头孢呋辛酯片干法制备工艺条件研究

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、流动性及成品率为考察指标,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2·5～3MPa、挤压速度15～20r·min-1、加料速度200～300g·min-1,控制压饼厚度1～2mm。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,压片成品率约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。

Preparation Of Cefllroxilme Axetil Tablets by Dry Granulation

OBJECTIVE： To study the dry granulating technology in the preparation of cefuroxime axetil tablets so as to establish the preparative method. METHODS： 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 prepared by wet process. RESULTS： The optimum conditions for the dry granulating technique were as follows： hydraulic pressure = 2,5-3 MPa, extrusion rate = 15-20 r·min^-1, powder feed rate= 200--300 g·min^-1. The extrusion thickness was controlled at 1--2 mm, By circular dry granulating method, the proportion of qualified granules （16--30 meshes） was as high as above 90%, with an angle of repose of 30° and good mobility, and the yield was about 94%, with all indexes in line with the standards specified in Chinese Pharmacopoeia （2005 edition） in the accelerated test and permanent stability test, CONCLUSION： The optimized technological parameters and the mildly readjusted formulation can meet the requirements for the dry granulation method, with the stability of the product superior to that by wet method, and this method has a good reproducibility and shorter production cycle.