得力生注射液细菌内毒素检查法的探讨

Bacterial endotoxin test for Delisheng injection

目的建立得力生注射液细菌内毒素检查法。方法参照《中国药典》2010年版一部细菌内毒素检查法进行实验。结果得力生注射液对鲎试剂与细菌内毒素的凝聚反应无干扰作用。结论本品采用鲎试剂(凝胶法)进行细菌内毒素检查是可行的。

OBJECTIVE To establish a bacterial endotoxin test for Delisheng injection.METHODS Please refer to the method for bacteria endotoxin test in Chp（2010）Ⅰ.RESULTS Delisheng injection has no interference with the aggregation of endotoxin and TAL.CONCLUSION Bacterial endotoxin could be directly tested with TAL（gel-clotmethod）.