10种中药制剂微生物限度检查方法学的验证

目的:建立10种中药制剂的微生物限度检查方法.方法:按照《中国药典》2010年版的规定,对10种中药制剂进行微生物限度检查方法的验证.结果:接供试品制备方法,各试验菌样品的回收率均达到70％.结论:慢咽合剂、过敏性鼻炎合剂、生发乌发合剂、咽痒咳合剂可用常规法检查；调脂口服液、消斑合剂、固卫合剂、健脾平肝合剂、鼻窦炎合剂可用培养基稀释法检查；毒结清口服液可用薄膜过滤法检查.各品种控制菌检查均可用常规法检出.

Verification of Microbial Limit Test Method for 10 Kinds of Traditional Chinese Medicine Preparations

Objective:To establish microbial limit test method for 10 kinds of traditional Chinese medicine preparations.Method: According to the rules of the 2010 edition ’Chinese Pharmacopoeia’,microbial limit test method for 10 kinds of traditional Chinese medicine preparations were verified.Result: According to sample preparation method,recovery rate of each test bacteria samples was up to 70%.Conclusion: Manyan mixture,allergic rhinitis mixture,germinal UFA mixture and Yanyangke mixture could use conventional method for detecting;Tiaozhi oral liquid,Xiaoban mixture,Guwei mixture,Jianpi Pinggan mixture and nasosinusitis mixture could take culture medium dilution method for inspection;Dujieqing oral liquid could check by membrane filtration method.All varieties of control bacteria examination could be detected by conventional method.