静注人免疫球蛋白变性后的毒性及作用机理研究

Studying the toxicity and toxic mechanism of intravenous human immunoglobulin after denaturation

目的:研究变性后静注人免疫球蛋白的毒性及致死机理。方法:用静脉注射法分别给小鼠和家兔注射不同来源的人免疫球蛋白样品,观察对2种动物的毒性作用;用硝酸和高温变性人免疫球蛋白查找毒性致死原因,并用血细胞凝集实验研究毒性致死机理。结果:2号样品和变性后的人免疫球蛋白均可通过血细胞凝集,导致心脑缺血而使动物迅速死亡;不同厂家的人免疫球蛋白热稳定性存在差异。结论:变性后的人免疫球蛋白可对动物产生致死性毒性,在日常的运输和保管过程中要注意温度的控制,避免因高温而使人免疫球蛋白药品变性。

Objective：Studying the toxicity and toxic mechanism of intravenous human immunoglobulin（IvIg） after denaturation.Method：Observing toxic effect of IvIg from different sources by intravenous injection to mice and rabbits.Screening the lethal effect of denaturated IvIg by using nitric acid and high temperature.Studying the toxic mechanism by observing hemagglutination test.Result：No.2 and denaturated IvIg samples kill animals fleetly by ischemia in heart and brain induced by hemagglutination.There is difference of heat stability between different IvIg suppliers.Conclusion：Because of denaturated IvIg could produce fatal toxic effect,we should control temperature to avoid temperature degeneration during daily transport and storage.