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革兰氏阴性菌细胞外膜中的细菌内素毒系脂多糖(LPS)一类的磷脂。细菌内毒素具有广泛的生理效应,包括致热原作用。近来普遍认为,细菌内毒素试验(BET)或鲎变形细胞溶解物(LAL)试验(简称鲎试验),是目前检测细菌内毒素最为灵敏的方法。美国食品药品管理局(FDA)的各个处已确认LAL对检测热原的灵敏性及实用性。生物制品处已为药厂制订出LAL试验标准,最近并批准一些产品符合标准要求的厂商。生物制品处及医药设计局均同意可将LAL试验代替美国药典家兔热原试验法。美国药典第20版(1980年)在“细菌内毒素试验”一章中亦将讨论LAL试验。
Bacterial endotoxins in the gram-negative bacterial outer membrane are phospholipids, such as lipopolysaccharide (LPS). Bacterial endotoxins have a wide range of physiological effects, including pyrogenic effects. It has recently been widely accepted that the bacterial endotoxin test (BET) or the 鲎 LAL test (鲎 test) is currently the most sensitive method for detecting bacterial endotoxins. Various points of the FDA have confirmed the sensitivity and usefulness of LAL for detecting pyrogens. Biological products at the pharmaceutical companies have developed LAL test standards, and recently approved a number of products meet the standards of the manufacturers. Biological Products Department and the Bureau of Pharmaceutical Design have agreed to replace the LAL test with the USP Rabbit pyrogen test. The US Pharmacopeia 20th Edition (1980) also discusses the LAL test in the chapter “Bacterial Endotoxin Tests.”