止痒搽剂微生物限度检查方法的验证

Study on the Microbial Limit Test of Zhiyangchaji

目的建立止痒搽剂微生物限度检查方法。方法用常规法、培养基稀释法、薄膜过滤法进行细菌、霉菌及控制菌计数方法的验证。结果采用常规法后白色念珠菌及黑霉菌的试验组及稀释剂对照组的回收率均大于70%,采用薄膜过滤法后的大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌的试验组及稀释剂对照组的回收率也可达到70%以上;采用培养基稀释法可检出金黄色葡萄球菌,采用薄膜过滤法可检出铜绿假单胞菌。结论经方法学验证,结果符合现行《中国药典》2005年版的要求。

Objective To establish a method for the determination of microbial limits in Zhiyangchaji. Methods The bacteria ,molds , yeasts and controlled bacteria were counted by the common methods ,dilution method and membrane adhering method. Results The recoveries of Candida albicans,Aspergillus niger in test group and diluted control group were above 70% when common method were used. The recoveries of Escherichiacoli, Staphylococcus aureus, Bacillus subtilis in test group and diluted control group were above 70% when membrane filtration method was used. Staphy lococcus aureus can be detected by dilution method and Pseudomonas aeruginosa can be detected by membrane filtration method. Conclusion Through t he technological validation , the result is consistent with the requirement of ChP.in force.