目的 制备尼达尼布乙磺酸盐固体分散体，并考察其性能。方法 采用溶剂蒸发法制备尼达尼布乙磺酸盐固体分散体，并采用差示扫描量热法、粉末 X 射线衍射和傅里叶变换红外光谱进行物理表征和高温高湿稳定性考察。结果 尼达尼布乙磺酸盐与Soluplus按质量比 1∶9 制备固体分散体。尼达尼布乙磺酸盐以无定形存在于分散体中。温度对固体分散体基本无影响，湿度的影响较大。结论 将尼达尼布乙磺酸盐制备固体分散体提高了药物的溶解度和溶出度。
Preparation and properties of nintedanib ethanesulfonate salt solid dispersion
Objective To prepare nintedanib ethanesulfonate salt solid dispersion and study its properties.Methods Nintedanib ethanesulfonate salt solid dispersion was prepared by solvent evaporation method,and its physical characterization and stability in high temperature and high humidity were investigated by differential scanning calorimetry(DSC),powder X-ray diffraction(PXRD),and Fourier transform infrared spectroscopy(FR-IR).Results Solid dispersions was prepared with nintedanib ethanesulfonate salt and Soluplus in a mass ratio of 1∶9.Nintedanib ethanesulfonate salt existed in an amorphous form in solid dispersion.Temperature had little effect on solid dispersion,but humidity had a greater impact.Conclusion Preparation of nintedanib ethanesulfonate salt solid dispersion can improve the solubility and dissolution of the drug.
nintedanib ethanesulfonate salt solid dispersionnintedanib ethanesulfonate saltDSCPXRDFR-IRsolubilitydissolution
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