盐酸安非他酮缓释片人体药代动力学研究

Pharmacokinetics of Bupropion Hydrochloride Sustained Release Tablets in Chinese Healthy Volunteers

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 bupropion hydrochloride sustained release tablets in Chinese healthy volunteers. Method: 19 male healthy subjects received a single oral dose of 300 mg bupropion hydrochloride sustained release tablets. The plasma concentrations of bupropion hydrochloride were determined by an improved HPLC method. Data of plasma level time were disposed with 3P97 software.Result: The main pharmacokinetic parameters of bupropion hydrochloride were as follow: C max was ( 221.08 ± 64.42 )μg·L -1 , t max was ( 2.95 ± 0.78 )h,t 1/2 was ( 16.78 ± 5.26 ) h,AUC 0-48 h was( 1758.4 ± 323.7 )μg·L -1 ·h, AUC 0-∞ was ( 1969.2 ± 351.4 ) μg·L -1 ·h .Conclusion: The study presented useful information for clinical trials.