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清热解毒类中成药微生物限度检查方法验证
引用本文:许威,吴虹. 清热解毒类中成药微生物限度检查方法验证[J]. 安徽医药, 2012, 16(5): 605-607
作者姓名:许威  吴虹
作者单位:安徽中医学院药学院,安徽省中药研究与开发重点实验室,安徽,合肥,230031;安徽省食品药品检验所,安徽,合肥,230051;安徽中医学院药学院,安徽省中药研究与开发重点实验室,安徽,合肥,230031
摘    要:目的研究清热解毒类中成药的抑菌作用,建立其微生物限度检查方法。方法按照《中国药典》2010年版一部的微生物限度检查法进行验证实验。结果 8种清热解毒类中成药均对金黄色葡萄球菌、枯草芽孢杆菌有一定的抑菌作用,可以分别通过培养基稀释法和薄膜过滤法得以消除。结论分别建立了8种清热解毒类中成药的微生物限度检查方法,为该类药品的微生物检查提供参考。

关 键 词:清热解毒类中成药  微生物限度检查  方法验证

Validation method in microbial limit test for antipyretic and antidotal Chinese patent medicines
XU Wei , WU Hong. Validation method in microbial limit test for antipyretic and antidotal Chinese patent medicines[J]. Anhui Medical and Pharmaceutical Journal, 2012, 16(5): 605-607
Authors:XU Wei    WU Hong
Affiliation:1.Anhui College of Traditional Chinese Medicine & Anhui Key Laboratory for Research and Development of Chinese Medicine,Hefei,Anhui 230031,China;2.Anhui Institute for Food and Drug Control,Hefei,Anhui 230051,China)
Abstract:Objective To study the antimicrobial effect of antipyretic and antidotal Chinese patent medicines and to establish microbial limit test method for them.Methods According to Chinese Pharmacopoeia 2010 Edition,validation method in microbial limit test for the medicines was validated.Results Eight kinds of antipyretic and antidotal Chinese patent medicines all showed inhibition effect on Staphylococcus aureus and Bacillus subtilis.The effect could be eliminated by culture medium dilution method and filtration membrane method.Conclusion Microbial limit test methods were established for the Chinese patent medicines respectivesly.The results could give experimental evidence for the kind of Chinese patent medicines.
Keywords:Chinese patent medicine  microbial limit test  validation of method
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