has an average particle diameter of talc (measured according to jis • M8016), and is preferably 0.1 to 2 〇Mm from the viewpoint of imparting high gloss, and particularly preferably, More preferably 2~7μιη. If the particle size of the stone is too large, the surface is rough and it is difficult to obtain sufficient gloss. Further, for the particle size of the beta stone, it is preferred that the particle size exceeds 75 μηι (the sieve which cannot pass through the mesh of 75 μηι) is 〇 2 mass% or less, and particularly preferably the particle diameter exceeds 45 μιη ( It is impossible to pass the sieve of 45 μm mesh to the mass% or less. Further, in the present invention, in order to obtain a high gloss, the whiteness of talc is important. It is preferred to use a whiteness of talc (measured according to JIS Μ8〇丨6) of 9 or more, and it is particularly preferable to use a whiteness of 93 or more. If the whiteness is small, it is difficult to show the shine of shine. The content of the talc in the composition for coating of the present invention is from 0,8 to 3.8 parts by mass, preferably from 1.2 to 3.8 parts by mass, particularly preferably 1 part by mass of the hydroxypropylmethylcellulose. It is 1.6 to 2.4 parts by mass. If the content of talc is small, it is difficult to express the brilliance. On the other hand, if a large amount of talc is blended, the film will become weak, and dust will be generated in the coating device, and even dust will adhere to the surface of the tablet. . In the composition for a coating of the present invention, it is preferred to further formulate a coloring agent in addition to the above ingredients in the amount of 132,034.doc 200950820. Examples of the coloring agent include catechin tannin powder, turmeric extract, yellow ferric oxide, 〇paSpray K-1-24904, fuzi essence, brown iron oxide, carbon black, caramel, magenta, carotene solution, /5 - carotene, licorice extract, gold foil, black iron oxide 'light anhydrous citric acid' titanium oxide, ferric oxide, edible blue No. 1, edible yellow No. 4, edible yellow No. 4 aluminum lake, edible Yellow No. 5, Edible Red No. 2, • Edible Red No. 3 'Edible Red No. 1 No. 2, Sodium Hydroxide, Copper Chlorophyll Sodium, Chlorophyll Copper, Naked Green Leaf Extract, d-borneol, Myristate Octyl Twelve © Burnt vinegar, medicinal carbon, riboflavin butyrate, riboflavin, green tea powder, riboflavin sodium sulphate, rose oil, etc. These may be used alone or in combination of two or more. The content of the coloring agent in the composition is preferably 5 parts or less, particularly preferably 2 parts or less, more preferably 1 part or less, based on 1 part by weight of hydroxypropylmethylcellulose. In the coating composition of the present invention, in addition to the above components, a pharmaceutical additive used in a coating of a general oral pharmaceutical product, such as a plasticizer, a coating agent, a dispersing agent, or a consumer, may be added as needed. Foaming agent, etc. Specific examples of the plasticizer include karion 83, triethyl citrate, glycerin, fatty acid glyceride, sesame oil, dimercapto polyoxyalkylene, cerium oxide mixture, D-sorbitol, and medium length. Chain triglyceride, corn alcohol-derived sugar alcohol solution, triacetin, concentrated glycerin, castor oil, diethyl phthalate, dibutyl phthalate, butyl phthalate Butyl methoxyglycolate, polyoxyethylene (105) polyoxypropylene (5) diol, propylene glycol 'polysorbate 80, cottonseed oil. Soybean oil mixture, glyceryl monostearate 132034.doc -10- 200950820 Etc., these may be used singly or in combination of two or more. In the case where a plasticizer is added, the content in the composition is preferably 40% by mass or less. Specific examples of the coating agent include ethyl acrylate, methyl methacrylate copolymer dispersion, acetyl glycerin fatty acid ester, aminoalkyl methacrylate copolymer oxime, and aminoalkyl methacrylate. Ester copolymer RS, gum arabic, gum arabic powder, ethyl cellulose, ethyl cellulose aqueous dispersion, octyl decyl triglyceride, Opadry AMB, Opadry OY-6950,

Opadry OY-S-7135, Opadry OY-S-8471, Opadry OY-S- 〇9607 ' Opadry OY-S-22829 > Opadry OY-S-22835 ' Opadry OY-S-22961, olive oil, kaolin, cocoa Lipid, Prunella vulgaris, ramie, caramel, Brazilian sapphire, renegducted ethylene polymer, cytosolic ethyl cellulose, carboxy hydrazine powder, good cellulose, slow sodium cellulose, Hydrated cerium oxide, dried aluminum hydroxide gel, dried milky white shellac, dry methacrylic acid copolymer LD, cold plum powder, fish scale foil, gold foil, silver foil, lemon acid diacetate, glycerin, fatty acid glycerin, Shixi acid, light anhydrous oxalic acid, hydroxypropyl cellulose containing light anhydrous citric acid, dilute liquid paraffin, whale® butterfly, crystalline cellulose, hardened oil, synthetic aluminum silicate, synthetic wax, high Glucose water injury, hard butterfly, cypress gelatin, wheat flour 'wheat starch, rice starch, cellulose acetate, vinyl acetate resin, cellulose acetate phthalate, white beeswax, titanium oxide, magnesium oxide, methyl Dimethylaminoethyl acrylate. Ethyl methacrylate copolymer, dimethyl polyoxyl (internal administration), dimercapto polyoxyalkylene. cerium oxide mixture, calcined gypsum, sucrose fatty acid vinegar, agarwood powder, hydrogenated gelatin, hydrogenated rosin glyceride, stearyl alcohol, stearic acid, stearic acid Aluminum, calcium stearate, polyoxyl stearate 4〇, stearin 132034.doc 200950820 ❹ acid town, refined gelatin, refined shellac, refined (four), zein, sesquisulphate sorbitol _, Series of alcohol, gypsum, alum, shellac, sorbitol (four) (four) H sorbitol, D · sorbitol liquid, wall acid three series, carbonic acid mother, carbon Lai, monosaccharide Li, Zhongjin box, Shen Dian carbonate mother, low Substituted propyl cellulose, (iv) resin, powder (soluble), corn syrup, corn oil, triacetin, lactic acid, lactose, concentrated glycerin, white shellac white sugar, honey, stone butterfly, pearl powder, horse Bell on the temple powder, propyl cellulose, propylmethyl cellulose phthalate _, piperonic butyl, dry sesame oil, phthalic acid diacetate, dibutyl phthalate, butyl Stupid dimethyl glycolic acid butyl vinegar, glucose, antibutanic acid. Stearic acid. Polyethylene Acetal diethylamine acetate, hydroxypropyl phthalocyanine 291 〇 mixture, polydextrose, propylene glycol, bentonite, polyglycol, polyoxyethylene hardened castor oil 40, polyoxyethylene hardened castor oil 6〇 , polyoxyethylene (ι〇5) polyoxypropylene (5) diol, f oxyethylene (160) polyoxypropylene (3 〇) diol, polysorbate 80, polyvinyl acetal diethylamine B Acid ester, small mannitol, water, beeswax, myristyl alcohol, anhydrous citric acid hydrate, phthalic anhydride, anhydrous calcium hydrogen phosphate, methacrylic acid copolymer L, methacrylic acid copolymer LD, methyl Acrylic copolymer S, magnesium metasilicate aluminate, methyl cellulose, 2-methyl-5-vinylpyridyl acrylate, methacrylic acid copolymer, lacquer wax, aluminum monostearate, monostearic acid Glyceride, sorbitan monolaurate, montan acid ester wax, medicinal carbon, polyglycerol, calcium sulfate, liquid paraffin, DL-malic acid, calcium orthophosphate, calcium hydrogen hydride, sodium hydrogen hydride "Dish acid dihydrogen, rosin, etc." These may be used singly or in combination of two or more. In the case of adding a coating agent, the content in the composition is preferably 4 〇 mass 132034.doc • 12- 200950820% or less. ❹

As a dispersing agent, a methyl (tetra) acid amine ketone copolymer RS, gum arabic, gum arabic powder, propylene glycol alginate, ethanol, oleic acid, carboxyvinyl polymer, vitamin sodium, and gin Fat powder, citric acid, sodium citrate, glycerin, fatty acid glycerin, magnesium aspartate, light anhydrous anhydrous acid, crystalline cellulose, hardened oil, synthetic (four) Ming, dish acid test, safflower oil, self Color bee butterfly, titanium oxide, _ acid steel dioctyl vinegar, curtain sugar fatty acid ester, sodium t-oxide, stearic acid, magnesium stearate, refined oleic acid, refined soybean imprinted phospholipid, sesquistea sesquistea Alkyd anhydride, sorbitan fatty acid ester, D-sorbitol, soybean oil, soybean (tetra) lipid, low-substituted hydroxypropyl cellulose, paste m temple powder, yellow R rubber powder, sorbic acid trioleate, Lactose, concentrated glycerin, potato powder, ethyl cellulose, propyl starch, propyl cellulose, propylene glycol, propylene glycol fatty acid vinegar, bentonite, povidone, polyoxyethylene hardened castor oil, polyoxyethylene hardened Sesame oil 4〇, polyoxyethylene hardened cannabis oil 6G, polyoxyethylene and Q5) polyoxypropylene (7) Glycol, polyoxyethylene_polyoxypropylene (10) diol, polysorbate 2, polysorbate 60, polysorbate 8 〇, sodium polyphosphate, anhydrous sodium sulphate, anhydrous sodium pyrophosphate, partial Magnesium phthalate, sodium metaphosphate, methylcellulose, lacquer wax, & sorbitol monooleic acid vinegar, aluminum monostearate, glyceryl monostearate, sorbitol, vinegar, sorbate Sugar anhydride monolaurate, sodium lauryl sulfate, polyglycerol, liquid paraffin, calcium hydrogen phosphate, and the like. The amount of the dispersant is added or less. When the fatty acid glycerin vinegar is used alone or in combination of two or more kinds, the content of the composition is preferably 25 as a specific example of the antifoaming agent, and ethanol: 132034.doc -13· 200950820 Dimethyl polyoxyalkylene (internal administration), dimethyl polyoxane, cerium oxide mixture, sucrose fatty acid ester, oxime resin emulsion, bismuth defoamer, stearic acid polyoxyn acetonide 40, The sorbitan fatty acid ester, the sorbitan trioleate, the polysorbate 80, etc. may be added individually or in mixture of two or more types. In the case where an antifoaming agent is added, the content in the composition is preferably at most 1% by mass. ❹

The coating preparation of the present invention is produced by preparing a coating liquid obtained by dissolving a composition containing a coating film of propylmethylcellulose, polyethylene glycol and talc, and spraying it. On the outermost surface of the solid preparation. As a dosage form of the solid preparation, a tablet is preferred. In the solid preparation, various medicinal ingredients can be suitably formulated, and examples thereof include vitamin C such as ascorbic acid, calcium ascorbate, and sodium ascorbate. Calcium pantothenate, thiamine nitrate, thiamine hydrochloride, dithiamine nitrate, and dithiothiamine. , cetyl thiosulphate sulphate, furan sulphate hydrochloride, hydrazine hydrazine, olto thiamine, seleton sulphate, bis-isobutyl thiamine, bis- phenyl thiamine, stupid sulphur sulphate, nuclear yellow , riboflavin butyrate, riboflavin sodium phosphate, pyridoxine hydrochloride, phosphoric acid furfural, cyanocobalamin, hydroxycobalt ammonium hydrochloride, hydroxycobalt ammonium acetate, methylcobalamin, nicotinic acid, nicotinamide, Vitamin B such as biotin and folic acid; autonomic nervous regulator such as r_ oryzanol; vitamin-like substance such as thioramine and whey acid; minerals such as calcium hydrogen phosphate and calcium lactate; Ester's acid-tocopheryl alcohol ester, succinic acid d_a_tocopherol ester, succinic acid dl-α-tocopheryl ester calcium and other vitamin E; ergocalciferol, cholecalciferol and other vitamin D; L. cysteine , amino acid such as methionine, glycine, (iv) arginine; aminoethyl acid, glucose Brewed amine, glucose-acid II 132034.doc •14· 200950820 s曰, glycyrrhizic acid, ursodeoxycholic acid and other liver damage medication; substance, European dogwood benzene running A1 „ horse pawlings, acanthopanax senticosus Extract, Epimedium extract, Coix seed extract, liver hydrolysate, bile extract powder, Bupleurum dry = extract, Chuan f dry extract, mountain red dry extract, tea dry extract and other natural medicines The method of producing the preparation is not particularly limited, and a preparation additive may be added to the medicinal ingredient as needed, and may be produced by a conventional method. For example, a conventional formulation method which is usually used (Tsuzu Kyoko· Ueno Shou, © "The Basics of Pharmaceutical Development XI Pharmaceutical Manufacturing Law (I), (below)", The Local Library, issued in 1971; Nakai Yusuke, "Preparation Engineering Handbook", The Local Library, issued in 1983 Nakai Yusuke, "The Latest Powder Material Design", Techno System, issued in 1988; Arakawa, "The Unit Operation and Machinery for the Development of Pharmaceutical Preparations", Hirokawa Bookstore, issued in 1989; Tian charged with, "Design and Evaluation of an oral formulation of" Pharmaceutical Times Company, issued in 1995; Hashida charged with, "oral formulations of prescription design" Pharmaceutical Times Company, 1995 release) can be prepared. Further, in the case where the granulated powder® must be prepared, it can be prepared by the usual granulation method (spray granulation using a solution or dispersion containing water or an organic solvent, stirring granulation) Method, fluidized granulation method, rotary granulation method, rotary fluidization method, wet granulation method such as granulation method, dry granulation method using compaction granulation method using powdery granules, etc. A powder, a powder, a fine granule, a granule, and the like are mixed with a preparation additive, and compression-molded. Further, the underside of the film layer obtained from the coating composition of the present invention may be subjected to undercoating to form a coating preparation having a multilayer film layer of two or three layers. 132034.doc -15· 200950820 = formulation additives used in the formulation, (4) carriers, such as stabilizers, surfactants, lubricants, solvents, buffers, sweeteners, substrates, Adsorbent,:, lubricating adhesive, county floating agent, agent, flavoring agent, antioxidant, brightening agent, wetting agent, moisturizing agent, filler, defoaming agent, Clear: sword bag, fragrance 'perfume, coloring agent, isotonic agent, softener, emulsifier,:, β Qi j pH adjustment, excipients, bifurcations, auxiliaries, fragrances, anti-wetting agents, Preservatives, preservatives, solubilizers, solvents, mobilization agents, dissolving agents, etc., as an example of such preparations, for example, a binding book can be used (Japan Pharmaceutical Additives Association, Eight Things) a pharmaceutical preparation for coating a composition for a coating on a solid preparation such as a die or a coated film manufactured as described above, and a method of coating the composition for coating on a film prepared by the above-mentioned method, and There is no particular limitation, and for example, a pot coating method, a fluidized layer Coating method, spin coating method 'dry coating method, or a combination method thereof. The coating liquid containing the composition for a coating of the present invention is used in propyl hydrazine cellulose, polyethylene glycol, and talc, and further, if necessary, a drug additive is added and the composition for coating is weighed. The product is prepared by dissolving/suspending in a purified alcohol or a lower alcohol such as ethanol or a mixture thereof. The coating liquid is preferably adjusted to have a solid content of usually 1 to 5 % by mass, particularly preferably 2 to 30% by mass, more preferably 5 to 20% by mass. In the present invention, the thickness of the film layer formed on the preparation varies depending on the shape or size of the preparation, but from the viewpoint of obtaining a surface having a beautiful luster, it is preferably 20 μm to 2 〇〇Mm. Especially good is 3〇μπι~1〇〇132034.doc •16· 200950820 (four) 'Better is 4°_~8. (4). For example, a tablet that is directly planted to a size of about 9 mm and a total of about 200 mg is *··, and the thickness of the above-mentioned film layer is obtained. The preferred county is coated with about 3 to 30 mg/tablet, more preferably It is especially preferred to coat with about 5% U6~12 mg/tablet. If the thickness is too thin, a sufficient thickness of the film layer cannot be obtained, and the time necessary for coating is required. t surface, if the film layer

The agent ' can also be coated on the underside of the film layer obtained from the film coating composition to form a film preparation having a plurality of film layers. For example, when the solid preparation contains a medicinal ingredient such as sputum cysteic acid which causes an unpleasant odor, the odor is masked, and it is preferred to wrap the envelope. In the envelope, the pharmaceutical additive used in the coating of the above oral pharmaceutical product can be suitably added. In particular, it is preferable to add a part of the saponified product of polyvinyl alcohol from the viewpoint of the deodorizing effect. The degree of recombination of the polyvinyl alcohol partial compound is preferably 70 to 97 mol% from the viewpoint of the unpleasant odor reduction effect, particularly preferably 78 to 96 m〇1%, and, on average, The degree of polymerization is preferably 200 to 3, 3 Å, particularly preferably 3 Å to 〖, 5 〇 (^ here, the degree of saponification is measured in accordance with JIS K6726 (polyvinyl alcohol test method). In terms of the deodorizing effect, the film strength, and the ease of coating, it is preferably from 3 to 1% by mass, particularly preferably from 40 to 95% by mass. When the solid preparation contains calcium phytate and L-cysteine, and the like, which has a function of decomposing calcium pantothenate to impair its stability, it is preferred to formulate an active ingredient other than calcium pantothenate in a solid preparation. And in the film layer coated with the preparation, calcium pantothenate is formulated. In this case, the coating film wrapped in the above-mentioned unpleasant odor medicinal ingredient may be wrapped in pantothenic acid or The upper side or the lower side of the film layer of the salt, or both sides. In the film layer containing calcium pantothenate, It is preferable to add a pharmaceutical additive used for the coating of the above oral pharmaceutical product. It is particularly preferable to add a water-soluble or gastric-soluble membrane material such as self-methylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose. One or more selected from the group consisting of polyvinylpyrrolidone, carboxyvinyl polymer, polyvinyl alcohol, methyl acrylate, aminoalkyl ester copolymer E, and polyvinyl acetal diethylaminoacetic acid. Therefore, the present invention can be specifically described by the following examples, but the present invention is not limited to the examples. 960 g of L-cysteine (manufactured by Kyowa Mastic), 1237 2 g of ascorbic acid for direct compression (BASF Japan), 147.6 g of pantothenic acid type S (BASF made in Japan), 567.2 g of crystalline cellulose (VIVAPUR12: manufactured by RETTENMAIER), 200 g of crystalline cellulose (Ceolus KG802: manufactured by Asahi Kasei Chemicals), 200 g of low-substituted hydroxypropylcellulose (LH-11: manufactured by Shin-Etsu Chemical Co., Ltd.), 16 g of light anhydrous yttrium Acid (Adsolider 1) 01 : FREUND (manufactured by FREUND), 32 g of magnesium stearate (manufactured by Taiping Chemical Co., Ltd.), a mixed powder for tableting, using a rotary tablet press (VIRGO-0512. 压. Tablet press: manufactured by Kikusui Seisakusho Co., Ltd.) The pellet was pressed with a mortar of 9 ηιιηφ until the mass of each tablet reached 210 mg, and a bare chip was obtained. Secondly, 36 g of hydroxypropylmethylcellulose 2910 (TC-5RW: manufactured by Shin-Etsu Chemical Co., Ltd.), 132034. Doc • 18- 200950820 21 g of polyethylene glycol 6000 (made by Nippon Oil & Fats), 69 g of talc (Shengguangshan Mining Institute; average particle size is 4.6 μπι, particle size 45 is 〇1%, whiteness is 93.6%) ), 24 g of titanium oxide (manufactured by Ishihara Sangyo Co., Ltd.), dissolved. Suspended in purified water: Japanese Pharmacopoeia B. (3: υ mixture 85 〇g, obtained a coating liquid. Then, put 3000 g of the die into the coating machine (Hic〇ater hct_ 48, FREUND industry), and coat until the mass of each piece of the die increases. When it reaches 10 mg, the mass of each piece is 220. Mg coated tablets (film thickness 64.5 μιη: n = 10 average, image analysis method). 〇Comparative Example 1 3000 g of the obtained die in the same manner as in Example 放入 was placed in a coating machine (Hi-Coater HCT-48, FREUND industry), and 8 g of propylmethylcellulose 2910 was used. (TC-5RW: manufactured by Shin-Etsu Chemical Co., Ltd.) dissolved in purified water: the coating liquid obtained in 920 g of the Japanese Pharmacopoeia Ethanol (3:1) mixture was coated until the mass of the die increased by 1 〇mg per piece. Thus, a coated film of 220 mg per mass (film thickness: 629 μηη: n=10 average, image analysis method) was obtained.实施 Example 2 4.8 kg of diphenhydramine hydrochloride (manufactured by King Kong Chemical Co., Ltd.), 4·8 kg of glycine acid (manufactured by Concord), and 6.36 kg of lactose (Tablettose 80:

Meggle Japan), 19.2 kg of crystalline cellulose (Ceolus KG-802 · Asahi Kasei Chemicals), 1152 g of low-substituted hydroxypropyl cellulose 仏-HPC LH-11: manufactured by Shin-Etsu Chemical Co., Ltd.), 960 g Sodium carboxymethylcellulose (Kiccolate: manufactured by Asahi Kasei Chemicals), 384 g of light anhydrous citric acid (Adsolider 101: manufactured by FREUND Industries), 384 g of magnesium stearate (Too 132034.doc •19·200950820) And 384 g of talc (manufactured by Kihara Kasei), a mixed powder for tableting, which was carried out by a rotary tablet press (VIRGO-0512 tablet press: manufactured by Kikusui Seisakusho Co., Ltd.) with a mortar rod of 9 mm < J) Dust tablets are obtained until the mass of each piece reaches 200 mg, and a bare piece of about 37,5 kg is obtained. Next, 36 g of hydroxypropylmethylcellulose 2910 (TC-5RW: manufactured by Shin-Etsu Chemical Co., Ltd.), 8 g of polyethylene glycol 6000 (manufactured by Nippon Oil & Fats Co., Ltd.), and 69 g of talc (Shengguang Shanzhen • Industry: The average particle size is 4.6 μηι, the particle size is 45 μιη, the remaining amount is 0.1%, the whiteness is 93.6%, and 24 g of titanium oxide (manufactured by Ishihara Sangyo Co., Ltd.) is dissolved. It is suspended in 863 g of purified water to obtain a coating. liquid. Then, a 3 kg piece of the die was placed in a coating machine (Hi-Coater HCT-48, FREUND industry), and the coating was applied until the mass of the die increased by 1 〇 mg per piece, and the mass of each piece was obtained. 210 mg of coated film (coating film thickness of 65 7 μϊη: n=l〇 average, image analysis method). Example 3 A gargle solution was obtained in the same manner as in Example 2 by adjusting the coating liquid of Example 2, changing the polyethylene glycol 6 为 to 1 〇 g and changing the purified water to 861 g. 3 kg of the die fabricated in Example 2 was coated in the same manner as in Example 2 to obtain a coated sheet having a mass of 21 〇g per sheet of the present invention (the film thickness was 65.4 μm ). Example 4 A mash was obtained in the same manner as in Example 2 by adjusting the coating liquid of Example 2, changing the polyethylene glycol 6 为 to 13 g and changing the purified water to 858 g. 3 kg of the die fabricated in Example 2 was coated in the same manner as in Example 2 to obtain a coated film having a mass of 210 mg per film 132034.doc • 20- 200950820 (film thickness 65.9 μπι ). Example 5 By adjusting the coating liquid of Example 2, the polyethylene glycol 6000 was changed to 15 g and the purified water was changed to 856 g, and the coating liquid was obtained in the same manner as in Example 2 and was carried out. In the same manner as in Example 2, 3 kg of the bare sheet prepared in Example 2 was coated to obtain a coated sheet having a mass of 210 mg per film (film thickness: 63.9 μm). Example 6 ® The coating liquid was obtained in the same manner as in Example 2 by adjusting the coating liquid of Example 2, changing the polyethylene glycol 6000 to 21 8 and changing the purified water to 85 μg. 3 kg of the die prepared in Example 2 was coated in the same manner as in Example 2 to obtain a coated film having a mass of 210 mg per film (film thickness: 65.8 μm). Example 7 A coating liquid was obtained in the same manner as in Example 2 by adjusting the coating liquid of Example 2, changing the polyethylene glycol 6 为 to 28 g and changing the purified water to 843 g ' 3 kg of the die fabricated in Example 2 was coated in the same manner as in Example 2 to obtain a coated film having a mass of 210 mg per film (film thickness: 64.4 μm). Example 8 A coating liquid was obtained in the same manner as in Example 2 by adjusting the coating liquid of Example 2 to change the polyethylene glycol 6 为 to 35 g and the purified water to 836 g. 3 kg of the die fabricated in Example 2 was coated in the same manner as in Example 2 to obtain a packet of the present invention having a mass of 21 〇 mg 132034.doc 21 200950820 (film thickness). It is 65·7 μπι). Example 9 By adjusting the coating liquid of Example 2, changing the polyethylene glycol 6000 to 40 8 and changing the purified water to 83 1 g, a coating liquid was obtained in the same manner as in Example 2, and In the same manner as in Example 2, 3 kg of the die fabricated in Example 2 was coated to obtain a coated sheet having a mass of 21 〇g per film (film thickness: 66.1 μm). Example 1 By adjusting the coating liquid of Example 2, the polyethylene glycol 6000 was changed to 43 g and the purified water was changed to 828 g, and the coating liquid was obtained in the same manner as in Example 2 and 3 kg of the die fabricated in Example 2 was coated in the same manner as in Example 2 to obtain a coated film having a mass of 210 mg per film (film thickness: 65.8 μηι). Example 11 By adjusting the coating liquid of Example 2, the polyethylene glycol 6000 was changed to 45 g and the purified water was changed to 826 g, and the coating liquid was obtained in the same manner as in Example 2 and was carried out. In the same manner as in Example 2, 3 kg of the die fabricated in Example 2 was coated to obtain a coated film having a mass of 210 mg per film (film thickness 66.3 μηι). • Comparative Example 2 By adjusting the coating liquid of Example 2, changing the polyethylene glycol 6000 to 5 g and changing the purified water to 866 g, the coating liquid was obtained in the same manner as in Example 2 and was carried out. In the same manner as in Example 2, 3 kg of the die fabricated in Example 2 was coated to obtain a coated film having a mass of 210 mg per film (film 132034.doc-22.200950820 thickness: 63.7 μm). Comparative Example 3 By adjusting the coating liquid of Example 2, the polyethylene glycol 6 was changed to 60 g and the purified water was changed to 811 g' to obtain a coating liquid in the same manner as in Example 2 3 kg of the dies produced in Example 2 were coated in the same manner as in Example 2 to obtain a coated sheet having a mass of 21 〇g per film (film thickness 63.7 μηι). Test Example 1 表面 The surface gloss of the coated sheets of Examples 1 to 丨丨 and Comparative Examples 1 to 3 was evaluated in accordance with the following five grades. The results are shown in Table 1. As is evident from Table 1, the tablets of the present invention can obtain a higher gloss than the comparative examples. Matte: - only a little gloss: ± shiny: + has a strong gloss: ++ © has a very strong luster: +++ [Table 1] The surface gloss of the coated film is compared to 1 part of the film.曱 曱 曱 皙孴 备 备 实施 实施 实施 实施 + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + + 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 0.2 Example 7 0.78 ----------- 132034.doc -23· 200950820 Example 8 0.92 Example 9 ++ 1.11 Reduction of adhesion rate Example 10 ++ 1.19 Reduction of adhesion rate Example 11 ++ 1.25 Reduced adhesion, a little dust Comparative Example 1 - Comparative Example 2 Soil 0.14 Comparative Example 3 ++ 1.67 Reduced adhesion, dust, rough surface Example 12 • Use of 7.2 kg of ibuprofen (manufactured by BASF Corp.), 11.136 kg of lactose (Tablettose 80: manufactured by Meggle Japan), 1 6.8 kg of crystalline cellulose φ (Ceolus KG-802: manufactured by Asahi Kasei Chemicals), 1152 g of low-substituted hydroxypropylcellulose (L-HPC LH-11 • manufactured by Shin-Etsu Chemical Co., Ltd.), 960 g of croscarmellose sodium (Kiccolate: Asahi Kasei Manufactured), 384 g of light anhydrous citric acid (Adsolider 101: manufactured by FREUND Industries), 384 g of magnesium stearate (manufactured by Taiping Chemical Industry Co., Ltd.) and 384 g of talc (manufactured by Kihara Kasei) Using a rotary tablet press (VIRGO-05 12 tablet press: manufactured by Kikusui Seisakusho Co., Ltd.), the tablet was pressed with a mortar stick of 9 πιηιφ until the mass reached 200 mg per month, and a bare Q of about 37 kg was obtained. sheet. Next, 36 g of hydroxypropyl guanidine cellulose 2910 (TC-5RW: manufactured by Shin-Etsu Chemical Co., Ltd.), 21 g of polyethylene glycol 6000 (made by Nippon Oil & Fats Co., Ltd.), 30 g of talc (Shengguangshan Mining Institute: average A particle size of 4.6 μm, a particle size of 45 μm, a sieve residue of 0.1%, a whiteness of 93.6%, and 24 g of titanium oxide (manufactured by Ishihara Sangyo Co., Ltd.) were dissolved and suspended in 889 g of purified water to obtain a coating liquid. Then, 3 kg of the die was placed in a coating machine (Hi-Coater HCT-48, FREUND industry), and the coating was applied until the mass of the die reached 7.5 mg per piece, and the mass per piece was 207.5. Mg coated film (film thickness is 132034.doc -24- 200950820 μηι : n=10 average, image analysis method). Example 13 A coating liquid was obtained in the same manner as in Example 12 by adjusting the coating liquid of Example 12, changing the talc to 44 g and changing the purified water to 875 g, and the same as in Example 2. Membrane 3 kg of the die fabricated in Example 2 was coated to obtain a coated sheet having a mass of 2〇75 mg per film (film thickness: 49.9 μηι). Example 14 By adjusting the coating liquid of Example 12, the talc was changed to 6 〇 and the purified water was changed to 859 g, and the coating liquid was obtained in the same manner as in Example 12 and was the same as in Example 2. In the manner of 3 kg of the die fabricated in Example 2, a coating sheet having a mass of 2〇7 5 mg per film (film thickness of 51.4 μm) was obtained. Example 15 By adjusting the coating liquid of Example 12, the talc was changed to 69 g and the purified water was changed to 850 g, and the coating liquid was obtained in the same manner as in Example 12 and was the same as in Example 2. Membrane 3 kg of the die fabricated in Example 2 was coated to obtain a coated sheet having a mass of 207.5 mg per one piece (the thickness of the placket was 50.1 μm). Example 16 By adjusting the coating liquid of Example 12, the talc was changed to 85 g and the purified water was changed to 834 g, and the coating liquid was obtained in the same manner as in Example 12 and was the same as in Example 2. In the manner of 3 kg of the die manufactured in Example 2, a coated film of 207.5 mg by mass per film (film 132034.doc -25 - 200950820 film thickness 53.8 μπι) was obtained. Example 17 A coating liquid was obtained in the same manner as in Example 12 by adjusting the coating liquid of Example 12, changing the talc to 1 〇 5 g and changing the purified water to 1014 g, and in the same manner as in Example 2 In the same manner, 3 kg of the die fabricated in Example 2 was coated to obtain a wrap sheet having a mass of 2〇75 mg per tablet (the thickness of the coat was 51.7 μηι). Example 18 © By adjusting the coating liquid of Example 12, the talc was changed to 135 g and the purified water was changed to 984 g '. The coating liquid was obtained in the same manner as in Example 并 2 and in the same manner as in Example 2 In the same manner, 3 kg of the die fabricated in Example 2 was coated to obtain a coated sheet having a mass of 207.5 mg per film (film thickness: 51.9 μηι). Comparative Example 4 By adjusting the coating liquid of Example 12, the talc was changed to 10 g and the purified water was changed to 909 g, and the envelope O, 3⁄4 was obtained in the same manner as in Example 12, and 2 3 kg of the die fabricated in Example 2 was coated in the same manner to obtain a coated sheet having a mass of 207.5 mg per film (film thickness: 51.9 μm). Comparative Example 5 By adjusting the coating liquid of Example 12, the talc was changed to 180 g and the purified water was changed to 1239 g, and the coating liquid was obtained in the same manner as in Example 12 and was the same as in Example 2. Membrane 3 kg of the die fabricated in Example 2 was coated to obtain a coated sheet of 207.5 mg each (film 132034.doc -26 - 200950820 thickness 52.1 μηη). Test Example 2 In the same manner as in Test Example 1, the surface gloss of the coated sheets of Examples 12 to 18 and Comparative Examples 4 to 5 was evaluated in five grades, and the results are shown in Table 2. As is apparent from Table 2, the tablets of the present invention were obtained to have a higher gloss than the comparative examples. [Table 2] Mass ratio of surface gloss talc of the coated sheet to 1 part of hydroxypropyl fluorene cellulose Remarks Example 12 + 0.83 Example 13 ++ 1.22 Example 14 +++ 1.67 Example 15 +++ 1.92 Example 16 +-H- 2.36 Example 17 ++ 2.92 Example 18 3.75 A little dust Comparative Example 4 Soil 0.28 Comparative Example 5 -H- 5.00 Dust, surface thick chain Example 19 Using 2.4 kg of L-half Cystamine (manufactured by Concord), 1.5 kg of ascorbic acid (BASF made in Japan), 1.5 kg of pyridoxine hydrochloride (manufactured by First Precision Chemicals), 1.2 kg of nicotine decylamine (manufactured by DSM NUTRITIONAL), 1.14 kg Sodium riboflavin sodium (manufactured by Yancheng Pharmaceutical Co., Ltd.), 300 g of thiamine nitrate (manufactured by Takeda Pharmaceutical Co., Ltd.), 3 g of biotin (manufactured by SUN CHEMICAL), 30 g of corn starch (manufactured by SAN-A saccharification), 2.547 kg Crystalline cellulose (manufactured by Asahi Kasei Chemicals), 1.2 kg of hydroxypropyl cellulose (manufactured by Sakamoto Soda), 660 g of low-substituted hydroxypropyl cellulose (manufactured by Shin-Etsu Chemical Co., Ltd.), 60 g of magnesium stearate ( Taiping Chemical Industry), 60 g of talc (Kiha) Ra Kasei 132034.doc -27- 200950820 Manufacture), the powder for tableting is produced by a conventional method, and the obtained mixed powder is compressed by a rotary tableting machine with a mortar of 9 ππηφ until the mass of each tablet reaches A bare piece was obtained up to 210 mg. Next, 3" of the die was placed in a coating machine (Hi-Coater HCT-48, FREUND industry), and 20% by mass of Opadry AMB White (premixed with polyethylene glycol: manufactured by COLORCON) was used. The purified water coating liquid is subjected to the undercoating until the mass increase of each tablet reaches 7 mg, and then, the hydroxypropyl group containing § mass% of calcium pantothenate (manufactured by ALPS Pharmaceutical Industry Co., Ltd.) and 8 mass ❶/〇 is used. Ethyl alcohol of cellulose 〇2910 (manufactured by TC-5 Shin-Etsu Chemical Co., Ltd.): a coating liquid of purified water = 1:1, and the bottom layer is coated until the mass increase per sheet reaches 20 111 §, and each piece is obtained. The mass is 237 mg of the undercoated coating. Next, '36 g of hydroxypropyl guanidine cellulose 29 l (TC-5RW: manufactured by Shin-Etsu Chemical Co., Ltd.), 21 g of polyethylene glycol 6 〇〇 〇 (made by 曰本油), 3〇g of talc (Shengguangshan Mining Institute: average particle size is 4 6 μιη, particle size 45 μιη sieve residue is 0, 1 ° / 〇, whiteness is 93.6%), 24 g Titanium oxide (manufactured by Ishihara Industry) 'dissolved. Suspended in 889 g of purified water to obtain a coating liquid. Then, ❹ 3 kg The coated film of the undercoat is placed in a coating machine (Hi-Coater HCT-48, FREUND industry) to coat until the mass of each tablet increases - the amount reaches 8 mg, and the quality of each piece is obtained. 245 mg of the coated film (film thickness of 53.4 μm: n=10 average, image analysis method). Comparative Example 6 3 kg of the die fabricated in Example 19 was placed in a coating machine (Hi_c) 〇ater HCT-48, FREUND industry) A double undercoat was applied in the same manner as in Example 19 to obtain a coated sheet of 237 mg of the undercoating 132034.doc -28-200950820. Then, using the coating of the composition of the present invention produced in Example 19, the coating was applied until the mass increase per tablet of the tablet reached 1 mg, and a coating of 238 mg per mass was obtained. The film thickness was 65 μm.) Example 20 3 kg of the die manufactured in Example 9 was placed in a coating machine (Hi c〇ater HCT-48, FREUND industry)' in the same manner as in Example 19. A double-layer coating to obtain a 237 mg mass of the underlying coating of each of the enamel coatings. The coating liquid of the composition of the present invention prepared in Example 19 was coated until the mass increase per tablet of the tablet reached 3, and a film of 240 mg per piece was obtained (the film thickness was 2). 〇7 μηι). Example 21 3 kg of the die fabricated in Example 19 was placed in a coater (Huc〇ater HCT-48, FREUND Industries), and a double undercoat was applied in the same manner as in Example 19. , get every! The mass of the tablet was 237 mg of the undercoated coating. Then, using the coating liquid of the composition of the present invention produced in Example 19, the coating was applied until the mass increase per tablet of the tablet reached 5 mg, and the package of the present invention having a mass of 242 mg per tablet was obtained. The film (film thickness is 32.9 μιη). Test Example 3 The surface gloss of the coated sheets of Examples 19 to 21 and Comparative Example 6 was evaluated in five stages in the same manner as in Test Example 1, and the results are shown in Table 3. As is apparent from Table 3, the tablet of the present invention can obtain a higher gloss than 132034.doc •29·200950820 as compared with the comparative example. [Table 3] Surface gloss of the coated film Thickness of the coating film (μιη) Example 19 -H-+ 53.4 Example 20 20.7 Example 21 +-H- 32.9 Comparative Example 6 Soil 6.5

132034.doc -30-

Claims (1)

200950820 X. Patent application scope: l :: Coating composition, characterized in that it contains (4) two base fibers, (B) polyethylene glycol and (C) talc, components (A) and (B) The mass ratio (A · : 〇·22~! 25, and the components (4) and (c) of C) is 1: 0_8 to 3.8. (2) The composition for coating of claim 1, wherein the content of (4) hydroxypropylmethylcellulose is 5 to 80 by mass of the solid content of the composition, and the composition for coating of claim 1 Wherein (Α) hydroxypropylmethylcellulose has a methoxyl substitution degree of 16.5 to 30. 〇, and a hydroxypropoxyl substitution degree of 4.0 to 32.0. Further, ',, 4, such as the claimed envelope composition, The weight average molecular weight of (Β) polyethylene glycol is 19〇~42,000. 5. The coated film composition of the request (c) has an average particle diameter of 0·1~20 μηι, whiteness is 9. The composition for a coating of the present invention, which further comprises a coloring agent. 7. The coating composition according to claim 6, wherein the coloring is relative to the hydroxypropylcellulose of the mash. The content of the agent is 5 parts or less by mass ratio. 8. A coating preparation which is coated with a coating having a thickness of 20 μm to 2 〇0 μm by using the composition according to any one of claims 1 to 7. 132034.doc 200950820 VII. Designated representative map: (1) The representative representative of the case is: (none) (2) The components of the representative figure No simple explanation: eight, if the case when the formula, please show most features disclosed invention of Formula: (None) square ❿ 132034.doc