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目的研究国产盐酸安非他酮缓释片在中国健康人体内的药代动力学特征。方法19名健康男性志愿者单剂量口服300mg盐酸安非他酮缓释片,采用HPLC法测定血浆中盐酸安非他酮浓度,并用3P97软件统计处理。结果盐酸安非他酮供试缓释片药时曲线符合二室模型,其Cmax为(221.08±64.42)μg·L-1;tmax为(2.95±0.78)h,t1/2为(16.78±5.26)h;AUC0-48为(1758.4±323.7)μg·L-1·h;AUC0-∞为(1969.2±351.4)μg·L-1·h。结论为临床合理用药提供了参考资料。
Objective To study the pharmacokinetics of domestic bupropion hydrochloride sustained-release tablets in healthy Chinese. Methods Nineteen healthy male volunteers were given a single oral dose of 300 mg bupropion hydrochloride sustained-release tablets, and the plasma concentrations of bupropion hydrochloride were determined by HPLC and analyzed by 3P97 software. The results showed that the Cmax of bupropion hydrochloride sustained release tablets was (221.08 ± 64.42) μg · L-1, tmax was (2.95 ± 0.78) h and t1 / 2 was (16.78 ± 5.26) ) h; AUC0-48 was (1758.4 ± 323.7) μg · L-1 · h; AUC0-∞ was (1969.2 ± 351.4) μg · L-1 · h. Conclusion provides a reference for clinical rational drug use.