EP8.0 2.6.14 细菌内毒素 （中英文 ）2.6.14. BACTERIAL ENDOTOXINS 细菌内毒素The test for bacterial endotoxins (BET) is used to detect or quantify endotoxins from gram-negative bacteria using amoebocyte lysate from the horseshoe crab (Limulus polyphenmus or Tachypleus tridentatus). There are 3 techniques for this test: the gel-clot techniques, which is based on gel formation; the turbidimetric technique, based on the development of turbidity after cleavage of an endogenouse substrate; and the chromogenic technique, based on the development of colour after cleavage of a synthetic peptide-chromogen complex.————本法利用鲎试剂（从鲎美洲鲎或中国鲎变形细胞溶解物制备而来）检测由革兰氏阴性菌产生的细菌内毒素或对内毒素进行定量。该检查包括三种方法：一为凝胶法，系利用鲎试剂与内毒素产生凝集反应的原理；第二种为浊度法（基于内源性底物断裂后，产生的浊度变化）；最后一种为显色法（得到的肽－呈色基团复合物断裂后，检测反应混合物的色度）。The following 6 methods are described in the present chapter:这一章阐述了下面 6 种方法：Method A. Gel-clot method: limit testMethod B. Gel-clot method: quantitative test Method C. Turbidimetric kinetic methodMethod D. Chromogenic kinetic methodMethod E. Chromogenic end-point methodMethod F. Turbidimetric end-point method方法 A：凝胶法：限度试验方法 B：凝胶法：定量试验方法 C：动态浊度法方法 D：动态显色法方法 E：终点显色法方法 F：终点浊度法Proceed by any of the 6 methods for the test. In the event of doubt or dispute, the final decision is made based upon method A unless otherwise indicated in the monograph.检测时，可用 6 种方法的任一种进行试验。当测定结果可疑或有争议时，除非另有规定，以专论中的方法 A 的测定结果为准。The test is carried out in a manner that avoids endotoxin contamination.试验操作过程应防止内毒素的污染。1. APPARATUS 仪器Depyrogenate all glassware and other heat...
