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人源重组蛋白类新药物因与小分子化药在生产方式、分子构成和药理作用等多方面的差异,在其临床前安全性评价研究过程中出现了一些新的问题,如相关动物种属的选择、剂量设置、试验过程中受试物免疫原性的干扰以及恰当的毒理学检测方法等。笔者综合该类新药在国内外的安全性评价研究进展和在实际工作中遇到的难点和解决方法,如重组人干扰素的相关动物选择、重组人胰岛素的剂量设定、重组人白介素1受体阻滞剂的免疫复合物检测等,对上述问题进行了初步探讨。
Due to the differences of production methods, molecular structures and pharmacological effects between small molecule drugs and other humanized recombinant protein drugs, new problems arise in the preclinical safety evaluation research, such as related animal species The choice of dose setting, the interference of the immunogenicity of the test substance during the test, and appropriate toxicological testing methods. The author synthesizes the research progress of safety evaluation of the new drugs at home and abroad and the difficulties and solutions encountered in the practical work such as the selection of relevant animal of recombinant human interferon, the dose setting of recombinant human insulin, Body blockers immune complex detection, the above issues were discussed.