龙胆泻肝丸微生物限度检查方法验证

目的:建立一种龙胆泻肝丸微生物限度检查方法。方法:采用药典规定的常规法和稀释法,通过验证确认所采用的方法是否适合于*该药品的细菌、霉菌和酵母菌、控制菌的检查。结果:细菌、霉菌和酵母菌方法验证中回收率在70%以上;控制菌方法验证中阳性对照菌检出,阴性对照菌未检出。结论:龙胆泻肝丸微生物限度检查法的细菌、霉菌和酵母菌数可以采用常规法或稀释法进行检查,控制菌检查可以采用常规法检查。

Microbial limit Test Method's Validation of Longdan Xiegan Pill

Objective： Establish a microbial limit test method of Longdan Xiegan Pill.Methods： Using the conventional method and the dilution method in Chinese pharmacopoeia to select a suitable method by validating the method used to bacteria,fungus and control bacteria checks.Results： The bacteria and fungus coefficients of recovery are all above 70 percents.Bacteria were detected in positive control and not detected in negative control of control bacteria check.Conclusions： We can use the conventional method or the dilution method to check the bacteria and fungus and can use the conventional method to check the control bacteria.