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目的 比较国产和进口奥美拉唑注射剂在健康人体内的药代动力学过程。方法 健康志愿者单剂量静脉滴注 80mg奥美拉唑钠 ,HPLC测定血浆中药物浓度 ,采用t检验比较 2种药品的药代动力学参数。结果 国产与进口奥美拉唑注射剂药-时曲线符合二室开放模型 ,主要药代动力学参数间无显著性差异 ,t1/2 β分别为 (1.80± 0 .70 )和 (1.6 0± 0 .6 7)h ;AUC分别为(495 0 .92± 870 .0 6 )和 (44 6 8.47± 736 .94)h·ng·mL-1。结论 国产与进口奥美拉唑注射剂具有相同的体内过程
Objective To compare the pharmacokinetics of domestic and imported omeprazole in healthy volunteers. Methods A single dose of 80 mg omeprazole sodium was given to healthy volunteers. The plasma concentrations of drugs were determined by HPLC. The pharmacokinetic parameters of two drugs were compared by t-test. Results The omeprazole injection-drug-time curve of domestic and imported products was in accordance with the two-compartment open model. There was no significant difference in the main pharmacokinetic parameters between the two groups. The t1 / 2 β were (1.80 ± 0.70) and (1.6 ± 0) .6 7) h; AUC were (495 0 .92 ± 870 .0 6) and (44 6 8.47 ± 736 .94) h · ng · mL-1, respectively. Conclusion Domestic and imported omeprazole injections have the same in vivo process