射干合剂2015年版《中华人民共和国药典》微生物检查方法适用性研究  

Study on Applicability of Microbiological Examination Methods for Shegan Mixture in Chinese Pharmacopoeia 2015

作　　者：田怀平[1] 王玲[1] 杜毅[1] 唐跃年[1] TIAN Huai-ping;WANG Ling;DU Yi;TANG Yue-nian(Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai 200092, China)

机构地区：[1]上海交通大学医学院附属新华医院,上海200092

出　　处：《中国中医药信息杂志》2017年第10期72-75,共4页Chinese Journal of Information on Traditional Chinese Medicine

基　　金：上海市卫生局中医药科研基金(2012G003A)

摘　　要：目的建立符合2015年版《中华人民共和国药典》(以下简称《中国药典》)要求的射干合剂的微生物限度检查方法。方法采用2015年版《中国药典》方法对射干合剂进行微生物限度检查方法学验证。薄膜过滤法进行样品前处理,使用6种菌株分别进行微生物计数检查和限度菌检查的方法适用性研究。结果微生物计数检查的5种菌株的回收比值均在0.5~2之间,控制菌检查的大肠埃希菌检出合格。结论射干合剂的微生物限度检查方法经验证符合2015年版《中国药典》要求。Objective To standardize the method of microbiological examination on Shegan Mixture in Chinese Pharmacopoeia2015.Methods Chinese Pharmacopoeia2015was used.Microbial enumeration test and specified microorganisms test were used to verify Shegan Mixture.The samples were treated by membrane filtration.Six kinds of strains for microbiological counting and limiting bacteria were used to study applicability.Results Microbial counts of the five strains of the recovery ratio were between0.5to2,and Escherichia coli tested by control bacteria was qualified.Conclusion The microbiological examination methods for Shegan Mixture can meet the requirements of Chinese Pharmacopoeia2015.

关 键 词：射干合剂 微生物计数检查 限度菌检查 薄膜过滤法 中华人民共和国药典 

分 类 号：R927.1[医药卫生—药学]