瑞格列奈二甲双胍片制备工艺研究

Study on Preparation Technology of Repaglinide and Metformin Hydrochloride Tablets

目的:设计并制备符合中试产业化生产的瑞格列奈二甲双胍片。方法:以溶出度为指标进行处方筛选和工艺优化。结果:以泊洛沙姆188、葡甲胺、聚维酮(PVP)K30、交联羧甲纤维素钠、微晶纤维素(MCC)PH101、山梨醇、硬脂酸镁及包衣粉为辅料,按照特定的制备工艺制备瑞格列奈二甲双胍片,在4种介质中的溶出行为与参比制剂相似。结论:瑞格列奈二甲双胍片的制备工艺简单可行,质量稳定可控。

Objective：To design and prepare repaglinide and metformin hydrochloride tablets for pilot scale test and industrial pro-duction. Methods：Dissolution was applied to optimize the formula and preparation process. Results： The tablets were prepared ac-cording to the determined formula and process with poloxamer 188, meglumine, PVP K30, croscarmellose sodium, microcrystalline cellulose PH101, sorbitol, magnesium stearate and coating powder as the adjuvants. The dissolution behavior of the tablets in four media was similar to that of the reference. Conclusion：The preparation process of repaglinide and metformin hydrochloride tablets is simple and feasible, and the quality is controllable and stable.