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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。
Objective To study the pharmacokinetics of midazolam tablets in healthy Hui and Han volunteers. Methods Twenty healthy volunteers (10 Hui and Han nationality, half male and half female) were enrolled in this study. After a single oral dose of 15 mg midazolam tablets, plasma concentrations of midazolam were determined by high performance liquid chromatography (HPLC) Kinetic software fitted the main pharmacokinetic parameters, using SPSS13.0 software for statistical analysis. Results The main pharmacokinetic parameters of healthy volunteers were: Cmax (130.1 ± 38.3) μg.L-1, tmax (1.0 ± 0.9) h, t1 / 2z ± 0.2) h, Clz / F (0.7 ± 0.2) Lh-1kg-1, Vz / F (3.5 ± 2.6) L.kg-1 and AUC0-12h (397.2 ± 99.8) μg.hL-1. The main pharmacokinetic parameters of Han subjects were: C max (103.1 ± 26.4) μg.L-1, tmax 1.5 ± 0.7 h, t1 / 2z 3.0 ± 0.8 h, 0.4) h, Clz / F (0.7 ± 0.2) Lh-1kg-1, Vz / F (2.7 ± 0.8) L · kg- 1 and AUC0-12h (368.8 ± 103.6) μg.hL-1. In addition, midazolam tablets plasma concentration - time curve of double-peaked phenomenon. Conclusions There is no significant difference in the pharmacokinetics between single dose oral midazolam tablets and healthy volunteers in Hui and Han nationality. There are significant gender differences in peak time and elimination rate.