厚朴总酚固体分散体不同制备方法的比较研究

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FT-IR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。

Comparison of total phenol of magnolia solid dispersion prepared by different methods

To compare the difference of total phenol of magnolia solid dispersion prepared by different methods. Hot melt extrusion, solvent evaporation method, and fusion-cooling method were used to prepare total phenol of Magnolia accessory solid dispersion, Plastone S-630 and HPC. The drug dispersion state in the prepared solid dispersion was evaluated with DSC and X-ray diffraction; FT-IR method was used to analyze the possible connections between drug and accessories. Finally, accelerated stability-in vivo dissolution test was use to compare the stability differences between these three processes. The results of DSC and X-ray diffraction showed that all of the drug in solid dispersion processed by three processes can exist in amorphous form; FT-IR results also could not distinguish the difference between the three processes; accelerated stability-in vivo dissolution test showed the stability of solid dispersion prepared by HPC was better than Plastone S-630, and the same kinds of materials solid dispersion prepared by hot melt extrusion showed a better stability than the other two processes.