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目的 :研究健康受试者口服国产格列美脲片的人体相对生物利用度及生物等效性。方法 :2 0例健康志愿者采用随机交叉自身对照试验 ,分别单次口服国产及进口格列美脲片剂各 4mg ,用HPLC法检测血药浓度 ,以内标法定量。结果 :国产片与进口片的Cmax分别为 (462 .3± 1 32 .2 )及 (41 2 .4± 1 1 7.7) μg·L- 1 ;Tmax分别为 (3 .2± 0 .6)及(3 .3± 0 .8)h;t1 / 2 分别为 (7.1± 1 .5)及 (7.5± 1 .7)h ;AUC0 -t分别为 (2 571 .6± 564 .9)及 (2 362 .3± 51 9.6) μg·h·L- 1 ;AUC0～∞ 分别为 (2 769.8± 60 8.2 )及 (2 592 .4± 572 .5) μg·h·L- 1 。国产片与进口片比较生物利用度为 (1 1 1 .3±2 3 .3) %。Cmax,AUC0～t及AUC0～∞ 经生物等效性检验均为等效。结论 :国产格列美脲片相对进口品具生物等效性
Objective: To study the relative bioavailability and bioequivalence of orally administered glimepiride tablets in healthy subjects. Methods: Twenty healthy volunteers were randomized to cross-over self-controlled trials, 4mg of domestic and imported glimepiride tablets were respectively orally administrated. The plasma concentration of the drug was measured by HPLC and quantified by internal standard method. Results: The Cmax of domestic and imported tablets were (462.3 ± 132.2) and (41.2 ± 4.1 7.7) μg · L-1, respectively; the Tmax were (3.2 ± 0.6) And (3. 3 ± 0. 8) h respectively; t1 / 2 was (7.1 ± 1.5) and (7.5 ± 1.7) h respectively; AUC0-t was (2 571.6 ± 564.9) and (2 362.3 ± 51 9.6) μg · h · L -1 and AUC 0 ~ ∞ were (2 769.8 ± 60 8.2) and (2 592.4 ± 572.5) μg · h · L -1, respectively. The bioavailability of domestic and imported tablets was (1 1 1 .3 ± 2 3 .3)%. Cmax, AUC0 ~ t and AUC0 ~ ∞ by the bioequivalence test are equivalent. Conclusion: The domestic imported glimepiride tablets are bioequivalent