人工牛黄甲硝唑胶囊微生物限度检查方法验证

Method for Microbial Limits of Artificial Galculus Bovis and Metronidazole Capsules

目的建立人工牛黄甲硝唑胶囊的微生物限度检查方法。方法通过5种阳性对照菌回收率试验,分别采用离心沉淀法+培养基稀释法和离心集菌薄膜过滤法消除其抑菌作用。结果根据回收率试验结果,必须采用离心集菌及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%。结论人工牛黄甲硝唑胶囊微生物限度检查方法的验证表明应按离心集菌薄膜过滤法对其进行微生物限度检查。

Objective To establish the methods for detecting the microbial limit of artificial galculus bovis and metronidazole capsules.Methods Centrifugal precipitation associated with medium dilution method and centrifugal membrane filtration method were applied to eliminate their bacteriostatic effect by means of the test of the recovery rate for the 5 species of the positive and control microorganisms.Results According to the results of the recovery rate test,the methods of centrifugation and membrane filtration must be used to completely eliminate the antimicrobial effects so that 70% recovery rate for the 3 species of bacteria were obtained.Conclusion The validation of the methods for detecting the microbial limit of artificial galculus bovis and metronidazole capsules shows that the examination of their microbial limit should adopt the methods of centrifugation and membrane filtration.