摘要
目的:建立注射用复合辅酶细菌内毒素检查法。方法:按照中国药典2010年版(二部)附录ⅪE细菌内毒素检查法进行干扰试验。结果:用灵敏度λ为0.5EU/ml的鲎试剂进行实验,当注射用复合辅酶中辅酶Ⅰ的浓度为0.8μg/ml时,供试品不干扰鲎试剂与细菌内毒素的凝集反应。结论:使用鲎试剂方法检查注射用复合辅酶中细菌内毒素是可行的。
Objective：To establish a method for the detection Of bacterial endotoxins in caenzyme Complex for injection. Methods：The interfercnce test was carried out in accordance with appendix XI E,volume two,chinese pharmacopoeia 2010 edition： Results：By using tachypleus amebocyte lysates whose sensitivity was 0.5 EU/ml,tbe sample did not interfere the congregating reactivity of tachypleus amebocyte lysate with baclerial endotoxins when the concemtration of cocnzyme I was below 0.8μg/ml.Coaelusion：The method of tachypleus amebocyte lysale test is fcasibte for detecting the bacterial endotoxins in coenzyme complex for injection.
出处
《中国医药导刊》
2011年第8期1452-1453,共2页
Chinese Journal of Medicinal Guide
关键词
注射用复合辅酶
细菌内毒素
鲎试剂
Coenzyme Complex for Injection Bacterial Endotoxins
Tachypleus Amebocyte Lysate
