摘要
建立盐酸纳洛酮原料药细菌内毒素的检查方法。采用凝胶法对盐酸纳洛酮进行方法学验证,用2个厂家的鲎试剂,对样品进行凝胶法干扰试验和内毒素检查。结果显示,盐酸纳洛酮原料药可用于细菌内毒素检查,限值定为“每1 mg盐酸纳洛酮中含内毒素的量应小于5.0 EU”。鲎试剂凝胶法可用于盐酸纳洛酮原料药细菌内毒素检查。
To establish a method for bacterial endotoxin test of naloxone hydrochloride active pharmaceutical in gredients(API).The method of naloxone hydrochloride was verified by gel method.The interference test and bacterial endotoxins test of batch samples were tested and the results were judged.The results showed that the limit value of bacterial endotoxins was set as‘No more than 5.0 Endotoxin Unit/mg of naloxone hydrochloride.The established method(gel-clot method)can be used for bacterial endotoxin test of naloxone hydrochloride API.
作者
王新宇
刘振华
卢海霞
张昦昉
赵丹宁
WANG Xinyu;LIU Zhenhua;LU Haixia;ZHANG Haofang;ZHAO Danning(Jilin Institute for Drug Control,Changchun Jilin,130033,China;Department of Cardiovascular Medicine,The Third Affiliated Hospital of Changchun University of Chinese Medicine)
出处
《质量安全与检验检测》
2025年第6期88-90,共3页
QUALITY SAFETY INSPECTION AND TESTING
关键词
盐酸纳洛酮
内毒素
干扰试验
凝胶法
Naloxone hydrochloride
Endotoxins
Interference test
Gel method
