摘要
目的应用挤出滚圆法及流化床包衣制备盐酸奈福泮缓释微丸和萘普生钠肠溶缓释微丸,并对各自性质进行考察。方法采用国产挤出滚圆机制备盐酸奈福泮微丸和萘普生钠微丸,运用L9(34)正交设计实验优化工艺条件;用微型流化床包衣设备,将盐酸奈福泮微丸包缓释衣、萘普生钠微丸包肠溶衣和缓释衣,分别考察两种微丸的粉体学性质及不同包衣增重微丸的体外释放实验。结果制得的盐酸奈福泮缓释微丸和萘普生钠肠溶缓释微丸圆整度好,大小均匀,体外释放也比较理想。结论应用挤出滚圆机制备盐酸奈福泮微丸和萘普生钠微丸工艺简便,圆整度好,硬度适宜,收率较高;采用适当的包衣工艺,可制得质量良好的盐酸奈福泮缓释微丸和萘普生钠肠溶缓释微丸。
OBJECTIVE To prepare nefopam hydrochloride（Nef） pellets and naproxen sodium （Npx-S） enteric-coated sustainedrelease pellets by the extrusion spheronization technology and the fluidized bed coating technology and to determine the pellets＇ properties. METHODS Nef pellets and Npx-S pellets were prepared using extrusion spheronization equipment. L9 （34 ） orthogonal design was used to obtain optimal formulation. Using fluid bed coating equipment, the Nef pellets were coated with sustained-release coats, the Npx-S pellets were coated with enteric coats and sustained-release coats. The micromeritic properties and in vitro dissolution of the two preparations were determined. RESULTS The pellets were round, smooth and even. The in vitro dissolution was also perfect. CONCLUSION The process of extrusion spheronization for preparing pellets is simpte and quick with excellent quality of pellets. Appling a proper coating technology, the coated pellets can be made successfully.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2011年第8期605-609,共5页
Chinese Pharmaceutical Journal
关键词
盐酸奈福泮
萘普生钠
挤出滚圆
微丸
流化床包衣
体外释放度
nefopam hydrochloride
naproxen sodium
extrusion spheronization
pellets
fluidized bed coating technology
dissolution in vitro
