盐酸曲马多骨架片的药物释放影响因素研究

 目的制备盐酸曲马多缓释骨架片,并对其体外药物释放影响因素和释药特性进行研究。方法分别采用不同黏度与用量的羟丙甲纤维素(HPMC),不同主药粒径与稀释剂,不同工艺制备盐酸曲马多缓释片。结果主药粒径、HPMC黏度、稀释剂、释放介质、制备工艺和压片力对药物释放影响不大,随着HPMC和预胶化淀粉(Starch 1500)用量的增加释药速率降低。结论研制的盐酸曲马多缓释片体外药物释放过程符合Higuchi方程,HPMC用量和预胶化淀粉(Starch 1500)是影响药物释放的主要因素。

Study on influencing factors on release of tramadol hydrochloride from matrix tablets

OBJECTIVE To prepare tramadol hydrochloride sustained release tablets and investigate the influencing factors on the release of tramadol hydrochloride from matrix tablets and drug release characteristics. METHODS Different particle size of tramadol hydrochloride, viscosity grades and the amount of HPMC, additive content and process were used to prepare tramadol hydrochloride sustained release tablets. RESULTS The tramadol hydrochloride partical size, HPMC viscosity grades, diluent agent, release medium, process and pressure used had little influence on drug release. The larger amount of HPMC and pregelatinized starch (Starch 1500) resulted in the slower release rate. CONCLUSION The release behavior of the tramadol hydrochloride sustained release tablets follow the Higuchi equation and the main factors affecting drug release are the content of HPMC and pregelatinized starch (Starch 1500),