Eudragit~ NM30D在双氯芬酸钠缓释骨架片中的应用

Application of Eudragit~ NM30D on Diclofenac sodium matrix tablet

目的研究双氯芬酸钠缓释片的处方和工艺,并了解聚合物的材料特性及释药机理。方法以聚合物Eudragit~ NM30D水分散体为缓释骨架材料和黏合剂,采用湿法造粒工艺制备双氯芬酸钠缓释骨架片。分别考察聚合物用量、填充剂种类、用量和颗粒大小对药物释放速率的影响。结果Eudragit~ NM30D聚合物在双氯芬酸钠缓释片中可起到缓释骨架的作用;在湿法制粒工艺中,可直接用作黏合剂制粒,简化生产过程。干聚合物的用量为10%、以乳糖为填充剂制备的双氯芬酸钠缓释片的缓释效果与市售对照制剂相似。结论Eudragit~ NM30D可用于双氯芬酸钠缓释骨架片的研制开发,且具有用量少、处方简单、工艺重复性好的特点。

OBJECTIVE New product Eudragit~ NM30D was used as matrix material to develop a formulation of diclofenac sodium sustained release tablet in order to simplify the formulation and production process and to investigate the properties of this polymer.METHODS Eudragit~ NM30D was used as binder and controlling agent in wet granulation process to prepare a dicolfenac sodium matrix tablet.The influence of polymer amount,types of fillers and particle size were studied.RESULTS Eudragit~ NM30D could be used as susl...