单剂量口服奥美拉唑在中国蒙古族和汉族健康人体的药代动力学

Pharmacokinetics of a Single dose of Omeprazole in Chinese Mongolian and Han Nationalities Healthy Volunteers

目的研究蒙古族和汉族健康受试者单剂量口服奥美拉唑肠溶片的药代动力学。方法健康蒙古族和汉族受试者各10名,男、女各半,单剂量口服奥美拉唑肠溶片40mg后,于不同时间点采集静脉血,经血浆样品处理后用反相高效液相色谱法测定人血浆中奥美拉唑的浓度。用DAS2.0药动学软件进行数据处理,SPSS11.5软件进行统计分析。结果蒙古族受试者的主要药动学参数分别为Cmax为(942.54±297.46)mg·L-1;Tmax为(3.05±1.21)h;t1/2(1.8±1.01)h;AUC0-12为(2325.08±1322.42)mg.h.L-1;AUC0-∞为(2381.40±1355.00)mg.h.L-1。汉族受试者的主要药动学参数分别为Cmax为(760.49±581.23)mg·L-1;Tmax为(2.70±0.82)h;t1/2(1.60±1.28)h;AUC0-12为(1437.61±798.05)mg.h.L-1;AUC0-∞为(1470.09±769.48)mg.h.L-1。结论蒙古族受试者、汉族受试者的Cmax,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主要药动学参数无统计学意义。

Aim To study the pharmacokinetics of omeprazole tablets after a single oral dose in Mongolian and Han healthy volunteers. Methods Twenty volunteers were involved in the study：ten Mongolian and ten Han volunteers. Each healthy volunheer was given a single oral dose （40mg） of omeprazole tablet, Blood samples were collected from the vein at certain sampling times. The concentration of omeprazole inplasma was determined by RPHPLC method and the pharameters were calculated by DAS 2.0 software. Results The main pharmacokinetic parameters of Mongolians were as follows ： Cmax was （942.54 ± 297.46） mg.L^- 1 ;Tmax was （3.05 ± 1.21 ） h ; t1/2 （ 1.8 ± 1.01）h;AUC0-12 was （2 325.08 ±1 322. 42 ） mg.h .L^-1 ;AUC0-∞ was （2 381.40 ±1 355.00）mg.h.L^-1. The main pharmaeokinetie parameters of Han were as follows ： Cmax was （760.49 ± 581.23 ） mg. L^- 1 ; Tmax was （ 2.70 ± 0.82）h;t1/2 was （1.60 ± 1.28）h;AUC0-12 was （1 437.61 ± 798. 05 ） mg .h .L^-1 ;AUC0-∞ was （1 470.09 ±769.48） mg.h .L^-1. Conclusion Individual difference was significant in Cmax, AUC （0-12）, AUC（0-∞） after an oral omeprazole, but the pharmacokinetic parameters obtained from results of ststistie analysis show no significant difference in the main pharmacokinetics of omeprazole between Mongolians and Han.