急支平喘软胶囊微生物限度检查的方法验证

Validation for determination method of microbacteria limit of Jizhipingchuan soft capsules

目的建立急支平喘软胶囊的微生物限度检查法。方法采用平皿法、培养基稀释法,通过5种阳性对照菌的回收率试验进行细菌、霉菌及酵母菌计数方法的验证;采用阳性菌对照与阴性菌对照的方法进行药品控制菌检查方法的验证。结果采用培养基稀释法,5种试验菌的回收率均高于70%;控制菌可用常规法检查。结论该方法可用于急支平喘软胶囊的微生物限度检查。

Objective To establish a method of microbial limit test of Jizhipingchuan soft capsule.Methods Plate counting method and culture medium diluted method were used.The method of counting bacteria and mould was validated by the recovery rates with 5 control trains.The method of checking control bacteria was validated by observing positive bacteria control and negative bacteria control.Results The recovery rate of every trial bacteria was higher than 70% when culture medium-diluting was used in the counting bacteria mould.The conventional method could be used for the examination of control bacteria.Conclusions The method can be used for the examination of microbacteria limit of Jizhipingchuan soft capsule.