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目的:研究国产奥卡西平分散片的人体生物等效性。方法:20名健康男性志愿者,分别随机交叉单剂量口服奥卡西平分散片(受试制剂)与奥卡西平片(参比制剂)300mg后,用高效液相色谱法测定血浆中奥卡西平的活性代谢物单羟基衍生物(MHD)的浓度,并用3p97软件计算药动学参数,对结果进行生物等效性评价。结果:20名受试者单剂量口服受试制剂与参比制剂后,MHD的Cmax分别为(4.231±0.841)、(4.350±0.861)μg·mL-1,tmax分别为(4.13±0.43)、(4.28±0.44)h,t1/2分别为(14.17±2.66)、(14.44±2.09)h,AUC0～60分别为(113.00±22.25)、(118.11±14.20)mg·h·L-1,AUC0～∞分别为(126.35±20.94)、(130.54±16.17)mg·h·L-1。受试制剂相对于参比制剂的生物利用度(F)为(95.67±12.80)%。结论:2种制剂生物学等效。
Objective: To study the bioequivalence of domestic oxcarbazepine dispersible tablets. Methods: Twenty healthy male volunteers were randomized to receive a single oral dose of oxcarbazepine dispersible tablets (test preparation) and oxcarbazepine tablets (reference preparation) at 300 mg respectively. The levels of oxcarbazepine in plasma were determined by HPLC Of the active metabolites monohydroxy derivatives (MHD) concentration, and 3p97 software pharmacokinetic parameters, the results of bioequivalence assessment. Results: The Cmax of MHD were (4.231 ± 0.841), (4.350 ± 0.861) μg · mL-1, and tmax were (4.13 ± 0.43), respectively, in 20 subjects after a single dose of oral test formulation and reference formulation (4.28 ± 0.44) h, t1 / 2 were (14.17 ± 2.66) and (14.44 ± 2.09) h respectively, AUC0 ~ 60 were (113.00 ± 22.25) and (118.11 ± 14.20) mg · h · L ~ ∞ were (126.35 ± 20.94) and (130.54 ± 16.17) mg · h · L-1, respectively. The bioavailability (F) of the test formulation relative to the reference formulation was (95.67 ± 12.80)%. Conclusion: The two preparations are bioequivalent.