柿叶黄酮分散片的处方优化及质量控制  

Prescription optimization and quality control of persimmon leaf flavone dispersible tablets

作　　者：韩伟 方琳 张玲贞 宋信莉 李哲 HAN Wei;FANG Lin;ZHANG Ling-zhen;SONG Xin-li;LI Zhe(School of Pharmacy,Guizhou University of Traditional Chinese Medicine,Guizhou 550025,China;College of Basic Medicine,Guizhou University of Traditional Chinese Medicine,Guizhou 550025,China;Innovation Research and Development Center of Veterinary Traditional Chinese medicine Preparations,Guizhou University of Traditional Chinese Medicine,Guizhou 550025,China)

机构地区：[1]贵州中医药大学药学院,贵阳550025 [2]贵州中医药大学基础医学院,贵阳550025 [3]贵州中医药大学兽用中药制剂创新研发中心,贵阳550025

出　　处：《哈尔滨商业大学学报（自然科学版）》2022年第4期387-391,共5页Journal of Harbin University of Commerce：Natural Sciences Edition

基　　金：贵州中医药大学博士启动基金(贵中医博士启动([2019]14号);贵州省国内一流学科建设项目(合同编号:GNYL[2017]008);贵州省特色功能食品与中药制剂开发攻关大平台(黔教合KY字[2020]006);贵州中医药大学药用高分子材料研究中心(贵中医党办发[2019]70号)。

摘　　要：制备柿叶黄酮分散片并优化其处方及对其进行质量控制.在单因素考察的基础上,以崩解时间为指标,通过正交试验设计优选出柿叶黄酮分散片的最优处方;采用酶标仪测定柿叶黄酮分散片中芦丁的含量.最优处方所制得的柿叶黄酮分散片崩解时限为(30.4±4.65)s,分散均匀度良好,45 min内释放完全.其最优选的处方为:选择10%L-HPC为崩解剂,79.5%MCC:乳糖(3∶1)为填充剂,以0.5%硬脂酸镁为润滑剂.柿叶黄酮分散片制备工艺合理可行,质量控制方法简单快捷,准确度高,重现性好.To prepare persimmon leaf flavone dispersible tablets and optimize its formulation and quality control.On the basis of single factor experiment,taking disintegration time as the index,the optimal formulation of persimmon leaf flavone dispersible tablets was optimized by orthogonal design;the content of Rutin in persimmon leaf flavone dispersible tablets was determined by microplate reader.The disintegration time limit of persimmon leaf flavone dispersible tablets prepared by the optimal formula was(30.4±4.65)s,the dispersion uniformity was good,and the release was complete within 45 minutes.The most preferred formula was:10%L-HPC as disintegrating agent,79.5%MCC:lactose(3:1)as filler,and 0.5%magnesium stearate as lubricant.The preparation technology of persimmon leaf flavone dispersible tablets was reasonable and feasible,and the quality control method is simple and fast,with high accuracy and good reproducibility.

关 键 词：柿叶黄酮 分散片 正交试验设计 崩解时限 处方优化 质量控制 

分 类 号：R286[医药卫生—中药学]