国产甲磺酸伊马替尼片在不同介质中的溶出曲线相似性评价

Similarity Evaluation of Dissolution Curves of Generic Imatinib Mesylate Tablets in Different Media

目的:考察2种国产甲磺酸伊马替尼片在多种溶出介质中溶出曲线的相似性,为临床用药提供参考。方法:采用桨法,转速50 r·min-1,分别以pH 1.2盐酸溶液、pH4.0醋酸-醋酸钠缓冲液、pH 6.8磷酸盐缓冲液和水作为溶出介质,溶出介质体积为1000 m L,采用紫外-可见分光光度法,检测波长为264 nm,分别测定2种国产甲磺酸伊马替尼片在不同时间点的平均累积溶出度,并绘制溶出曲线,评价二者溶出曲线的相似性。结果:在4种溶出介质中,2种国产甲磺酸伊马替尼片在15 min内溶出量均超过85%,说明二者溶出曲线具有相似性。结论:国产甲磺酸伊马替尼片的体外溶出行为具有相似性,故其质量一致性较好。

Objective： To investigate the similarity of dissolution curves of generic Imatinib mesylate tablets in various dissolution mediums and make reference for clinical use. Methods： The paddle method was adopted with rotation speed of 50 r·min-1,using pH 1. 2 hydrochloric acid solution,pH 4. 0 acetic acid-sodium acetate buffer solution,pH 6. 8 phosphate buffer solution and water as dissolution media,volume of dissolution medium was 1000 m L. UV spectrometry was performed on the column of 264 nm to determine average accumulative dissolution of 2 kinds of generic Imatinib mesylate tablets at different time points to draw out dissolution curves,then to evaluate the similarity of dissolution curves. Results： In 4 dissolution media,the dissolution rate of 2 kinds of generic Imatinib mesylate tablets both were more than 85%,which indicated that the dissolution curves had similarity. Conclusion： The dissolution profile of Imatinib mesylate tablet generic preparations showed similarity,so the quality consistency is good.