摘要
目的建立依诺肝素钠原料药的细菌内毒素检查方法。方法按照《中国药典》2010年版二部,确定合理的依诺肝素钠细菌内毒素限值,并研究依诺肝素钠对细菌内毒素与鲎试剂反应的干扰情况,以确定其不干扰试验浓度。结果确定依诺肝素钠的细菌内毒素限值为0.01 EU/U,使用2个厂家生产的鲎试剂试验,本品配制成3 U/mL浓度对反应均无干扰作用。结论细菌内毒素检查法可用于依诺肝素钠细菌内毒素的检查。
Objective To establish a method of examining bacterial endotoxin for Enoxapain sodium. Methods The reasonable limit of endotoxin was determined by using Chinese Pharmacopoeia （2010 edition, 2 volume）, and study on testing for bacterial endotoxin to determine the noninterference concentration for Enoxaparin Sodium. Results The most suitable limit of bacterial endotoxin in preparation for Enoxaparin Sodium was 0.01 EU/U and the TAL of two manufacturers was used to test, and it was proved that the best noninterference concentration was 3 U/mL. Conclusion It is showed that, the method is suitable for the Enoxaparin Sodium of bacterial endotoxin test.
出处
《中国医药导报》
CAS
2014年第12期92-94,98,共4页
China Medical Herald
基金
江苏省科技成果转化专项资金项目(编号BA20 12033)
关键词
依诺肝素钠
细菌内毒素
干扰试验
Enoxaparin Sodium
Bacterial endotoxin test
Interference test
