EP8.0细菌内毒素检查法中英文对照

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 test Method B. Gel-clot method: quantitative test Method C. Turbidimetric kinetic method Method D. Chromogenic kinetic method Method E. Chromogenic end-point method Method 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 glass...