自十九世纪使用注射剂后,曾发现所谓注射热,引起了对导致注射热原因的注意和研究。现已确知导致致热反应的物质主要来自革兰氏阴性细菌的内毒素,经生物化学检定为一类高分子的类脂多糖。但当注射剂含有其他细菌或微生物如病毒或霉菌时,静脉注射后也能导致致热反应。热原一词主要是指内毒素而言,但也包括其他细菌或微生物所引入的致热物质在内。水是注射剂的常用溶媒,在注射用溶媒内所占比例最大,故供制备注射剂的水是否含有热原,对注射剂的安全使用有重要关系。因此,在本世纪四十年代后期,许多药典都将供制备注射剂的蒸溜水另行规定为注射用水,并严格规定注射用水除应符合蒸溜水项下规定的规格外,还应符合热原的检验标准,以便保证 Since the injection of the nineteenth century it has been found that the so-called injection heat causes concern and research into the causes of injection heat. It is now known that the material responsible for the pyrogenic reaction is mainly derived from endotoxins of Gram-negative bacteria and biochemically identified as a class of macromolecular lipopolysaccharides. However, when the injection contains other bacteria or microorganisms such as viruses or molds, pyrogenic reactions can also occur after intravenous injection. The term pyrogens refers mainly to endotoxins, but also includes pyrogenic substances introduced by other bacteria or microorganisms. Water is the common solvent for injectables and takes up the largest proportion in the solvent for injection. Therefore, the water used for the preparation of injectables contains pyrogen, which is of great importance for the safe use of injectables. Therefore, in the late 1940s, many pharmacopoeia will be provided for the preparation of injectable distilled water separately for the injection of water, and strictly regulate the injection of water in addition to the provisions of distilled water should meet the specifications, but also in line with the pyrogen test Standard, in order to guarantee