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目的:研究国产格列美脲片剂的药代动力学和相对生物利用度。方法:18名健康志愿者随机交叉单剂量口服国产与进口格列美脲4mg,采用柱前衍生化HPLC－紫外法测定其血药浓度。结果:国产片与进口片的主要药代动力学参数tmax分别为3.44±0.92和2.79±0.88h,Cmax分别为2.96.1±108.4和331.8±103.3μ·L-1,t(1/2)ke分别8.03±3.01和 7.73±2.79h,AUCO-t分别为2307.9±800.9和 2302.8±794.8μg·h·L-1,AUC0-∞分别为2672.7±990.5和2589.1±752.5μg·h·L-1。国产片的相对生物利用度为102.4%±19.7%。结论:统计学结果显示,两种片剂具有生物等效性。
Objective: To study the pharmacokinetics and relative bioavailability of domestic glimepiride tablets. Methods: Eighteen healthy volunteers were randomized to receive a single oral dose of glimepiride (4 mg). The plasma concentrations of glimepiride were determined by precolumn derivatization HPLC-UV. Results: The main pharmacokinetic parameters of domestic and imported tablets tmax were 3.44 ± 0.92 and 2.79 ± 0.88h, Cmax were 2.96.1 ± 108.4 and 331.8 ± 103.3μ · L-1, t (1/2) ke were respectively 8.03 ± 3.01 and 7.73 ± 2.79h, with AUCO-t of 2307.9 ± 800.9 and 2302.8 ± 794.8μg · h · L-1, respectively, and AUC0-∞ of 2672.7 ± 990.5 and 2589.1 ± 752.5μg · h · L-1 . The relative bioavailability of domestic tablets was 102.4% ± 19.7%. Conclusion: The statistical results show that the two tablets are bioequivalent.