藏药二十五味鬼臼丸微生物限度检查方法验证

Validation method for microbial limits of Ershiwuwei Guijiu pills

目的建立二十五味鬼臼丸的微生物限度检查方法。方法分别采用常规法、培养基稀释法和薄膜过滤法对4种阳性菌进行回收率试验。结果根据回收率试验结果,二十五味鬼臼丸有较强的抑菌作用,必须采用薄膜过滤法才能彻底消除其抑菌作用,3种细菌的回收率均能达到70%。结论二十五味鬼臼丸微生物限度检查方法的验证表明其细菌计数应按薄膜过滤法,霉菌、酵母菌数和各控制菌均可采用常规法测定。

Objective To establish the method of microbial for Ershiwuwei Guijiu pills. Methods The recovery rate of 4 positive control germs was tested by routine method, medium diluting method and membrane filtration. Results Based on the results of the recovery rate test, the method of membrane filtration must be used to completely eliminate the antimierobial effects so that recovery rate reached up to 70% for the 3 species of bacteria. Conclusion The membrane fil- tration method is available for the bacterial count for Ershiwuwei Guijiu pills. The routine method is available for the mold number, yeast number and the control microbes test.