麝香草酚《中国药典》2015年版微生物限度检查法方法学研究

Verification and Evaluation of Methodology on the Microbial Limit Test for Thymol by Ch P 2015

目的：建立麝香草酚《中国药典》2015年版微生物限度检查方法。方法：需氧菌总数检查为薄膜过滤法,冲洗量为800ml;霉菌和酵母菌总数检查为薄膜过滤法,冲洗液为p H 7.0无菌氯化钠-蛋白胨缓冲液,冲洗量为800 ml;大肠埃希菌检查、金黄色葡萄球菌、铜绿假单胞菌检查均为薄膜过滤法,冲洗液为p H7.0无菌氯化钠-蛋白胨缓冲液,冲洗量为800 ml。结果：在三次独立平行的试验中,5株试验菌的回收比值0.5~2.0。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。

Objective： To provide a method of microbial limit test for thymol and carry out the verification of the mothed. Mothed： Membrane filtration method was used in total aerobic microbial count and total yeast and mould count with pH 7.0 sodium chloride-peptone buffer 800 ml as flush fluid. Membrane filtration method was used for the detection of Escheriehia coli, Staphylococcus aureus and Pseudomonas aeruginosa with pH 7.0 sodium chloride-peptone buffer 800 ml as flush fluid. Results： In 3 parallel independent experiments, the recovery rate of 5 positive bacterium were 0.5-2.0. Conclusion： It can eliminate the antimicrobial properties, and it can be used for the microbial limit test for thymol.