Influence of sex on the pharmacokinetics of modafinil in healthy Chinese volunteers  

性别因素对莫达非尼在中国健康志愿者体内的药动学的影响(英文)

作　　者：赵龙山[1] 高硕[2] 郭涛[3] 夏东亚[3] 

机构地区：[1]沈阳药科大学药学院,沈阳辽宁110016 [2]沈阳药科大学图书馆,沈阳辽宁110016 [3]沈阳军区总医院药剂科,沈阳辽宁110016

出　　处：《Journal of Chinese Pharmaceutical Sciences》2010年第6期477-481,共5页中国药学（英文版）

基　　金：Entire Armed Forces 15 Medicine Health Science and Technology Attack Topic(Grant No.06G023)

摘　　要：The purpose of this study was to determine the pharmacokinetic characteristics of modafinil and its metabolite modafinil acid in healthy subjects including Chinese Mongolian, Korean and Uyghur, and assess the influence of sex on the pharmacokinetic profiles of modafinil in Chinese subjects. Fifteen healthy Chinese male subjects and fifteen female subjects received 200 mg of modafinil, and the plasma samples were collected at the designed time points. The plasma modafinil concentration was determined by HPLC-UV method. Pharmacokinetic parameters were calculated by DAS software. The pharmacokinetics of modafinil for all of the subjects were in accordance with the two-compartment open model. The mean pharmacokinetic parameters for males and females are as follows： Cmax （4.39±0.53） and （5.86±1.23） μg/mL, AUC0 -∞（65.36±13.93） and （71.74±16.48） μg.h/mL, t1/2β （15.19±3.05） and （14.48±3.95） h for modafinil; Cmax （2.68±0.52） and （3.56±0.57） μg/mL, AUC0 -∞ （29.99±6.05） and （34.53±6.41） μg.h/mL, t1/2β （6.46±1.31） and （5.35±1.46） h for modafinil acid, respectively. Statistical analysis of the pharmacokinetics ofmodafinil and modafmil acid in male and female groups shows that sex has a significant impact on the metabolism of modafinil and modafinil acid. More attention should be paid on the dosage to male or female patients.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。

关 键 词：MODAFINIL SEX PHARMACOKINETICS 

分 类 号：R96[医药卫生—药理学]