熊胆粉微生物限度检查方法学验证

目的建立熊胆粉微生物限度检查方法,并对方法进行验证。方法采用《中国药典》2010年版一部附录ⅩⅢC微生物限度检查法对熊胆粉进行微生物限度检查。结果用pH 7.0的无菌氯化钠蛋白胨缓冲液制备样品,可采用培养基稀释法（1∶20供试液,0.1 mL/皿）进行细菌计数;采用培养基稀释法（400 mL营养肉汤）进行沙门菌检查;采用1∶10供试液的常规法进行霉菌及酵母菌计数和控制菌检查。结论该方法消除了样品的抑菌性,可用于该品种的微生物限度检查。

Validation on microbial limit test method of bear gall powder

Objective To set up the microbial limit test ways for bear gall powder and verification of the method.Methods A microbial limits method of Chinese Pharmacopeia(2010 edition) part one appendix ⅩⅢC was used to detected the microbial limit test method of bear gall powder.Results Sodium chloride-peptone aseptic buffer solution(pH=7.0) was used to prepare the test sample.Culture media dilution(1∶20 sample solution,0.1 mL/dish) was used to count the bear gall powder bacteria.Salmonella test method for culture media dilution method(400 mL NB) was used.1∶10 selected liquid was adopted to do the mildew and yeast count and control bacteria inspection by the conventional method.Conclusion This method can eliminate the antimicrobial properties and it can be used for the microbial limit test for bear gall powder.