采用鲎试剂与细菌内毒素形成凝胶反应检查药品、生物制品和医疗器械中的致热物质,已受到世界各国的普遍重视,并日益广泛地收载于标准中,形成替代热原检查的趋势。USP、EP和JP收载细菌内毒素检查法较早,《中国药典》(2005年版),已有133个品种进行细菌内毒素检查。其中 The use of limulus reagents and bacterial endotoxins to form gel reactions to examine pyrogenic substances in pharmaceuticals, biologics and medical devices has gained the universal attention of all countries in the world and has been increasingly widely accepted in the standards to create an alternative to pyrogen testing . USP, EP and JP contained earlier bacterial endotoxin test, “Chinese Pharmacopoeia” (2005 edition), 133 species have been bacterial endotoxin test. among them