细菌内毒素检查方法(国际药典)20140424.docVIP

木文档下载口文库下载网,内容可能不完整，您可以点击以下网址继续阅读或下载: HYPERLINK /doc/b95a792cl68884868762d69c.html/doc/b95a792cl68884868762d69c.html 细菌内毒素检查方法（国际药典endotoxinsMet hods of An al ysis: 3. Biological methods: 3. 4 Test for bac terial endotoxins 分析方法：3.生物方法：3.4细菌内毒素的检查 This text is based on the internationally-harmonized texts developed by the Pharmacopoeia1 Discussion Group (PDG). Some editorial modifications have been made in order to be in line with the style used in The Intcrnational Pharmacopoeia. 木文是根据药典讨论组(PDG)的国际协调文件编写的。为了使其与国际药典的格式-致，对其 作了一些编辑修订。 The bactcrial endotoxins test (BET) is a test to detect or quantify endotoxins from Gram-negative bacteria using amoebocyte 1ysate from the horseshoe crab (Limulus polyphemus orTachypleus tridentatus). There are three methods for this test: 细菌内毒素检测(BET)是指用(Limulus polyphemus 或 Tachypleus tridentatus)的变形 细胞溶解物(卷试剂)来检测或量化由革兰氏阴性菌产生的内毒素。有以下三种方法： ? Method A. The gel~clot technique, which is based on gel formation; 方法A：凝胶凝结技术，此方法基丁?凝胶的形成。 ? Method B. The turbidimetric technique, based on the development of turbidity http://www. wcnkuxiazai. com/doc/b95a792cl68884868762d69c.htmlaftcr cleavage of an endogenous substrate; 方法B：浊度技术，此方法基于内源性底物分裂后所产生的浊度。 ? Method C. The chromogenic technique, based on the development of colour after cleavage of a synthetic peptide-chromogen complex. 方法c：显色技术，此方法基于合成的肽显色复合物裂解后产生的颜色。 Unless otherwise indicated in the individual monograph proceed by Method A. 除在单独的检测专著中另有规定外，采用方法A。 The test is carried out in a manner that avoids endotoxin contamination. 试验过程中应防止内毒素污染。 APPARATUS 器械 Depyrogenate al 1 glassware and other hea t stable mat erials in a hot air ove n using a validated process. A commonly used minimum time and temperature is 30 minutes at 250 ° C. If employing plastic apparatus such as microplates and pipet tips for automatic pipetters, use apparatus shown to be free of detectable endotoxin and which docs not intorfere in the test. 用 已 验 证 过 的 方 法 在 热 风 烘 http://www. wenkuxiazai. com/doc/b95a792c 16