琥珀酸美托洛尔缓释片溶出曲线对比研究

Comparative studies on dissolution curves of Metoprolol Succinate Extended-Release Tablets in different dissolution mediums

目的对自制和原研琥珀酸美托洛尔缓释片进行体外溶出曲线的对比研究,为制剂处方研究提供质量依据。方法利用Agilent 708-DS溶出仪并采用桨法,以转速为50 r/min,分别考察不同溶出介质中的溶出曲线,用HPLC法在280 nm波长下检测吸收度。结果自制和原研产品在不同溶出介质中溶出曲线对比f2值均大于50。结论自制与原研产品溶出曲线相似。

Objective To compare the dissolution profiles of Metoprolol Succinate Extended-Release Tablets from different strengths and different batch,and provide the basis for a comprehensive evaluation of the quality of Metoprolol Succinate Extended-Release Tablets. Methods Paddle method was adopted at 50 r·min-1,the dissolution in different dissolution mediums,HPLC method was developed for quantitative determination,wavelength：280 nm.ResultsHomemade and imported drugs had similar in vitro release profiles. Conclusion The dissolution curves of self-made and original are similar, which provide the quality basis for the formulation.