关于我国药品无菌试验用培养基质量的现状分析及改进建议  

Analysis on the Current Situation of the Quality of media with Sterility Test and Recommendations for Improvement

作　　者：谢文[1] 赵宏大[1] 纪绍梅[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2010年第1期67-68,共2页Chinese Pharmaceutical Affairs

摘　　要：目的讨论目前我国药品无菌试验的实际情况。方法从当前药品无菌试验及高压灭菌存在的问题分析了两者对药品安全的重要性。结果目前我国无菌试验培养基管理不适应药品行业的发展。结论应实行无菌试验培养基生产企业生产许可证制度。Objective To discuss the current situation of drug sterility test in our country.Methods From the problems of the current drug sterility testing and autoclave sterilized,analyze the importance of both for drug safety.Results At present,Chinese management of sterility test medium not suited to the pharmaceutical industry＇s development.Conclusion Sterility test medium manufacturers should be put in production license system.

关 键 词：无菌试验 高压灭菌 灵敏度试验 培养基 

分 类 号：R95[医药卫生—药学]