头孢呋辛酯片制剂工艺研究

目的：通过选择合适辅料及适当的工艺方法，制备溶出度符合要求的头孢呋辛酯片。方法：考察包括淀粉、微晶纤维素、乳糖、羟丙纤维素钠、羧甲基淀粉钠、交联聚维酮、硬脂酸镁、滑石粉、十二烷基硫酸钠、聚维酮K30、微粉硅胶、2％HPMC水溶液、5％HPMC水溶液等辅料进行湿法制料压片、粉末直接压片对样品溶出的影响。结果：采用内外加法添加羧甲基淀粉钠，用微粉硅胶吸附原辅材料，湿法制粒压片，片芯迅速崩解为颗粒，然后再将其崩解为细粉，这样有利于颗粒继续崩解成细小颗粒，样品溶出度较为理想，符合质量标准要求。结论：该方法制备工艺简单，设备要求低。且成品合格率高，可用于头孢呋辛酯片的规模化生产。

Study on preparation process of Cefuroxime Axetil Tablets

Objective:To prepare the Cefuroxime Axetil Tablets with the dissolution rate meeting the requirements,by selecting the right auxiliary materials and appropriate processing methods.Methods:The impact of starch,microcrystalline cellulose,lactose,hydroxypropyl cellulose sodium,sodium carboxymethyl starch,cross-linked povidone,magnesium stearate,talc powder,lauryl sodium sulfate,povidone K30,aerosil,2% HPMC aqueous solution,5% HPMC aqueous solution and other auxiliary materials used in the wet process material ...