靛玉红固体分散体的制备及其体外溶出研究

Preparation and in vitro dissolution of polyvinylpyrrolidone solid dispersion containing indirubin

目的采用固体分散体技术制备难溶性药物靛玉红固体分散体,提高其体外溶出性能。方法采用溶剂法制备靛玉红-聚乙烯吡咯烷酮(PVPK30)固体分散体;利用扫描电镜(SEM)和差示扫描量热法(DSC)鉴别药物在载体中的存在状态;以靛玉红的溶出百分量作为评价指标,研究靛玉红制成固体分散体后对溶出性能的影响。结果扫描电镜和差示扫描量热法结果显示靛玉红在载体中以高度分散形式存在,制成固体分散体后药物的累计溶出度(36.93%)与原料药(4.81%)和物理混合物(11.42%)相比都有明显的提高。结论靛玉红与PVPK30制成固体分散体,靛玉红的分散状态发生了改变,提高了其溶出性能。

Objective To prepare the indirubin solid dispersion with polyvinyplyrrolidone（PVPK30） in order to improve the dissolution of indirubin.Methods The solid dispersion containing indirubin was prepared with PVPK30 as carrier（1∶9） by solvent evaporation.The status of indirubin existence in the dispersion form was studied by scanning electron microscopy（SEM） and differential scanning calorimetry（DSC）.Indirubin from the solid dispersion was determined to evaluate the dissolution property after being prepared as solid dispersion.Results SEM and DSC results showed that indirubin was distributed in solid dispersion as an amorphous state.The dissolution percentage of indirubin was significantly higher in solid dispersion（36.93%） when compared with those as indirubin power（4.81%） and physical mixture（11.42%）.Conclusion Our prepared PVPK30 solid dispersion containing indirubin has indirubin changed its dispersedness with higher dissolution.