9个生产企业清开灵注射液细菌内毒素检查方法学研究  

Research on Bacterial Endotoxin Test of Qingkailing Injection in Nine Production Enterprises

作　　者：樊华[1] 林鹏[1] 焉媛媛[1] 孙丹[1] 王秀英[1] 

机构地区：[1]辽宁省食品药品检验所,辽宁沈阳110023

出　　处：《辽宁中医药大学学报》2014年第4期48-50,共3页Journal of Liaoning University of Traditional Chinese Medicine

摘　　要：目的:考察清开灵注射液细菌内毒素检查法可行性。方法:利用不同厂家生产的鲎试剂和不同厂家生产的清开灵注射液进行干扰试验,全面考察清开灵注射液对细菌内毒素检查的干扰作用,以确定其最大不干扰浓度。结果:18批清开灵注射液稀释至60倍,使用灵敏度为0.125?EU·mL-1?的鲎试剂进行细菌内毒素检查,12批(66.7%)供试品细菌内毒素检查符合规定;其余6批(33.3%)供试品对此法存在一定干扰因素。结论:清开灵注射液细菌内毒素检查仍需要严格的方法学验证。Objective ： To study the feasibility of bacterial endotox to test the Qingkailing Injection. Method： The interference test was conducted by using the Taehypleus Amebocyte Lysate from the different factories and Qingkailing Injection produced from the same and different factories to investigate the interference effects of Qingkailing on bacterial endotoxins tests in order to determine a maximum interference concentration. Result ： 18 batches of Qingkailing Injection were diluted to 60 times, using the sensitivily of 0.125 EU/mL Tachypleus Amebocyte Lysate on bacterial endotoxin inspection. The tests showed that the bacterial endotox ins of the twelve samples （ 66.7% ） accorded with the define, but other six samples had certain interference factor by this method. Conclusion ： The bacterial endotoxin inspection of Qingkailing Iniection still need strict methodology validation.

关 键 词：清开灵注射液 细菌内毒素 干扰试验 

分 类 号：R457.2[医药卫生—治疗学]