论文部分内容阅读
比较研究厚朴总酚固体分散体不同制备方法之间的差异。分别使用热熔挤出法、溶剂蒸发法、熔融冷却法制备厚朴总酚Plastone S-630及HPC 2种辅料固体分散体。采用DSC,X-射线衍射评价所制备固体分散体中药物的分散状态;通过FTIR分析药物与辅料之间可能存在的连接方式;最后通过加速稳定性-溶出试验比较3种工艺的稳定性差异。DSC及X-射线衍射结果显示3种工艺制备的固体分散体中药物均能以无定形态存在;FT-IR结果也无法区别3种工艺间的差异;加速稳定性-溶出试验表明HPC所制备的固体分散体稳定性明显优于Plastone S-630,同种辅料间热熔挤出技术制备的固体分散体稳定性要好于其他2种工艺。
The differences between different preparation methods of Magnolia Total phenolic solid dispersions were compared. The solid dispersions of Plastone S-630 and HPC were prepared by hot melt extrusion, solvent evaporation and melt-cooling respectively. The dispersion state of the drug in the prepared solid dispersion was evaluated by DSC and X-ray diffraction. The possible connection between the drug and the excipients was analyzed by FTIR. Finally, the stability differences of the three kinds of technology were compared by accelerated stability-dissolution test. The results of DSC and X-ray diffraction showed that all the three solid dispersions could be in amorphous state. The FT-IR results could not distinguish the differences among the three processes. The accelerated stability-dissolution test showed that HPC prepared Solid dispersion is obviously superior to Plastone S-630. The stability of the solid dispersion prepared by the same kind of inter-material hot melt extrusion is better than the other two kinds of processes.