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目的研究盐酸地芬尼多片在健康人体中的药动学过程。方法采用双周期试验设计,12名健康志愿者单次和多次口服盐酸地芬尼多片50mg。建立GC-MS测定血药浓度,用DAS软件计算药动学参数,用AIC法结合F检验判别房室模型。结果盐酸地芬尼多片的药-时曲线符合一级吸收的二室开放模型,单次和多次给药主要药动学参数如下:ρmax分别为(321.15±162.46)和(360.98±175.58)μg·L-1,tmax分别为(2.25±0.62)和(1.75±0.54)h,t1/2β分别为(21.22±22.30)和(29.27±49.65)h,AUC0-36分别为(1052.75±596.25)和(2300.01±1533.73)μg·h·L-1,AUC0-∞分别为(1287.19±2931.36)和(2931.36±1668.27)μg·h·L-1,ρss-max为(360.98±175.58)μg·L-1,ρss-min为(127.23±61.22)μg·L-1,ρss-av为(129.12±136.36)μg·L-1,DF为(1.10±0.39),AUCSS为(1526.77±734.69)μg·h·L-1。结论单次与多次给药,主要药动学参数ρmax、AUC0-36、AUC0-∞统计学配对t检验呈极显著性差异。
Objective To study the pharmacokinetics of phenylephrine hydrochloride in healthy volunteers. Methods A double-cycle trial design was used. Twelve healthy volunteers received 50 mg of epinephrine hydrochloride single and multiple orally. The concentration of plasma was determined by GC-MS. The pharmacokinetic parameters were calculated by DAS software. The AIC method and F-test were used to identify the atrioventricular model. Results The drug-time curve of difenidol hydrochloride tablets conformed to the two-compartment open model of first-order absorption. The main pharmacokinetic parameters of single-dose and multiple-dose administration were as follows: ρmax were (321.15 ± 162.46) and (360.98 ± 175.58) (21.22 ± 22.30) and (29.27 ± 49.65) h respectively, and the AUC0-36 were (1052.75 ± 596.25) μg · L-1, tmax were (2.25 ± 0.62) and And (2300.01 ± 1533.73) μg · h · L-1, respectively. The AUC0-∞ was (1287.19 ± 2931.36) and (2931.36 ± 1668.27) μg · h · L-1, Ρss-min was (127.23 ± 61.22) μg · L-1, ρss-av was (129.12 ± 136.36) μg · L-1, DF was 1.10 ± 0.39 and AUCSS was (1526.77 ± 734.69) μg · h · L-1. Conclusion Single and multiple administrations, the main pharmacokinetic parameters ρmax, AUC0-36, AUC0-∞ statistical paired t-test showed a very significant difference.