Objective: To prepare compound metformin hydrochloride sustained-release capsules, and investigate the release behavior of metformin hydrochloride (MH) and glimepiride. Methods: The MH pellets were prepared by extrusion-spheronization, and used as the core to prepare the sustained-release pellets by coating with ethylcellulose dispersion. Granules of the immediate-release granules containing glimepiride were prepared by grinding mixture and using aqueous wet granulation technology. The final sustained-release capsules were obtained by mixing the MH sustained-release pellets and granules of glimepiride. Results: The release behavior indicated the successful preparation of compound sustained-release capsules. MH enabled desired drug release for up to 12 h,whereas glimepiride showed an immediate-release in 45 min. Conclusion: The optimal technique for the preparation of compound metformin hydrochloride sustained-release capsules is stable. The capsules have a good behavior of immediate- and sustained-release.%目的:研制复方盐酸二甲双胍缓释胶囊,并对盐酸二甲双胍(MH)和格列美脲进行释放度研究.方法:采用挤出滚圆法制备MH微丸,以乙基纤维素水分散体进行包衣,得到MH缓释微丸;采用混合物研磨法,结合湿法制粒技术得到格列美脲速释颗粒.将MH缓释微丸与格列美脲颗粒混合灌装成胶囊.结果:释放度测定结果表明,制得胶囊满足格列美脲在45 min内迅速释放,MH可在12 h内持续缓慢释放.结论:优选工艺稳定,复方盐酸二甲双胍缓释胶囊具有较好的速释、缓释效果.
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