阿加曲班原料药细菌内毒素检查法的建立  

Establishment of argatroban bacterial endotoxin test

作　　者：王欣[1] 周继春[1] 李展[1] 张广伟[1] 

机构地区：[1]河南省食品药品检验所,郑州450008

出　　处：《临床医学》2017年第10期91-92,共2页Clinical Medicine

摘　　要：目的按《中国药典》2010年版二部附录ⅪE细菌内毒素检查法,对不同批号原料药进行预试验、干扰试验和细菌内毒素检查。供试品配制为0.062 5 mg/ml时可排除对鲎试剂(TAL)与细菌内毒素的凝集反应的干扰,其内毒素限值定为5.0 EU/mg。采用细菌内毒素检查法可对阿加曲班原料药进行质量控制。According to Ch P.2010 edition VolⅡAppedix ⅪE,the preliminary test,the interference test and bacterial endotoxin test on different batches of samples were carried out.When argatroban solution was diluted to 0.062 5 mg/ml and below it,the interference of the agglutination between the TAL and bacterial endotoxin can be eliminated,and test can not be interfered,and the limitation value of bacterial endotoxin was set as 5.0 EU/mg.The bacterial endotoxin test can be used to control the quality the raw material of argatroban.

关 键 词：阿加曲班 细菌内毒素 干扰试验 

分 类 号：R927.1[医药卫生—药学]