左卡尼汀注射液细菌内毒素检查方法的研究

Study on the method of bacterial endotoxin test in L-carnitine Injection

目的:建立左卡尼汀注射液细菌内毒素的检查方法。方法:按《中国药典》2005年版二部"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的左卡尼汀注射液分别进行干扰试验。结果:左卡尼汀注射液稀释至浓度5mg/ml或以下的溶液对细菌内毒素检查法无干扰作用。结论:本方法对左卡尼汀注射液进行细菌内毒素检查是可行的。

Objetive：To establish the bacterial endotoxin test method in L-carnitine Injection. Methods：According to the bacterial endotoxins test in Chinese Pharmacopoeia 2005 version （Ⅱ） appendix,different batches of L-carnitine Injection from different TAL manufacturers were underwent the interference tests. Results：There was no interference in the bacterial endotoxins test when the concentration of L-carnitine Injection was less than or equal to the detection limit 5 mg/ml. Conclusion：The method is feasible to carry out the bacterial endotoxin test for L-carnitine Injection.