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目的 研究重组人促红细胞生成素静脉应用时在正常人的生物等效性。方法将 12名男性健康志愿者交叉分组，分别用相同单剂量静脉注射国产试验制剂 A和进口标准参比制剂 B两种重组人促红细胞生成素（ EPO） 3000 IU，用 ELISA法测定血药浓度变化情况，计算二者的生物利用度。用双单侧 t检验分析 A、 B两种制剂的生物等效性。结果A、 B两种制剂的消除半衰期分别为（ 5.31± 0.53）和（ 5.45± 0.67） h；药-时曲线下面积分别为（ 4585.06± 214.27）和（ 4638.78± 751.98） mIU· h· ml~(－1)。 结论国产试验制剂相对于进口标准参比制剂的生物利用度为 98.84％，两种 EPO为生物等效。
Objective To study the bioequivalence of recombinant human erythropoietin in healthy volunteers. Methods Twelve male healthy volunteers were divided into groups and injected with 3000 IU two kinds of recombinant human erythropoietin (EPO), respectively, in the same single dose intravenously, and the blood concentration Change, calculate the bioavailability of the two. Bilateral unilateral t-test analysis of the bioequivalence of both A and B formulations. Results The elimination half-lives of A and B preparations were (5.31 ± 0.53) and (5.45 ± 0.67) h, respectively. The areas under the drug-time curve were (4585.06 ± 214.27) and (4638.78 ± 751.98) mIU · h · ml ~ (-1). Conclusion The bioavailability of domestic test preparation relative to imported standard reference preparation is 98.84%, and the two EPO are bioequivalent.