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目的:研究人重组γ干扰素(Hu-rIFN-7)对小鼠的急性毒性及对大鼠、狗的长期毒性.方法:小鼠肌注或静注Hu-rIFN-γ 4.4×10~9IUm~(-2)观察一周.长期毒性研究中,肌注给予临床推荐剂量1×10~6IU m~(-2)的10,50及100倍(大鼠)及5和50倍(狗),观察血液学、血液生化、尿分析、心电图和组织器官的病理变化.结果:Hu-rIFN-γ对小鼠im或iv的最大耐受剂量为4.4×109 IU m~(-2).长期毒性试验中未发现药物相关的毒性.结论:人重组γ干扰素对大鼠及狗不产生毒性反应.
AIM: To investigate the acute toxicity of HuIFN-7 in mice and its long-term toxicity to rats and dogs.Methods: The mice were intramuscularly injected with Hu-rIFN-γ 4.4 × 10 ~ 9IUm In the long-term toxicity study, 10, 50 and 100 times (rats) and 5 and 50 times (dogs) of clinical recommended dose of 1 × 10 ~ 6 IU m -2 were intramuscularly injected, The pathological changes of hematology, blood biochemistry, urinalysis, electrocardiogram and tissues and organs were observed.Results: The maximum tolerated dose of Hu-rIFN-γ to mouse im or iv was 4.4 × 109 IU m -2. No drug-related toxicity was found in the trial.Conclusion: Human recombinant interferon-gamma did not produce toxic reaction in rats and dogs.