双氯芬酸钠缓释微丸胶囊的制备

Preparation of diclophenac sodium sustained-release pellets

目的探讨双氯芬酸钠缓释微丸的制备工艺。方法采用离心造粒法制备双氯芬酸钠缓释微丸,分别对影响微丸收率和释放的因素进行考察。结果主药与辅料比例为1:5,制备含药素丸,分别用聚丙烯酸树脂RL/RS 20:1和7:3对素丸进行包衣,再将两种包衣微丸等比例配混,即可达到释放度要求。结论微丸制备工艺稳定,适于产业化放大。

Objective To prepare diclophenac sodium sustained - release pellets. Methods Diclophenac sodium sustained - release pellets were prepared by using a centrifugal granulator. The factors influencing the yield and releasing percentage were investigated. Results The pellets can be prepared with the drug/vehicle proportim of 1/5. To achieve the release standard, the pellets coated with Eudragit RL/RS 20：1 and RL/RS 7：3 should be mixed at the same quantity. Conclusions The process is stable and easy to industrial amplification.