CN103006590A - Dispersible tablet for chronic ulcerative colitis and preparation method thereof - Google Patents
Dispersible tablet for chronic ulcerative colitis and preparation method thereof Download PDFInfo
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- CN103006590A CN103006590A CN201110416010XA CN201110416010A CN103006590A CN 103006590 A CN103006590 A CN 103006590A CN 201110416010X A CN201110416010X A CN 201110416010XA CN 201110416010 A CN201110416010 A CN 201110416010A CN 103006590 A CN103006590 A CN 103006590A
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- ulcerative colitis
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- chronic ulcerative
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Abstract
The invention discloses a dispersible tablet for chronic ulcerative colitis and a preparation method thereof. The dispersible tablet for chronic ulcerative colitis comprises the following material components in parts by weight: 50 parts of salazosulfapyridine, 10 parts of sodium carboxymethyl starch, 13.2 parts of polyvinyl polypyrrolidone, 24 parts of microcrystalline cellulose, 0.5 part of magnesium stearate, 0.5 part of aerosol and 50 parts of alcohol. The anti-inflammatory drug for treating ulcerative colitis disclosed by the invention has the advantages of small dosage, convenience in taking, fast absorption, high bioavailability, convenience in carrying, accurate ration, stable quality and the like to the ulcerative colitis and the non-specific ulcerative colitis in comparison with other relevant products.
Description
Technical field
The invention belongs to the ethical goods technical field, particularly a kind of dispersible tablet for chronic ulcerative colitis and preparation method thereof.
Background technology
Along with the change of compatriots' dietetic variety and popularizing of fibercolonscopy, chronic ulcerative colitis (being called for short the knot of bursting) has the trend that increases in China.Routed knot is a kind of special colitis, and take ulcer as major lesions, the position is limited to mucous membrane of colon, particularly rectum.Ulcerative colitis is the not bright inflammatory bowel of a kind of cause of disease, also is one of main hazard factor of colon tumor generation, is known as special clinical difficult and complicated illness by World Health Organization (WHO).In China, because the change of living environment and dietary habit, the sickness rate of intestinal tract disease is year by year ascendant trend.Original drug dose is large, take inconvenience, absorb slow, bioavailability is low.
Summary of the invention
Purpose of the present invention aims to provide a kind of dispersible tablet for chronic ulcerative colitis and preparation method thereof, and it has the effect for the treatment of ulcerative colitis, non-specific chronic colitis.And taking dose is little, taking convenience, absorption is fast, bioavailability is high, easy to carry, quantitatively accurately, steady quality.
Technical scheme of the present invention is: design a kind of dispersible tablet for chronic ulcerative colitis, it is characterized in that material composition and weight proportion thereof that it contains are: 50 parts of sulfasalazines, 10 parts of carboxymethyl starch sodium, 13.2 parts of polyvinylpolypyrrolidone, 24 parts of microcrystalline Cellulose, 0.5 part of magnesium stearate, 0.5 part of micropowder silica gel, 50 parts of ethanol.
The preparation method of above-mentioned a kind of dispersible tablet for chronic ulcerative colitis is characterized in that it may further comprise the steps:
1) takes by weighing raw material by following weight ratio: 50 parts of sulfasalazines, 10 parts of carboxymethyl starch sodium, 13.2 parts of polyvinylpolypyrrolidone, 24 parts of microcrystalline Cellulose, 0.5 part of magnesium stearate, 0.5 part of micropowder silica gel, 50 parts of ethanol;
2) with sulfasalazine, the carboxymethyl starch sodium of half amount, the polyvinylpolypyrrolidone of half amount, the microcrystalline Cellulose mix homogeneously is with 95 ethanol soft material processed;
3) 14 mesh sieves are granulated, 50-60 ℃ of forced air drying;
4) 14 mesh sieve granulate add the residue adjuvant, mix homogeneously.
5) tabletting gets final product.
The specific embodiment
The invention will be further described below in conjunction with specific embodiment, but not as limitation of the present invention.The part that is not described in detail in the present embodiment is to adopt prior art, and industry standard or known approaches.
Embodiment
A kind of dispersible tablet for chronic ulcerative colitis and preparation method thereof adopts following steps to make:
1) takes by weighing raw material by following weight ratio: 50 parts of sulfasalazines, 10 parts of carboxymethyl starch sodium, 13.2 parts of polyvinylpolypyrrolidone, 24 parts of microcrystalline Cellulose, 0.5 part of magnesium stearate, 0.5 part of micropowder silica gel, 50 parts of ethanol;
2) with sulfasalazine, the carboxymethyl starch sodium of half amount, the polyvinylpolypyrrolidone of half amount, the microcrystalline Cellulose mix homogeneously is with 95 ethanol soft material processed;
3) 14 mesh sieves are granulated, 50-60 ℃ of forced air drying;
4) 14 mesh sieve granulate add the residue adjuvant, mix homogeneously.
5) tabletting gets final product.
The below is the embodiment of the inventionA kind of dispersible tablet for chronic ulcerative colitis (hereinafter to be referred as dispersible tablet)
Results of Animal is summed up
SSZ does not all show mutagenic action in Salmonella reversion test and L51784 mouse lymphoma cell HGPRT gene test.But in rat, Micronuclei In The Mouse Bone Marrow test and mice periphery RBC test, sister chromatid exchange test, chromosomal aberration test and human lymphocyte micronucleus test, its mutagenic action is still not clear.Genotoxicity: when the male rat dosage is 800 mg/kg/ days (4800 mg/m2), the male fertility infringement occurs, have clinically the sulfasalazine administration to cause oligospermia and sterile report, can recover voluntarily after the drug withdrawal.During rat and rabbit dosage intelligent consumption 6 times, obvious damage does not appear in jenny fertility and tire son.There is no at present the clinical research data of anemia of pregnant woman's this product administration of abundant and strict control.Carcinogenecity: carried out F344/N rat and the carcinogenecity research in 2 years of B6C3F1 its mouse oral administration.The rat dosage is respectively 84 mg/kg/ days (496 mg/m2), 168 mg/kg/ days and 337.5 mg/kg/ days, the papillomatous incidence rate of male rat bladder transitional cell raises (statistics significance) as a result, and female rats 337.5 mg/kg/ daily dose groups have 2 examples (4%) kidney transitional cell papillary tumor to occur; The increase of rat bladder and tumor of kidney incidence rate is relevant with the hypertrophy of the formation of renal calculus and transitional cell epithelium.The mice dosage is respectively 675 mg/kg/ days (2025 mg/m2), 1350 mg/kg/ days and 2700 mg/kg/ during day, and the incidence rate of female, the male mouse liver cell adenoma of each administration group, cancer is all apparently higher than matched group.
Behind the oral dispersible tablet involved in the present invention, fraction can reenter intestinal (intestinal-liver circulation) in gastrointestinal absorption by bile.Most of unabsorbed this product is 5-aminosalicylic acid and sulfapyridine by the bacterial decomposition of terminal ileum and colon, and residual fraction is discharged from feces.5-aminosalicylic acid is absorbed hardly, and major part is discharged from feces with original shape, but the former N-acetyl derivative is found in the urine.Sulfapyridine can be absorbed and drain, and can predict its acetylation metabolite in the urine.(20-40 ug/mL) is relevant with toxicity for the concentration of serum sulfapyridine and metabolite thereof.Tool toxicity therefore should reduce dosage, was avoided toxic reaction when concentration surpassed 50 ug/mL.Sulfapyridine and metabolite thereof also can come across in the breast milk.
Embodiment of the invention dispersible tablet enters intestinal and is decomposed into sulfapyridine and 5-aminosalicylic acid through intestinal bacteria, and 5-aminosalicylic acid is finally excreted by feces.Sulfapyridine can be attracted into blood, is discharged by urine at last.In blood, have the original shape and sulfapyridine of this product except finding, its acetylate and glucuronide conjugate are still arranged.Sulfapyridine and acetylate thereof can be discharged with urine.
Claims (2)
1. a dispersible tablet that is used for chronic ulcerative colitis is characterized in that material composition and weight proportion thereof that it contains are: 50 parts of sulfasalazines, 10 parts of carboxymethyl starch sodium, 13.2 parts of polyvinylpolypyrrolidone, 24 parts of microcrystalline Cellulose, 0.5 part of magnesium stearate, 0.5 part of micropowder silica gel, 50 parts of ethanol.
2. the preparation method of above-mentioned a kind of dispersible tablet for chronic ulcerative colitis is characterized in that it may further comprise the steps:
1) takes by weighing raw material by following weight ratio: 50 parts of sulfasalazines, 10 parts of carboxymethyl starch sodium, 13.2 parts of polyvinylpolypyrrolidone, 24 parts of microcrystalline Cellulose, 0.5 part of magnesium stearate, 0.5 part of micropowder silica gel, 50 parts of ethanol;
2) with sulfasalazine, the carboxymethyl starch sodium of half amount, the polyvinylpolypyrrolidone of half amount, the microcrystalline Cellulose mix homogeneously is with 95 ethanol soft material processed; 3) 14 mesh sieves are granulated, 50-60 ℃ of forced air drying; 4) 14 mesh sieve granulate add the residue adjuvant, mix homogeneously; 5) tabletting gets final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110416010XA CN103006590A (en) | 2011-12-14 | 2011-12-14 | Dispersible tablet for chronic ulcerative colitis and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201110416010XA CN103006590A (en) | 2011-12-14 | 2011-12-14 | Dispersible tablet for chronic ulcerative colitis and preparation method thereof |
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| CN103006590A true CN103006590A (en) | 2013-04-03 |
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| CN201110416010XA Pending CN103006590A (en) | 2011-12-14 | 2011-12-14 | Dispersible tablet for chronic ulcerative colitis and preparation method thereof |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1452490A (en) * | 2000-03-28 | 2003-10-29 | 纽若泰克 | Composition and method for intervening neuronal death using sulfasalazine |
| CN101564402A (en) * | 2009-04-10 | 2009-10-28 | 辽东学院 | Rehabilitation new dispersing tablet and preparation method thereof |
| CN102106838A (en) * | 2009-12-23 | 2011-06-29 | 上海信谊嘉华药业有限公司 | Sulfasalazine enteric-coated preparation and preparation method thereof |
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2011
- 2011-12-14 CN CN201110416010XA patent/CN103006590A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1452490A (en) * | 2000-03-28 | 2003-10-29 | 纽若泰克 | Composition and method for intervening neuronal death using sulfasalazine |
| CN101564402A (en) * | 2009-04-10 | 2009-10-28 | 辽东学院 | Rehabilitation new dispersing tablet and preparation method thereof |
| CN102106838A (en) * | 2009-12-23 | 2011-06-29 | 上海信谊嘉华药业有限公司 | Sulfasalazine enteric-coated preparation and preparation method thereof |
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Application publication date: 20130403 |