知柏地黄丸微生物限度检查细菌计数方法验证简析

目的验证细菌计数在知柏地黄丸微生物限度中的检查,建立知柏地黄丸的微生物限度细菌检查方法。方法取样品10g,分次加入pH7．0氯化钠蛋白胨缓冲液至100mL,研混均匀,使成均匀混悬液,采用常规法用3种阳性对照菌测定进行方法验证。结果以pH7．0氯化钠蛋白胨缓冲液为稀释剂,1：10的供试品稀释剂为供试液。按照常规法进行检验,试验组、稀释剂组回收率均达70％以上,适用于本品的微生物限度中的细菌检查。结论对知柏地黄丸采用常规法进行微生物限度细菌检查,可行。

Analysis on Verification of Bacterial Colony Counting in Microbial Limit Test of Zhi Bai Di Huang Wan

Objective To verify the examination of bacterial colony counts in microbial limit test of Zhi Bai Di Huang Wan so as to establish a method of microbial limit test of Zhi Bai Di Huang Wan. Methods Pepton sodium chloride buffer pH 7.0 was added to the specimen, 10 g up to 100 mL to prepare it into e- ven suspension. The method is verified by routine determination of 3 kinds of positive control bacteria. Resuits Pepton sodium chloride buffer pH 7.0 was taken as diluter. The tested solution was the diluter 1 ： 10. The verification was done with routine method. The recycling rate was up to over 70% in trial group and diluter group, which was applicable for the bacterial colony examination in microbial limit of this product. Condusion It is feasible to apply routine method to examine the bacteria of microbial limit of Zhi Bai Di Huang Wan.