摘要
目的基于固体分散技术制备布洛芬缓释微丸胶囊并对其进行质量评价。方法采用流化床喷雾干燥工艺,以空白丸芯为基丸,硬脂酸为隔离层,PVP为载体材料制备布洛芬骨架型缓释微丸,并对影响药物释放的处方因素、制备工艺因素、测定方法等进行考察,并对所制备的布洛芬缓释微丸胶囊进行质量评价。结果制备的缓释微丸含量均匀、释放均一、圆整度好、粒度分布窄、载药量大、收率高。结论基于固体分散技术流化床包衣制备的布洛芬缓释微丸,辅料用量少、原药无需微粉化、工艺简单、质量可靠,适合产业化生产。
OBJECTIVE To prepare ibuprofen sustained release pellet capsules based on solid dispersion technology and evaluate the quality. METHODS Ibuprofen matrix sustained release pellets were prepared by fluidized-bed spray drying process, using blank pill core as based pills, stearic acid as isolation layer, and PVP as carrier material. The factors itffluencing the pellet release were stud- ied, including coating dispersion, preparation method, and assay method of release. RESULTS The prepared ibuprofen sustained re- lease pellets had ideal controlled release and characteristics, including particle size, spherical degree, drug loading, and content. CON- CLUSION A new preparation method of ibuprofen sustained release pellets with advantages of less adjuvants, no deed to micronize crude drug, simple process, and controllable quality is successfully developed. It can be used in industrialized manufacture.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第22期1938-1943,共6页
Chinese Pharmaceutical Journal
基金
深圳市重大产业技术攻关计划项目(SW201110152)
关键词
布洛芬
缓释微丸
流化床
固体分散技术
ibuprofcn
sustained release pellet
fluidized bed
solid dispersion technology
