Preparation method of clotrimazole vaginal tablets

A technology for vaginal tablets and clotrimazole, which is applied to medical preparations with non-active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, etc., can solve the problem of reducing product impurity levels, unstable clotrimazole, and unconcerned impurities and product acidity and other issues, to achieve the effect of industrialized production, migration prevention and good stability

Active Publication Date: 2019-03-29
南京泽恒医药技术开发有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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 disc

Method used

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  • Preparation method of clotrimazole vaginal tablets
  • Preparation method of clotrimazole vaginal tablets
  • Preparation method of clotrimazole vaginal tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

1000 pieces

[0031] Preparation Process:

[0032] ① Preparation of binder solution for wet granulation: Dissolve the prescribed amount of lactic acid in an aqueous solution of hypromellose.

[0033] ②Preparation of granule coating liquid: add sodium lauryl sulfate, stearic acid and Eudragit E PO in the ratio of 10:1:1.5, and then add appropriate amount of water to make Eudragit E PO with a concentration of 10%. The coating liquid is homogeneous and uniform.

[0034] ③Preparation of lactic acid and calcium lactate granules: Place the prescribed amount of calcium lactate and cornstarch in a fluidized bed and mix evenly, granulate with the binder solution in step ①, dry, and coat the granules with the coating solution in step ②. For coating, the material temperature is 25-30°C, the amount of coating liquid is 40% of the weight of the substrate, after the liquid spraying, reduce the degree of fluidization, dry at 30°C for 5 minutes, and then dry in an oven at 40°C for 2 ho...

Embodiment 5

[0059] The samples of Examples 1-4 were kept as stability samples, and the change of impurity A was determined.

[0060]

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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...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/12A61K47/32A61K31/4174A61P15/02A61P31/10A61P31/02
CPCA61K9/0034A61K9/2013A61K9/2027A61K31/4174A61P15/02A61P31/02A61P31/10
Inventor 朱亚芳单鹏程张自强
Owner 南京泽恒医药技术开发有限公司
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