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目的:评价国产米氮平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国产和进口米氮平片,采用液相色谱-质谱-质谱联用法测定血浆中米氮平的浓度,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:1.43±0.72和1.43±0.71 h;Cmax:69.1±34.8和65.4±35.3 ng/ml;t?:24.5±6.1和23.8±6.1h;AUC0-t:842±387和814±419 ng·h/ml;AUCO-∞:885±103和857±436 ng·h/ml。以AUCO-t计算,米氮平片的相对生物利用度平均为107.3±19.2%。结论:国产与进口米氮平片生物等效。
Objective: To evaluate the bioavailability and bioequivalence of domestic mirtazapine tablets. METHODS: Twenty-two healthy male subjects were randomized to receive domestic and imported mirtazapine at randomized crossover intervals and plasma concentrations of mirtazapine were determined by liquid chromatography-mass spectrometry-mass spectrometry (GC-MS). Results: Drugs and reference drugs The main parameters of the kinetics were: Tmax: 1.43 ± 0.72 and 1.43 ± 0.71 h; Cmax: 69.1 ± 34.8 and 65.4 ± 35.3 ng / ml; t ?: 24.5 ± 6.1 and 23.8 ± 6.1 h; AUC0-t: 842 ± 387 and 814 ± 419 ng · h / ml; AUCO-∞: 885 ± 103 and 857 ± 436 ng · h / ml. The relative bioavailability of mirtazapine was 107.3 ± 19.2% on an AUCO-t basis. Conclusion: Domestic and imported mirtazapine tablets are bioequivalent.