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 Tanshinone IIA and Immediate-release Excipients

    • 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。

       

      Abstract: OBJECTIVE To explore the miscibility of tanshinone IIA(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.

       

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