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目的 研究国产西沙必利胶囊和普瑞博思片药代动力学和人体生物等效性。方法 采用高效液相色谱法测定 12名健康受试者po 15mg后 ,血浆中西沙必利的浓度。结果 经 3P97拟合 ,两者在体内的过程皆符合血管外给药二室开放模型 ,国产西沙必利胶囊和普瑞博思片的 :AUC分别为 (82 2 .98± 80 .6 0 )和 (80 2 .39± 73.5 9) μg·h·L- 1 ,tmax分别为 (1.5 8± 0 .31)和 (1.6 5± 0 .36 )h ,cmax分别为 (6 5 .5 2± 5 .15 )和 (6 4.2 9± 5 .42 ) μg·L- 1 ,t1 2 β分别为 (9.111± 0 .893)和 (8.713± 1.0 0 6 )h ,采用梯形法计算的两者的AUC0~t均值分别为 (817.35± 80 .6 7)和 (80 1.94± 73 .33) μg·h·L- 1 ,实测cmax均值分别为 (70 .74± 6 .0 3)和 (70 .6 1±6 .93) μg·L- 1 ,实测tmax均值分别为 (1.8± 0 .3)和 (1.6± 0 .2 )h ,国产西沙必利胶囊的相对生物利用度为 (10 2 .0± 4.9) %。结论 经统计学分析 ,国产西沙必利胶囊和普瑞博思片具有生物等效
Objective To study the pharmacokinetics and bioequivalence of domestic cisapride capsules and prepress tablets. Methods Plasma concentrations of cisapride in plasma were determined by high performance liquid chromatography after po 15 mg was administered to 12 healthy volunteers. Results The results of fitting by 3P97 showed that the in vivo process of the two preparations was in accordance with the two-compartment open model of extravascular administration. The AUC of domestic cisapride capsules and prepress tablets were (82.298 ± 80.60) and (80 2 .39 ± 73.5 9) μg · h · L -1 and tmax were (1.5 8 ± 0.31) and (1.6 5 ± 0.36) h, respectively, and the values of cmax were (6.52 ± 5 .15) and (6.24 ± 5.42) μg · L -1 and t1 2 β were (9.111 ± 0.893) and (8.713 ± 1.0 0 6) h, respectively. The AUC0 The average values of ~ (t) were (817.35 ± 80.67) and (80.194 ± 73.33) μg · h · L-1, respectively, and the mean values of cmax were (70.74 ± 6.03) and 1 ± 6. 93) μg · L -1. The mean values of tmax were (1.8 ± 0.3) and (1.6 ± 0.2) h, respectively. The relative bioavailability of domestic cisapride capsules was (10 2 .0 ± 4.9)%. Conclusion By statistical analysis, domestic cisapride capsules and prepress tablets have bioequivalence