健儿消食口服液微生物限度检查方法学验证

目的：建立健儿消食口服液微生物限度检查方法，并对方法进行验证。方法：采用《中国药典》2010年版一部附录ⅩⅢC微生物限度检查法对健儿消食口服液进行微生物限度检查。通过3次独立的平行试验，分别计算5种试验菌每次试验的回收率。采用观察大肠埃希菌与阴性金黄色葡萄球菌在相同环境下的培养基来验证控制菌的检查方法。结果：5种试验菌的回收率均高于70%，稀释剂对5种试验菌的回收率均高于70%，表明可以按常规法进行细菌、霉菌及酵母菌菌数的测定；控制菌检查中，试验组均可检出试验菌，阴性组均无菌生长，阴性菌对照组均无生长。结论：健儿消食口服液可按常规方法进行微生物限度检查。

Validation on Microbial Limit Test Method of Athletes Xiaoshi Oral Liquid

Objective：To set up the microbial limit test ways for Jianerxiaoshi oral liquid and verification of the method. Meth-ods：A microbial limits method of Chinese Pharmacopeia（2010 edition）part one appendixⅩⅢC was used to detected the microbial limit test method of Jianerxiaoshi oral liquid.Every trail recovery rate was calculated in three independent trails.The control bacteria checking method was valiated by observing escherichin coli and positive staphylococcus aureus under the same envirionment. Results：Five kinds of positive test bacteria recovery were higher than 70%,Diluent for 5 kinds of recovery test bacteria were higher than 70%, indicated that the conventional method can be used for the number of bacteria, mold and yeast fungus determination;In checking con-trol bacteria, the test group can be checked out bacteria, negative groups are sterile growth, negative control group had no growth. Con-cluslon：May carry on the microbial limit test of Jianerxiaoshi oral liquids inspection according to the conventional method.