Slow release butoconazole nitrate directly compressed tablet and preparation method thereof

Abstract

The invention discloses a slow release butoconazole nitrate directly compressed tablet and a preparation method thereof and belongs to the technical field of medicines. The slow release butoconazole nitrate directly compressed tablet comprises a, an active component butoconazole nitrate, b, a single or compound directly compressed slow release material and c, a hydrophilic carrier material. The preparation method comprises blending the butoconazole nitrate and the hydrophilic carrier material, grinding the mixture, sieving the mixture, blending the mixture, the single or compound directly compressed slow release material, any pharmaceutically acceptable diluents and a flow aid, adding a lubricant into the mixture, carrying out mixing and direct tabletting and carrying out coating or not.

Description

technical field [0001] The invention relates to a slow-release butoconazole nitrate direct-compression tablet and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Gynecological inflammation is a common disease of women, and the incidence of vaginitis accounts for about one-third of gynecological inflammation. The reasons for the high incidence of vaginitis include: abuse of antibiotics, corticosteroids, oral contraceptives, endocrine disorders, etc. Candida vulvovaginitis is very common in women, accounting for 30-45% of vaginal diseases. Among them, vaginitis caused by Candida albicans occupies the vast majority. [0003] The treatment of candidal vulvovaginitis in my country is mainly imidazole antifungal drugs, which usually rely on the inhibition of cytochrome P45014α-demethylase to convert lanosterol to ergosterol, thereby changing the lipids of fungal cell membranes. composition. This structural change leads t...

AI Technical Summary

Problems solved by technology

We must see the defects of wet granulation: In terms of product quality, due to the complexity of the wet granulation process, the long process, and the great influence of materials and workers' operations, the reproducibility between batches is poor, and the wet and hot conditions in the wet granulation process vary. The introduction may lead to unstable product quality; in terms of energy conservation and environmental protection, due to the high energy consumption of wet granulation, high material costs and labor costs, low production efficiency, low yield, and the use of hypromellose for the purpose of slow and controlled release High-viscosity excipients such as base cellulose bring great difficulty to the cleaning of the preparation workshop

[0016] At present, there is no report of direct compression of butoconazole nitrate sustained-release preparation powder. The reason and possible technical bottlenecks are: if the active ingredient butoconazole nitrate is made into a sustained-release preparation, the main drug content is relatively high, and The fluidity of the raw material medicine is poor after crushing, and it is impossible to realize the direct compression of the powder by using the existing excipients and technical process

Images