乌索酸固体分散体胶囊的制备及体外溶出度研究

Preparation of Usolic Acid Solid Dispersion Capsule and Study on its Dissolution in vitro

目的评价乌索酸固体分散体胶囊等3种制剂的体外溶出度及其质量。方法以PVP-K30为水溶性载体,采用溶剂法制备乌索酸固体分散体胶囊;选择0.5%十二烷基硫酸钠溶液为溶出介质,建立高效液相色谱法测定乌索酸固体分散体胶囊等3种制剂的体外溶出度,并检测分析了乌索酸在制剂中的存在状态。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。45min之内,乌索酸固体分散体胶囊的体外溶出度比片剂提高2.3倍,比物理混合物胶囊提高1.1倍。结论选择PVP-K30为载体制备乌索酸固体分散体胶囊可显著提高乌索酸的体外溶出速度。

Objective To evaluate the dissolution in vitro and quality of three kinds of preparations. Methods Using PVP-K30 as water soluble carrier, ursolic acid solid dispersion capsule was prepared by a solvent method. The HPLC method for determination of the dissolution in vitro of ursolic acid preparations was established. The existed form of ursolic acid in preparations was detected. Results HPLC method was accurate and reliable, and no interference occurred from carriers. The dissolution rate in vitro of ursolic acid solid dispersion capsule increased 2.3 and 1.1 times than tablet and mixture capsule within 45 min, respectively. Conclusion The solid dispersion capsule with PVP-K30 remarkably improves the dissolution rate of ursolic acid.