iData_头孢呋辛酯片干法制备工艺条件研究_胡世国.pdfVIP

* 胡世国 (重庆医药高等专科学校,重庆市 4 0003 0 ) R944.4;R978.1+1;TQ460.6 A 100 1-0408 (2008 )10-0767-03 目的:研究头孢呋辛酯片的干法制备工艺条件,确定制备方法。方法:以颗粒粒度、流动性及成品 为考察指标, 筛选干法 制粒的工艺条件, 并进行质量考察和稳定性研究。结果:确定干法制粒三要素分别为液压压力2.5 ～3 MPa、挤压速度15 ～20 r · -1 -1 min 、加料速度200 ～300 g ·min , 控制压饼厚度1 ～2 mm 。循环干法制粒的合格颗粒(16 ～30 目)可达90 %以上, 休止角约 30°, 流动顺畅,压片成品 约94 %,经加速试验和长期稳定性试验考察, 各项指标符合2005 年版《中国药典》相关规定。结论:经筛 选后的工艺参数及微调后的处方能适应干法制粒的要求,产品稳定性优于湿法样品,工艺重现性良好,生产周期缩短。 头孢呋辛酯片;干法制粒;颗粒粒度;流动性;成品 ;稳定性 Pre aration of Cefuroxime Axetil Tablets b Dr Granulation p y y HU Shi-guo(Chongqing Medical School of Higher Learning, Chongqing 400030, China) ABSTRACT BJECTIVE:To study the dry granulating technology in the preparation of cefuroxime axetil tablets so as to establish the preparative method.METH DS :With granule size, fluidity and yield as indexes to optimize the dry granulating technology for cefuroxime axetil tablets, and a comparative study was conducted on quality and stability of the samples pre- pared by wet process.RESULTS :The optimum conditions for the dry granulating technique were as follows:hydraulic pres- -1 -1 sure =2.5 ～3 MPa, extrusion rate =15 ～20 r ·min , owder feed rate =200 ～300 ·min .The extrusion thickness was p g controlled at 1 ～2 mm.B circular dr ranulatin method, the ro ortion of ualified ranules (16 ～30 meshes)was as hi h y y g g p p q g g as above 90 %, with an an leof re ose of 30°and ood mobilit , and the ield was about 94 %, with all indexes in line with the g p g y y standards s ecified in Chinese Pharm aco oeia (2005 edition)in the accelerated test and ermanent stabilit test .C NCLU- p p