Preparation method of clotrimazole vaginal tablets

Abstract

The invention discloses a preparation method of clotrimazole vaginal tablets, and belongs to the field of pharmaceutical preparations. The method comprises the following steps: 1, preparation of an adhesive solution by wet granulation; 2, preparation of a granule coating liquid; 3, preparation and coating of lactic acid and calcium lactate granules; 4, total mixing of materials; and 5, tableting and packaging. The method separately granulates lactic acid, calcium lactate and starch, and coats granules, and can effectively isolate the direct contact between raw materials and acidic components and prevent the migration of the acidic components during the tablet placing process, thereby effectively avoiding the curative effect reduction caused by the degradation of active components, and theprepared sample has good stability. The preparation process of the invention uses common equipment, can realize industrial production, and is worthy of application and promotion.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a preparation method of clotrimazole vaginal tablets. Background technique [0002] In healthy women of reproductive age, the vagina is acidic, with a pH generally between 3.8 and 4.5. This is because the lactase secreted by Lactobacillus kescheri degrades glycogen into lactic acid, creating an acidic environment that prevents the growth of pathogenic microorganisms. Candida infection can cause vaginal flora imbalance, resulting in increased leucorrhea, burning itching, dysuria and other symptoms, which seriously interfere with the quality of life of patients. [0003] Clotrimazole vaginal tablets are used for the treatment of candida vulvovaginosis, which was first developed by Bayer and launched in Italy in 1973. In 1996, Bayer's clotrimazole vaginal tablets were imported and launched in China. In the Chinese market, there are 18 manufacturers holding production ap...

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Problems solved by technology

[0009] Chinese patent CN103830198 discloses a preparation method of clotrimazole vaginal tablets, which uses the preparation technology of multi-layer tablets, but does not pay attention to impurities and product acidity

[0010] Aiming at the problem that clotrimazole is unstable in acidic environment, the applicant of this patent researched and discovered a unique preparation method of clotrimazole vaginal tablets, which can not only meet the requirements of vaginal tablets for product acidity, but also reduce the product acidity. impurity level, and the prepared tablet after stability retention sample, the degradation impurity level is much lower than that of commercially available products

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