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目的 :研究皮下注射重组人白介素 11(rhIL 11)衍生物在人体内的药代动力学过程。方法 :16例健康志愿者 ,男女各半 ,随机分成 2组。rhIL 11皮下注射剂量分别为 4 0和 2 5 μg·kg-1。定时采血 ,利用酶标仪测定不同时间血浆中rhIL 11衍生物浓度。采用WinNonlin软件进行房室模型拟合 ,求算药代动力学参数。结果 :rhIL 11衍生物两种剂量的主要药代动力学参数分别为 :Tmax为 (1.76± 0 .80 )和 (2 .4 9± 1.2 0 )h ;Cmax为 (2 5 .5 0± 4 .98)和(18.2 8± 5 .82 )ng·mL-1;t1/ 2 为 (6 .33± 0 .76 )和 (5 .14± 0 .92 )h ;AUC为 (2 77.10± 4 0 .79)和 (189.38± 5 4 .2 7)ng·h·mL-1。rhIL 11衍生物的体内过程符合一室模型。结论 :rhIL 11衍生物的药代特征可为指导临床制订给药方案及合理用药提供重要信息。
OBJECTIVE: To study the pharmacokinetics of recombinant human interleukin 11 (rhIL 11) derivatives in humans. Methods: Sixteen healthy volunteers were divided into two groups randomly. The doses of rhIL 11 subcutaneous injection were 40 and 25 μg · kg-1, respectively. Timed blood collection, the use of microplate reader determination of plasma concentrations of rhIL 11 derivatives at different times. The WinNonlin software was used to fit the model of atrioventricular compartment, and the pharmacokinetic parameters were calculated. RESULTS: The main pharmacokinetic parameters of the two doses of rhIL 11 derivatives were: Tmax (1.76 ± 0.80) and (2.49 ± 1.2 0) h; Cmax was (25.5 ± 4) .98) and (18.28 ± 5.82) ng · mL-1; t1 / 2 was (6.33 ± 0.76) and (5.14 ± 0.92) h respectively; AUC was (2 77.10 ± 4 0 .79) and (189.38 ± 54.27) ng · h · mL-1. The in vivo process of the rhIL 11 derivative conformed to the one-compartment model. Conclusion: The pharmacokinetics of rhIL 11 derivatives may provide important information for guiding the clinical formulation of drug delivery and rational drug use.