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速效止泻胶囊微生物限度检查方法的验证
引用本文:乐正永,杨晓淑,朱成露.速效止泻胶囊微生物限度检查方法的验证[J].中医药导报,2011,17(10):72-73.
作者姓名:乐正永  杨晓淑  朱成露
作者单位:1. 遵义市药品检验所,贵州,遵义,563002
2. 遵义医学院第一附属医院,贵州,遵义,563002
摘    要:目的:建立速效止泻胶囊微生物限度检查法.方法:细菌计数、霉菌及酵母菌计数,按培养基稀释法进行验证;控制菌按常规法验证.结果:细菌计数、霉菌及酵母菌计数,试验菌的回收率均达70%以上;控制菌按常规法检查.结论:本方法可用于速效止泻胶囊的微生物限度检查.

关 键 词:速效止泻胶囊  微生物限度检查  方法验证  常规法  培养基稀释法

Validation of methods in microbial limits tests for Suxiao zhixie jiaonang
LE Zheng -yong,YANG Xiao-shu,ZHU Cheng-lu.Validation of methods in microbial limits tests for Suxiao zhixie jiaonang[J].GUIDING JOURNAL OF TCM,2011,17(10):72-73.
Authors:LE Zheng -yong  YANG Xiao-shu  ZHU Cheng-lu
Institution:LE Zheng-yong1,YANG Xiao-shu2,ZHU Cheng-lu1(Zunyi Institute for Drug Control,First Affiliated Hospital of Zunyi Medical College Zunyi 563000.China)
Abstract:Objective: To establish a Suxiao zhixie jiaonang Microbial Limit Tests.Methods: The bacteria count,mold and yeast count,verified by medium dilution method;control of bacteria by conventional method validation.Results: The bacterial count,mold and yeast counts,recovery of test bacteria reached more than 70%;control the conventional method for detecting bacteria.Conclusion: This method can be used for quick diarrhea capsule microbial limit test.
Keywords:Suxiao zhixie jiaonang  microbial limit test  method validation  conventional method  medium dilution method  
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