目的 制備尼達(dá)尼布乙磺酸鹽固體分散體，并考察其性能。方法 采用溶劑蒸發(fā)法制備尼達(dá)尼布乙磺酸鹽固體分散體，并采用差示掃描量熱法、粉末X射線衍射和傅里葉變換紅外光譜進(jìn)行物理表征和高溫高濕穩(wěn)定性考察。結(jié)果 尼達(dá)尼布乙磺酸鹽與Soluplus按質(zhì)量比1∶9制備固體分散體。尼達(dá)尼布乙磺酸鹽以無定形存在于分散體中。溫度對固體分散體基本無影響，濕度的影響較大。結(jié)論 將尼達(dá)尼布乙磺酸鹽制備固體分散體提高了藥物的溶解度和溶出度。

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.

R944

天津市科技計劃項目（22JCQNJC01610）