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Method for preparing metronidazole, clotrimazole and chlorhexidime vaginal acetate effervescent tablet and quality control method

A quality control method and technology of effervescent tablets, applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as uneven foam size, affecting vaginal physiological pH value, and large pH fluctuations. Achieve the effect of high drug effective concentration, reduce adverse reactions, and promote disease recovery

Inactive Publication Date: 2009-04-15
DAKANG JUNBISHA XIANYANG SHAANXI PROV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there are many varieties of gynecological drugs, there are certain problems in use and treatment; in addition, the patent application number 94113652 describes a kind of Shuangzotai vaginal effervescent tablet, which is currently on the market, and has the influence of moisture absorption and gas production during storage Storage stability, unstable gas production during use, and large pH fluctuations (4.0-6.0) after disintegration, which not only affect the physiological pH value of the vagina, but also affect the effect of inhibiting and killing pathogenic bacteria, as well as uneven foam size and insufficient drug dispersion. The problem that the drug is not assayed

Method used

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  • Method for preparing metronidazole, clotrimazole and chlorhexidime vaginal acetate effervescent tablet and quality control method
  • Method for preparing metronidazole, clotrimazole and chlorhexidime vaginal acetate effervescent tablet and quality control method
  • Method for preparing metronidazole, clotrimazole and chlorhexidime vaginal acetate effervescent tablet and quality control method

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Experimental program
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Embodiment

[0025] Embodiment: (1) metronidazole 200g, clotrimazole 160g, chlorhexidine acetate 8g, starch 50.0g, calcium lactate 60g, lactic acid 82g, fumaric acid 100g, sodium bicarbonate 120g, polyethylene glycol 4000 60g, Silicon dioxide 20.0g, povidone K 30 4g, Tween-80 0.3g, magnesium stearate 4.0g to make 1000 tablets

[0026] The preparation method of this product is:

[0027] A Dissolve polyethylene glycol 4000, add sodium bicarbonate to wrap, cool, crush and pass through 80-100 mesh sieve to make alkaline component.

[0028] B Povidone K 30 Add appropriate amount of ethanol to dissolve Tween-80 to make a solution, which is used to prepare the binder of the acid component particles.

[0029] C, add the prescribed amount of metronidazole, clotrimazole, chlorhexidine acetate, starch, calcium lactate, lactic acid, and fumaric acid into the mixer and mix evenly, put it in a wet granulator, and add binder (B) to prepare Form into wet granules, dry at 50-60°C, and granulate to for...

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Abstract

The invention relates to a method for preparing a new gynecological anti-bacterial anti-inflammatory drug, namely dithiazole vaginal effervescent tablet and a method for quality control. The dithiazole vaginal effervescent tablet is used for treating gynecopathy, anorectal diseases and skin commonly-encountered diseases such as pelvic inflammatory disease, cervical erosion, vaginitis and the like caused by anaerobic bacteria, aerobic bacteria, trichomoniasis, pure or mixed fungal infections. The dithiazole vaginal effervescent tablet is characterized in that lactic acid and a calcium lactate buffer system are added to the formulation so that the pH value of the drug is between 3.5 and 4.0 similar to the vaginal physiological pH and is advantageous to remove pathogen and infusorian, provide living conditions suitable for vaginal beneficial bacterium group of lactic acid bacteria, and promote the illness rehabilitation. Besides, the dithiazole vaginal effervescent tablet uses pharmaceutical acceptable water-soluble polymer materials such as water-soluble polymer polyethylene glycol, polyvidone K30 and the like to enwrap acidic or alkaline components of an effervescent disintegrant so as to avoid the occurrence of hidden spots or even collapsing phenomenon on the surface of the tablet caused by gas production reaction resulted from small amount of water in the storage process, and uses a ethanol solution with adhesives and surface-active agents for granulation so that the hydrolysis of clotrimazole can be prevented, the infiltration of moisture is promoted in use, the uniform collapse is accelerated, and gas bubbles are homogeneous and stable.

Description

technical field [0001] The invention relates to a preparation method and a quality control method of a new gynecological antibacterial and anti-inflammatory drug Shuangzotai vaginal effervescent tablet. Background technique [0002] At present, trichomonas, anaerobes, molds and other bacterial infectious gynecological diseases seriously threaten women's health. Although there are many kinds of gynecological medicines, there are certain problems in their use and treatment; in addition, the patent application number 94113652 describes a kind of Shuangzotai vaginal effervescent tablet, which is currently on the market, and has the influence of moisture absorption and gas production during storage Storage stability, unstable gas production during use, and large pH fluctuations (4.0-6.0) after disintegration, which not only affect the physiological pH value of the vagina, but also affect the effect of inhibiting and killing pathogenic bacteria, as well as uneven foam size and ins...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/46A61K31/4164A61K31/155A61P15/02
Inventor 王世锋
Owner DAKANG JUNBISHA XIANYANG SHAANXI PROV
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