盐酸曲马朵双层片的研制

Studies on the double layer tablet of tramadol hydrochloride

目的 制备盐酸曲马朵 (TMD)速释缓释双层片并对其体外释药 ,体内动力学进行研究。方法 正交试验设计优选缓释层处方。对双层片试制品与进口对照品进行体外释药和体内动力学的研究。体外释放采用转篮法 ,以紫外分光光度法测定。体内释药以家兔为实验动物 ,HPLC 荧光检测法定量。结果 双层片试制品具明显缓释作用。释药特性与进口对照药基本一致。

OBJECTIVE To investigate the preparation of the double layer tablet of tramadol hydrochloride(TMD)and tostudy its in vitro/in vivo release.METHOD Orthogonal design was used to determine theoptimal formulation of the sustained release layer of the tablets.The characteristics of the in vitro/in vivo release were compared between the prepared tablets and the imported tablets.The dissolution was tested by rotating basket method and was determined by UVspectrophotometry. In vivo study,rabbits' serum concentration was determined by HPLCmethod with a fluorescence detector.RESULT The sustained release property of theprepared double layer tablets was remarkable and there was no significant differencebetween the pharmacokinetic parameters of the prepared and imported tablets.CONCLUSION TMD double layer tablets provide an ideal preparation for the study of central analgesicsdomestic.