摘要
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。
OBJECTIVE To compare the pharmacokinetics between the domestic and imported omeprazole(Ome) infusion preparations.METHODS 16 healthy volunteers were divided into two groups.They were administered with a single infusion dose of 80 mg Ome of the two formulations respectively.The plasma concentrations of Ome were determined by an improved HPLC method.RESULTS The plasma concentration time curve was fitted to a two compartment open pharmacokinetic model.The elimination half life ( t 1/2β ) were (1.80±0.70) and ( 1.60 ±0.67)h;the area under the concentration time curve ( AUC ) were (4950.92±870.06) and (4468.47±736.94) h·ng·mL -1 ,respectively.CONCLUSION The pharmacokinetic profile of domestic Ome infusion preparation was similar to that of the imported one.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2001年第2期109-111,共3页
Chinese Pharmaceutical Journal
