细菌内毒素检查法在盐酸普鲁卡因注射液中的应用

Baterial Endotoxin Test Applied in procalne Hydrochloride Injection

目的建立盐酸普鲁卡因注射液的细菌内毒素检查法。方法根据《中国药典》2000年版二部收载的细菌内毒素检查法的要求进行实验。结果盐酸普鲁卡因注射液经2倍稀释可消除干扰因素,用标示灵敏度为0.25EU·mL-1的鲎试剂可有效检测该药细菌内毒素。结论可用鲎试验法对盐酸普鲁卡因注射液进行细菌内毒素检查,控制热原。

OBJECTIVE To establish a bacterial endotoxin test for procaine hydrochloride injection.METHODS The bacterial endotoxin test was experimented according to the requirement of the 2nd ed《China Pharmacopoeia》2000.RESULTS The interference factors could be excluded in the procaine hydrochloride diluted to two times the bacterial endotoxin conld be determined effectively by 0.25EU·mL -1 of TAL.CONCLUSION The pyrogen notoxin in procaine hydrochloride injection can be determined by LLA.