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进口与国产奥美拉唑注射剂在健康人体内药代动力学过程比较
引用本文:李珍,胡晋红,金桂兰.进口与国产奥美拉唑注射剂在健康人体内药代动力学过程比较[J].中国药学杂志,2001,36(2):109-111.
作者姓名:李珍  胡晋红  金桂兰
作者单位:李珍(第二军医大学长海医院临床药理研究室,上海 200433)       胡晋红(第二军医大学长海医院临床药理研究室,上海 200433)       金桂兰(湖北省宜昌市第一人民医院药剂科,湖北 宜昌443000)
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,t1/2b分别为(1.80±0.70)和(1.60±0.67)h; AUC分别为(4950.92±870.06)和(4468.47±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。

关 键 词:奥美拉唑  血药浓度  高效液相色谱法  药代动力学
文章编号:1001-2494(2001)02-0109-03
收稿时间:1999-04-21;
修稿时间:1999年4月21日

Pharmacokinetic comparison of domestic vs imported omeprazole infusion preparations
LI Zhen ,HU Jin hong ,JIN Gui lan.Pharmacokinetic comparison of domestic vs imported omeprazole infusion preparations[J].Chinese Pharmaceutical Journal,2001,36(2):109-111.
Authors:LI Zhen  HU Jin hong  JIN Gui lan
Institution:LI Zhen 1,HU Jin hong 1,JIN Gui lan 2
Abstract: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 concen-tration-time curve was fitted to a two-compartment open pharmacokinetic model. The elimination half-life(t1/2b)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, re-spectively. CONCLUSION The pharmacokinetic profile of domestic Ome infusion preparation was similar to that of the imported one.
Keywords:Omeprazole  Plasma drug concentrations  HPLC  Pharmacokinetics
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