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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 for the treatment of hypertension and angina drugs, belongs to the third generation of dihydropyridine calcium channel blockers. In this study, population pharmacokinetic analysis of amlodipine was performed in 60 healthy volunteers from three bioequivalence studies of amlodipine. Data and covariates were analyzed using a non-linear mixed-effects model NONMEN fitting. A two-compartment model of absorption was used to fit amlodipine plasma concentration data. No significant covariates were found during modeling. Individual (residual) variation was expressed as a coefficient of variation of 18.7%. The inter-individual variations of CL, V2, V3 and Ka were 27.3%, 26.6%, 49.9% and 65.7%, respectively. The relatively high variability (> 40%) between V3 and Ka may be due to genetic variation during amlodipine absorption and disposal.