克拉霉素胶囊微生物限度检查方法的验证

Validation Method for Microbial Limit Tests of Clarithromycin Capsules

目的:建立克拉霉素胶囊的微生物限度检查法。方法:采用5种阳性对照菌回收率试验测定其抑菌作用的消除。结果:根据回收率试验结果,必须采用离心集菌法及薄膜过滤法才能彻底消除其抑菌作用。结论:用离心集菌薄膜过滤法进行微生物限度检查,方法准确、可靠。

Objective： To establish the method for Clarithromycin capsules microbial limit tests. Methods： To eliminate the antimicrobial effect of Clarithromycin capsules by recovery rate with 5 control tests Results： According to the results, centrifugation and membrane filtration must be used to completely eliminate the antimicrobial effect. Conclusion： The centrifugation and membrane filtration method should be suggested for clarithromycin capsules, and the method is reliable and accurate.