目的 研究格列美脲二甲双胍双层片的最佳处方和制备工艺，以期得到溶出度和有关物质均优于原研片Amaryl? M的复方制剂。方法 以格列美脲溶出度为考察指标，采用单因素试验和正交设计试验，对格列美脲二甲双胍双层片的处方和制备工艺进行优化。结果 按优化得到的处方工艺制备的格列美脲二甲双胍双层片中格列美脲在各种介质中的溶出度以及盐酸二甲双胍在10 min左右达到全溶出情况，与Amaryl? M基本一致；在高温条件下放置10 d后，杂质的增长与Amaryl? M相比减少了0.507%。结论 制备的格列美脲二甲双胍双层片处方合理、工艺可行，较原研片具有明显优势。

Objective To obtain the compound tablet that dissolution and related substance of glimepiride better than the original product Amaryl? M through investigating the preparation process and the optimal formulation of Glimepiride and Metformin Hydrochloride Bilayer Tablets. Methods The formulation of glimepiride and metformin hydrochloride Bilayer Tablets was optimized in terms of the dissolution of glimepiride by single factor test and orthogonal test. Results The products formulated with the optimum techniques had the similar dissolution profile of glimepiride in different solution and metformin hydrochloride within 10 min comparing to the original product Amaryl? M. After being stored under high temperature for 10 d, the increase of impurities was reduced by 0.507%. Conclusion This prescription and technology of Glimepiride and Metformin Hydrochloride Bilayer Tablets are reasonable and effective, and have the obvious advantages compared to the original product.

国家重点基础研究发展计划（973计划）资助项目（2010CB735602，2012CB724002）