CN1879641A - Dispersible tablet of glycyrrhizin and preparation method thereof - Google Patents
Dispersible tablet of glycyrrhizin and preparation method thereof Download PDFInfo
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- CN1879641A CN1879641A CN 200510078743 CN200510078743A CN1879641A CN 1879641 A CN1879641 A CN 1879641A CN 200510078743 CN200510078743 CN 200510078743 CN 200510078743 A CN200510078743 A CN 200510078743A CN 1879641 A CN1879641 A CN 1879641A
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Abstract
The invention relates to a glycyrrhizin dispersible tablet and method for preparation, wherein the formula comprises (by weight ratio) glycyrrhizin 25-300, filling agent 15-350, crumbling agent 15-250, lubricating agent 1-10, and right amount of wetting agent or binding agent. The crumbling agent is one selected from the following or their various combination: sodium carboxymethylstarch, crosslinked povidone, cross-linked sodium carboxymethylcellulose, or low substituted methylcellulose propylene glycol ether. The filling agent is one selected from the following or their various combination: lactose, crystalline cellulose, starch, starch gum, mannitol. The lubricating agent is one selected from the following or their various combination: magnesium stearate, talcum powder, magnesium dodecylsulfate, sodium dodecylsulfate, miropowdered silica gel. The tablet also comprises right amount of wetting agent or binding agent, the wetting agent or binding agent being one of water, 10-95% ethanol, and 10% polyvinylpyrrolidone-K30.
Description
One. technical field
The present invention relates to the pharmaceutical preparation of glycyrrhizin, is a kind of dispersible tablet of glycyrrhizin and preparation method thereof more particularly, belongs to medical technical field.
Two. background technology
Glycyrrhizin is the monopotassium glycyrrhizunate that Radix Glycyrrhizae is made through extraction, is off-white color or little apparent flaxen powder, odorless, and it is sweet to distinguish the flavor of, easily molten in water, is gelatin, dissolves slightly soluble in dehydrated alcohol, ether in rare alcohol.Have and obviously alleviate the hepatic cell fattydegeneration necrosis, alleviate matter inflammatory reaction between hepatocyte, suppress hepatocyte fibroplasia, reduce the liver cirrhosis incidence rate, promote effects such as liver cell regeneration, to chronic animal migration hepatitis, chronic active hepatitis all have better curative effect (Chen Yeyi. glycyrrhizin is treated chronic hepatitis B 128 routine observation of curative effect with the hepatitis spirit. Medical Colleges Of Guilin's journal, 1995,8 (1), 42～43).
State Food and Drug Administration approval be " glycyrrhizin tablet " arranged and being " diammonium glycyrrhizinate injection " of effective ingredient of main effective ingredient with glycyrrhizin with the diammonium glycyrrhizinate.Existing how tame pharmaceutical factory produces the glycyrrhizin tablet list marketing, every contains glycyrrhizin 75mg, 150mg, oral, a 150mg, 2 times on the one, but when tablet was oral, the effective ingredient stripping was slow, onset in time, the result can not obtain satisfactory therapeutic effects, dust is big during tablet manufacturing, and required adjuvant is many, the production cost height; The diammonium glycyrrhizinate injection of the honest day fine pharmaceutical Co. Ltd in Lianyun Harbour production, intravenous drip 30ml (specification: 10ml:50mg), slowly instil with 10% glucose injection 250ml dilution back, once-a-day, clinical therapeutic efficacy is remarkable, but drug administration by injection, the necessary hospitalization of patient, and pain very all during patient's per injection especially concerning chronic and long-term prescription person, is carried and is used all very inconvenient.So existing dosage form tablet and injection still can not satisfy the demand of clinical extensive patients.
Three. summary of the invention
The purpose of this invention is to provide a kind of dispersible tablet of glycyrrhizin and preparation technology thereof that can substitute injection and tablet, product is an oral administered dosage form, and its steady quality is easy to use, effective.
The material that the present invention has adopted novel form, adjuvant and prescription to form preferably reaches superfine communication technique and makes dispersible tablet of glycyrrhizin, all deficiencies of the bioavailability difference of the use inconvenience of injection and tablet have been overcome, shorten its disintegration greatly, the effective ingredient stripping is fast, take the back medicine and exist, be beneficial to absorption of human body with liquid form.The dispersible tablet good looking appearance of making, the content good stability be beneficial to the oral and Long-term Storage of patient, and preparation is simple, is the new formulation of present comparatively ideal glycyrrhizin.
The invention provides a kind of dispersible tablet of glycyrrhizin and preparation method thereof.The main weight ratio of components of its prescription is: glycyrrhizin 25～300, filler 15～350, disintegrating agent 15～250, lubricant 1～10; Contain wetting agent in addition or binding agent is an amount of.Wherein disintegrating agent be carboxymethyl starch sodium, polyvinylpolypyrrolidone, uprightly collapse, a kind of in the super carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or their various combinations; Wherein filler is a kind of in lactose, microcrystalline Cellulose, starch, dextrin, the mannitol or their various combinations; Wherein lubricant is selected from a kind of in magnesium stearate, Pulvis Talci, Stepanol MG, sodium lauryl sulphate, the differential silica gel or their various combinations; Also contain wetting agent or binding agent is an amount of, wetting agent or binding agent are water, 10～95% ethanol, a kind of among 10% polyvinylpyrrolidone-K30.Also can select other disintegrating agents with disintegration, other filler and other lubricant with lubrication with filling effect is used in the present invention.Glycyrrhizin content is every 25～300 milligrams, and preferred every specification is for containing glycyrrhizin 75mg or 150mg.
The weight ratio of components series 1 of the dispersible tablet prescription that optimizes is: glycyrrhizin 25～300, and carboxymethyl starch sodium 2～100, low-substituted hydroxypropyl cellulose 2～100, microcrystalline Cellulose 20～300, aspartame 2～40, binding agent is an amount of, magnesium stearate 1～10.The weight ratio of components series 2 of the dispersible tablet prescription that optimizes is: glycyrrhizin 25～200, lactose 50～250, low-substituted hydroxypropyl cellulose 5～50, crospolyvinylpyrrolidone 5～50, microcrystalline Cellulose 25～200, magnesium stearate 1～8.
Dispersible tablet preparation method of the present invention comprises the step of following order: supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, disintegrating agent, filler, the mix homogeneously of formula ratio; With binding agent system soft material, 18～24 mesh sieves are granulated, and wet granular is in 50～80 ℃ of dryings; 18～24 mesh sieve granulate add lubricant, and compacting gets dispersible tablet of glycyrrhizin.
Beneficial effect of the present invention
(1) dispersible tablet of glycyrrhizin of the present invention is the dosage form improvement on glycyrrhizin common oral preparation (tablet and capsule) basis, form by principal agent and specific disintegrating agent and good mixed with excipients pelletizing press sheet, steady quality is significantly improved than common oral preparation.
(2) good absorbing, disintegrate and stripping are the speed limit processes that oral formulations absorbs.Dispersible tablet is put jolting in the 100ml water, and in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves fully in 3min; Therefore the then disintegrate in 30min of conventional tablet, capsule has incomparable disintegrate of ordinary tablet and dissolving out capability, and it is fast to take post-absorption, the bioavailability height.
(3) taking convenience can be contained in it and suck clothes in mouth or swallow, and is particularly suitable for old man and dysphagia patients and uses.
(4) preparation technology is simple, and equipment is not had specific (special) requirements, is fit to the big production of scale.
Four, the specific embodiment
Can further be well understood to the present invention by specific embodiments of the invention given below, but they not the qualifications to invention.
Embodiment 1:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of: glycyrrhizin 150g, carboxymethyl starch sodium 21g, low-substituted hydroxypropyl cellulose 21g, microcrystalline Cellulose 209g, aspartame 2,10% polyvinylpyrrolidone-K30 is an amount of, and magnesium stearate 2g makes 1000 altogether.
Supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, the aspartame mix homogeneously of formula ratio; Make soft material with 10% polyvinylpyrrolidone-K30,24 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, mixing, and tabletting promptly gets dispersible tablet of glycyrrhizin of the present invention, and every contains glycyrrhizin 150mg, the heavy 405mg of theoretical sheet.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 2:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of: glycyrrhizin 75g, and lactose 35g, microcrystalline Cellulose 80g, mannitol 23g, starch 12g, 95% ethanol is an amount of, and magnesium stearate 1g makes 1000 altogether.
Supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, the lactose of formula ratio, mannitol and crospolyvinylpyrrolidone, mix homogeneously; Ethanol system soft material with 95%, 24 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, and mixing with 9mm drift tabletting, promptly gets dispersible tablet of glycyrrhizin of the present invention, and every contains glycyrrhizin 75mg, the heavy 226mg of theoretical sheet.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 3:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of: glycyrrhizin 150g, and lactose 60g, microcrystalline Cellulose 50g, low-substituted hydroxypropyl cellulose 9g, crospolyvinylpyrrolidone 10g, 50% ethanol is an amount of, and magnesium stearate 1g makes 1000 altogether.Supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, the lactose of formula ratio, microcrystalline Cellulose, low-substituted hydroxypropyl cellulose and crospolyvinylpyrrolidone, mix homogeneously; Ethanol system soft material with 50%, 30 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, and mixing with 9mm drift tabletting, promptly gets dispersible tablet of glycyrrhizin of the present invention, and every contains glycyrrhizin 150mg, the heavy 280mg of theoretical sheet.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 4:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of: glycyrrhizin 150g, and lactose 40g, microcrystalline Cellulose 80g stands and collapses 17g, and 95% ethanol is an amount of, and magnesium stearate 3g makes 1000 altogether.
Supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, the lactose of formula ratio, mannitol and crospolyvinylpyrrolidone, mix homogeneously; Ethanol system soft material with 95%, 24 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, mixing, and tabletting promptly gets dispersible tablet of glycyrrhizin of the present invention, and every contains glycyrrhizin 150mg, the heavy 290mg of theoretical sheet.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 5:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of: glycyrrhizin 75g, and lactose 50g, mannitol 50g, crospolyvinylpyrrolidone 15g, 95% ethanol is an amount of, and magnesium stearate 1g makes 1000 altogether.
Supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, the lactose of formula ratio, mannitol and crospolyvinylpyrrolidone, mix homogeneously; Ethanol system soft material with 95%, 24 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, and mixing with 8mm drift tabletting, promptly gets dispersible tablet of glycyrrhizin of the present invention, and every contains glycyrrhizin 75mg, the heavy 191mg of theoretical sheet.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min
Embodiment 6:
By 1000 calculating that feed intake of preparation, the weight of raw material consists of: glycyrrhizin 75g, and lactose 60g, low-substituted hydroxypropyl cellulose 9g, crospolyvinylpyrrolidone 10g, microcrystalline Cellulose 69g, 95% ethanol is an amount of, and magnesium stearate 3g makes 1000 altogether.
Supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, the lactose of formula ratio, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, microcrystalline Cellulose mix homogeneously; Ethanol system soft material with 95%, 24 mesh sieves are granulated, and wet grain is in 50～60 ℃ of dryings; 24 mesh sieve granulate add magnesium stearate, mixing, and tabletting promptly gets dispersible tablet of glycyrrhizin of the present invention, and every contains glycyrrhizin 75mg, the heavy 226mg of theoretical sheet.
Dispersing uniformity: get 2 of dispersible tablets, put jolting in the 100ml water, in 20 ± 1 ℃ of water, disintegrate also can be by No. 2 sieves (2000 editions two appendix IA of Chinese Pharmacopoeia) fully in 3min.
Claims (11)
1, a kind of dispersible tablet of glycyrrhizin is characterized in that: the main weight ratio of components of its prescription is: glycyrrhizin 25～300, filler 15～350, disintegrating agent 15～250, lubricant 1～10.
2, the described dispersible tablet of glycyrrhizin of claim 1 is characterized in that described glycyrrhizin content is every 25～300 milligrams, and preferred every specification is for containing glycyrrhizin 75mg or 150mg.
3, the described dispersible tablet of glycyrrhizin of claim 1 is characterized in that: wherein disintegrating agent be carboxymethyl starch sodium, polyvinylpolypyrrolidone, uprightly collapse, a kind of in the super carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose or their various combinations.
4, the described dispersible tablet of glycyrrhizin of claim 1 is characterized in that: wherein filler is a kind of in lactose, microcrystalline Cellulose, starch, dextrin, the mannitol or their various combinations.
5, the described dispersible tablet of glycyrrhizin of claim 1 is characterized in that: wherein lubricant is selected from a kind of in magnesium stearate, Pulvis Talci, Stepanol MG, sodium lauryl sulphate, the differential silica gel or their various combinations.
6, the described dispersible tablet of glycyrrhizin of claim 1 is characterized in that: also contain wetting agent or binding agent is an amount of, wetting agent or binding agent are water, 10～95% ethanol, a kind of among 10% polyvinylpyrrolidone-K30.
7, the described dispersible tablet of glycyrrhizin of claim 1, it is characterized in that: the weight ratio of components of dispersible tablet prescription is: glycyrrhizin 25～300, carboxymethyl starch sodium 2～100, low-substituted hydroxypropyl cellulose 2～100, microcrystalline Cellulose 20～300, aspartame 2～40, binding agent is an amount of, magnesium stearate 1～10.
8, the described dispersible tablet of glycyrrhizin of claim 1 is characterized in that: the weight ratio of components of dispersible tablet prescription is: glycyrrhizin 25～200, lactose 50～250, low-substituted hydroxypropyl cellulose 5～50, crospolyvinylpyrrolidone 5～50, microcrystalline Cellulose 25～200, magnesium stearate 1～8.
9, dispersible tablet of glycyrrhizin according to claim 7, it is characterized in that: the weight ratio of components of dispersible tablet prescription is: glycyrrhizin 150, carboxymethyl starch sodium 21, low-substituted hydroxypropyl cellulose 21, microcrystalline Cellulose 209, aspartame 2,10% polyvinylpyrrolidones-K30, magnesium stearate 2.
10, dispersible tablet of glycyrrhizin according to claim 8 is characterized in that: the weight ratio of components of dispersible tablet prescription is: glycyrrhizin 75, lactose 60, low-substituted hydroxypropyl cellulose 9, crospolyvinylpyrrolidone 10, microcrystalline Cellulose 69,95% ethanol is an amount of, magnesium stearate 3.
11, a kind of as claim 1, the preparation method of 7～10 described dispersible tablet of glycyrrhizin is characterized in that: adopt the step preparation of following order:
(1) supplementary material is crossed 100 mesh sieves respectively, get glycyrrhizin, disintegrating agent, filler, the mix homogeneously of formula ratio;
(2) with binding agent system soft material, 18～24 mesh sieves are granulated, and wet granular is in 50～80 ℃ of dryings;
(3) 18～24 mesh sieve granulate add lubricant, and compacting gets dispersible tablet of glycyrrhizin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200510078743 CN1879641A (en) | 2005-06-18 | 2005-06-18 | Dispersible tablet of glycyrrhizin and preparation method thereof |
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| CN 200510078743 CN1879641A (en) | 2005-06-18 | 2005-06-18 | Dispersible tablet of glycyrrhizin and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009070917A1 (en) * | 2007-11-30 | 2009-06-11 | Chi, Yu-Fen | An oral pharmaceutical composition for treating barythymia |
| CN101347495B (en) * | 2007-07-16 | 2011-11-23 | 兰州大学 | Preparation of Glabridin dispersible tablets and use of the tablets in reducing blood sugar as medicament active composition |
-
2005
- 2005-06-18 CN CN 200510078743 patent/CN1879641A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101347495B (en) * | 2007-07-16 | 2011-11-23 | 兰州大学 | Preparation of Glabridin dispersible tablets and use of the tablets in reducing blood sugar as medicament active composition |
| WO2009070917A1 (en) * | 2007-11-30 | 2009-06-11 | Chi, Yu-Fen | An oral pharmaceutical composition for treating barythymia |
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