猪胆粉微生物限度检查方法学验证

目的:建立猪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猪胆粉进行微生物限度检查。结果:用pH7.0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(1:10供试液,0.1ml/皿)进行细菌计数;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法。

Validation on Microbial Limit Test Method of Porcine Gall Powder

Objective:To set up the microbial limit test ways for Porcine 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 Porcine gall powder.Results: Sodium chloride-peptone aseptic buffer solution(pH=7.0)was used to prepare the test sample.Culture media dilution(1:10 sample solution,0.1ml/dish)was used to count the porcine gall powder bacteria.1:10 selected liquid was adopted to do the mildew and yeast count and control bacteria inspection by the conventional method.Concluslon: This method can eliminate the antimicrobial properties and it can be used for microbial limit test for porcine gall powder。