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夏荔芪胶囊微生物限度检查方法研究
引用本文:何丽娟,马桂云,郭金芝,等.夏荔芪胶囊微生物限度检查方法研究[J].中国中医药现代远程教育,2014(1):154-155.
作者姓名:何丽娟  马桂云  郭金芝
作者单位:石家庄以岭药业股份有限公司,石家庄050035
摘    要:目的 为了消除夏荔芪胶囊在微生物限度检查中药用成分的抑菌作用,建立其适宜的微生物限度检查方法.方法 本试验采用平皿法和培养基稀释法对该品种进行微生物限度检查方法验证,通过三次独立平行试验,各试验菌的回收率均可达到70%以上.结论 采用平皿法、培养基稀释法联用检查细菌数,霉菌及酵母菌数,可客观地反映该药物中微生物的污染状况,且可操作性强.

关 键 词:夏荔芪胶囊  微生物限度检查  平皿法  培养基稀释法  回收率

Research on Microbial Limit Test for Xialiqi Capsule
He Lijuan Ma Guiyun Guo Jinzhi Liu Wenbo ren Xiaoming.Research on Microbial Limit Test for Xialiqi Capsule[J].Chinese Medicine Modern Distance Education of China,2014(1):154-155.
Authors:He Lijuan Ma Guiyun Guo Jinzhi Liu Wenbo ren Xiaoming
Institution:He Lijuan Ma Guiyun Guo Jinzhi Liu Wenbo ren Xiaoming (shzjmzhuang Yiling Pharmaceutical Co. ,L td ,Shijulzhuang, Hebei Province,050035,China)
Abstract:Objeetive To develop an appropriate protocol to remove the antirnicrobial activity of Xialiqi Capsule and establish a suitable method for the microbial enumeration testing. Methods A combination of the plating procedure and media dilution method was used to do the validation. In the three independent parallel tests, the mean counts of each of the test organisms were all not less than 70 %. Colusion The combination of the plating procedure and media dilution method was verified to be an appropriate method for microbial enumeration testing. The validated method is easily operational, and can reflect the microbial contamination condition objectively.
Keywords:Xiatiqi Capsule  Microbial limit test  Plating procedure  Media dilution method  Recovery rate
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