CN102755332A - Asiatic acid salt tablet and preparation method thereof - Google Patents
Asiatic acid salt tablet and preparation method thereof Download PDFInfo
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- CN102755332A CN102755332A CN2011101130738A CN201110113073A CN102755332A CN 102755332 A CN102755332 A CN 102755332A CN 2011101130738 A CN2011101130738 A CN 2011101130738A CN 201110113073 A CN201110113073 A CN 201110113073A CN 102755332 A CN102755332 A CN 102755332A
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- asiatic acid
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Abstract
The invention discloses an asiatic acid salt tablet and a preparation method thereof. A formula of the tablet comprises 1-40 percent of asiatic acid amino butantriol salt, 25-60 percent of a filling agent, 1-10 percent of an adhesive, 0.5-40 percent of a disintegrating agent and 0.1-1.5 percent of a lubricant, wherein the percentage refers to the mass percentage of each component in the total amount of the asiatic acid salt tablet. The method comprises the following steps of: in the terms of the formula, uniformly mixing the smashed and sieved asiatic acid amino butantriol salt, filling agent, adhesive and disintegrating agent; mixing with 5-20 percent by mass of an ethanol solution; pelletizing and drying; mixing with the lubricant; and tableting. The asiatic acid salt tablet disclosed by the invention has high bioavailability.
Description
Technical field
The present invention relates to a kind of asiatic acid salt tablets and preparation method thereof.
Background technology
Report asiatic acid and salt thereof can be prevented and treated the fibrotic disease of some internal organs in the prior art, and still, the drug effect of relevant tablet is unsatisfactory, and bioavailability is extremely low, effectively utilizes this medicine for maximizing, and this present situation needs to be resolved hurrily.
Summary of the invention
Technical problem to be solved by this invention is that to have overcome the drug effect of existing asiatic acid and salt tablets thereof unsatisfactory, and the low defective in biological utilisation earth polar, and a kind of asiatic acid salt tablets with good biological availability and preparation method thereof is provided.
Asiatic acid salt tablets prescription of the present invention contains 1%～40% asiatic acid tromethane salt, 25%～60% filler, 1%～10% binding agent, 0.5%～40% disintegrating agent and 0.1%～1.5% lubricant, and percentage ratio accounts for the mass percent of asiatic acid salt tablets total amount for each composition.
Among the present invention, described asiatic acid tromethane salt is the conventional described asiatic acid tromethane salt in this area, commercially available get or extract by the asiatic acid raw material according to this area conventional method obtain.
Among the present invention; Described filler is the conventional described filler in this area; Can use diluent for water-soluble diluent, water-insoluble diluent or direct compression; Preferable in trihydroxy aminomethane, sorbitol, sorbitol instant, D-xylose, xylitol, propylene carbonate, calcium glycerophosphate, mannitol, the corn starch of can sterilizing, compressible sugar, crospolyvinylpyrrolidone, inositol, Thomas balsam, maltose alcohol, soda-lime, alpha-lactose, lactose, aluminium hydroxide, medicinal sugar, calcium oxide, zinc oxide, prepared teobroma, pregelatinized Starch, Powderd cellulose, colloidality silicon dioxide, aluminium silicate, Aluminum calcium silicate., starch, sodium chloride, calcium chloride, aluminum chloride, calcium sulfate, glucose, Pulvis Talci, microcrystalline Cellulose, bagasse regrowth, carboxymethylcellulose calcium, polyethylene, polyethylene azoxy ketone, polyvinyl butyral resin, polyethylene acetal diethyl acetate ester, calcium carbonate, magnesium carbonate, magnesium oxide, sucrose, spherical sucrose, compressible sugar, sugar,confectioner's, dextrin, white dextrin, calcium phosphate and the sodium starch phosphate one or more, one or more that better is in microcrystalline Cellulose, starch, alpha-lactose and the crospolyvinylpyrrolidone.
Among the present invention; Described binding agent is the conventional described binding agent in this area, preferable is ethylmethylcellulose, ethyl cellulose, ethyl cellulose aqueous suspension, butadiene-styrene rubber, natural rubber, acrylic acid, butylacrylate, acrylic acid methyl ester., acrylic resin I number, acrylic resin II number, acrylic resin III number, acrylic resin IV number, Eudragit E
30, chitin, chitose, methyl methacrylate, EMA, butyl methacrylate, EUDRAGIT S100, Eudragit E, acrylic resin L, acrylic resin S, acrylic resin RL, acrylic resin RS, metering system-2-ethoxy, methacrylic acid-2-hydroxypropyl acrylate, methylcellulose, glycerol three rosin esters, zein, compressible sugar, sesbania gum, tara gum, Ficus elastica, carbomer, Petropols, Furcellaran, tragacanth, arabic gum, Resina persicae, maltose alcohol, carrageenin, tamarind gum, high fructose syrup, Nulomoline, fructose, Colophonium, loose glue, POLY-karaya, modified starch, poloxamer, medicinal sugar, alginic acid, sodium alginate, potassium alginate, ammonium alginate, calcium alginate, pregelatinized Starch, Powderd cellulose, hydroxyethylmethyl-cellulose, hydroxyethyl-cellulose, hydroxypropyl emthylcellulose, hydroxypropyl cellulose, xanthan gum, aluminium-magnesium silicate, terpene resin, liquid glucose, starch, sodium starch glycol, potassium metaphosphate, scleroglucan, glucose, glucosan, Pullulan, acetyl group Pullulan, microbial alginate, microcrystalline Cellulose, bagasse regrowth, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, Mel, guaiac gum, polyethylene, polyethylene azoxy ketone, polyvinyl butyral resin, polyethylene acetal diethyl acetate ester, polybutene, polybutadiene, polymethyl methacrylate, gather methyl 2-methylmethacrylate copolymer, gather methyl and gather L-methyl methacrylate, sodium polyacrylate, polyacrylic acid, polyisobutylene, Parleam, polystyrene-maleic anhydride, polyvinyl-maleic anhydride, gather in 2-ethoxy formyl acrylic ester, polyvidone, polyvinyl acetate, sucrose, spherical sucrose, compressible sugar, sugar,confectioner's, sucrose fatty acid ester, sucrose monolaurate, sucrose palmitic acid ester, locust bean gum, dextrin, white dextrin, cellulose acetate, a cellulose acetate, cellulose diacetate, Triafol T, cellulose acetate dibutylamino-hydrox-ypropyl ether and the sodium starch phosphate one or more, better in pregelatinized Starch, hydroxypropyl emthylcellulose, tragacanth and the modified starch one or more.
Among the present invention; Described disintegrating agent is the conventional described disintegrating agent in this area; One or more that preferable is in crospolyvinylpyrrolidone, silicon dioxide, sodium lauryl sulphate, Stepanol MG, natrium carbonicum calcinatum, fumaric acid, methylcellulose, glycine, cross-linking sodium carboxymethyl cellulose, crosslinked carboxymethyl fecula crystallite aluminum spray drying thing, POLY-karaya, polacrilin potassium, modified starch, malic acid, citric acid, alginic acid, sodium alginate, tartaric acid, pregelatinized Starch, Powderd cellulose, silica sol, hydroxyethylmethyl-cellulose, aluminium-magnesium silicate, starch, sodium starch glycol, microbial alginate, microcrystalline Cellulose, bagasse regrowth, microwax, sodium carboxymethyl cellulose, carboxymethylcellulose calcium, polyethylene azoxy ketone, Polyoxyethylene Sorbitan Monooleate, polyoxyethylene, sodium bicarbonate, potassium bicarbonate, potassium carbonate, sucrose fatty acid ester, sucrose monolaurate, sucrose palmitic acid ester, sodium dioctyl sulfosuccinate, dioctyl sulphosuccinate calcium, dioctyl sulphosuccinate potassium, sodium dihydrogen phosphate and the potassium dihydrogen phosphate, one or more that better is in crospolyvinylpyrrolidone, starch, microcrystalline Cellulose and the sodium carboxymethyl cellulose.
Among the present invention; Described lubricant is the conventional described lubricant in this area; Be generally kollag; In preferable is hard paraffin, Palmic acid, synthetic wax, zinc oleate, lithium stearate, potassium stearate, calcium stearate, boric acid, calcium silicates, aluminium silicate, Aluminum calcium silicate., magnesium silicate, silicone rubber, liquid paraffin, hard esteramides, stearic palmitamide, stearic acid, isostearic acid, sodium stearate, hard soap, curdled milk soap, sodium stearate, cobaltous octadecanate, zinc stearate, magnesium stearate, Pulvis Talci, sodium palmitate, Oleum Ricini, SHCO, Polyethylene Glycol, sucrose fatty acid ester, sucrose monolaurate, sucrose palmitic acid ester, olive oil and the calcium phosphate one or more, one or more that better is in magnesium stearate, Pulvis Talci, calcium silicates and the sucrose monolaurate.
Preferable being made up of 1.0%～40.0% asiatic acid tromethane salt, 25%～60% filler, 1%～10.0% binding agent, 0.5%～40.0% disintegrating agent and 0.1%～1.5% lubricant of asiatic acid salt tablets prescription of the present invention, percentage ratio accounts for the mass percent of asiatic acid salt tablets total amount for each composition.
The invention still further relates to the asiatic acid salt tablets preferred embodiments of filling a prescription and comprise 3.33%～32.26% asiatic acid tromethane salt; 40.32%～56.82% filler; 6.1%～17.05% binding agent, 5.3%～16.13% disintegrating agent and 1.89%～3.33% lubricant, percentage ratio account for the mass percent of asiatic acid salt tablets total amount for each composition.
The invention still further relates to the asiatic acid salt tablets another preferred embodiments of filling a prescription and comprise 5%～30% asiatic acid tromethane salt; 40%～60% microcrystalline Cellulose; 5%～10% crospolyvinylpyrrolidone; 5%～20% pregelatinized Starch and 0.3%～1% lubricant, percentage ratio account for the mass percent of asiatic acid salt tablets total amount for each composition.
The invention still further relates to asiatic acid salt tablets prescription again a preferred embodiments by 5%～30% asiatic acid tromethane salt; 40%～60% microcrystalline Cellulose; 5%～10% crospolyvinylpyrrolidone; 5%～20% pregelatinized Starch and 0.3%～1% lubricant are formed, and percentage ratio accounts for the mass percent of asiatic acid salt tablets total amount for each composition.
Asiatic acid salt tablets of the present invention can also contain conventional various other additives that add and other active substances in the conventional tablet of this area, as long as it does not have antagonism or not appreciable impact tablet effect of the present invention.
Asiatic acid salt tablets of the present invention can make by this area conventional method; Preferable method for preparing comprises the steps: by prescription; With asiatic acid tromethane salt, filler, binding agent and the disintegrating agent uniform mixing behind the crushing screening, be that 5%～20% alcoholic solution mixes with mass percent then, granulation, drying; Afterwards again with mix lubricant, tabletting gets final product.
What wherein, described asiatic acid tromethane salt crushing screening was preferable was 60～100 mesh sieves.
What wherein, described filler, binding agent and disintegrating agent crushing screening were preferable was 80～100 mesh sieves.
What wherein, the grain diameter of described granulation size was preferable is 20～50 orders.
What wherein, described exsiccant temperature was preferable is in 50 ℃～90 ℃ control moisture mass percents 3%.
Wherein, the preparation of described asiatic acid salt tablets uses equipment to be this area conventional equipment.
Agents useful for same of the present invention and raw material are all commercially available to be got.
On the basis that meets this area general knowledge, each above-mentioned among the present invention technical characterictic optimum condition can combination in any obtain preferred embodiments.
Positive progressive effect of the present invention is: asiatic acid salt tablets of the present invention has the good biological availability, and mobility of particle and compressibility are all good, and institute's tablet agent any surface finish is attractive in appearance; Hardness is big; The principal agent dissolution is greater than 90% simultaneously, and all other detect the prescription that index all meets product, and preparation technology of the present invention is simple; Easy to operate, be applicable to industrialized great production.
The specific embodiment
Mode through embodiment further specifies the present invention below, but does not therefore limit the present invention among the described scope of embodiments.
Embodiment 1
Method for preparing: by above-mentioned prescription; Asiatic acid tromethane salt, microcrystalline Cellulose, pregelatinized Starch and crospolyvinylpyrrolidone uniform mixing with behind the crushing screening mix with 5% alcoholic solution then, granulation, drying; Afterwards again with mix lubricant, tabletting gets final product.
Wherein, described asiatic acid tromethane salt crushing screening was 60 mesh sieves; Described microcrystalline Cellulose, pregelatinized Starch and crospolyvinylpyrrolidone crushing screening were 80 mesh sieves; The grain diameter size of described granulation is 20 orders; What described exsiccant temperature was preferable is in 90 ℃ of control moisture mass percents 3%.
Through detecting (rat tail vein injection, visible " Nanfang Medical Univ's journal " 06 phase in 2009), the bioavailability of asiatic acid tromethane salt is 17.9% in the gained tablet.
Embodiment 2
Method for preparing: by above-mentioned prescription; With the asiatic acid tromethane salt behind the crushing screening, 4/5ths starch, hydroxypropyl emthylcellulose uniform mixing, mix with 20% alcoholic solution then, granulate, drying; Afterwards again with remaining starch and mix lubricant, tabletting gets final product.
Wherein, described asiatic acid tromethane salt crushing screening was 100 mesh sieves; Described starch and hydroxypropyl emthylcellulose crushing screening were 100 mesh sieves; The grain diameter size of described granulation is 50 orders; What described exsiccant temperature was preferable is in 50 ℃ of control moisture mass percents 3%.
Embodiment 3
Method for preparing: by above-mentioned prescription, asiatic acid tromethane salt, microcrystalline Cellulose, alpha-lactose and tragacanth uniform mixing with behind the crushing screening mix with 20% alcoholic solution then, granulation, drying, afterwards again with mix lubricant, tabletting gets final product.
Wherein, described asiatic acid tromethane salt crushing screening was 60 mesh sieves; Described microcrystalline Cellulose, alpha-lactose and tragacanth crushing screening were 80 mesh sieves; The grain diameter size of described granulation is 20 orders; What described exsiccant temperature was preferable is in 50 ℃ of control moisture mass percents 3%.
Embodiment 4
Method for preparing: by above-mentioned prescription; Asiatic acid tromethane salt, crospolyvinylpyrrolidone, modified starch and sodium carboxymethyl cellulose uniform mixing with behind the crushing screening mix with 20% alcoholic solution then, granulation, drying; Afterwards again with mix lubricant, tabletting gets final product.
Wherein, described asiatic acid tromethane salt crushing screening was 60 mesh sieves; Described crospolyvinylpyrrolidone, modified starch and sodium carboxymethyl cellulose crushing screening were 80 mesh sieves; The grain diameter size of described granulation is 20 orders; What described exsiccant temperature was preferable is in 50 ℃ of control moisture mass percents 3%.
Effect embodiment
Measure according to 2010 editions correlation methods of Chinese Pharmacopoeia, the result is following:
Comparative Examples 1
Method for preparing: by above-mentioned prescription; With the asiatic acid potassium salt behind the crushing screening, microcrystalline Cellulose, pregelatinized Starch and crospolyvinylpyrrolidone uniform mixing, mix granulation, drying then with 5% alcoholic solution; Afterwards again with mix lubricant, tabletting gets final product.
Wherein, described asiatic acid potassium salt crushing screening was 60 mesh sieves; Described microcrystalline Cellulose, pregelatinized Starch and crospolyvinylpyrrolidone crushing screening were 80 mesh sieves; The grain diameter size of described granulation is 20 orders; What described exsiccant temperature was preferable is in 50 ℃ of control moisture mass percents 3%.
Through detecting (rat tail vein injection, visible " Nanfang Medical Univ's journal " 06 phase in 2009), the bioavailability of asiatic acid potassium salt is 12.4% in the gained tablet.
Comparative Examples 2
Method for preparing: by above-mentioned prescription; With the asiatic acid arginine salt behind the crushing screening, microcrystalline Cellulose, pregelatinized Starch and crospolyvinylpyrrolidone uniform mixing, mix granulation, drying then with 20% alcoholic solution; Afterwards again with mix lubricant, tabletting gets final product.
Wherein, described asiatic acid arginine salt crushing screening was 60 mesh sieves; Described microcrystalline Cellulose, pregelatinized Starch and crospolyvinylpyrrolidone crushing screening were 80 mesh sieves; The grain diameter size of described granulation is 50 orders; What described exsiccant temperature was preferable is in 90 ℃ of control moisture mass percents 3%.
Through detecting (rat tail vein injection, visible " Nanfang Medical Univ's journal " 06 phase in 2009), the bioavailability of asiatic acid arginine salt is 0.7% in the gained tablet.
Claims (9)
1. asiatic acid salt tablets; Its prescription contains 1%～40% asiatic acid tromethane salt, 25%～60% filler, 1%～10% binding agent, 0.5%～40% disintegrating agent and 0.1%～1.5% lubricant, and percentage ratio accounts for the mass percent of asiatic acid salt tablets total amount for each composition.
2. asiatic acid salt tablets as claimed in claim 1; It is characterized in that: described asiatic acid salt tablets prescription is made up of 1%～40% asiatic acid tromethane salt, 25%～60% filler, 1%～10% binding agent, 0.5%～40% disintegrating agent and 0.1%～1.5% lubricant, and percentage ratio accounts for the mass percent of asiatic acid salt tablets total amount for each composition.
3. asiatic acid salt tablets as claimed in claim 1; It is characterized in that: described asiatic acid salt tablets prescription contains 3.33%～32.26% asiatic acid tromethane salt; 40.32%～56.82% filler; 6.1%～17.05% binding agent, 5.3%～16.13% disintegrating agent and 1.89%～3.33% lubricant, percentage ratio account for the mass percent of asiatic acid salt tablets total amount for each composition.
4. like each described asiatic acid salt tablets of claim 1～3, it is characterized in that: described filler is one or more in microcrystalline Cellulose, starch, alpha-lactose and the crospolyvinylpyrrolidone; And/or described binding agent is one or more in pregelatinized Starch, hydroxypropyl emthylcellulose, tragacanth and the modified starch; And/or described disintegrating agent is one or more in crospolyvinylpyrrolidone, starch, microcrystalline Cellulose and the sodium carboxymethyl cellulose; And/or described lubricant is one or more in magnesium stearate, Pulvis Talci, calcium silicates and the sucrose monolaurate.
5. asiatic acid salt tablets as claimed in claim 1; It is characterized in that: described asiatic acid salt tablets prescription comprises 5%～30% asiatic acid tromethane salt; 40%～60% microcrystalline Cellulose; 5%～10% crospolyvinylpyrrolidone, 5%～20% pregelatinized Starch and 0.3%～1% lubricant, percentage ratio account for the mass percent of asiatic acid salt tablets total amount for each composition.
6. asiatic acid salt tablets as claimed in claim 5; It is characterized in that: described asiatic acid salt tablets prescription is by 5%～30% asiatic acid tromethane salt; 40%～60% microcrystalline Cellulose; 5%～10% crospolyvinylpyrrolidone, 5%～20% pregelatinized Starch and 0.3%～1% lubricant are formed, and percentage ratio accounts for the mass percent of asiatic acid salt tablets total amount for each composition.
7. method for preparing like each described asiatic acid salt tablets of claim 1～6; It comprises the steps: by described prescription; With asiatic acid tromethane salt, filler, binding agent and the disintegrating agent uniform mixing behind the crushing screening, be that 5%～20% alcoholic solution mixes with mass percent then, granulation, drying; Afterwards again with mix lubricant, tabletting gets final product.
8. method for preparing as claimed in claim 7 is characterized in that: described asiatic acid tromethane salt crushing screening was 60～100 mesh sieves; Described filler, binding agent and disintegrating agent crushing screening were 80～100 mesh sieves; The grain diameter size of described granulation is 20～50 orders.
9. method for preparing as claimed in claim 7 is characterized in that: described exsiccant temperature is in 50 ℃～90 ℃ control moisture mass percents 3%.
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| CN2011101130738A CN102755332A (en) | 2011-04-29 | 2011-04-29 | Asiatic acid salt tablet and preparation method thereof |
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| CN2011101130738A CN102755332A (en) | 2011-04-29 | 2011-04-29 | Asiatic acid salt tablet and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106511351A (en) * | 2016-12-27 | 2017-03-22 | 吉林省博大伟业制药有限公司 | Application of polaprezinc in preparing medicine for eradicating helicobacter pylori |
| CN108210467A (en) * | 2018-02-05 | 2018-06-29 | 湖南博隽生物医药有限公司 | A kind of pharmaceutical composition for treating cardiovascular and cerebrovascular and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101969942A (en) * | 2008-01-11 | 2011-02-09 | 上海医药工业研究院 | Therapeutic formulations based on asiatic acid and selected salts thereof |
-
2011
- 2011-04-29 CN CN2011101130738A patent/CN102755332A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101969942A (en) * | 2008-01-11 | 2011-02-09 | 上海医药工业研究院 | Therapeutic formulations based on asiatic acid and selected salts thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106511351A (en) * | 2016-12-27 | 2017-03-22 | 吉林省博大伟业制药有限公司 | Application of polaprezinc in preparing medicine for eradicating helicobacter pylori |
| CN106511351B (en) * | 2016-12-27 | 2020-04-03 | 吉林省博大伟业制药有限公司 | Application of polaprezinc in preparation of anti-helicobacter pylori medicines |
| CN108210467A (en) * | 2018-02-05 | 2018-06-29 | 湖南博隽生物医药有限公司 | A kind of pharmaceutical composition for treating cardiovascular and cerebrovascular and preparation method thereof |
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Application publication date: 20121031 |