酒石酸唑吡坦片在蒙古族和汉族人体内的药动学研究

Pharmacokinetics Study of Zolpidem Tartrate Tablets in Mongolian and Han Healthy Volunteers

目的:研究酒石酸唑吡坦在我国蒙古族和汉族健康受试者体内的药动学。方法:选择蒙古族和汉族健康受试者各10名(男、女各5名),分别口服酒石酸唑吡坦10mg后,用高效液相色谱-荧光检测法测定受试者血浆中酒石酸唑吡坦的浓度,以DASVer2.0计算药动学参数,研究其药动学过程。结果:蒙、汉两民族受试者口服酒石酸唑吡坦后,药-时曲线均符合一室开放模型,主要药动学参数分别为t1/(22.47±0.50)、(2.21±0.77)h,tma(x0.90±0.38)、(0.93±0.47)h,Cma(x221.85±109.97)、(190.81±70.59)μg·L-1,AUC0～1(2770.00±405.64)、(624.48±192.15)μg·h·L-1,AUC0～∞(808.85±434.10)、(649.58±210.17)μg·h·L-1。结论:本方法可用于人体内酒石酸唑吡坦的的药动学研究,两民族受试者各主要药动学参数之间无显著性差异。

OBJECTIVE：To investigate the pharmacokinetics of zolpidem tartrate in Mongolian and Han healthy volunteers.METHODS：10 healthy volunteers（5 male,5 female）of every nation were involved in study and given a single oral dose of 10 mg zolpidem tartrate respectively.The concentration of zolpidem tartrate was determied by HPLC-fluorescence method and the pharmacokinetic parameters were calculated by DAS Ver 2.0 software to study the pharmacokinetics of zolpidem tartrate.RESULTS：The plasma concentration-time curves of zolpidem tartrate were both fitted to one-compartment model after a single oral dose of 10 mg zolpidem tartrate.The main pharmacokinetic parameters of zolpidem tartrate in Mongolian healthy volunteers and Han healthy volunteers were as follows：t1/（22.47±0.50）h vs.（2.21±0.77）h;tma（x0.90±0.38）h vs.（0.93±0.47）h;Cma（x221.85±109.97）μg·L-1 vs.（190.81±70.59）μg·L-1;AUC0～1（2770.00±405.64）μg·h·L-1 vs.（624.48±192.15）μg·h·L-1;AUC0～∞（808.85±434.10）μg·h·L-1 vs.（649.58±210.17）μg·h·L-1,respectively.CONCLUSION：The method is suitable for pharmacokinetics study of zolpidem tartrate.Obtained pharmacokinetic parameters show no significant difference between Mongolian healthy volunteers and Han healthy volunteers.