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

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.