四味颗粒微生物限度检查方法学验证

Validation of Microbial Limit Test Method for Siwei Granules

目的建立四味颗粒的微生物限度检查方法。方法分别采用常规法、稀释法对四味颗粒的微生物限度检查方法学进行验证。结果取1∶50供试液,采用稀释法测定需氧菌总数,回收率比值均为0.84～1.12;采用常规法测定霉菌和酵母菌总数,回收率比值在1.05～1.08;采用常规法验证控制菌(大肠埃希杆菌),检出阳性菌,阴性对照未检出。结论可采用稀释法(1∶50)测定四味颗粒需氧菌总数,以及常规法进行霉菌和酵母菌总数及控制菌检查。

Objective To establish a microbial limit test method of Siwei Granules.Methods The microbial limit test method of Siwei Granules was validated by the routine method and dilution method.Results The total number of aerobic bacteria was determined by dilution method with 1 ∶ 50 test solution,and the recovery ratio was 0.84-1.12.The total number of mould and yeast was determined by the routine method, and the recovery ratio was 1.05-1.08.The control bacteria(Escherichia coli) were verified by the routine method,the positive bacteria were detected,but negative control was not detected.Conclusion Dilution method(1 ∶ 50) can be used to determine the total number of aerobic bacteria in Siwei Granules.The routine method can be used to examine the total number of mould and yeast,as well as the control bacteria.