文献类型：期刊文献

中文题名：左羟丙哌嗪-β-环糊精包合物分散片的制备与评价

英文题名：Preparation and evaluation of dispersible tablets containing levodropropizine-β-cyclodextrin inclusion complexes

作者：王慧娟 郭东贵 赵珊 李俐 周英

第一作者：王慧娟

机构：[1]贵州大学药学院;[2]贵州省药食两用资源应用开发工程实验室;[3]贵州理工学院制药工程学院

第一机构：贵州大学药学院,贵州贵阳550025

年份：2017

卷号：37

期号：7

起止页码：583-586

中文期刊名：中国医院药学杂志

外文期刊名：Chinese Journal of Hospital Pharmacy

收录：CSTPCD;;北大核心:【北大核心2014】；

基金：贵州省科技创新人才团队项目[编号:黔科合人才团队(2015)4010号];贵州省科技计划项目[编号:黔科合G字(2015)4001];贵州省发展和改革委员会工程实验室建设项目[编号:黔发改投资(2015)542号]

语种：中文

中文关键词：左羟丙哌嗪;分散片;β-环糊精;包合物;制备

外文关键词：levodropropizine; dispersible tablets; β-cyclodextrin; inclusion complexes; preparation

摘要：目的:优选左羟丙哌嗪-β-环糊精包合物分散片的处方组成与制备工艺。方法:制备左羟丙哌嗪-β-环糊精包合物,并以此为中间体添加适宜的辅料制备分散片。以崩解时限、片剂外观等为评价指标,进行处方及制备工艺的全面考察优化。结果:分散片最优处方为:左羟丙哌嗪-β-环糊精包合物80.0%,L-HPC10.0%,MCC9.6%,硬脂酸镁0.4%。其崩解时间不超过60 s,5 min溶出可达85%以上。结论:该分散片处方设计简单合理,工艺稳定可行,符合《中国药典》2015年版的规定。
OBJECTIVE To screen the optimal formula and preparation process for dispersible tablets containing levodropropizine-β-cyclodextrin inclusion complexes.METHODS Levodropropizine-β-cyclodextrin inclusion complexes were prepared firstly and used as the intermediates, then dispersible tablets were developed with inclusion complexes mixed with some appropriate excipients. The prescription composition and preparation process were optimized and evaluated by using disintegration time and tablet appearance as indicators.RESULTS The optimal formulation was as follows：80.0% β-cyclodextrin inclusion complexes, 10.0% L-HPC, 9.6% MCC and 0.4% magnesium stearate. The disintegration time of dispersible tablets was no more than 60 s.Dissolution of levodropropizine from dispersible tablets at 5 min was ≥ 85%.CONCLUSION The dispersible tablets have simple, reasonable prescription and stable, feasible preparation process. It meets the requirements of the Chinese Pharmacopoeia （2015）.