葛根素注射液的细菌内毒素检查法

Bacterial endotoxin testing method for puerarin injection

目的建立葛根素注射液的细菌内毒素检测法。方法根据中国药典2005年版二部收载的细菌内毒素检查的要求进行实验。结果葛根素注射液稀释到2.083g·L-1浓度1→24后可消除对鲎试剂的干扰,用灵敏度为0.25EU·ml-1的鲎试剂检测内毒素是有效的,并与家兔法的结果一致。结论对葛根素注射液可用内毒素检查法替代家兔法的热原检查。

Aim To establish a testing method for bacterial endotoxin in puerarin injection. Method The experiment was made according to the request of endotoxin testing method collected in the China phamacopeia in 2005. Result The result showed that the interference factors can be excluded by diluting puerarin injection. It was effective that endotoxins were tested by amebocyte lysate agent with the sensitivity of 0.25 EU · ml^-1,and was consistent with rabbit method. Conclusion The pyrogen test for gegengsu injection by baterial endotoxin can be used instead of dometic rabbit method.