速效心痛滴丸微生物限度检查方法学验证

Validation of Method of Microbial Limit Test of Quick-acting Xintong Dropping Pill

目的:建立速效心痛滴丸微生物限度检查法。方法:以3株细菌、2株真菌对速效心痛滴丸进行了微生物限度检查方法的验证试验。结果:试验组金黄色葡萄球菌、大肠埃希菌、枯草芽孢杆菌采用薄膜过滤法(冲洗量300mL)回收率为86%以上;白色念珠菌、黑曲霉菌采用常规法回收率为75%以上;控制菌检查试验组采用500mL以上增菌培养基,可检出大肠埃希菌。结论:经验证速效心痛滴丸采用薄膜过滤法检查细菌,常规法检查霉菌、酵母菌,培养基稀释法检查控制菌。

Objective：To establish a method for microbial limit test of Quick -acting Xintong Dropping Pill. Methods： Validation of microbial limit tests of Quick - acting Xintong Dropping Pill with 3 strains of bacterium and 2 strains of fungus. Results：The recoveries were over 86% when the membrane filtration method was used with Staphylococcus aureus, Escbefichia coli ,Bacillus subtilis. The recoveries were over 75% when routine test method was used with Candida albieavs, Asper^llus niger. Eschefichia coli can be tested while more than 500mL increasing bacteria be culture was used. Conclusion： With membrane filtration method ,the anlount of bacteria and controlled in Quick -acting Xintong Dropping Pill ,with conven- tional method,molds and soccharmyces can be determined,also with diluted culcure method,eontrolcd bacteria can be deter- mined.