中国临床药学杂志

目的研究皮下注射重组人白介素-11(rhIL-11)在人体内的药动学过程。方法24名健康志愿者,男女各半,随机分成2组。rhIL-11皮下注射剂量分别为5和7.5μg·kg^-1,定时采血,用ELISA法测定不同时间血浆中rhIL-11的浓度。浓度-时间数据经3P97软件进行房室模型拟合,计算药动学参数。结果rhIL-112种剂量(5、7.5μg·kg^-1)的主要药动学参数分别为:t_max(2.25±0.53)、(3.32±0.85)h;c_max(6.42±2.57)、(9.75±3.75)μg·L^-1;T_1/2(4.03±1.24)、(4.42±1.32)h;AUC(52.68±14.06)、(102.73±36.26)μg·h·L^-1。体内过程符合一室模型。结论rhIL-11的药动学特征和参数可作为临床合理用药和制定给药方案的依据。

AIM To study the pharmacokinetics of recombinant human interleukin-11(Δ1-9.Ala¹⁰,Asn¹³⁴IL-11).METHODS Twenty-four healthy volunteers were randomly and equally divided into 2 groups. After subcutaneous injection of rhIL-11 of 5 and 7.5 μg·kg^-1,blood samples were taken at predetermined time. The concentration of rhIL-11 in plasma was determined by ELISA and then assessed with 3P97 software to obtain the pharmacokinetic parameters.RESULTS The pharmacokinetic parameters of rhIL-11 were t_max(2.25±0.53)h and (3.32±0.85)h; c_max(6.42±(2.57))μg·L^-1 and (9.75±3.75) μg·L^-1;T_1/2(4.03±1.24)h and(4.42±1.32)h;AUC (2.68±14.06)μg·h·L^-1 and(102.73±36.26) μg·h·L^-1,which were fitted to one-compartment model. CONCLUSION The pharmacokinetic characteristics of rhIL-11 would provide information for clinical purpose.