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目的 :研究盐酸地尔硫芯卓 缓释胶囊在人体内药动学特性及其两种不同剂量的药动学参数变化规律。方法 :健康志愿者 12名 ,随机分组 ,单剂量口服 6 0 ,12 0mg盐酸地尔硫芯卓 缓释胶囊 ,采用反相高效液相色谱法测定不同时间的血药浓度 ,经3P87程序拟合 ,求算药动学参数。结果 :6 0、12 0mg地尔硫 芯卓 缓释胶囊在中国健康志愿者体内的药动学参数为Ka(2 .2±2 .1) ,(1.6± 1.2 )h-1;K(0 .0 45± 0 .0 0 78) ,(0 .0 5 4± 0 .0 15 )h-1;T1/2 Ka(0 .6 0± 0 .36 ) ,(0 .7± 0 .4)h ;T1/2 K(15 .8± 2 .7) ,(13.9± 4.4)h ;V(33.2± 11.9) ,(2 9.8± 11.8)L·kg-1;Cl(1.4± 0 .37) ,(1.5± 0 .5 )L·h·kg-1;Tmax(4 .8± 0 .9) ,(4 .6± 1.0 )h ;Cmax(2 8.9± 10 .8) ,(6 5 .6± 2 4.8)ng·ml-1;AUC(75 1.2± 2 11.1) ,(1487.4± 5 33.1) μg·h·L-1。结论 :经配对t检验 ,两剂量组间药动学参数差异无显著性 (P >0 .0 5 ) ,在研究剂量内表现为线性动力学。
Objective: To study the pharmacokinetics of diltiazem hydrochloride sustained-release capsules in human and its pharmacokinetic parameters at two different doses. Methods: Twelve healthy volunteers were randomly assigned to single oral dose of 60, 120 mg of diltiazem hydrochloride hydrochloride sustained-release capsules. The plasma concentrations of different concentrations of Diltiazem hydrochloride were determined by reversed-phase high performance liquid chromatography (HPLC) , Calculated pharmacokinetic parameters. Results: The pharmacokinetic parameters of 60, 120 mg Diltiazem SD capsules in Chinese healthy volunteers were Ka (2.2 ± 2.1), (1.6 ± 1.2) h-1, K (0 .0 45 ± 0. 0 0 78), (0. 05 4 ± 0. 0 15) h-1; T1 / 2Ka (0.60 ± 0.36), (0.7 ± 0.4 ); T1 / 2 K (15.8 ± 2 .7), (13.9 ± 4.4) h; V (33.2 ± 11.9), (2 9.8 ± 11.8) L · kg -1; Cl (1.4 ± 0.37 ), (1.5 ± 0.5) L · h · kg-1, Tmax (4.8 ± 0.9), (4.6 ± 1.0) h, Cmax .6 ± 2 4.8) ng · ml-1; AUC (75 1.2 ± 2 11.1), (1487.4 ± 5 33.1) μg · h · L-1. Conclusion: There was no significant difference in the pharmacokinetic parameters between the two groups by paired t-test (P> 0.05). The pharmacokinetic parameters were linear in the study dose.