人工牛黄微生物限度检查方法适用性实验

Applicability of Microbial Limits Test Method for Artificial Bovis Calculus

目的建立人工牛黄微生物限度检查方法。方法参照《中华人民共和国药典》2015年版四部通则1105,1106,1107规定,对人工牛黄微生物限度检查方法进行适用性实验。通过测试实验菌株回收率,确认所采用的微生物限度检查方法是否适用。结果人工牛黄微生物限度检查方法为加入中和剂的平皿法测定需氧菌菌数及真菌和酵母菌总数;常规法测定控制菌大肠埃希菌、乙型副伤寒沙门菌、耐胆盐革兰阴性菌。结论该实验建立了人工牛黄微生物限度检查方法。

Objective To establish a microbial limits test method for artificial Bovis Calculus. Methods Study on applicability of microbial limits test method for artificial Bovis Calculus according to the instructions in Chinese Pharmacopoeia 2015 Edition general rules 1105, 1106 and 1107 to validate the applicability of microbial limits test methods for artificial Bovis Calculus through examining the recovery rate of the microbial strains. Results Plating method by adding neutralizing agent could be used for counting bacteria, fungi and yeast.Routine method could be used for testing the control bacteria, such as Escherichia coli , bile-tolerant gram-negative bacteria and Salmonella paratyphi B. Conclusion The microbial limits test methods for artificial Bovis Calculus have been established successfully.