复方地蒽酚软膏的微生物限度检查方法验证  

Validation of methodology of microbial limit test for Compound Dithranol Ointment

作　　者：杨宗学 陈丽 姚青[2] 张道利[2] 马晨[2] 

机构地区：[1]解放军82医院149临床部药械科,江苏连云港22042 [2]江苏康缘药业股份有限公司,江苏连云港222047

出　　处：《东南国防医药》2011年第4期302-304,共3页Military Medical Journal of Southeast China

基　　金：南京军区医学科技创新资助项目(09MB118)

摘　　要：目的建立一种复方地蒽酚软膏制剂的微生物限度检查方法。方法对本软膏的细菌、霉菌、酵母菌及控制菌微生物限度检查法方法进行验证,验证试验进行3次独立的平行验证试验,分别计算各试验菌每次试验的回收率。结果 平皿菌落计数法(常规法),大肠埃希菌、金黄色葡萄球菌、白色念珠菌和黑曲霉的回收率均达到70%以上;培养基稀释法,枯草芽孢杆菌的回收率达到70%以上。结论细菌数测定采用培养基稀释法;霉菌及酵母菌数测定采用常规法;控制菌检查采用常规法。Objective To establish a method of microbial limit test for Compound Dithranol Ointment.Methods Three parallel tests were carried out for testing bacteria,fungi,yeast and control bacteria.And their recoveries were investigated.Results Plate method was used for testing escherichia coli,staphylococcus aureus,candida albicans and aspergillus niger and the recovery exceeded 70%.Culture medium dilution method was used for testing bacillus subtilis and the recovery exceeded 70%.Conclusion Culture medium dilution method was adopted for bacteria count,while routine method for fungi,yeast and control bacteria count.The Validation of methodology showed the method for microbial limit was accurate,reliable and specific.

关 键 词：复方地蒽酚软膏 微生物 限度检查 验证 

分 类 号：R927.11[医药卫生—药学]