复方利多卡因注射液细菌内毒素检测的初步探讨  

Preliminary study on the bacterial endotoxin test for compound lidocaine injection

作　　者：谢冬梅[1] 张大萍[1] 

机构地区：[1]蚌埠医学院附属医院药剂科,安徽蚌埠233004

出　　处：《蚌埠医学院学报》2005年第4期349-350,共2页Journal of Bengbu Medical College

摘　　要：目的:建立复方利多卡因注射液的细菌内毒素检查法。方法:按《中国药典》2000年版(二部)附录收载的细菌内毒素检查方法及指导原则进行实验。结果:复方利多卡因注射液对鲎试剂的凝集反应无干扰作用,用灵敏度0.5EU/ml的鲎试剂检查细菌内毒素的方法可行有效。结论:可以用细菌内毒素检查法来控制复方利多卡因注射液的质量。Objective:To establish a bacterial endotoxin test for monitoring pyrogens in compound lidocaine injection.Methods:The bacterial endotoxin test procedure and guiding principle in Chinese Pharmacopoeia were used.Results:The test using limulus agent with a sensitivity of 0.5 Eu/m showed that the reaction was not interfered by compound lidocaine injection.Conclusions:Limulus bysate method can be used to monitor the pyrogens in compound lidocaine injection.

关 键 词：药物质量检验 复方利多卡因注射液 细菌内毒素检查法 致热原/分析 

分 类 号：R927.11[医药卫生—药学]