盐酸索他洛尔注射液内毒素检查方法探讨

INVESTIGATION OF BET METHODS FOR SOTALOL HYDROCHLORIDE INJECTION

目的:探讨盐酸索他洛尔注射液细菌内毒素检查法的可行性。方法:根据《中国药典》2005版细菌内毒素检查法,运用干扰初筛法对供试品进行干扰试验和内毒素限量检查。结果:盐酸索他洛尔注射液对本检查法无干扰作用,用灵敏度为0.25EU/ml鲎试剂检测细菌内毒素的方法可行、有效。结论:可以用细菌内毒素检查法代替家兔法来控制盐酸索他洛尔注射液的质量。

Objective ：To establish bacteria endotoxin test for monitoring pyrogen in Sotalol Hydrochloride injection.Method：According to the pharmacopoeia of China （2005）, the disturbance experiment and limited amount test of bacterial endotoxins with taehypleus amebocyte lysate （TAL） were performed. Result： The test showed that agglutination with TAL （k=0.25 EU/ml） was not disturbed by Sotalol Hydrochloride injection. Conclusion： The bacteria endotoxin test can be used to monitor pyrogen in Sotalol Hydrochloride injection.