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Bifonazole vaginal effervescent tablet and its preparation method

A technology of bifonazole and effervescent tablets is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, medical preparations containing active ingredients, etc. Large volume, easy to save, easy to use effect

Active Publication Date: 2011-12-07
济南龙华医药技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Another object of the present invention is to provide the preparation method of the bifonazole vaginal effervescent tablet, which optimizes and improves the process, overcomes the defect that the gas foaming amount of the original preparation method is not easy to control, and the quality of the obtained product is stable

Method used

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  • Bifonazole vaginal effervescent tablet and its preparation method

Examples

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Comparison scheme
Effect test

Embodiment 1

[0025] Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 200 parts of sodium bicarbonate, 60 parts of low-substituted hydroxypropyl cellulose, 70 parts of microcrystalline cellulose, 50 parts of lactose, 87 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 10 parts, tartaric acid 215 parts, magnesium stearate 8 parts.

[0026] Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 5% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 65°C until the water content is less than 1%, take them out, and use 14-mesh nylon sieve to granulate to obtain Granule A: Mix tartaric acid with the remaining low-substituted hydroxypropyl c...

Embodiment 2

[0028] Vaginal effervescent tablets are composed of: 100 parts of bifonazole, 265 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl cellulose, 100 parts of microcrystalline cellulose, 70 parts of lactose, 60 parts of sodium starch glycolate, hydroxypropyl cellulose 10 parts of methylcellulose, 275 parts of citric acid, 20 parts of polyethylene glycol.

[0029] Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, make soft material with 5% hypromellose ethanol solution, granulate with 14-mesh nylon sieve, dry the wet granules at 70°C until the water content is ≤1%, take them out, and granulate with 14-mesh nylon sieve. Granule A is obtained; tartaric acid is mixed with remaining low-substituted hydrox...

Embodiment 3

[0031] Vaginal effervescent tablets are composed of: 80 parts of bifonazole, 290 parts of sodium bicarbonate, 70 parts of low-substituted hydroxypropyl cellulose, 70 parts of microcrystalline cellulose, 60 parts of lactose, 90 parts of sodium starch glycolate, polyvinyl chloride Ketone K30 24 parts, tartaric acid 300 parts, polyethylene glycol 8 parts, sodium lauryl sulfate 2 parts.

[0032] Preparation method: crush various raw and auxiliary materials separately, pass through a 80-mesh sieve, and set aside; take the prescribed amount of bifonazole, sodium bicarbonate, partly low-substituted hydroxypropyl cellulose, microcrystalline cellulose, lactose, and carboxymethyl starch Mix the sodium evenly, use 10% povidone K30 ethanol solution to make soft material, use 14-mesh nylon sieve to granulate, dry the wet granules at 70°C until the water content is less than 1%, take them out, and use 14-mesh nylon sieve to granulate to obtain Granule A: Mix tartaric acid with the remaining...

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Abstract

The invention discloses a bifonazole vagina effervescent tablet. The tablet comprises the following components in part by weight: 80-120 parts of bifonazole, 200-400 parts of sodium bicarbonate, 60 to 120 parts of low-substitution hydroxypropylcellulose, 70 to 180 parts of microcrystalline cellulose, 50 to 100 parts of lactose, 60 to 180 parts of sodium starch glycolate, 10 to 30 parts of adhesive, 200 to 400 parts of organic acid, and 5 to 20 parts of lubricant. The invention also discloses a preparation method of the bifonazole vagina effervescent tablet. In the preparation method, production equipment of common tablets is adopted, the process is simple, and the cost is low; and the prepared vagina effervescent tablet has the advantages of large foaming volume, stable quality, as well as convenience for preservation, carriage, transportation and storage, quick disintegration, convenience for use, quick response, high bioavailability, well acceptance by patients and the like.

Description

technical field [0001] The invention relates to a vaginal effervescent tablet, in particular to an external preparation of bifonazole vaginal effervescent tablet and a preparation method thereof, belonging to the technical field of pharmaceutical synthesis and preparation. Background technique [0002] According to statistics, the incidence of gynecological diseases is more than 65%, and the incidence is younger, seriously affecting women's work and life. Candida vaginitis, also known as fungal vaginitis, is common in pregnant women, young girls, diabetic patients and those receiving a large amount of estrogen therapy. About 80% of primiparous pregnant women suffer from this disease, and patients aged 20 to 30 can account for it. 80% of the total number of patients, about 5 to 10% of patients with trichomonas infection, which is mainly caused by Candida albicans infection. The most common symptoms are excessive leucorrhea, burning and itching of the vulva and vagina, spread...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/46A61K47/12A61K31/4174A61K47/38A61P15/02A61K47/04
Inventor 马全龙刘红秦昌金高恒忠刘永霞王庆生王浩骅夏春梅宋金燕
Owner 济南龙华医药技术有限公司
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