微生物验证试验中枯草芽孢杆菌菌悬液制备的探讨

Research on Preparation Methods of Bacillus Subtilis Suspension in Microbial Validation Test

目的探讨采用培养7d芽孢量达到85%以上的枯草芽孢杆菌菌悬液代替培养18～24h的菌悬液作为微生物菌落计数方法验证用菌液的可行性。方法选取对枯草芽孢杆菌有抑制作用的6种药品,按《中国药典》2005年版附录微生物限度检查法的要求,采用2种菌悬液分别进行微生物验证试验,对验证结果进行比较。结果2种菌悬液对同一供试品的验证结果保持一致。结论采用培养7d的枯草芽孢杆菌菌悬液作为微生物验证用菌液是可行的且更为合理。

Objective To determine the feasibility of using Bacillus subtilis suspension cultivated for 7 days as a substitute for suspension cultivated for 18 -24h in microbial validation test. Methode： Validation tests were carried out on six samples which had inhibition effect on Bacillus subtilis by using the above two bacterial suspensions. Data were collected and compared. Results ： For the same sample, the validation results of two suspensions kept consistent. Conclusion： It proves to be feasible and more reasonable to use suspension cultivated for 7 days instead of 18 -24h in microbial validation test.