注射用辅酶Ⅰ的细菌内毒素检查  

Bacterial endotoxin inspection of Coenzyme Ⅰ for injection

作　　者：武玉虹 刘丽梅 姚红谊 

机构地区：[1]合肥平光制药有限公司,安徽合肥231131 [2]合肥永生制药有限公司,安徽合肥230601 [3]安徽安科生物工程(集团)股份有限公司,安徽合肥230088

出　　处：《安徽医药》2013年第6期950-952,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的探讨注射用辅酶I的细菌内毒素检查方法。方法按2010年版《中国药典(二部)》细菌内毒素检查法进行试验。结果注射用辅酶I稀释至浓度为0.25 g.L-1时可消除干扰,其细菌内毒素限值L为1.0 EU.mg-1。结论可用细菌内毒素检查法对注射用辅酶I进行细菌内毒素检查。Objective To establish the inspection method of bacterial endotoxin in Coenzyme I for injection. Methods The experiment was implemented according to the endotoxin inspection in Chinese Pharmacopoeia（ edition 2010, vol. Ⅱ）. Results Coenzyme I for injec- tion when diluted to 0.25 g · L-l had no interference on tachypleus ameboeyte lysate in detecting endotoxin,whose limit was I. 0 EU · mg-1. Conclusion The endotoxin inspection method can be used for Coenzyme I for injection.

关 键 词：注射用辅酶I 细菌内毒素 鲎试剂 

分 类 号：R927[医药卫生—药学]