CN1557306A - Flavescent sophora root essence dispersion tablet - Google Patents
Flavescent sophora root essence dispersion tablet Download PDFInfo
- Publication number
- CN1557306A CN1557306A CNA2004100234405A CN200410023440A CN1557306A CN 1557306 A CN1557306 A CN 1557306A CN A2004100234405 A CNA2004100234405 A CN A2004100234405A CN 200410023440 A CN200410023440 A CN 200410023440A CN 1557306 A CN1557306 A CN 1557306A
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- CN
- China
- Prior art keywords
- sophora root
- dispersion tablet
- flavescent sophora
- kurarinol
- kurarinone
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Abstract
The present invention relates to kurarinol dispersing tablet, and belongs to the field of medicine technology. The kurarinol dispersing tablet consists of kurarinol 1-65 wt%, disintegrating agent 2-90 wt%, lubricant and flow assistant 0-20 wt% and adhesive 0-20 wt%. The preparation process of the kurarinol dispersing tablet includes sieving the said components, mixing kurarinol and disintegrating agent, adding adhesive to form soft material, pelletizing, stoving, finishing, mixing with disintegrating agent, lubricant and flow assistant, measuring the content of kurarinol in pellet, weighing, and tablet pressing to obtain kurarinol dispersing tablet. The medicine may be taken after being dispersed in water, chewed or swallowed, and is used clinically in treating chronic viral hepatitis B, leucopenia caused by different reasons and allergic dermatosis. The medicine has the advantages of good dispersing state, high bioavailability, etc.
Description
(1) technical field
The present invention relates to Flavescent sophora root essence dispersion tablet, belong to medical technical field.
(2) background technology
Kurarinone is an oxymatrine, is the effective ingredient that extracts from the Chinese medicine Radix Sophorae Flavescentis, because of having special oxide structure, thereby has changed the polarity of drug molecule, has also therefore had the mechanism of action and the curative effect unique than matrine.The dosage form of the domestic present listing of kurarinone has Matrine Injection, injection kurarinone, kurarinone sodium chloride or glucose injection and kurarinone capsule, kurarinone formulation is through in recent years clinical showing, it is at the treatment chronic viral hepatitis B, the leukopenia that leukocyte increasing and other reasons cause after tumour patient radiotherapy, the chemotherapy, the anaphylaxis dermatosis aspect has evident in efficacy, the characteristics that safety is good.Especially the kurarinone capsule because of its taking convenience, being easy to carry is subjected to the welcome of extensive patients.Yet the disintegration time of capsule is generally longer, generally all disintegrates in 1 hour of soft capsule, generally disintegrate in 30 minutes of hard capsule (2000 editions two appendix XA inspection techniques disintegration of the Pharmacopoeia of the People's Republic of China), in addition because the particularity of capsule shells production technology, the ubiquity catabiosis is serious, stores after 1.5 years, and its disintegration is longer, not even disintegrate, thereby because of disintegrate and the slow abundant absorption that influences medicine of stripping; Though the liquid preparation absorption is fast, need to inject, use inconvenience, and poor stability, packing, transportation, storage be inconvenience all.
(3) summary of the invention
The present invention is directed to the deficiencies in the prior art, a kind of Flavescent sophora root essence dispersion tablet and preparation method thereof is provided.
The present invention is a Flavescent sophora root essence dispersion tablet, it is characterized in that, comprises following component, all is weight percentage: kurarinone 1～65%, disintegrating agent 2～90%, lubricant and fluidizer 0～20%, binding agent 0～20%.
Above-mentioned disintegrating agent is one or more in starch, modified starch, cellulose powder, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, alginic acid, kaolin, veegum, the silica sol.Molecular weight gets final product by this area normal ranges.
Above-mentioned lubricant and fluidizer are one or more in stearic acid, magnesium stearate, zinc stearate, calcium stearate, hard paraffin, hydrogenated vegetable oil, politef, Polyethylene Glycol, sodium benzoate, sodium laurylsulfate, glyceryl monostearate, monopalmitin, spermol, silicon dioxide, micropowder silica gel, Pulvis Talci, the hydrated sodium aluminosilicate.Molecular weight gets final product by this area normal ranges.
Above-mentioned binding agent is one or more in hypromellose, starch slurry, dextrin, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, the mucialga of arabic gummy.Molecular weight gets final product by this area normal ranges.
The preparation method of Flavescent sophora root essence dispersion tablet of the present invention comprises that step is as follows:
(1) kurarinone, adjuvant are crossed 100 mesh sieves respectively, standby.
(2) take by weighing disintegrating agent by recipe quantity, add the kurarinone of recipe quantity, mix homogeneously.
(3) add binding agent and be mixed and made into soft material, granulate with the 18-24 mesh sieve, granule carries out drying under 50-80 ℃ of condition.
(4) after the granule oven dry, 20 mesh sieve granulate.
(5) add disintegrating agent, lubricant and fluidizer mixing.
(6) sample examination, the content of kurarinone in the mensuration granule determines that sheet is heavy, tabletting.
Preparation finishes, and packing promptly gets Flavescent sophora root essence dispersion tablet.
Prior art is compared, and excellent results of the present invention is as follows:
(1) Flavescent sophora root essence dispersion tablet is made up of medicine and disintegrating agent and good excipient, therefore its in 3 minutes rapidly disintegrate be uniformly dispersed, oral after disintegrate promptly become homodisperse fine particle, have good dispersing state, disintegration time is short, and the medicine stripping is rapid.
(2) absorb soon the bioavailability height.
(3) taking convenience, Flavescent sophora root essence dispersion tablet can add after the aqueous dispersion oral, also it can be contained in to chew in the mouth to contain to suck or swallow.
(4) Flavescent sophora root essence dispersion tablet has improved stability of drug, has guaranteed the quality of medicine.Sample kept sample 6 months through accelerated test 6 months and room temperature, and significant change does not all take place for its character, dispersing uniformity, content and microorganism project, met the quality standard regulation.This product shows through 6 months result of accelerated test investigation: every index is all stable.
Flavescent sophora root essence dispersion tablet by said method makes all complies with relevant regulations in the check aspect content, content uniformity, stripping, disintegration, dispersing uniformity.This product can add after the aqueous dispersion oral, also it can be contained in to chew in the mouth to contain to suck or swallow.Can be used for chronic viral hepatitis B, the leukopenia that leukocyte increasing and other reasons cause after tumour patient radiotherapy, the chemotherapy, anaphylaxis dermatosis.
(4) specific embodiment
Embodiment 1: Flavescent sophora root essence dispersion tablet, and component following (being weight ratio):
Kurarinone 43.6%
Starch 17.4%
Microcrystalline Cellulose 17.4%
Cross-linking sodium carboxymethyl cellulose 17.4%
Magnesium stearate 1.3%
Silicon dioxide 2.2%
Hypromellose 0.7%
Preparation method is as follows:
(1) earlier kurarinone, starch, microcrystalline Cellulose are crossed 100 mesh sieves respectively, standby.
(2) take by weighing starch 400g, microcrystalline Cellulose 400g, mix homogeneously by prescription.The kurarinone 1000g that adds recipe quantity, mix homogeneously adds binding agent 1% hypromellose aqueous solution 1500g system soft material, 20 mesh sieves are granulated, in 50-60 ℃ of oven dry, 20 mesh sieve granulate add cross-linking sodium carboxymethyl cellulose 400g, magnesium stearate 30g, silicon dioxide 50g mixing.
(3) sample examination granule content, according to measured granule content, it is heavy to calculate sheet, tabletting.
(4) the full review of sampling, pack after qualified finished product.
Disintegration
Whole disintegrates meet the pharmacopeia appendix dispersible tablet regulation of disintegration also by No. 2 screen clothes in 2 minutes in 37 ℃ of water.
Embodiment 2: Flavescent sophora root essence dispersion tablet, and component following (being weight ratio):
Kurarinone 36.9%
Microcrystalline Cellulose 38.9%
Cross-linking sodium carboxymethyl cellulose 29.0%
Calcium stearate 0.9%
Micropowder silica gel 2.3%
Polyvinylpyrrolidone 8.6%
Preparation method is with embodiment 1.
Disintegration
Whole disintegrates meet the pharmacopeia appendix dispersible tablet regulation of disintegration also by No. 2 screen clothes in 2 minutes in 37 ℃ of water.
Embodiment 3: Flavescent sophora root essence dispersion tablet, and component following (being weight ratio):
Kurarinone 19.2%
Starch 38.3%
Carboxymethyl starch sodium 19.2%
Low-substituted hydroxypropyl cellulose 23.0%
Hypromellose 0.3%
Preparation method is with embodiment 1.
Disintegration
Whole disintegrates meet the pharmacopeia appendix dispersible tablet regulation of disintegration also by No. 2 screen clothes in 2 minutes in 37 ℃ of water.
Claims (5)
1, the present invention is a Flavescent sophora root essence dispersion tablet, it is characterized in that, comprises following component, all is weight percentage: kurarinone 1～65%, disintegrating agent 2～90%, lubricant and fluidizer 0～20%, binding agent 0～20%.
2, Flavescent sophora root essence dispersion tablet as claimed in claim 1, it is characterized in that described disintegrating agent is one or more in starch, modified starch, cellulose powder, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, low-substituted hydroxypropyl cellulose, alginic acid, kaolin, veegum, the silica sol; Molecular weight gets final product by this area normal ranges.
3, Flavescent sophora root essence dispersion tablet as claimed in claim 1, it is characterized in that described lubricant and fluidizer are one or more in stearic acid, magnesium stearate, zinc stearate, calcium stearate, hard paraffin, hydrogenated vegetable oil, politef, Polyethylene Glycol, sodium benzoate, sodium laurylsulfate, glyceryl monostearate, monopalmitin, spermol, silicon dioxide, micropowder silica gel, Pulvis Talci, the hydrated sodium aluminosilicate; Molecular weight gets final product by this area normal ranges.
4, Flavescent sophora root essence dispersion tablet as claimed in claim 1, it is characterized in that described binding agent is one or more in hypromellose, starch slurry, dextrin, syrup, maltose, gelatine size, polyvinylpyrrolidone, Polyethylene Glycol, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, the mucialga of arabic gummy; Molecular weight gets final product by this area normal ranges.
5, the described Flavescent sophora root essence dispersion tablet preparation method of claim 1, step is as follows
(1) kurarinone, adjuvant are crossed 100 mesh sieves respectively, standby.
(2) take by weighing disintegrating agent by recipe quantity, add the kurarinone of recipe quantity, mix homogeneously.
(3) add binding agent and be mixed and made into soft material, granulate with the 18-24 mesh sieve, granule carries out drying under 50-80 ℃ of condition.
(4) after the granule oven dry, 20 mesh sieve granulate.
(5) add disintegrating agent, lubricant and fluidizer mixing.
(6) sample examination, the content of kurarinone in the mensuration granule determines that sheet is heavy, tabletting promptly gets Flavescent sophora root essence dispersion tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100234405A CN1557306A (en) | 2004-01-15 | 2004-01-15 | Flavescent sophora root essence dispersion tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2004100234405A CN1557306A (en) | 2004-01-15 | 2004-01-15 | Flavescent sophora root essence dispersion tablet |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1557306A true CN1557306A (en) | 2004-12-29 |
Family
ID=34352136
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2004100234405A Pending CN1557306A (en) | 2004-01-15 | 2004-01-15 | Flavescent sophora root essence dispersion tablet |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1557306A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102091049A (en) * | 2011-01-17 | 2011-06-15 | 广东东阳光药业有限公司 | Matrine dispersible tablet and preparation process thereof |
| CN103877046A (en) * | 2014-03-24 | 2014-06-25 | 张绪伟 | Donepezil hydrochloride dispersible tablet and preparation method thereof |
-
2004
- 2004-01-15 CN CNA2004100234405A patent/CN1557306A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102091049A (en) * | 2011-01-17 | 2011-06-15 | 广东东阳光药业有限公司 | Matrine dispersible tablet and preparation process thereof |
| CN102091049B (en) * | 2011-01-17 | 2015-12-02 | 广东东阳光药业有限公司 | A kind of matrine dispersible tablet and preparation technology thereof |
| CN103877046A (en) * | 2014-03-24 | 2014-06-25 | 张绪伟 | Donepezil hydrochloride dispersible tablet and preparation method thereof |
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| PB01 | Publication | ||
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |