左归丸微生物限度检查方法的研究

Research on Microbiological Limit Test of ZuoGui Pills

摘要: 目的：通过对不同厂家同一品种的方法学验证，建立左归丸的微生物限度检查方法。方法：按照《中国药典》2015年版通则1105、1106和1107，用平皿法及常规法对左归丸进行需氧菌、霉菌及酵母菌和控制菌检查法的适用性试验。结果：有两个厂家生产的左归丸对枯草芽孢杆菌有抑菌性，采用1:50平皿法后，抑菌性消除，回收率为0.5~2.0。结论：三个厂家生产的左归丸在进行微生物限度检查时，需氧菌计数可用平皿法，霉菌及酵母菌计数和控制菌检查可采用常规法。

Abstract: Objective: To establish a microbial limit test method of ZuoGui pills through the validation of different manufacturers of the same species methodology verification. Methods: According to the general guidelines of 1105, 1106, and 1107 in Chinese Pharmacopoeia 2015, the experiments were performed by using plate method and routine method to validate the aerobic bacteria, mycete, and saccharomycetes test methods for determination of ZuoGui pills. Results: The samples from 2 manufacturers had inhibition to Bacillus subtilis, the inhibition disappeared when 1:50 plate method was used, and the recovery rate was over 50%. Conclusion: When performing microbial limit tests of the samples from 3 manufacturers, the plate method should be used for aerobic bacteria count, and the routine method can be used for mycete, saccharomycetes count and control bacteria test.