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自从临床采用注射剂以来就要求生产无热原制剂,并对此加以相应的检查。目前各国卫生部门所确认的热原检查法系家兔体内生物学试验法,即取家兔3只,自耳静脉注入规定剂量的供试品溶液,隔一定时间测量其体温。如果体温升高度数超过一定数值就认为供试品溶液含有热原。假如体温升高度数适在某一范围内,则须用更多的动物复试。以上方法操作困难,需有经验的人员和具空调设备的房间,因而试验费用较多。同时试验
Since the clinical use of injection has been required to produce pyrogen-free preparations, and to be the appropriate inspection. At present, the pyrogen test method confirmed by the health departments in various countries is the biological test method in rabbits, that is, three rabbits are taken and the prescribed dose of the test solution is injected from the ear vein to measure the body temperature at intervals. If the temperature rise over a certain number of degrees that the test solution contains pyrogen. If the degree of temperature rise within a certain range, you must use more animal retest. The above method is difficult to operate, require experienced personnel and room with air conditioning equipment, and thus more costly test. At the same time test