复方黄连素片微生物限度检查法的建立及检验结果分析  

Establishment of microbial limit test for Fufang Huangliansu tablets and the analysis of the test results

作　　者：刘广桢[1] 胡文红[1] 徐晓洁[1] 丁勃[1] 国明[1] 

机构地区：[1]山东省食品药品检验所,济南250101

出　　处：《药物分析杂志》2014年第1期64-70,共7页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立复方黄连素片微生物限度检查法,并对26个生产企业198个批次的产品的微生物限度检查结果进行分析。方法:细菌计数采用薄膜过滤法,霉菌和酵母菌计数采用培养基稀释法,大肠埃希菌和大肠菌群检查采用直接接种法。结果:26个生产企业26个批次的产品进行方法验证,细菌、霉菌和酵母菌计数验证中各菌的回收率均大于70%,大肠埃希菌和大肠菌群检查验证中可检出验证菌,该方法可行。结论:26个生产企业198个批次的微生物限度检查结果均符合规定。Objective： To establish the method of microbial limit test of Fufang Huangliansu tablets,and analyze the test results of 198 batches from 26 manufacturers. Methods： The membrane filtration method was used for bacteria counting.The medium dilution method was used for counting total combined molds and yeasts.The direct inoculation method was used for the detection of Escherichia coli and coliform bacteria. Results： The validation of method tests of 26 batches from 26 manufacturers was conducted.The recoveries of five validation strains for the count of bacterium,total combined molds and yeasts were more than 70%.In validation of method tests on Escherichia coli and coliform bacteria,validation strains were detected. Conclusion： It is satisfactory that the results of microbial limit tests of 198 batches of Fufang Huangliansu tablets from 26 manufacturers meet test requirements.

关 键 词：复方黄连素片 微生物限度检查 方法验证 常规注皿法 培养基稀释法 薄膜过滤法 直接接种法 质量分析 

分 类 号：R917[医药卫生—药物分析学]