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目的以共聚维酮(Co-PVP)为载体制备吲哚美辛非晶态制剂,对其加以表征以探讨药物分子与Co-PVP间的相互作用形式,并比较吲哚美辛晶态与非晶态的体外溶出差异。方法考察了Co-PVP对吲哚美辛超饱和溶液的结晶抑制作用。采用溶剂蒸发法制备吲哚美辛非晶态制剂,通过差示扫描量热(DSC)、粉末X射线衍射(PXRD)和傅立叶红外光谱(FTIR)技术对其表征,并进行了体外溶出实验。结果 Co-PVP对吲哚美辛超饱和溶液有较强的抑晶作用。吲哚美辛与Co-PVP分子之间形成氢键,主药以非晶态分散于载体中,该非晶态制剂的体外溶出速率和程度均显著增加。结论以Co-PVP为载体制备的非晶态制剂能显著提高吲哚美辛体外溶出,可为获得稳定的药物非晶态制剂提供参考。
OBJECTIVE To prepare indomethacin amorphous formulations with co-PVP as a carrier, and to characterize the interaction between drug molecules and Co-PVP and to compare the crystalline and non-crystalline forms of indomethacin Crystalline dissolution differences in vitro. The effect of Co-PVP on the crystallization of indometacin supersaturated solution was investigated. Indomethacin amorphous formulations were prepared by solvent evaporation method and characterized by differential scanning calorimetry (DSC), powder X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). Results Co-PVP has a strong inhibitory effect on indomethacin supersaturated solution. Hydrogen bonds are formed between indomethacin and Co-PVP molecules, and the main drug is dispersed in the carrier in an amorphous state. The dissolution rate and the degree of in vitro dissolution of the amorphous agent are significantly increased. Conclusion Amorphous preparations prepared with Co-PVP as carrier can significantly improve the dissolution of indomethacin in vitro and provide a reference for obtaining stable amorphous drugs.