酒石酸唑吡坦片在蒙古族和汉族人体内的药动学研究

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。

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

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.