几种乳膏剂微生物限度检查法的验证  

The Validation of the Microbial Limit Test for Creams

作　　者：陆蓓 卢涛 王峥帅 

机构地区：[1]浙江省金华市药品检验所,金华321000 [2]浙江省金华市康恩贝生物制药有限公司

出　　处：《中国药品标准》2007年第2期78-79,共2页Drug Standards of China

摘　　要：目的:建立部分乳膏剂的微生物限度检查法,并对方法进行验证。方法:取样品10g,加吐温-801ml,研混均匀,再分次加入预热至45℃的pH7.0氯化钠蛋白胨缓冲液至100ml,使成均匀混悬液。结果:此方法简便,可作为部分乳膏剂的供试液制备方法。Objective：To establish a method of the microbial limit test for creams and carry out the validation of the method. Methods：First, 1ml polysorbate-80 was added to 10g of the specimen. Then,pH 7. 0 pepton sodium chloride solution which previously has been warmed to 45 ℃ was added in them to make 100ml,finally this mixture was made to effect complete solution. Result： This method is simple and can be used as a method of preparing suspensions for creams.

关 键 词：乳膏剂 微生物限度 验证 

分 类 号：R978.7[医药卫生—药品]