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t_max分别为(2.20±0.75)和(1.60±0.74)h,ρ_max分别为(4.86±0.67)和(5.15±1.08)mg·L^-1,t_1/2α分别为(2.59±0.73)和(2.65±1.25)h,t_1/2β分别为(15.25±4.70)和(13.07±3.78)h,AUC_0-48分别为(63.32±8.74)和(67.11±19.99)mg·h·L^-1,AUC_0-∞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 in Mongolian and Han healthy volunteers. METHODS 10 Monglian and 10 Han healthy volunteers were given a single oral dose of 200 mg modafinil. The plasma concentration of modafinil and modafinil acid were determined by HPLC. The pharmacokinetic parameters were calculated with 3P97 software. RESULTS The plasma concentration-time curves of modafinil were fitted to a two-compartment model with a first order absorption. The main pharmacokinetic parameters of Mongolian and Han healthy volunteers were as follows: t_max (2.20±0.75) and (1.60±0.74)h,ρ_max(4.86±0.67) and (5.15±1.08)mg·L^-1,t_1/2α(2.59±0.73) and (2.65±1.25)h,t_1/2β (15.25±4.70) and (13.07±3.78)h,AUC_0-48(63.32±8.74) and (67.11±19.99) mg·h·L^-1,AUC_0-∞(68.61±11.59) and (71.05±22.60) mg·h·L^-1,respectively. CONCLUSION There is no significant difference in the pharmacokinetic parameters between Monglian and Han healthy volunteers.