摘要
目的:制备布洛芬缓释胶囊,达到与上市品芬必得体外释放相似。方法:以微晶丸芯包覆2%聚维酮的布洛芬乙醇液,再包覆尤特奇RL100(EUDRAGIT)缓释层,制得膜控球型缓释微丸的布洛芬缓释胶囊。结果:释放度试验在37.79-377.90mg/L浓度范围内线性关系良好(r=0.999 8)、精密度试验相对标准差(RSD)为1.08%、释放度均一性试验RSD<2.5%、释放20%的平均回收率为98.92%、释放50%的平均回收率为99.30%、释放80%的平均回收率为99.05%。布洛芬缓释胶囊与上市品芬必得作释放曲线对比试验,相似因子F2为71,两种制剂释放行为具有相似性。结论:本法制备的布洛芬缓释胶囊,药丸粒度均匀,外观圆润,工艺条件可控,质量重复性良好。与上市品芬必得对比的体外释放具有相似性。释放度符合中国药典2010年版布洛芬缓释胶囊的释放度质量标准。
Objective： To prepare sustained release capsules of Ibuprofen and to reach the same in vitro dissolution of Fenbid. Methods： The microcrystalline core was covered with Ibuprofen-ethanol mixtures which contains 2% povidone and then was wrapped up with RL100 （EUDRAGIT） as sustained release layer, thus membrane controlled release pellets was made for capsules of Ibu- profen. Results： The calibration curve in release test was linear in the range of 37. 79-377. 9 μg/ ml, r=0. 999 8. The relative standard deviation （RSD） was 1.08% in precision test and RSD 2.5% in release degree homogeneity test. The average recoveries were 98.92% （20% Ibuprofen was released）, 99. 30% （50% Ibuprofen was released）, and 99. 05% （80% Ibuprofen was re- leased）, respectively. Compared with the release of Fenbid, the similarity factor （F2） of the re- lease curves is 71. Conclusion： The tested capsule is round with uniformed size and the producing process is easy to repeat. The data shows that it has similar in vitro dissolution of Fenbid and it has remarkable sustained-release property in accordance with the standards of Chinese Pharmaco- poeia 2010.
出处
《武汉大学学报（医学版）》
CAS
北大核心
2013年第5期711-713,718,共4页
Medical Journal of Wuhan University
基金
江苏省盐城市科技计划项目(编号:yk2011124)
关键词
布洛芬
缓释胶囊
释放度
相似因子
Ibuprofen
Sustained-Release Capsule
Release Similarity Factor
