咪达唑仑片在中国回族和汉族健康人体的药动力学研究  

Pharmacokinetics of Midazolam Tablets in Chinese Hui and Han Healthy Volunteers

作　　者：郭涛[1] 毛桂福[2] 夏东亚 郑谊[4] 肖勇[4] 郭红亮[4] 刘鹏[4] 申玉强[4] 王宁芹[4] 

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]不详 [4]解放军第5医院药剂科,宁夏银川830000

出　　处：《解放军药学学报》2009年第4期314-317,共4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;No.06G023

摘　　要：目的研究健康回族和汉族志愿者单剂量口服咪达唑仑片的药代动力学。方法健康志愿者20名(回族、汉族各10名,男女各半),单剂量口服15mg咪达唑仑片后,用高效液相色谱法测定咪达唑仑的血浆浓度,用DAS2.0药动学软件拟合主要药代动力学参数,采用SPSS13.0软件进行统计学分析。结果回族健康志愿者的主要药代动力学参数分别为:Cmax(130.1±38.3)μg.L-1,tmax(1.0±0.9)h,t1/2z(3.5±1.9)h,MRT0-12h(3.4±0.2)h,Clz/F(0.7±0.2)L.h-.1kg-1,Vz/F(3.5±2.6)L.kg-1和AUC0-12h(397.2±99.8)μg.h.L-1。汉族受试者的主要药代动力学参数分别为:Cmax(103.1±26.4)μg.L-1,tmax(1.5±0.7)h,t1/2z(3.0±0.8)h,MRT0-12h(3.6±0.4)h,Clz/F(0.7±0.2)L.h-.1kg-1,Vz/F(2.7±0.8)L.kg-1和AUC0-12h(368.8±103.6)μg.h.L-1。另外,咪达唑仑片的血药浓度-时间曲线中存在双峰现象。结论单剂量口服咪达唑仑片,回族和汉族健康志愿者的药代动力学无显著性种族差异,达峰时间和消除速率等方面存在显著的性别差异。Aim To study the pharmacokinetics of midazolam tablets after a single oral dose in Hui and Han healthy volunteers.Methods Ten Hui volunteers and ten Han healthy volunteers were involved in the study.Each subject received a single dose of 15mg midazolam tablets.The plasma concentration was determined by HPLC.The pharmacokinetic parameters were calculated by DAS2.0 software and compared by SPSS 13.0 software.Results The main pharmacokinetic parameters of Chinese Hui were as follows：Cmax（130.1±38.3）μg·L-1,tmax（1.0±0.9）h,t1/2z（3.5±1.9）h,MRT0-12h（3.4±0.2）h,Clz/F（0.7±0.2）L·h-1·kg-1,Vz/F（3.5±2.6）L·kg-1 and AUC0-12h（397.2±99.8）μg·h·L-1.Those of Han were as follows：Cmax（103.1±26.4）μg·L-1,tmax（1.5±0.7）h,t1/2z（3.0±0.8）h,MRT0-12h（3.6±0.4）h,Clz/F（0.7±0.2）L·h-1·kg-1,Vz/F（2.7±0.8）L·kg-1 and AUC0-12h（368.8 ±103.6）μg·h·L-1.There were double peaks in the plasma concentration-time profile after oral administration.Conclusion There was no significant difference in main pharmacokinetic parameters after oral administration between healthy Hui and Han volunteers,but the difference in elimination and peak time was statistically significant between males and females.

关 键 词：咪达唑仑 药物动力学 回族 汉族 

分 类 号：R927.1[医药卫生—药学] R949