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研究莫达非尼及其代谢物莫达非尼酸在中国蒙古族、朝鲜族和维吾尔族健康志愿者体内的药动学特征。15名男性及相应的女性健康受试者单剂量口服200mg莫达非尼片,在规定的时间点采血,采用HPLC-UV法测定血药浓度,用DAS2.0软件计算药动学参数。莫达非尼在上述三个民族的体内过程均符合二室开放模型,上述三个民族中莫达非尼的男、女性药动学参数分别为:C_(max)(4.39±0.53)和(5.86±1.23)μg/mL,AUC_(0-∞)(65.36±13.93)和(71.74±16.48)μg·h/mL,t_(1/2β)(15.19±3.05)和(14.48±3.95)h;莫达非尼酸的男、女性药动学参数分别为:C_(max)(2.68±0.52)和(3.56±0.57)μg/mL,AUC_(0-∞)(29.99±6.05)和(34.53±6.41)μg·h/mL,t_(1/2β)(6.46±1.31)和(5.35±1.46)h。莫达非尼及其代谢物在上述三个民族的性别间的统计分析表明:性别对其代谢的影响比较显著,因此在不同性别给药时要格外注意。
To study the pharmacokinetics of modafinil and its metabolite modafinil in Chinese Mongolian, Korean and Uigur healthy volunteers. Fifteen men and corresponding female healthy subjects were given 200 mg modafinil tablets orally, and the blood was collected at the prescribed time points. The plasma concentration was determined by HPLC-UV and the pharmacokinetic parameters were calculated by DAS 2.0 software. The modal phenopharmacokinetic parameters of modafinil in both groups were in accordance with the two-compartment open model. The pharmacokinetic parameters of modafinil in the three ethnic groups were C max (4.39 ± 0.53) and 5.86 ± 1.23 μg / mL, AUC 0-∞ (65.36 ± 13.93) and (71.74 ± 16.48) μg · h / mL, t 1/2 1/2 15.5 and 14.48 ± 3.95 h, The pharmacokinetic parameters of modafinil in male and female patients were respectively: C max (2.68 ± 0.52) and (3.56 ± 0.57) μg / mL, AUC 0 to ∞ (29.99 ± 6.05) and (34.53 ± 6.41) μg · h / mL, t 1/2 (6.4 ± 1.31) and (5.35 ± 1.46) h. The statistical analysis of the effects of modafinil and its metabolites among the three ethnicities mentioned above shows that gender has a significant effect on their metabolism and therefore needs to pay special attention to the different sexes.