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熊胆粉微生物限度检查方法学验证

     

摘要

Objective To set up the microbiai limit test ways for bear gall powder and verification of the method. Methods A microbiai limits method of Chinese Pharmacopeia (2010 edition) part one appendix X III C was used to detected the mi erobial limit test, method of bear gall powder. Results Sodium chloride-peptone aseptic buffer solution (pH-7.0) was used io prepare the test sample. Culture media dilution (1:20 sample solution, 0.1 mL/dish) was used 1.o 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 microbiai limit test for bear gall powder.%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.

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