细菌内毒素检查新方法进展

Progress on new methods of bacterial endotoxin test

细菌内毒素检查法(鲎试验法)作为检验药品、植入医疗器械中细菌内毒素污染的一种经典方法,广泛应用于药品检验、科研工作。本文综述了该方法的最新方法重组C因子法的相关进展,并且与经典的细菌内毒素检查法、热原检查法和体外热原检查法进行了优缺点比较,并对这种方法的发展做了展望。

The bacterial endotoxin test （limulus amebocyte lysate test） is widely used in the drug inspection and scientific researches is a classical method to test contamination of endotoxins on drugs and implantable medical de- vices. The development of a latest bacterial endotoxin test method,which was indicated as the recombinant factor C method,was summarized in this article. The major differences between bacterial endotoxin test, pyrogen test and in vitro pyrogen test were compared. Moreover, the future prospect of this method was predicted as well.