丹参酮ⅡA/速释辅料二元固态溶液的玻璃化转变温度研究  

Study on the Glass Transition Temperature of Binary Solid Solution Composed with TanshinoneⅡA and Immediate-release Excipients

作　　者：李厚丽 刘杭 熊礼龙[3] 程晓亮[1] 王茂义[1] 马瑛[1] 封卫毅[1] LI Houli;LIU Hang;XIONG Lilong;CHENG Xiaoliang;WANG Maoyi;MA Ying;FENG Weiyi(Department of Pharmacy,The First Affiliated Hospital of Xi’an Jiaotong University,Xi’an 710061,China;College of Pharmacy,Xi’an Medical University,Xi’an 710021,China;School of Chemistry,Xi’an Jiaotong University,Xi’an 710049,China)

机构地区：[1]西安交通大学第一附属医院药学部,西安710061 [2]西安医学院药学院,西安710021 [3]西安交通大学化学学院,西安710049

出　　处：《中国现代应用药学》2020年第12期1417-1421,共5页Chinese Journal of Modern Applied Pharmacy

基　　金：国家自然科学基金项目(81603305);中央高校基本科研业务费专项资金资助项目(xjj2018119);西安交通大学第一附属医院院基金项目(2017QN-21)。

摘　　要：目的探索丹参酮ⅡA与不同速释辅料的相容性及对辅料玻璃化转变温度的影响。方法采用溶剂法制备不同种类及比例的丹参酮ⅡA/速释辅料二元固态溶液,并进行差示扫描量热分析,测定其玻璃化转变温度。结果丹参酮ⅡA与3种速释辅料均具有良好的相容性,不同种类辅料及比例的二元固态溶液,受到药物与辅料间的分子作用力、辅料的抗增塑作用等的影响,可对体系的玻璃化转变温度产生不同程度的改变。结论本研究为以聚合物HPMC K4M、Kollidon VA64或Soluplus为辅料制备具有速释特性的丹参酮ⅡA无定型态给药体系提供了技术支持。OBJECTIVE To explore the miscibility of tanshinoneⅡA(Tan-ⅡA)with different immediate-release excipients and to evaluate the influences on glass transition temperature(Tg)values of the excipients by Tan-ⅡA.METHODS Binary solid solution consisting by different types and ratios of immediate-release excipient/Tan-ⅡA were prepared by solvent method.Then the Tg of the solid solutions was measured by differential scanning calorimetry.RESULTS Tan-ⅡA had good miscibility with the three types of immediate-release excipients,and the Tg values of the binary solid solution with different types and ratios of excipients could be influenced with different degrees through anti-plasticizing effect of excipients and/or the molecular force between excipients and drug.CONCLUSION This study can provide technical support for the preparation of Tan-ⅡA loaded immediate-release amorphous drug delivery system using HPMC K4M,Kollidon VA64 or Soluplus as excipients.

关 键 词：丹参酮ⅡA 速释辅料 固态溶液 差示扫描量热分析 玻璃化转变温度 

分 类 号：R283.6[医药卫生—中药学]