奥美拉唑肠溶胶囊健康人体药动学及生物等效性

    Pharmacokinetics and bioequivalence of omeprazole enteric-coated capsules in healthy volunteers

    • 摘要: 目的:研究2个不同厂家生产的奥美拉唑肠溶胶囊在健康人体的生物等效性。方法:20名健康志愿者采用双周期交叉试验,分别单剂量空腹口服奥美拉唑肠溶胶囊60mg,高效液相色谱法测定其血清中奥美拉唑浓度,血药浓度-时间数据经DAS 2.0统计软件处理,计算主要药代动力学参数,并进行两种制剂的生物等效性评价。结果:受试制剂及参比制剂的主要药代动力学参数t1/2、Cmax、Tmax和AUC0-12h分别为(1.789±0.862)h和(1.499±0.503)h、(0.506±0.25)μg/ml和(0.493±0.195)μg/ml、(2.050±0.642)h和(2.038±0.630)h、(1.640±1.408)μg·h-1·ml-1和1.570±0.997)μg·h-1·ml-1。受试制剂的相对生物利用度为(101.48±33.82)%。结论:两种奥美拉唑肠溶胶囊具有生物等效性。

       

      Abstract: Objective: To investigate the bioequivalence of omeprazole enteric-coated capsules of two manufactories in Chinese healthy volunteers.Methods: Twenty volunteers were randomly divided into two groups(test and reference),with double cross-over design.The concentration of omeprazole in serum was determined by high performance liquid chromatography(HPLC) and pharmacokinetic parameters were calculated with DAS2.0 practical pharmacokinetics program.Results: The pharmacokinetic parameters of the test and reference preparation were as follows:t1/2 were(1.789±0.862) h and(1.499±0.503) h;Cmax were(0.506±0.25) μg/ml and(0.493±0.195) μg/ml,Tmax were(2.050±0.642) h and(2.038±0.630) h,AUC0-12 h were(1.640±1.408) μg·h-1·ml-1 and(1.570±0.997) μg·h-1·ml-1,respectively.The relative bioavalibility of the test peparation was(101.48±33.82)%.Conclusions: The statistical analysis showed that the test and reference preparations were bioequivalent.

       

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