注射用左卡尼汀细菌内毒素检查方法的研究

Methodological study on the detection of bacterial entoxin in levocarnitine for injection

目的建立注射用左卡尼汀细菌内毒素的检查方法。方法按《中国药典》2005年版二部附录进行。结果选用灵敏度为0.25EU·ml-1的鲎试剂,本品在5mg·ml-1以下浓度不干扰内毒素实验。结论用本法检查注射用左卡尼汀中的细菌内毒素可行。

Objective To establish a method for detection of bacterial endotoxin in levocarnitine for injection. Methods The detection was carried out according to the principle in Chinese Pharmacopeia 2005 edition,second volume. Results When the tachypleus amebocyte lysate＇s sensitivity（λ） was 0.25EU ·ml^-1 and the concentration was 5mg·ml^-1 ,the bacterial endotoxin test was not interfered at a concentration of lower than 5mg·ml^-1. Conclusion The method is practical for test of the bacterial endotoxin of levocarnitine for injection.