盐酸吡咯列酮固体分散体的制备及体外溶出度研究

Research on the preparation and dissolution rate of the solid dispersion of pioglitazone hydrochloride

目的:采用冷冻干燥法制盐酸吡格列酮(Pioglitazone Hydrochloride,PGH)速释固体分散体(SD)来提高其体外溶出度。方法:将PGH与载体及酸性调节剂制备成固体分散体,通过测定药物的体外溶出度,来选择最优辅料及比例,结果:当以羟丙甲基纤维素(HPMC)为载体,酒石酸(TA)为酸性调节剂,且PGH:HPMC:TA=1:1:10%时药物呈现了很好的水溶性。在2h内累积溶出度可达65%以上,溶出速率显著提高。

Objective： Prepare the solid dispersions ofpioglitazone Hydrochloride （PGH） by the freeze-drying method to enhance the dissolution rate of the drug. Methods： The solid dispersions of PGH have been prepared with carrier and aeidifier, then chose the optimal materials and the ratio by the dissolution rate data. Conclusion： The dissolution rate improved to the 65% during 2h, when used HPMC as the carriers, TA as the acdifier and the ratio of PGH： HPMC： TAwas 1：1：10% in this solid dispersion system. The dissolution rate of the drug has been increased significantly.