目前各国药典规定的热原检查法,均为家兔升温试验。由于放射药品中放射核素的半衰期以及射线的生物效应的影响,采用家兔法检测这类药品的热原遇到很大困难。为了控制放射药品质量,保证临床核医学使用放射药品的安全有效,卫生部药品生物制品检定所在中国科学院原子能研究所同位素生产管理部的协作下, At present, the pyrogen test method stipulated in the pharmacopoeias of all countries is a heating test for rabbits. Because of the half-life of radionuclides in radiopharmaceuticals and the biological effects of radiation, it is very difficult to detect the pyrogen of these drugs by the rabbit method. In order to control the quality of radiopharmaceuticals and ensure the safe and effective use of radiopharmaceuticals in clinical nuclear medicine, with the cooperation of the Department of Atomic Energy Research and Management, Institute of Atomic Energy, Chinese Academy of Sciences,