乌索酸固体分散体的制备及其体外溶出度研究

Preparation of Usolic Acid Solid Dispersion Systems and Study on Their Dissolution in Vitro

目的:提高制剂中乌索酸的溶出度。方法:选择聚乙烯吡咯烷酮K30、泊洛沙姆188两种载体,用溶剂法制备乌索酸固体分散体;建立高效液相色谱-光电二极管阵列检测器法测定固体分散体的体外溶出度,并检测分析了乌索酸的峰纯度。结果:高效液相色谱法测定乌索酸的溶出度,结果准确可靠、稳定、无载体的干扰。制备的固体分散体能显著地提高乌索酸的体外溶出度;以聚乙烯吡咯烷酮为载体制备的固体分散体溶出速度快于泊洛沙姆。结论:选择聚乙烯吡咯烷酮为载体制备乌索酸固体分散体可显著提高乌索酸的体外溶出度。

Subjective： To enhance the dissolution rate of ursolic acid from its preparation. Method： Solid dispersion sys- tems of ursolic acid in PVP - K30 or Poloxamer 188 were prepared by co - evaporation of the drug and PVP- K30 or Poloxamer 188 ethanol solution. The HPLC - PAD method for determination of the dissolution in vitro of ursolic acid was established.The chromatogram peaks purity was detected with PAD detection. Results： HPLC method was accurate and reliable, and no interference occun＇ed from carriers. The dissolution rates in vitro of ursolic acid solid dispersion were obviously raised, and PVP - k30 was a better carrier in increasing the dissolution rate than Poloxamer 188. Conclusion： The solid dispersion system in PVP - K30 improves well the dissolution in vitro of ursolic acid.