CN1586471A - Silibinin meglumine salt oral disintegration tablet preparation and its preparing method - Google Patents
Silibinin meglumine salt oral disintegration tablet preparation and its preparing method Download PDFInfo
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- CN1586471A CN1586471A CN 200410069355 CN200410069355A CN1586471A CN 1586471 A CN1586471 A CN 1586471A CN 200410069355 CN200410069355 CN 200410069355 CN 200410069355 A CN200410069355 A CN 200410069355A CN 1586471 A CN1586471 A CN 1586471A
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- silybin
- methylglucamine
- sodium
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Abstract
The present invention relates to one kind of orally disintegrated silibinin-meglumine salt tablet for protecting liver cell, stimulating the biological synthesis of protein inside liver cell, promoting recovery of damaged liver cell, resisting fibrillation, capturing free oxygen radical and inhibiting the deposition and infiltration of fat in liver, and its preparation. The orally disintegrated silibinin-meglumine salt tablet is prepared with silibinin-meglumine salt as main material, and through adding stuffing, disintegrating agent, corrective, flow assistant and other supplementary material, pressing into tablet and other steps. The present invention has the features of low production cost, fast disintegration, good taste, etc.
Description
[technical field]
The present invention relates to a kind ofly have significant protection and stablize hepatocellular effect; be used for the treatment of the silybin-N-methylglucamine preparation of diseases such as acute, chronic hepatitis, liver cirrhosis, liver poisoning, relate in particular to a kind of silibinin meglumine salt oral disintegration tablet preparation with rapid release effect.
[background technology]
Silybin-N-methylglucamine is silibinin and meglumine (1-methylamino-1-deoxidation sorbitol) be combined into, and silybin-N-methylglucamine is soluble in water than silibinin, so the performance of infiltration rate and curative effect is excellent than silibinin all.
Silybin-N-methylglucamine has identical indication and clinical efficacy with silibinin.
Silybin-N-methylglucamine is because its slightly solubility causes its bioavailability lower.The dosage form of silybin-N-methylglucamine preparation mainly contains ordinary tablet and capsule formulation at present.Still find no the orally disintegrating tablet preparation or the relevant document of silybin-N-methylglucamine.Silybin-N-methylglucamine is made oral cavity disintegration tablet, make the patient easy to carry and use, help improving patient's compliance, and then can guarantee the silybin-N-methylglucamine curative effect.
[summary of the invention]
The objective of the invention is to improve existing silybin-N-methylglucamine aspect peroral dosage form deficiency, provide a kind of taking convenience, absorption is rapid-action, bioavailability is high silibinin meglumine salt oral disintegration tablet preparation to extensive patients and medical personnel.Needn't drink water when the present invention relates to take, in the oral cavity, only need get final product rapid disintegrate or dissolving in tens seconds, can finish silibinin meglumine salt oral disintegration tablet of taking medicine and preparation method thereof with saliva hypopharynx.
One, prescription
The silibinin meglumine salt oral disintegration tablet that reaches of the present invention comprises the material medicine silybin-N-methylglucamine, needs following former, the auxiliary material of 9 classes altogether, wherein: when not making Cotton seeds, then do not use coating material, effervescent also can for selecting adjuvant for use as one sees fit.
Silybin-N-methylglucamine (5-50) %, binding agent (0-5) %, filler (10-80) %, disintegrating agent (2-35) %, correctives (1-40) %, coating material (0-40) %, effervescent (0-30) %, fluidizer (0.01-5) %, lubricant (0.3-3) %.
Wherein:
Binding agent includes but are not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum and hydroxypropyl emthylcellulose (HPMC), can use use also capable of being combined separately.
Filler includes but are not limited to mannitol (granular or powdery), xylitol, sorbitol, maltose, microcrystalline Cellulose, PROSOLV
SMCC, polymerization sugar (EMDEX
), glucose, lactose, sucrose, dextrin and starch etc., can use separately, also can applied in any combination, consumption is generally (10-80) %.
Disintegrating agent includes but are not limited to microcrystalline Cellulose, PROSOLV
SMCC, crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide (EMCOSOY
) etc., can use use also capable of being combined separately.
Correctives includes but are not limited to mannitol, xylitol, stevioside, lactose, fructose, sucrose, protein sugar, maltose alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, aspartame, flavoring banana essence, flavoring pineapple essence, vanillin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Coating material includes but are not limited to gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol etc., can use use also capable of being combined separately.
Fluidizer includes but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant includes but are not limited to magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, magnesium laurylsulfate, Stepanol MG and Pulvis Talci etc., can use use also capable of being combined separately.
Effervescent includes but are not limited to the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
Two, preparation method
The silibinin meglumine salt oral disintegration tablet that reaches of the present invention, its preparation method is a direct compression process, the manufacturer with preparation conventional tablet all can adopt.
The silybin-N-methylglucamine mildly bitter flavor is puckery, and the present invention can adopt two kinds of distinct methods to carry out flavoring or taste masking: 1. adopt the direct flavoring of correctives; 2. in advance silybin-N-methylglucamine is carried out powder coating with taste masking.
Concrete preparation method is as follows:
The preprocess method of first step silybin-N-methylglucamine:
1. directly the flavoring method---this law is granulated to the silybin-N-methylglucamine raw material or is not dealt with, and directly enters for second step;
2. powder coating taste masking---get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, the Silybin meglumine of fetching water again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get silybin-N-methylglucamine powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and silybin-N-methylglucamine or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
[beneficial effect]
Tablet is a kind of conventional dosage forms, because of its steady quality, dosage accurately, take, easy to carry, mechanization degree is high, low one of the at present the most frequently used dosage form that becomes of production cost, but because of the tablet extrusion forming, disintegrate is slow, bioavailability is lower, and part patient swallows comparatively difficult, thereby promoting the use of to a certain extent of tablet is restricted.The oral administration solid quick releasing formulation becomes a focus, particularly oral cavity disintegration tablet of new drug development in recent years for this reason, because of its taking convenience, rapid-action, bioavailability is high, the good emphasis that becomes tablet exploitation of mouthfeel.
Oral cavity disintegration tablet is meant not to be needed water or only needs low amounts of water, need not to chew, and tablet places lingual surface, meets after saliva separates rapidly or collapse, and borrows and swallows power, and medicine can be gone into the tablet of stomach onset.The characteristics of oral cavity disintegration tablet are that absorption is fast, bioavailability is high, and intestinal is residual few, and side effect is low, avoids liver first-pass effect etc.
According to the requirement of " formulation characteristic of oral cavity disintegration tablet and quality control meeting summary ", oral cavity disintegration tablet has essential leap than the disintegration rate of drop pill and ordinary tablet, and the disintegrate of oral cavity disintegration tablet generally in 30 seconds, is no more than 1 minute at most.
[specific embodiment]
For the preparation method of silibinin meglumine salt oral disintegration tablet of the present invention better is described, in conjunction with directly flavoring method and powder coating taste masking method are as follows for an embodiment respectively:
Embodiment one direct flavoring method
One. prescription
1. raw material---silybin-N-methylglucamine 100.0g;
2. binding agent---polyvinylpyrrolidone K-30 1.0g;
3. filler---mannitol 154.0g;
4. correctives---aspartame 3.0g;
Flavoring orange essence 6.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 14.0g;
Cross-linking sodium carboxymethyl cellulose 16.0g;
6. fluidizer---micropowder silica gel 3.0g;
7. lubricant---sodium stearyl fumarate 3.0g.
Gross weight 300g makes 2000 altogether.
Two. preparation method
1) water intaking Silybin meglumine raw material pulverizing is granulated with polyvinylpyrrolidone K-30, and water or ethanol are wetting agent, crosses 26 mesh sieves, and oven dry is standby;
2) with crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, micropowder silica gel, sodium stearyl fumarate, flavoring orange essence and aspartame, cross 40 mesh sieves respectively, mix homogeneously adds the silybin-N-methylglucamine granule of having granulated again, and mix homogeneously is standby;
3) add the mannitol mix homogeneously again;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Embodiment two powder coating taste masking methods
One. prescription
1. raw material---silybin-N-methylglucamine 100.0g;
2. coating material---Eudragit
E100 20.0g;
3. filler---mannitol 132.0g;
4. correctives---aspartame 3.0g;
Flavoring orange essence 6.0g;
5. disintegrating agent---crospolyvinylpyrrolidone 14.0g;
Cross-linking sodium carboxymethyl cellulose 16.0g;
6. fluidizer---micropowder silica gel 6.0g;
7. lubricant---sodium stearyl fumarate 3.0g.
Gross weight 300g makes 2000 altogether.
Two. preparation method
1) gets Eudragit
E100 is with the dissolving of the medicinal industrial alcohol more than 95% and to be diluted to finite concentration standby;
2) the water intaking Silybin meglumine places ebullated bed to seethe with excitement, and sprays into above-mentioned solution by certain speed and carries out powder coating, makes silybin-N-methylglucamine powder coating granule, and dry back is standby;
3) with mannitol, micropowder silica gel, PVPP, L-HPC, aspartame, sodium stearyl fumarate and flavoring orange essence mix homogeneously, again and sieve after the coated granule mixing standby;
4) intermediate content detection, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
Claims (8)
1. one kind has treatment and prevents suddenly, the pharmaceutical preparation silibinin meglumine salt oral disintegration tablet of effect such as chronic hepatitis and chronic persistent hepatitis and blood fat reducing, by silybin-N-methylglucamine, filler, disintegrating agent, correctives, fluidizer, supplementary materials such as lubricant, according to circumstances can also add binding agent, effervescent or coating material, with suitable proportioning, form through specific method for preparing, it is characterized in that its prescription is composed as follows: silybin-N-methylglucamine (5-50) %, binding agent (0-5) %, filler (10-80) %, disintegrating agent (2-35) %, correctives (1-40) %, coating material (0-40) %, effervescent (0-30) %, fluidizer (0.01-5) %, lubricant (0.3-3) %.
2. various adjuvants of addressing according to claim 1 of being addressed is characterized in that selection kind separately is as follows:
Binding agent---include but are not limited to starch, pregelatinized Starch, dextrin, maltodextrin, sucrose, arabic gum, methylcellulose, carboxymethyl cellulose, ethyl cellulose, polyvinyl alcohol, Polyethylene Glycol, polyvinylpyrrolidone (PVP), alginic acid and alginate, xanthan gum and hydroxypropyl emthylcellulose (HPMC), can use use also capable of being combined separately.
Filler---include but are not limited to mannitol (granular or powdery), xylitol, sorbitol, maltose, microcrystalline Cellulose, PROSOLV
SMCC, polymerization sugar (EMDEX
), glucose, lactose, sucrose, dextrin and starch etc., can use separately, also can applied in any combination, consumption is generally (10-80) %.
Disintegrating agent---include but are not limited to crospolyvinylpyrrolidone (PVPP), carboxymethyl starch sodium (CMS-Na), low substituted hydroxy-propyl methylcellulose (L-HPC), cross-linking sodium carboxymethyl cellulose (CCNa) and soybean polysaccharide (EMCOSOY
) etc., can use use also capable of being combined separately.
Correctives---include but are not limited to mannitol, xylitol, stevioside, lactose, fructose, sucrose, protein sugar, maltose alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, aspartame, flavoring banana essence, flavoring pineapple essence, vanillin, fragrant citrus essence, flavoring orange essence, Herba Menthae essence, ginseng essence, strawberry essence, citric acid, citric acid etc., can use use also capable of being combined separately.
Coating material---include but are not limited to gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol etc., can use use also capable of being combined separately.
Fluidizer---include but are not limited to micropowder silica gel, Pulvis Talci, Cab-O-sil, Arosil, hydrated sodium aluminosilicate etc., can use use also capable of being combined separately.
Lubricant---include but are not limited to magnesium stearate, calcium stearate, zinc stearate, glyceryl monostearate, Polyethylene Glycol, hydrogenated vegetable oil, sodium stearyl fumarate, polyoxyethylene monostearate, single Laurel sucrose acid ester, sodium laurylsulfate, magnesium laurylsulfate, Stepanol MG and Pulvis Talci etc., can use use also capable of being combined separately.
3. preparation method that is used for the silibinin meglumine salt oral disintegration tablet that claim 1 addresses is characterized in that being made up of following steps:
The pretreatment of first step silybin-N-methylglucamine:
(1) directly flavoring---this law is granulated to the silybin-N-methylglucamine raw material or is not dealt with, and directly enters for second step;
(2) powder coating taste masking---get selected coating material, with the dissolving of the solvent that adapts with it and to be diluted to debita spissitudo standby, the Silybin meglumine of fetching water again places ebullated bed to make boiling, spray into above-mentioned solution with suitable speed then and carry out powder coating, get silybin-N-methylglucamine powder coating granule, dry back sieving for standby;
Second step took by weighing correctives and silybin-N-methylglucamine or the feed particles after first step taste masking processing according to quantity, and mix homogeneously is standby;
The 3rd step took by weighing filler, disintegrating agent, effervescent, fluidizer and mix homogeneously according to quantity, made evenly again with through second mixing of materials that goes on foot gained, and adding lubricant mixing is standby;
The 4th step gained material detects through intermediate, determine that sheet is heavy after, send into the tablet machine tabletting promptly.
4. the preparation method of addressing according to claim 3 is characterized in that: the method for the first step (2) need be used coating material that silybin-N-methylglucamine is carried out taste masking in advance and handle.
5. the preparation method of addressing according to claim 4, it is characterized in that: the coating material that is used for the taste masking processing is gelatin, arabic gum, alginate, chitosan, carboxymethyl cellulose salt, cellulose acetate phthalate ester, ethyl cellulose, methylcellulose, hypromellose, crylic acid resin (homemade acrylic resin I, II, III, IV, Eudragit
Series), any one or two or more mixture such as polyvinyl alcohol, polyvinylpyrrolidone, Polyethylene Glycol.
6. any preparation method of addressing according to claim 3 is characterized in that: according to circumstances also can add the adjuvant effervescent.
7. the effervescent of addressing according to claim 6, it is characterized in that: this adjuvant is the mixture of malic acid, citric acid or citric acid and sodium bicarbonate or sodium carbonate.
8. preparation method that is used for the silibinin meglumine salt oral disintegration tablet that claim 1 addresses, the hardness that it is characterized in that the tablet that obtains are between 10 to 45 newton, and disintegration time is at 1-60 in second.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410069355 CN1254240C (en) | 2004-07-19 | 2004-07-19 | Silibinin meglumine salt oral disintegration tablet preparation and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410069355 CN1254240C (en) | 2004-07-19 | 2004-07-19 | Silibinin meglumine salt oral disintegration tablet preparation and its preparing method |
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| Publication Number | Publication Date |
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| CN1586471A true CN1586471A (en) | 2005-03-02 |
| CN1254240C CN1254240C (en) | 2006-05-03 |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810594A (en) * | 2010-03-16 | 2010-08-25 | 江苏中兴药业有限公司 | Production method of silybin meglumine tablets |
| CN103768048A (en) * | 2012-10-21 | 2014-05-07 | 江苏中兴药业有限公司 | Silybin meglumine tablet and lipid-reducing function thereof |
| CN111297814A (en) * | 2019-12-18 | 2020-06-19 | 湖南千金协力药业有限公司 | Compound preparation for reducing liver toxicity of tripterygium glycosides tablets and preparation method thereof |
| CN112587488A (en) * | 2020-12-16 | 2021-04-02 | 福建瑞泰来医药科技有限公司 | Silybin composition and preparation method thereof |
-
2004
- 2004-07-19 CN CN 200410069355 patent/CN1254240C/en not_active Expired - Fee Related
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101810594A (en) * | 2010-03-16 | 2010-08-25 | 江苏中兴药业有限公司 | Production method of silybin meglumine tablets |
| CN101810594B (en) * | 2010-03-16 | 2013-07-10 | 江苏中兴药业有限公司 | Production method of silybin meglumine tablets |
| CN103768048A (en) * | 2012-10-21 | 2014-05-07 | 江苏中兴药业有限公司 | Silybin meglumine tablet and lipid-reducing function thereof |
| CN103768048B (en) * | 2012-10-21 | 2015-11-25 | 江苏中兴药业有限公司 | Silybin meglumine tablets and effect for reducing fat thereof |
| CN111297814A (en) * | 2019-12-18 | 2020-06-19 | 湖南千金协力药业有限公司 | Compound preparation for reducing liver toxicity of tripterygium glycosides tablets and preparation method thereof |
| CN112587488A (en) * | 2020-12-16 | 2021-04-02 | 福建瑞泰来医药科技有限公司 | Silybin composition and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN1254240C (en) | 2006-05-03 |
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Address after: 100083 A building, block 15, Tiangong building, No. 30, Haidian District, Beijing, Xueyuan Road Patentee after: COSCI MED-TECH Co.,Ltd. Address before: 100080, Haidian District satellite building, No. 63, Zhichun Road, Beijing, room 1410, Beijing Patentee before: COSCI MED-TECH Co.,Ltd. |
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