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目的 :研究复方二甲双胍胶囊在健康受试者体内的药物动力学和相对生物利用度。方法 :2 0名男性志愿者随机交叉口服复方二甲双胍胶囊 (试验药 )或合用二甲双胍片 格列本脲片 (参比药 ) ,HPLC 紫外法和LC MS法测定人血浆中二甲双胍和格列本脲浓度 ,计算药动学参数和相对生物利用度。结果 :口服试验药和参比药后二甲双胍的Cmax 分别为1.87± 0 .36和 1.77± 0 .35mg·L-1;Tmax为 1.7± 0 .6和 1.8± 0 .5h ;AUC0 -∞ 为 8.13± 1.32和 8.6 2±1.4 7mg·L-1·h-1,格列本脲的Cmax分别为 12 9.2±5 1.4和 12 3.9± 5 0 .7μg·L-1;Tmax 为 2 .3± 0 .7和2 .6± 0 .9h ;AUC0 -∞ 为 0 .6 90± 0 .2 2 8和 0 .6 32±0 .2 11mg·L-1·h-1,以上参数在试验药和参比药之间皆无显著性差异。试验片中二甲双胍和格列本脲相对于参比药的生物利用度分别为 95 .0 %±11.5 %和 10 9.6 %± 8.8%。结论 :复方二甲双胍胶囊中二甲双胍和格列本脲与参比药相比皆生物等效
Objective: To study the pharmacokinetics and relative bioavailability of compound metformin capsules in healthy volunteers. Methods: Twenty male volunteers were randomized to receive metformin capsules (test drug) or metformin tablets (reference drug) randomly. HPLC and UV-vis were used to determine the concentration of metformin and glyburide Concentration, pharmacokinetic parameters and relative bioavailability were calculated. Results: The Cmax values of oral metformin and reference drug metformin were 1.87 ± 0.36 and 1.77 ± 0.35 mg · L-1, respectively. The Tmax was 1.7 ± 0.6 and 1.8 ± 0.5 h, and the AUC0-∞ was 8.13 ± 1.32 and 8.6 2 ± 1.4 7 mg · L-1 · h-1, respectively. The C max of glibenclamide were 12 9.2 ± 5 1.4 and 12 3.9 ± 50.7 μg · L-1, respectively. The Tmax was 2.3 ± 0 .7 and 2 .6 ± 0 .9 h; AUC0-∞ was 0.690 ± 0.228 and 0.632 ± 0.21 11 mg · L-1 · h-1, the above parameters in the test drug and There was no significant difference between the reference drugs. The bioavailability of metformin and glyburide relative to the reference drug in the test panels was 95.0% ± 11.5% and 10 9.6% ± 8.8%, respectively. Conclusion: Both metformin and glibenclamide in metformin capsules are bioequivalent compared with reference drugs