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10名男性健康志愿者交叉口服单剂量(600mg)国产瑞巴匹特片剂和进口瑞巴匹特片剂两种制剂,用高效液相色谱法测定血浆中瑞巴匹特浓度,进行相对生物利用度研究。试验结果表明,口服国产和进口瑞巴匹特片剂的血药浓度-时间曲线均符合具有滞后时间的一级吸收一级消除的一房室模型,体内药物达峰时间分别为1.95±0.73和1.57±0.55h;Cmax分别为510.8±152.0和564.8±187.7μg/L;T1/2分别为1.75±0.63和1.66±0.31h;AUC分别为2506.9±413.9和2549.7±513.1μg·h·L-1;国产瑞巴匹特片的相对生物利用度为99.36±7.87%。经统计分析,两种制剂的药代动力学参数均无显著性差异(P>0.05),两种制剂具有生物等效性。
Ten male healthy volunteers were given oral single oral dosage (600mg) of domestic rebamipide tablets and imported rebamipide tablets two kinds of preparations, the determination of plasma concentration of rebamipide by high performance liquid chromatography, the relative biology Utilization Research. The results showed that oral administration of domestic and imported rebamipide tablets plasma concentration - time curve are in line with the first-order absorption with a lag time to eliminate one-compartment model, the peak drug levels in vivo were 1.95 ± 0.73 and 1.57 ± 0.55h respectively; Cmax was 510.8 ± 152.0 and 564.8 ± 187.7μg / L respectively; T1 / 2 was 1.75 ± 0.63 and 1.66 ± 0.31h; AUC was 2506.9 ± 413.9 and 2549.7 ± 513.1μg · h · L-1, respectively. The relative bioavailability of domestic rebamipide tablets was 99.36 ± 7.87%. By statistical analysis, there was no significant difference in pharmacokinetic parameters between the two preparations (P> 0.05), and the two preparations were bioequivalent.