阿莫西林盐酸溴己新胶囊及颗粒剂微生物限度检查

目的:建立优化的微生物限度检查方法,用于检查复方制剂阿莫西林盐酸溴己新胶囊及颗粒剂中所污染的微生物.方法:以青霉素酶法与离心沉淀集菌法联用,制备供检查细菌菌数及控制菌用的供试液,而以常规供试品分散法,制备供检查霉菌与酵母菌菌数用的供试液,然后分别用平皿菌落计数法进行胶囊及颗粒剂中的细菌、霉菌与酵母菌菌数的测定,用常规增菌培养法检查控制菌.同时对所建立的检查方法进行了方法验证.结果:加入足够量的青霉素酶,能有效地灭活胶囊及颗粒剂中阿莫西林的抗细菌活性,一定程度上使该制剂的微生物限度检查方法操作简化,而且所建方法重复性好,对5种试验菌的各组回收率均达75%以上,控制菌检查方法验证各项指标均符合规定要求.结论:本法可用于含抗生素成分阿莫西林制剂的微生物限度检查.

Microbateria limit test of amoxicillin bromhexine hydrochloride capsule and granules

Objective:To establish an optimum microbateria limit test method to examine the compound preparation of amoxicillin bromhexine hydrochloride capsule and granule polluted by microbacteria. Method: Tested solution for testing the number of bacterium and specified bacteria were prepared with combination use of benzylpenicillin enzyme method and deposit centrifugal method. While the tested solution for testing the number of mildew and microzyme were prepared with general method. Assay the number of bacterium, mildew and microzyme of those capsules and granules with plate count method. Examine the specified bacteria with regular diluting culture medie method. Test method is also validated. Result: With enough benzylpenicillin enzyme, germproof ability of amoxicillin in the compound preparation can be removed effectively. The established method is shown to be simple and repeatable. Recoveries of five types of tested bacterium are all over 80% and all indexes of this method meet with regulation requirement. Conclusion: This method can be used for microbateria limit test of oral compound preparation of amoxicillin.