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目的:评价国产伊曲康唑片人体生物利用度和生物等效性。方法:22名健康男性受试者随机交叉口服伊曲康唑分散片和伊曲康唑胶囊,采用液相色谱-质谱-质谱联用法测定血浆中伊曲康唑的浓度,结果:受试药物和参比药物的药代动力学主要参数分别为:Tmax:4.55±0.83和4.25±1.02h;Cmax:170.7±70.8和155.5±73.3ng/ml;t1/2:19.3±4.6和20.4±11.4h;AUC0-t:2385±1281和2257±1168ng.h/ml,AUC0-∞:2496±1334和2371±1207ng.h/ml。以AUC0-t计算,伊曲康唑分散片的相对生物利用度平均为112.5±39.2%。结论:伊曲康唑分散片和伊曲康唑胶囊生物等效。
Objective: To evaluate the bioavailability and bioequivalence of domestic itraconazole tablets. Methods: Twenty-two healthy male subjects were randomized to receive itraconazole dispersible tablets and itraconazole capsules. The concentration of itraconazole in plasma was determined by liquid chromatography-mass spectrometry-mass spectrometry. Results: And the reference pharmacokinetic parameters were: Tmax: 4.55 ± 0.83 and 4.25 ± 1.02h; Cmax: 170.7 ± 70.8 and 155.5 ± 73.3ng / ml; t1 / 2: 19.3 ± 4.6 and 20.4 ± 11.4h ; AUC0-t: 2385 ± 1281 and 2257 ± 1168 ng.h / ml, AUC0-∞: 2496 ± 1334 and 2371 ± 1207 ng.h / ml. The relative bioavailability of itraconazole dispersible tablets was 112.5 ± 39.2% based on AUC0-t. CONCLUSION: Itraconazole dispersible tablets and itraconazole capsules are bioequivalent.