目的 研究格列美脲二甲雙胍雙層片的最佳處方和制備工藝，以期得到溶出度和有關(guān)物質(zhì)均優(yōu)于原研片Amaryl? M的復(fù)方制劑。方法 以格列美脲溶出度為考察指標(biāo)，采用單因素試驗(yàn)和正交設(shè)計(jì)試驗(yàn)，對(duì)格列美脲二甲雙胍雙層片的處方和制備工藝進(jìn)行優(yōu)化。結(jié)果 按優(yōu)化得到的處方工藝制備的格列美脲二甲雙胍雙層片中格列美脲在各種介質(zhì)中的溶出度以及鹽酸二甲雙胍在10 min左右達(dá)到全溶出情況，與Amaryl? M基本一致；在高溫條件下放置10 d后，雜質(zhì)的增長與Amaryl? M相比減少了0.507%。結(jié)論 制備的格列美脲二甲雙胍雙層片處方合理、工藝可行，較原研片具有明顯優(yōu)勢(shì)。

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.

國家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃（973計(jì)劃）資助項(xiàng)目（2010CB735602，2012CB724002）