论文部分内容阅读
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 solid indirubin solid dispersion with solid dispersion technology and improve its in vitro dissolution performance. Methods The solid dispersion of indirubin-polyvinylpyrrolidone (PVPK30) was prepared by solvent method. The existence of drug in the carrier was identified by scanning electron microscopy (SEM) and differential scanning calorimetry (DSC) The percentages were used as evaluation indexes to study the influence of indirubin to the solid dispersion on the dissolution performance. Results The results of scanning electron microscopy (SEM) and differential scanning calorimetry (DSC) showed that indirubin was highly dispersed in the carrier and the cumulative dissolution (36.93%) and drug substance (4.81% 11.42%) compared to have significantly improved. Conclusion Indirubin and PVPK30 can be used as solid dispersions. The dispersion state of indirubin has been changed and its dissolution performance has been improved.