氧化苦参碱缓释胶囊的制备及体外释放特性研究

Preparation and in vitro release of oxymatrine sustained-release capsules

目的制备氧化苦参碱24h缓释胶囊并对其体外释放特性进行研究。方法采用流化床包衣法,先将氧化苦参碱与聚乙烯吡咯烷酮溶于85%乙醇中,喷于空白丸芯制成含药微丸,再以乙基纤维素水分散体(Surelease()作为主要包衣材料进行包衣,得微丸装胶囊。建立体外分析方法并进行体外释药模型拟合。结果该缓释胶囊的释药符合Higuchi方程,具有缓释制剂的体外溶出特征。结论苦参碱缓释胶囊制备工艺简单,释药稳定,具备优良缓释制剂的特征。

Objective To study the preparation and the in vitro release of oxymatrine 24 h sustained-release capsulesMethods Oxymatrine drug pellets were prepared by fluid bed with polyvinylpyrrolidone （PVP）. Then we coated sustained-release layer with ethylcellulose dipersion （Surelease） in different weight increases. The sustained-pellets were filled in capsules. The vitro analytical method was established and stability was investigated. The release data of the best prescription fit the release model equations. Results The in vitro drug release was consistent with Higuchi formula. The sustained-release capsules had the vitro release characteristics of sustained-release preparatum. Conclu-sion Oxymatrine 24 h sustained-release capsules have the characteristics of good sustained-release preparatum with stable release and simple technology.