富马酸氯马斯汀分散片的研制与质量控制  

Study on preparation of Clemastine Fumarate Dispersible Tablets and its quality control

作　　者：焦守宗 

机构地区：[1]山东博山制药有限公司,山东淄博255215

出　　处：《药学研究》2013年第4期226-228,共3页Journal of Pharmaceutical Research

摘　　要：目的制备富马酸氯马斯汀分散片。方法以崩解时间为指标,筛选填充剂和崩解剂,以正交试验确定处方。结果填充剂以微晶纤维素、崩解剂以交联聚维酮效果最佳,崩解时限、分散均匀度均达到《中国药典》2010年版(二部)要求。结论本试验研制的富马酸氯马斯汀分散片溶出迅速,工艺合理。Objective To prepare Clemastine Fumarate Dispersible Tablets. Methods With disintegration time as index, bulking agent and disintegrating agent were optimized and the prescription was confirmed by orthogonal experiment. Resuits With microcrystalline cellulose as bulking agent and polyvinylpolypyrrolidone as disintegrating agent, the result was best. Disintegration time limit and dispersion uniformity all met the requirements in 2nd Section of Chinese Pharmacopoeia （2010 edition）. Conclusion The dissolution of Clemastine Fumarate Dispersible Tablets in this study was rapid and the process was reasonable.

关 键 词：富马酸氯马斯汀 分散片 处方筛选 

分 类 号：R927.1[医药卫生—药学]