3种药品不同加菌时机对菌回收率的影响  

Influence of the different time points to add bacteria for 3 drugs

作　　者：李珏[1] 王知坚[1] 赵嘉[1] 

机构地区：[1]浙江省食品药品检验所,杭州310004

出　　处：《药物分析杂志》2011年第6期1116-1118,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:对2005年版中国药典微生物限度检查法中,细菌、霉菌及酵母菌计数方法验证试验中不同加菌时机对菌回收率的影响进行考察,使得验证结果更加准确、可靠。方法:收集了不同剂型、不同抑菌性的样品共3个,比较了不同加菌时机与菌回收率的关系。结果:这3种药品不同加菌时机的菌回收率结果存在显著性差异,将现行标准中的加菌时机提前,可能存在回收率偏低的情况。结论:这3种药品不同加菌时机对菌回收率存在显著影响。Objectives：To examine the effects of the different time points to add bacteria on the bacteria recovery in the bacteria,mold and yeast count method validation testing,which is recorded in the Microbial Limit Tests on ChP（2005）.Methods：Collected six samples which have different formulations and different antimicrobial activities,and compared the relationship between the different time points to add bacteria and the bacteria recovery.Results：The bacteria recovery was significantly different due to the different time points to add bacteria.The recovery may reduce if to add bacteria ahead of the current standard time.Conclusions：The different time points to add bacteria have significantly influence on the bacteria recovey in the study.

关 键 词：药品 剂型 微生物限度 细菌 霉菌 酵母菌 计数 方法验证 加菌时机 回收率 

分 类 号：R917[医药卫生—药物分析学]