论文部分内容阅读
目的:以Soluplus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Soluplus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Soluplus对药物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与Soluplus非晶态制剂。通过粉末X射线衍射(PXRD)、差示扫描量热(DSC)及傅立叶红外光谱(FTIR)加以表征,并进行体外溶出实验。结果:Soluplus可明显抑制吲哚美辛超饱和溶液的结晶。吲哚美辛与Soluplus以氢键形式缔合,药物以非晶态分散于载体中。该非晶态制剂显著提高了药物的溶出速度和程度。结论:以Soluplus为载体制备的吲哚美辛非晶态制剂使药物的溶出速度和程度显著提高,为获得稳定的非晶态制剂提供参考。
OBJECTIVE: Indomethacin amorphous preparation was prepared using Soluplus as a carrier and characterized to explore the interaction between drug molecules and Soluplus, and to compare the in vitro dissolution of indomethacin with amorphous. Methods: To investigate the crystallization inhibitory effect of Soluplus on supersaturated solution. Indomethacin and Soluplus amorphous formulations were prepared by solvent evaporation. Characterization by powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR), and in vitro dissolution experiments. Results: Soluplus significantly inhibited the crystallization of the indomethacin supersaturated solution. Indomethacin is associated with Soluplus in the form of hydrogen bonds, and the drug is dispersed in the carrier in an amorphous state. The amorphous formulation significantly improves the rate and extent of drug dissolution. Conclusion: The indomethacin amorphous preparation with Soluplus as carrier has significantly improved the dissolution rate and degree of drug dissolution, providing a reference for obtaining stable amorphous preparation.