盐酸曲马多缓释片的制备及药动学研究  

Studies on Sustained Release Tablets of Tramadol Hydrochloride and its Human Pharmacokinetics

作　　者：孙国庆[1] 朱颖[1] 刘艳梅 王锦宏 平其能[1] 

机构地区：[1]中国药科大学药剂学教研室,南京210009

出　　处：《中国药科大学学报》1996年第7期408-411,共4页Journal of China Pharmaceutical University

摘　　要：研制了盐酸曲马多缓释片,其体外溶出符合一级动力学过程,释药常数K_t=0.198h^(-1)。盐酸曲马多体内吸收符合一室模型,药动学参数为K_a=0.5702 h^(-1),K=0.0856h^(-1),C_(max)=219.57 ng/ml,T_(max)=4.62h,AUC_(0→∞)=3721.09 ng/ml·h。经双单侧t检验,结果表明普通胶囊与缓释片的C_(max)、T_(max)具有显著性差异,而AUC_(0→∞)无差异,表明两制剂生物等效。Sustained release tablet of tramadol hydrochloride(SRT) and its human pharmacokinetics were studied. The drug release pattern in vitro of the SRT was well described by one-order kinetics, and in vivo profiles were demonstrated to fit one compartment model. The pharmacokinetic parameters K_a, K, C_(max), T_(max) and AUC_(0→∞) of SRT were 0.5702h^(-1), 0.0856 h^(-1), 219.57ng/ml, 4.62h, and 3721.09ng/ml·h, respectively. The SRT was bioequivalent to the capsule.

关 键 词：盐酸曲马多 缓释片 药代动力学 

分 类 号：R971.1[医药卫生—药品]