论文部分内容阅读
8名健康志愿者,随机交叉口服国产劳卡胺胶囊剂100及200mg,测得药一时数据,按口服二房室模型方程拟合,求得药代动力学参数。t1/2(β)分别为4.79±1.85h和18.69±11.63h,Cl分别为104.08±57.94 l/h和49.16±21.75 l/h,AUC/D_0分别为1.40 10~(-5)±0.94 10~(-5)h/ml和2.24 10~(-5)±1.65 10~(-5)h/ml,经自身配对t检验,上述参数在两个剂量间的差异具有显著性统计学意义(p<0.05),推测劳卡胺在人体内存在非线性药动学过程。
Eight healthy volunteers were randomized crossover with 100 and 200 mg of domesticoclave amine capsules. The pharmacokinetic parameters were determined by fitting the two-compartment oral model with oral data. t1 / 2 (β) were 4.79 ± 1.85h and 18.69 ± 11.63h respectively, Cl was 104.08 ± 57.94 l / h and 49.16 ± 21.75 l / h respectively, and AUC / D_0 was 1.40 10 -5 ± 0.94 10 ~ (-5) h / ml and 2.24 10 ~ (-5) ± 1.65 10 ~ (-5) h / ml respectively. The paired t test showed that the above parameters had significant difference between the two doses ( p <0.05), suggesting that there is a nonlinear pharmacokinetic process of buclamine in the human body.