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目的:比较两种格列美脲制剂的人体生物等效性。方法:20名健康男性志愿者随机交叉口服单剂量格列美脲分散片(受试制剂)与格列美脲片(参比制剂)2 mg,采用HPLC-MS法测定血浆中格列美脲浓度,用DAS 2.1软件计算药动学参数和生物利用度。结果:口服格列美脲受试制剂与参比制剂后的药动学参数分别为以C_(max)(135.4±40.3)和(146.5±39.2)ng·ml~(-1),t_(max)(3.2±1.2)和(2.8±0.9)h,t_(1/2)(7.3±3.9)和(6.7±2.8)h,AUC_(0-36)(757.1±217.2)和(849.4±250.4)ng·h·ml~(-1),AUC_(0-∞)(784.0±217.4)和(871.5±265.2)ng·h·ml~(-1)。受试制剂的相对生物利用度为(90.7±17.5)%。结论:两种格列美脲制剂具有生物等效性。
Objective: To compare the bioequivalence of two glimepiride preparations. Methods: Twenty healthy male volunteers were randomized to receive oral administration of glimepiride dispersible tablets (test preparation) and glimepiride tablets (reference preparation) at a randomized interval of 2 mg. Plasma glimepiride Concentration, pharmacokinetic parameters and bioavailability were calculated using DAS 2.1 software. Results: The pharmacokinetic parameters of glimepiride in the test preparation and the reference preparation were respectively Cmax (135.4 ± 40.3) and (146.5 ± 39.2) ng · ml -1, t max ) Were significantly lower than those in the control group (P <0.01), (3.2 ± 1.2) and (2.8 ± 0.9) h, t 1/2 (7.3 ± 3.9) and (6.7 ± 2.8) h, AUC 0-36 (757.1 ± 217.2) and (849.4 ± 250.4) ng · h · ml -1, AUC 0 -∞ (784.0 ± 217.4) and (871.5 ± 265.2) ng · h · ml -1, respectively. The relative bioavailability of the test preparation was (90.7 ± 17.5)%. Conclusions: Both glimepiride formulations are bioequivalent.