左卡尼汀注射液细菌内毒素检查法研究

Study on Bacterial Endotoxin Test of Levocarnitine Injection

目的:对左卡尼汀注射液进行细菌内毒素检查法研究,建立其细菌内毒素检查方法。方法:采用《中国药典》2005年版二部附录XIE细菌内毒素检查法进行。结果:左卡尼汀注射液经10倍及以上稀释,即在20g·L-1以下浓度对鲎试剂与内毒素的反应无干扰。结论:左卡尼汀注射液可以建立细菌内毒素检查法。

Objective：To establish a method for the bacterial endotoxin test of Levocarnitine Injection. Method：The bacterial endotoxin test was carried out according to the method of bacterial endotoxin test in Appendix XI E of China Pharmacoppeia 2005 Edition. Result：After more than ten times of dilution,ie below the concentration of 20 g·L^ -1,the Injection was found no interference in the reaction of endotoxin with TAL. Conciusion：Bacterial endotoxin test is applicable to Levocarnitine.