左羟丙哌嗪-β-环糊精包合物分散片的制备与评价

发布时间：2018-09-11 14:43

【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。
[Abstract]:Objective: to optimize the formulation and preparation of levodropromazine-尾-cyclodextrin inclusion dispersible tablets. Methods: levodropromazine-尾-cyclodextrin inclusion compound was prepared and used as intermediate to prepare dispersible tablets. The disintegrating time and the appearance of tablets were used as evaluation indexes to optimize the formulation and preparation process. Results: the optimal prescription of dispersible tablets was as follows: the inclusion compound of levohydroxypromazine-尾-cyclodextrin was 80. 0. 0 and MCC 9. 6, and magnesium stearate was 0. 4. The disintegration time was less than 60 sm 5 min and the dissolution rate was more than 85%. Conclusion: the formulation of the dispersible tablets is simple and reasonable, the process is stable and feasible, and it is in accordance with the Chinese Pharmacopoeia 2015 edition.
【作者单位】：贵州大学药学院;贵州省药食两用资源应用开发工程实验室;贵州理工学院制药工程学院;
【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]
【分类号】：R943

【参考文献】