国产米氮平片人体生物等效性研究

Study on Bioequivalente of Domestic Mirtazapine

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 relative Bioavailability and Bioequivalence of Domestic Mirtazapine Tablet. Methods：The bioavailability and bioequivalence of Mirtazapine Tablets in cross-over trial in 22 healthy volunteers after oral admintrarion of two kinds of tablets domestic and imported , drug concentration in plasma was assayed by HPLC/MS/MS. Results：The main pharmacokinetic parameters for the test product and referenc product showed Tmax： 1.43±0.72 and 1.43±0.71 h; Cmax：69.1±34.8 and 65.44±35.3 ng/ml;24.5±6.1 and 23.8±6.1 h AUC0-t AUC0-t ;842±378 and 814＋±419 ng · h/ml;AUC0-∞：885±403 and 857±436 ng· h/ml. Conclusion, The two formulations were bioequivalent.