目的研制齐墩果酸-PVP固体分散物,增加齐墩果酸溶出,并探讨其增溶机制。方法采用溶剂法制备齐墩果酸-PVP固体分散物。利用差热分析、X射线衍射和体外溶出度测定等方法研究固体分散体中齐墩果酸的结晶性质及对溶出度的影响。结果差示热分析及X-射线衍射证明药物的晶型消失,溶出度增加8倍。结论通过固体分散法,药物以无定型或者分子状态分散于载体中,因而显著改善溶出度。

Object To study the formation and solubilizing mechanism of oleanolic acidsolid dispersion. Methods The solid dispersion consisting of oleanolicacid and polyvinyply rrolidone(PVP)was made by solvent evaporation method.By using differential thermal analysis(DTA) ,X-ray diffraction and dissolution test,the effects of the polymorphi sm of oleanolicacid in solid dispersion on its dissolution were investigated.The dissolution rates of various solid dispersions and physical mixtures were determined.Results The crystal form of oleanolic acid disappeared in the dispersion and the dissolution was increased evidently.Conclusion By using solid dispersion phase,the drug was dispersed in PV PK30 in the amorphous formormolecule form, and its solubility was increased.