USP30NF25_85细菌内毒素.docVIP

85 BACTERIAL ENDOTOXINS TEST细菌内毒素检查法 Portions of this general chapter have been harmonized with the corresponding texts of the European Pharmacopeia and/or the Japanese Pharmacopeia. Those portions that are not harmonized are marked with symbols () to specify this fact. 此通则的各部分已经与欧洲药典和日本药典的对应部分做了协调。那些不一致的部分用符号（）来标明。 This chapter provides a test to detect or quantify bacterial endotoxins that may be present in or on the sample of the article(s) to which the test is applied. It uses Limulus Amebocyte Lysate (LAL) obtained from the aqueous extracts of circulating amebocytes of horseshoe crab (Limulus polyphemus or Tachypleus tridentatus) which has been prepared and characterized for use as an LAL Reagent.1 此章节提供了一项检验，用于检测或量化供试样品中或其表面上可能存在的细菌内毒素。其使用从鲎（鲎或者中国鲎）的循环变形细胞的水溶性提取物中得到的鲎试剂（LAL），该试剂已经进行了配制和处理以作为鲎试剂使用。1 There are two types of techniques for this test: the gel-clot techniques, which are based on gel formation, and the photometric techniques. The latter include a turbidimetric method, which is based on the development of turbidity after cleavage of an endogenous substrate, and a chromogenic method, which is based on the development of color after cleavage of a synthetic peptide-chromogen complex. Proceed by any one of these techniques, unless otherwise indicated in the monograph. In case of dispute, the final decision is based on the gel-clot techniques, unless otherwise indicated in the monograph. 细菌内毒素检测包括两种方法，即基于凝胶的形成的凝胶法和光度测定法，后者包括基于内源酶作用物分裂后浊度发展的浊度法，和基于合成的缩氨酸-色原体联合体分裂后颜色的发展的显色基质法。当测定结果有争议时，除该各论中另有规定，最终结果应以凝胶法为准。 In the gel-clot techniques, the reaction endpoint is determined from dilutions of the material under test in direct comparison with parallel dilutions of a reference endotoxin, and quantities of endotoxin are expressed in USP Endotoxin Units (USP-EU). [NOTE—One USP-EU is equal to one IU of endotoxin.] 在凝胶法中，反应终点是通过将供试物质的稀释物与一个内毒素标准品的平行稀释物进行直接比较而确定的，并且内毒素的数量以USP内毒素单位（USP-EU）来表示。[注意：一个USP内毒素单位等于一个内毒素国际单位。] Because LAL Reagents have been formula