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目的比较莫达非尼在中国维吾尔族和汉族健康受试者体内的药动学。方法20名维吾尔族和汉族健康受试者(男女各半)单剂量口服莫达非尼片200 mg,采用高效液相色谱法测定血浆中莫达非尼及代谢物莫达非尼酸的浓度。用DAS2.0软件计算药动学参数并比较其在两个民族及性别间的差异,并与已报道的数据进行比较。结果莫达非尼片在维吾尔族和汉族健康受试者的主要药动学参数如下:t_(max)分别为(1.80±0.54)和(1.60±0.74)h,ρ_(max)分别为(4.79±0.68)和(5.15±1.08)mg·L~(-1),t_(1/2)分别为(15.02±4.03)和(11.39±1.53)h,AUC_(O→∞)分别为(70.92±15.68)和(71.05±22.60)mg·h·L~(-1)。结论维吾尔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除t_(1/2)和Vd/F外均无统计学意义,莫达非尼和莫达非尼酸的主要药动学参数与国外文献报道大体一致。
Objective To compare the pharmacokinetics of modafinil in Chinese healthy Uygur and Han subjects. Methods Twenty healthy subjects (half male and half female) of Uighur and Han nationality were given 200 mg modafinil tablets orally. The plasma concentrations of modafinil and its metabolite modafinil were determined by high performance liquid chromatography (HPLC) . The pharmacokinetic parameters were calculated using the DAS 2.0 software and their differences between the two ethnicities and their genders were compared and compared with those reported. Results The main pharmacokinetic parameters of modafinil tablets in healthy Uygur and Han subjects were as follows: t max (1.80 ± 0.54) and (1.60 ± 0.74) h respectively, and ρ max were (4.79 ± 0.68) and (5.15 ± 1.08) mg · L -1, t 1/2 was (15.02 ± 4.03) and (11.39 ± 1.53) h, respectively. The AUC_ (O → ∞) 15.68) and (71.05 ± 22.60) mg · h · L -1, respectively. Conclusion The difference of pharmacokinetic parameters between single dose oral modafinil tablets and healthy volunteers in Uygur and Han nationality is not statistically significant except t_ (1/2) and Vd / F, and there is no significant difference between modafinil and modafin The main pharmacokinetic parameters of niacin are generally consistent with those reported in foreign literature.