乙基纤维素骨架缓释片处方工艺对水溶性药物释放的影响因素研究

目的 探索以乙基纤维素（EC）作为骨架材料制备缓释片时,不同处方、不同工艺对水溶性药物释放的影响.方法 以紫外分光光度法为检测方法和累积释放度为检测指标,通过单因素试验,考察各因素对水溶性模型药物盐酸维拉帕米EC骨架缓释片中药物释放的影响.结果 制备方法、EC用量以及与主药比例、片剂硬度、片剂比表面积、EC黏度、EC粒径、EC生产厂家等因素均对药物的释放有明显影响,在实验中润湿剂用量的影响可以忽略.结论 从实验中获得的影响因素数据,为水溶性药物EC骨架缓释片的研制提供参考.

Investigation on the influence-factor of preparation of ethyl cellulose ethoce matrix sustained-release tablets for water-soluble drug

Objective To systematically investigate the factors of preparation of ethyl cellulose ethoce matrix sustained-release tablets for water-soluble drug. Methods Cordilox was taken as a water - soluble model drug, accumulative release rate was taken as index testing by ultraviolet spectrophotometry,to study the influencing factors through single-factor test, to determine the release degree of ethyl cellulose ethoce matrix sustained-release tablets. Results These preparation parameters such as preparation method, amount, viscosity and grain size and manufacturer of ethyl cellulose ethoce, tablet hardness and specific surface area that were proved to had sig- nificantly influence on the accumulative release rate. Conclusion After a series of comprehensive researches, some references could be provided for further study on in vitro release of water - soluble drug from ethyl cellulose ethoce matrix sustained - release tablets.