细菌内毒素检查新方法进展

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 devices. 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.

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