愈喘至圣膏微生物限度检查法验证  

Validation of Methods in Microbial Limit Tests for Yuchuan Zhisheng Gream

作　　者：王威[1] 

机构地区：[1]南京中医药大学泰州附属医院,225300

出　　处：《首都医药》2013年第18期55-56,共2页Capital Medicine

摘　　要：目的愈喘至圣膏为医院制剂,是补肺益肾的传统中药制剂,分析研究该品种微生物限度检查方法。方法按《中国药典》2010年版的规定,对3个批次愈喘至圣膏进行了微生物限度检查方法验证。结果愈喘至圣膏对5株阳性代表菌株有不同程度的抑菌活性。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 Yuchuan Zhisheng Cream from the hospital preparations was a traditional Chinese herbal pharmaceutic with double supplementation of Lungs and kidney.The necessity of validation of methods in microbial limit tests for Yuchuan Zhisheng Gream was analyzed.Methods As regulated by Chinese Pharmacopoeia 2010,the microbiological test method of Yuchuan Zhisheng Cream was validated for five batches from three manufacturers.Results These Yuchuan Zhisheng Cream were antibacterial with different grade to five kinds of control bacteria.Conclusion Methods validation of microbiological tests for Yuchuan Zhisheng Cream was necessary.

关 键 词：愈喘至圣膏 医院制剂 补剂 微生物限度检查 方法验证 

分 类 号：R972.12[医药卫生—药品]