奥美拉唑肠溶胶囊含药丸芯工艺改进研究

Study on Improvement of Pill Core Technology of Omeprazole Enteric-Dissolved Capsules

奥美拉唑结构中含有磺酰基苯并咪唑化学结构,属于弱碱性化合物,在酸性及见光条件下会很快分解,因此,用1.0%甘露醇做主要填充剂,加入辅料羟丙纤维素EXF、羟丙纤维素LH-32、微晶纤维素、200目乳糖、十二烷基硫酸钠和磷酸氢二钠,用12.5%比重的纯化水制成软料,采用挤出-滚圆方法制备奥美拉唑含药丸芯,选用1~2 mm孔径挤出机筛选,设置挤出机送料速度为30 rpm,挤出速度为30 rpm。将挤出物料放入滚圆机,设置滚圆速度为500 rpm,滚圆时间为1 min,出料后得含药丸芯,该工艺提高了奥美拉唑的得率和含量。

Omeprazole structure containing benzene and imidazole sulfonyl chemical structure,belongs to the weak alkaline compound,under the condition of acid and see the light will soon decomposition,so do the main filler with 1.0%mannitol,add accessories EXF hydroxypropyl cellulose,hydroxypropyl cellulose LH-32,microcrystalline cellulose,200 mu of lactose,sodium dodecyl sulfate and sodium hydrogen phosphate,with a 12.5%share of purified water is made of soft materials,extrusion-rolling method preparation of omeprazole contain pill core,choose 1~2 mm aperture extruder filter,set the extruder feeding speed of 30 rpm,speed of 30 rpm,extrusion.Put the extruder into the rounding machine,set the rounding speed as 500 rpm,and the rounding time as 1 min.After the material is discharged,the pill core can be obtained to improve the yield and content of omeprazole.