粉末直接压片法制备布洛芬分散片  

Preparation of ibuprofen dispersible tablets by direct compression of powder

作　　者：柴宝丽[1] 王双侠[1] CHAI Bao-li;WANG Shuang-xia(School of Food and Pharmaceutical Engineering,Suihua University,Suihua 152061,China)

机构地区：[1]绥化学院食品与制药工程学院,黑龙江绥化152061

出　　处：《哈尔滨商业大学学报（自然科学版）》2020年第2期137-141,共5页Journal of Harbin University of Commerce：Natural Sciences Edition

基　　金：绥化学院科学技术研究项目(项目编号:K1301004)。

摘　　要：研究确定了直接压片法制备布洛芬分散片的处方及工艺.采用经反溶剂结晶法制备的布洛芬微粉为主药,通过单因素试验,以溶出度为考察指标,筛选填充剂、崩解剂、助流剂,确定分散片基本处方.通过正交试验,以颗粒休止角、溶出度、分散均匀性为考察指标,根据其在成型性、质量稳定性所占权重拟定评分标准,设计4因素3水平正交试验,以综合评分结果确定最优处方.最终确定的布洛芬分散片处方为:以乳糖∶微晶纤维素=6∶4及12%预胶化淀粉为填充剂,以10%交联聚乙烯吡咯烷酮(PVPP)为崩解剂,以0.8%二氧化硅改善流动性,以此处方及工艺制得的布洛芬分散片溶出度好,分散均匀性及其他质量指标均符合《中国药典》要求.The formulation and process of preparation of ibuprofen dispersible tablets by direct tablet pressing were determined in this paper.Ibuprofen powder prepared by anti-solvent crystallization method was used as the main drug,and the basic prescription of dispersible tablets was determined by single factor test and screening filling agent,disintegrating agent and low aid with dissolution as the inspection index.Through orthogonal test and with angle of repose of particles,dissolution and dispersion uniformity as the examination indicators,the four-factor and three-horizontal orthogonal test was designed according to its weight in molding,quality stability to draw up scoring criteria to determine the best formula with the comprehensive scoring results.The final formula for ibuprofen dispersible tablets was:taking lactose∶avicel=6∶4 and 12%amylum pregelatinisatum as the filler,taking 10%crospolyvinylpyrrolidone(PVPP)as the disintegrating agent,improving its flowability with 0.8%silicon dioxide.Ibuprofen dispersible tablets prepared with this formulation and process were good in the dissolution.The dispersion uniformity and other quality indexes met the requirements of Chinese Pharmacopoeia.

关 键 词：布洛芬 微粉 分散片 直接压片 溶出度 分散均匀性 

分 类 号：R943[医药卫生—药剂学]