重组猪α干扰素急性毒性研究

摘要

[目的] 研究小白鼠体内重组猪α干扰素急性毒性反应,为临床安全用药提供依据.[方法] 依据急性毒性实验原则,将小白鼠分为2大组:腹腔注射组和肌肉注射组,每组又分高、中、低3个剂量组,同时设正常对照组.给药后14 d内连续观察小鼠行为活动等指标和毒性反应程度,取血作血液学检查和生化检查,以获得重组猪α干扰素初步毒性资料,并在实验结束时处死小白鼠进行剖检.[结果] 各组小鼠外部表现及行为特征均正常,体温和体重的变化也在正常范围之内,内脏病理解剖无器官病变情况,血液、生化指标与正常对照组无明显差异.[结论] 该实验设定的猪α干扰素最高剂量(5.0×10~5 IU/只)及其以下剂量,均对小白鼠无明显毒性作用,在临床上应用重组猪α干扰素是安全的.%[Objective] To observe the acute toxicity of recombinant porcine IFN-α in mice and thus provide a basis for the clinical safety. [Method] According to the principles of acute toxicity, all the mice were divided into two major groups (intraperitoneally injected group and intramuscularly injected group) respectively at high dose, moderate dose and low dose. And the normal control group was also set up. Within 14 d after administration, the behavior of mouse and the degree of toxicity were continuously observed. The hematological indexes and biochemical indexes of blood were detected to obtain the preliminary toxicity data of the recombinant porcine IFN-α. And at the end of the experiment, mice were sacrificed for autopsy. [Result] There was not significant difference in external performance, behavioral characteristics, body temperature, weight, pathological anatomy of visceral organs, hematological indexes and biochemical indexes between the experimental groups and the control group. [Conclusion] The highest dose of porcine interferon-α (5.0×10~5 IU per mouse) in this experiment or the dose lower than this dosage should not have significant toxic effects on mice, and the recombinant porcine IFN-α is safe in clinical application.