EP8.0细菌内毒素检查法中英文对照.doc

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 glassware and other heat-stable apparatus in a hot-air oven using a validated process. A commonly used minimum time and temperature is 30 minutes at 25?C. If employing plastic apparatus, such as microtitre plates and pipette tips for automatic pipetters, use apparatus shown to be free of detectable endotoxin and which does not interfere in the test. 所有的玻璃器皿及由其他耐热材料制成的器皿需用已验证的工艺在热烘箱内进行去热原处理。去热原时，常用的最小时间和温度设置分别为30分钟和250℃。若使用塑料器械，如微孔板和微量进样器配套的吸头等，它们必须标明无内毒素并确对试验无干扰。 NOTE: in this chapter, the term ‘tube’ i