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目的研究莫达非尼片在蒙古族和汉族健康人体内的药动学。方法选择蒙古族和汉族健康受试者各10人,单剂量口服莫达非尼片200mg。用高效液相色谱法测定血浆中莫达非尼及莫达非尼酸的浓度。用3P97药动学程序进行房室模型判断并计算药动学参数。结果口服莫达非尼后的体内过程符合一级吸收二室模型,蒙古族和汉族受试者的主要药动学参数tmax分别为(2.20±0.75)和(1.60±0.74)h,ρmax分别为(4.86±0.67)和(5.15±1.08)mg·L-1,t1/2α分别为(2.59±0.73)和(2.65±1.25)h,t1/2β分别为(15.25±4.70)和(13.07±3.78)h,AUC0-48分别为(63.32±8.74)和(67.11±19.99)mg·h·L-1,AUC0-∞分别为(68.61±11.59)和(71.05±22.60)mg·h·L-1。结论蒙古族和汉族健康受试者单剂量口服莫达非尼片后药动学参数的差异无统计学意义。
Objective To study the pharmacokinetics of modafinil tablets in healthy Mongolian and Han Chinese. Methods A total of 10 healthy subjects from Mongolian and Han nationalities were enrolled. A single dose of 200 mg modafinil tablets was given. Plasma concentrations of modafinil and modafinil were assayed by high performance liquid chromatography. Pharmacokinetic procedures with 3P97 room model to determine and calculate the pharmacokinetic parameters. Results The in vivo process of oral modafinil conformed to the first-order absorption two-compartment model. The main pharmacokinetic parameters tmax of Mongolian and Han nationality subjects were (2.20 ± 0.75) and (1.60 ± 0.74) h, respectively, and ρmax were (2.56 ± 0.67) and (5.15 ± 1.08) mg · L-1, and the t1 / 2α were (2.59 ± 0.73) and (2.65 ± 1.25) h respectively and the t1 / 2β were (15.25 ± 4.70) and (13.07 ± 3.78 ) h and AUC0-48 were (63.32 ± 8.74) and (67.11 ± 19.99) mg · h · L-1, respectively. The AUC0-∞ were 68.61 ± 11.59 and 71.05 ± 22.60 mg · h · L -1 . Conclusion There was no significant difference in the pharmacokinetic parameters between the Mongolian and Han nationality subjects after single dose of modafinil tablets.