吲哚美辛缓释胶囊人体药物动力学与生物利用度

Pharmacokinetics and relative bioavailability of indomethacin sustained-release capsule

目的:研究吲哚美辛(Ind)缓释胶囊在正常人体内的药物动力学和相对生物利用度.方法:采用RP-HPLC测定Ind的血药浓度,研究18名健康志愿受试者单剂量po150mg国产与进口Ind缓释胶囊后的人体内药物动力学和相对生物利用度.结果:两种制剂的t_(max)、c_(max)和AUC(?).均无显著差异(P>0.05);国产Ind缓释胶囊的相对生物利用度为103.02%.结论:两种制剂为生物等效.

AIM: To study the pharmacokinetics and relative bioavailability of in-domethacin sustained-release capsule. METHODS;The indomethacin concentrations in plasma were determined by reversed-phase high performance liquid chromatography method fol--159lowing a single oral dose of two different indomethacin sustained-release capsules respectively given to 18 volunteers for studying on the pharmacokinetics and bioavailability in vivo. RESULTS: The concentration-time curves of the two formulations were conformed to one compartment open model. The results of statistical analysis showed that there was no significant difference between the two formulations in the t_(max)、c_(max) and AUC0-∞（P>0. 05）. The relative bioavailability of native formulation was 103.02%. CONCLUSION: The two formulations are bioequivalent.