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热原指能够导致机体发热的物质,热原通过刺激哺乳动物体内的免疫细胞分泌细胞因子产生内源性热原,从而引起机体发热。对其进行有效控制和检查是临床安全使用药物的重要保证。热原检测的目的主要是对外源性的热原进行总量控制,使其对机体不产生危害。目前的方法主要有家兔检查法和细菌内毒素检查法。家兔检查法的优点是能够真实反映外源性热原引起哺乳动物复杂升温反应过程;缺点是种属差异和个体差异较大,重复性差;灵敏度低,试验费用高,检测时间长。细菌内毒素检查法的优点是快速、简便、可
Pyrogen refers to a substance that causes the body to heat up. Pyrogens cause endogenous pyrogen by stimulating the secretion of cytokines by immune cells in mammals, causing fever in the body. Its effective control and inspection is an important guarantee for the safe use of drugs in clinical practice. The purpose of pyrogen testing is mainly to control the total amount of exogenous pyrogen so that it does not harm the body. The current methods are mainly rabbit test and bacterial endotoxin test. The advantage of the rabbit test method is that it can truly reflect the process of exogenous pyrogen causing complex heating reaction in mammals. The disadvantage is that there are many differences between species and individuals, and the repeatability is poor. The sensitivity is low, the testing cost is high, and the testing time is long. Bacterial endotoxins have the advantage of being quick, easy and acceptable