十全大补丸微生物限度检查方法验证  

Validation of methods in microbial limit tests for Shiquan Dabu pills

作　　者：特玉香[1] 曹艳玲 林丽英[3] 祁文娟[1] 马仕洪[1] 

机构地区：[1]中国药品生物制品检定所,北京100050 [2]新疆维吾尔自治区药品检验所,乌鲁木齐830000 [3]广东省药品检验所,广州510000

出　　处：《药物分析杂志》2008年第6期932-935,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:十全大补丸为气血双补的传统中药制剂,分析研究该品种微生物限度检查方法。方法:按中国药典2005年版的规定,对3个生产企业的5个批次十全大补丸进行了微生物限度检查方法验证。结果:十全大补丸对5株阳性代表菌株有不同程度的抑菌活性;但不同企业以及同一企业不同批次的产品抑菌活性存在差异。结论:通过方法验证实验建立本品微生物限度检查极为必要,根据方法验证实验结果建议采用薄膜过滤法进行本品的微生物限度检查。Objective：Shiquan Dabu pills was a traditional Chinese herbal pharmaceutic with double supplementation of vital energy and blood. The necessity of validation of methods in microbial limit tests for Shiquan Dabu pills was analyzed. Methods：As regulated by Chinese Pharmacopoeia 2005,the microbiological test method of Shiquan Dabu pills was validated for five batches from three manufacturers. Results：These Shiquan Dabu pills were antibacterial with different grade to five kinds of control bacteria,but some batches were non -antibacterial;different batches had different antibacterial capability even from the same manufacturer. Conclusion：Methods validation of microbiological tests for Shiquan Dabu pills was necessary.

关 键 词：十全大补丸 补剂 微生物限度检查 方法验证 

分 类 号：R917[医药卫生—药物分析学]