单剂量口服奥美拉唑在中国维吾尔族和汉族健康人体内药物动力学考察

目的研究维吾尔族和汉族健康受试者单剂量口服奥美拉唑肠溶片的药物动力学,旨在为战时救治和平时临床合理应用奥美拉唑提供依据。方法健康维吾尔族和汉族受试者各10名,男、女各半,单剂量口服奥美拉唑肠溶片40 mg后,于不同时间点采集静脉血,血浆样品经处理后用HPLC法测定奥美拉唑的质量浓度。用DAS 2.0药物动力学软件处理数据,用SPSS11.5软件统计分析。结果奥美拉唑在维吾尔族受试者体内的主要药物动力学参数分别为:ρmax(728.4±214.3)μg.L-1,tmax(2.8±0.5)h,t1/2(1.2±0.5)h,AUC0-12(1 837.0±861.8)μg.h.L-1,AUC0-∞(1 847.6±869.1)μg.h.L-1;在汉族受试者体内的主要药物动力学参数分别为:ρmax(760.5±581.2)μg.L-1,tmax(2.7±0.8)h,t1/2(1.6±1.3)h,AUC0-12(1 437.6±798.1)μg.h.L-1,AUC0-∞(1 470.1±769.5)μg.h.L-1。结论奥美拉唑在维吾尔族、汉族受试者体内的ρmax、AUC(0-12)、AUC(0-∞)个体间差异较大,但统计学分析结果显示两民族人体内主要药物动力学参数差异无统计学意义。

Pharmacokinetics of a single dose omeprazole in Chinese Uighur and Han nationalities healthy volunteers

Objective To study the pharmacokinetics of omeprazole tablets after a single oral dose in Uighur and Han healthy volunteers. Methods Twenty volunteers were involved in the study, including ten Uighur volunteers and ten Han volunteers. Each healthy volunteers were given a single oral dose (40 mg) of omeprazole tablet. Blood samples were collected from vein at certain sampling times. The concentration of omeprazole in plasma was determined by HPLC method and the pharmacokinetic parameters were calculated by DAS 2.0 software. Results The main pharmacokinetic parameters of Uighur were as follows: ρmax（728.4±214.3）mg·L-1，tmax (2.8±0.5) h；t1/2(1.2±0.5) h，AUC0-12 (1 837.0±861.8) mg·h·L-1，AUC0-∞ (1 847.6±869.1) mg·h·L-1。The main pharmacokinetic parameters of Han were as follows: ρmax (760.5±581.2) mg·L-1， tmax (2.7±0.8)h; t1/2(1.6±1.3) h，AUC0-12(1 437.6±798.1) mg·h·L-1，AUC0-∞(1 470.1±769.5) mg·h·L-1. Conclusions Individual difference is significant in ρmax，AUC(0-12)，AUC(0-∞) after an oral omeprazole, but the pharmacokinetic parameters obtained from the results of statistical analysis show no significant difference in the main pharmacokinetics of omeprazole between Uighur and Han.