EP5.1.10细菌内毒素测试使用指南(中英文11)要点解析.docVIP

EP5.1.10 细菌内毒素测试使用指南（中英文1/2）?? 2015-12-28 22:58:13|??分类：?EP 07/2016: 50110 5.1.10. GUIDELINES FOR USING THE TEST FOR BACTERIAL ENDOTOXINS 1. INTRODUCTION?概述 Endotoxins from gram-negative bacteria are the most common cause of toxic reactions resulting from contamination of pharmaceutical products with pyrogens; their common pyrogenic activity is much higher than that of other known pyrogenic substances. These endotoxins are lipopolysaccharides. Although there are a small number of pyrogens that possess a different structure, the conclusion is generally justified that the absence of bacterial endotoxins in a substance or product implies the absence of pyrogenic components, provided the presence of non-endotoxin pyrogenic substances can be ruled out. The monocyte-activation test (2.6.30) is a suitable method to use to rule out the presence of non-endotoxin pyrogens in substances or products. 革兰氏阳性菌产生的内毒素是最常见的有毒性反应原因，其原因是药品受到热源污染。其常见热源活性大大高于其它已知热源物质。这些内毒素为脂多糖。尽管有少量热源具有不同的结构，如果排除了非内毒素热源物质的存在的话，通常该原料药或制剂中不存在细菌内毒素的话就能下结论说其中不存在热源成分。单核细胞激活测试（2.6.30）是用来排除原料药或制剂中非内毒素热源存在的适当方法。 The presence of endotoxins in a substance or product may be masked by factors interfering with the reaction between the endotoxins, the test reagents and the amoebocyte lysate. Also, the ability to detect endotoxins may be affected by storage conditions or storage time. Hence, the analyst who wishes to implement a test for bacterial endotoxins or to replace the pyrogen test by a test for bacterial endotoxins has to demonstrate that a valid test can be carried out on the substance or product concerned: this may entail a procedure for removing interference. 原料药或制剂中含有的内毒素可能会被干扰因子通过与内毒素、测试用试剂和阿米巴样细胞鲎试剂的反应所掩蔽。存贮条件和存贮时间也可能影响其检出内毒素的能力。因此，期望进行细菌内毒素测试，或采用细菌内毒素测试取代热源测试的化验员必须证明对相关的原料药和制剂能进行有效的测试：可以通过消除干扰因素来使得一个测试方法有效。 As indicated in general chapter 2.6.14. Bacterial endotoxins, information must be available on the following 2 aspects before a test on a sample can be regarded as valid. 正如通论2.6.14“细菌内毒素”中所指出，在对一个样品进