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氨氯地平用以治疗高血压和心绞痛的药物,属于第三代双氢吡啶类钙通道阻滞剂.本研究对来自3个氨氯地平生物等效性试验的60个健康志愿者数据进行氨氯地平的群体药代动力学分析.数据及协变量用非线性混合效应模型NONMEN拟合分析.一级吸收的二室模型用以拟合氨氯地平血药浓度数据.在建模过程中没有找到显著的协变量.个体内(残余)变异用变异系数表示,为18.7％.CL,V2,V3和Ka的个体间变异分别为27.3％,26.6％,49.9％和65.7％.V3和Ka的个体间变异相对较高(＞40％),可能因为氨氯地平吸收和处置过程中的基因变异所导致.“,”Amlodipine is a third-generation dihydropyridine calcium channel blocker that is indicated for treatment of hypertension and angina in adults.The population pharmacokinetics of amlodipine was evaluated in 60 healthy volunteers enrolled in three bioequivalence studies.These data,along with a set of covariates,were the subject of a nonlinear mixed-effect modeling analysis using the NONMEM program.A two-compartment model with first order absorption was fitted to the serum amlodipine concentration data.No significant·covariates were found in the model-building.The intraindividual(residual)variability expressed as coefficient of variation was 18.7％,whereas the interindividual variability of CL,V2,V3 and K,,was 27.3％,26.6％,49.9％ and 65.7％,respectively.The relatively high(＞40 ％)interindividual variability for V3 and Ka parameters,observed under the controlled experimental settings of bioequivalence trials in healthy volunteers,may result from genetic variability of the processes involved in amlodipine absorption and disposition.