朝鲜族和汉族单剂量口服莫达非尼片的人体药动学研究  

Comparation of Pharmacokinetics of Modafinil between Korean and Han Healthy Volunteers in China

作　　者：郭涛[1] 赵龙山[2] 夏东亚[1] 杨长青[3] 朴虎日[3] 

机构地区：[1]沈阳军区总医院药剂科,辽宁沈阳110016 [2]沈阳药科大学药学院,辽宁沈阳110016 [3]延边大学药学院,吉林延吉133000

出　　处：《解放军药学学报》2009年第1期13-17,共5页Pharmaceutical Journal of Chinese People's Liberation Army

基　　金：全军医学科学技术研究"十一五"计划科技攻关课题资助项目;No.06G023

摘　　要：目的研究中国朝鲜族和汉族志愿者单剂量口服200mg莫达非尼片的体内药动学过程。方法采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DAS2.0.1计算其主要药动学参数。结果原形药及代谢物的平均血药浓度-时间数据符合二室模型,朝、汉两组莫达非尼的主要药动学参数Tmax分别为(1.61±0.55)、(1.60±0.74)h,Cmax分别为(5.88±1.78)、(5.15±1.08)mg·mL-1,t1/2分别为(11.78±1.98)、(11.37±1.54)h-1;AUC0-∞分别为(69.88±14.87)、(70.95±22.57)mg.h.L-1。结论莫达非尼在朝、汉两组的各项药动学参数经统计学分析处理,无显著性差异(P>0.05),代谢物莫达非尼酸Tmax,t1/2,CL/F,AUC0-∞有显著性差异(P<0.05),性别间除Cmax外,其余药动学参数均无显著性差异(P>0.05)。Aim To study the pharmacokinetics of modafinil after an oral administration of 200mg in Korean and Han healthy volunteers. Methods The drug and metabolite （modafinil acid） were determined by HPLC method and the pharmacokinetic parameters were fitted by DAS 2.0.1 software. Results The mean plasma concentration-time curves of modafinil and modafinil acid fitted the two-compartment model. The modafinil＇ s main pharmacokinetic parameters of Korean and Han healthy volunteers were as follows： Tmax was （ 1.61 ±0.55）h and （ 1.60 ±0.74）h; C max was （5.88 ± 1.78）mg·L^-1 and （5.15 ±1.08）mg·L^-1 ; t 1/2 was （11.78 ±1.98）h^-1 and （11.37 ± 1.54）h^-1 ; AUC0-∞ was （69.88 ± 14.87 ） mg·h·L^-1 and （70.95 ±22.57 ）·h·L^-1, respectively. Conclusion The pharmacokinetic parameters of modafinil between the two groups showed no significant difference（ P 〉 0.05 ） ,while parameters Tmax 1/2, CL/F , AUC0-∞ of modafinil acid between the two groups showed significant difference （ P 〈 0.05 ）. There was no significant difference （ P 〉 0.05 ） between genders except for the parameters of Cmax.

关 键 词：莫达非尼 莫达非尼酸 药动学 HPLC 

分 类 号：R969.1[医药卫生—药理学]