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目的研究健康维吾尔族和汉族志愿者单剂量口服咪达唑仑片的药动学。方法维吾尔族、汉族健康志愿者各10名,男、女各半,单剂量口服15 mg咪达唑仑片后,用HPLC法测定咪达唑仑的血浆浓度,运用DAS 2.0程序以非室模型拟合药动学参数,并对药动学参数进行独立样本t检验和非参数Mann-Whitney U test检验,以判断药动学是否存在显著性的民族差异。结果单剂量口服15 mg咪达唑仑片后,维吾尔族志愿者的主要药动学参数分别为:ρmax(124.8±50.0)μg.L-1,tmax(0.8±0.5)h,t1/2z(1.9±0.7)h,MRT0-12 h(2.8±0.8)h,CL/F(0.9±0.4)L.h-1.kg-1,Vz/F(2.3±0.7)L.kg-1和AUC0-12 h(343.2±150.9)μg.h.L-1。汉族健康受试者的主要药动学参数分别为:ρmax(103.1±26.4)μg.L-1,tmax(1.5±0.7)h,t1/2z(3.0±0.8)h,MRT0-12 h(3.6±0.4)h,CL/F(0.7±0.2)L.h-.1kg-1,Vz/F(2.7±0.8)L.kg-1和AUC0-12 h(368.8±103.4)μg.h.L-1。经检验,维吾尔族的tmax、t1/2z和MRT0-12 h比汉族的短,差异有显著性统计学意义,其余参数的民族差异无显著性统计学意义。两个民族的部分受试者的药-时曲线有双峰。结论单剂量口服咪达唑仑片后,汉族和维吾尔族健康志愿者的药动学存在较大的个体差异,且消除速率的民族差异有显著性统计学意义,临床应用时应注意个体化给药。
Objective To study the pharmacokinetics of single-dose oral midazolam tablets in healthy Uygur and Han volunteers. Methods 10 healthy volunteers from Uygur and Han nationalities were enrolled in this study. Each male and female were divided into two groups. After a single oral dose of 15 mg midazolam tablets, the plasma concentrations of midazolam were determined by HPLC. The non-compartmental model Pharmacokinetic parameters were fitted and pharmacokinetic parameters were tested by independent samples t-test and non-parametric Mann-Whitney U test to determine whether there were significant ethnic differences in pharmacokinetics. Results The main pharmacokinetic parameters of Uzyl volunteers after a single oral dose of 15 mg midazolam tablets were: ρmax (124.8 ± 50.0) μg.L-1, tmax (0.8 ± 0.5) h, t1 / 2z 1.9 ± 0.7 h, MRT0-12 h (2.8 ± 0.8) h, CL / F (0.9 ± 0.4) Lh-1.kg- h (343.2 ± 150.9) μg.hL-1. The main pharmacokinetic parameters of healthy Han nationality subjects were ρmax (103.1 ± 26.4) μg.L-1, tmax (1.5 ± 0.7) h, t1 / 2z (3.0 ± 0.8) ± 0.4) h, CL / F (0.7 ± 0.2) Lh-1kg-1, Vz / F (2.7 ± 0.8) L.kg-1 and AUC0-12 h (368.8 ± 103.4) μg.hL-1. After testing, Uygur tmax, t1 / 2z and MRT0-12h shorter than the Han, the difference was statistically significant, the remaining parameters of the national differences were not statistically significant. Some people from both ethnic groups had a doublet of drug-time curves. Conclusions After a single oral dose of midazolam tablets, the pharmacokinetics of Han and Uygur volunteers have large individual differences, and there is a significant statistical difference in the national differences in elimination rate. In clinical application, individualized medicine.