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目的制备磺胺嘧啶固体分散体,考察其溶解度和体外溶出度,并对物相进行鉴定。方法以体外溶出度为指标,利用单因素试验与正交设计试验优化固体分散体的制备工艺。采用差示扫描量热法(DSC)、红外光谱法和粉末X-射线衍射法鉴定药物在固体分散体中的存在状态。结果以最佳工艺制备的磺胺嘧啶固体分散体,与原料药相比药物溶解度提高了17倍,溶出速率提高了3倍;物相鉴定表明,药物在分散体中主要以无定型状态存在。结论以PEG4000为载体,采用溶剂熔融法制备的磺胺嘧啶固体分散体,可显著提高磺胺嘧啶的溶解度和溶出速率。
Objective To prepare solid dispersions of sulfadiazine, investigate their solubility and in vitro dissolution, and identify the phases. Methods In vitro dissolution as an indicator, using single factor experiments and orthogonal design test to optimize the preparation of solid dispersion. Differential scanning calorimetry (DSC), infrared spectroscopy and powder X-ray diffraction were used to identify the drug’s presence in the solid dispersion. Results The solid dispersions of sulfadiazine prepared by the optimal process showed a 17-fold increase in drug solubility and a 3-fold increase in dissolution rate compared to the drug substance. The identification of the phase showed that the drug was mainly present in the amorphous state in the dispersion. Conclusion The solid solution of sulfadiazine prepared by solvent melting method using PEG4000 as the carrier can significantly improve the solubility and dissolution rate of sulfadiazine.