瑞巴匹特在消化性溃疡患者体内的药物动力学

目的 观察瑞巴匹特在消化性溃疡患者体内的药物动力学。方法 27 例消化性溃疡患者随机分成2组,分别单剂量口服国产或进口瑞巴匹特600mg,用高效液相色谱法测定口服后不同时间的血药浓度,模拟房室模型并计算药物动力学参数。结果 国产和进口瑞巴匹特单剂量口服后的血药浓度- 时间曲线均符合一级吸收开放二室模型,主要药动学参数C_max分别为(0.56 ±0.24)和(0.59 ±0.29)mg·L^-1,t_max为(1.75±0.92)和(1.98±1.05)h,t_1/2(β)分别为(1.86±1.38)和(1.93 ±1.45)h,AUC_0~∞为(2.48 ±1.06)和(2.62±1.35)mg·h·L-1 ,经统计学分析无明显差别(P>0.05);以进口药物为参比,国产药物相对生物利用度为94.66 %。结论 国产瑞巴匹特与进口制剂具有相同动力学特性。

Pharmacokinetics of rebamipide in the patients with peptic ulcer

Aim The pharmacokinetics of rebamipide domestic and imported pro ducts in 27 patients with peptic ulcer was investigated.Methods The rebamipide concentrations in plasma were determined by high performance liquid chromatographic method following a single oral dose of 600 mg rebamipide made either in China or in Japan.The pharmaco kinetic parameters were computed with PKBP-N₁ program.Results Following a single oral dose of rebamipide, the concentration-time curves of the domestic and imported products fitted to two compartment open model.There was no significant difference in each pharmacokinetic parameters between the two product s(P>0.05). C_max of domestic and imported rebamipide tablet were (0.56±0.24) and (0.59±0.29)mg·L^-1,with that t_max were (1.75±0.92)and (1.98±1.05) h, t_1/2(β) were (1.86±1.38)and (1.93±1.45)h, AUC_0~∞ were (2.48±1.06) and (2.62±1.35)mg·h·L_-1. Conclusion The pharmacokinetics of the two products are similar.