单剂量口服奥美拉唑在中国回族和汉族健康人体的药代动力学

Pharmacokinetics of omeprazole in Chinese Hui and Han nationalities healthy volunteers after a single dose administration

目的研究奥美拉唑肠溶片(抗溃疡药)在回族和汉族健康受试者的药代动力学。方法健康回族和汉族受试者各10名,男、女各半,单剂量口服奥美拉唑肠溶片40mg后,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药代动力学软件进行数据处理,SPSS11.5软件进行统计分析。结果回族和汉族受试者的主要药代动力学参数:Cmax分别为(941.94±446.08)和(760.49±581.23)μg.L-1;tmax分别为(2.7±0.68)和(2.70±0.82)h;t1/2分别为(2.43±2.83)和(1.60±1.28)h;AUC0-12分别为(2.29±1.12)和(1.44±7.98)mg.h.L-1;AUC0-∞分别为(2.33±1.11)和(1.47±7.69)mg.h.L-1。结论回族、汉族受试者的Cmax,AUC0-12,AUC0-∞个体间差异较大;但2民族主要药代动力学参数差异无统计学意义。

Objective To study the pharmacokineties of omeprazole tablets in Chinese Hui and Han healthy volunteers. Methods Twenty volunteers were involved in the study, including ten Chinese Hui volunteers and ten Han volunteers. Each healthy volunheers were given asingle oral dose （40 mg） of omeprazole tablet. The concentration of omeprazole in plasma was determined by RP-HPLC and the pharameters were calculated by DAS 2.0 software. Results The main pharmacokinetic parameters of Chinese Hui and Han were as follows： Cmax were （941.94 ±446.08）and （760.49±581.23） μg·L^-1 tmax were （2.7 ±0.68） and （2.70± 0. 82） h; t1/2 were （2. 43 ±2.83） and （1.60 ± 1.28） h; AUC0-2 were （2.29 ± 1.12） and （1.44 ±7.98） mg ·h·L^-1; AUC0-∞ were （2.33 ± 1.11 ） and （ 1.47±7.69 ）mg·h· L^-1, respectively. Conclusion Individual difference is significant in C AUC0-12, AUC0-∞ after an oral omeprazole, but the pharmacokinetic parameters obtained from the results of ststistical analysis show no significant difference in the main pharmaeokinetic of omeprazole between Chinese Hui and Han.