挤出滚圆法制备克拉霉素微丸的处方工艺研究

Process of Clarithromycin pellet by extrusion-spheronization method

目的应用挤出滚圆法制备克拉霉素微丸,研究微丸制备的最佳工艺和处方。方法采用挤出滚圆造粒机制备克拉霉素微丸;采用单因素考察和正交设计筛选最优化处方及工艺条件;评价了微丸的粉体学性质、收率和体外溶出度〔1〕。结果用挤出滚圆法制备的克拉霉素微丸在30min内体外溶出均达80%以上,且圆整度好,收率高。结论挤出滚圆法制备克拉霉素微丸工艺简便易行,制得的微丸质量好,收率高,体外释药迅速。

OBJECTIVE To study the formulation and process of Clarithromycin formulation pellet by extrusion-spheronization.METHODS Clarithromycin pellet was prepared by extrusion-spheronization equipment;The optimal process and formulation were obtained on the studies of influenitial factors and L9（34） orthogonal design,.Then their characters were evaluated.RESULTS The active components could release more than 90% in 30 min and the pellet spresented a perfect sphericity.CONCLUSION Clarithromycin formulat ion pellet could be prepared by extrusion-spheronization machine and the pellet s show a perfect sphericity.In vitro dissolution is satisfactory with high quality and yield.