制备工艺对格列美脲片溶出行为的影响.PDF

制备工艺对格列美脲片溶出行为的影响  * 马莉，刘兆迅，王文笙，陶元景 ( 山东达因海洋生物制药股份有限公司，山东 荣成 264300) 摘要：目的 探索不同制备工艺对格列美脲片溶出行为的影响。方法 以溶出度及在 pH(7.20±0.05)缓冲液中溶出曲线为 检测指标，并结合流动性和可压性，考察粉末直接压片、干法制粒压片、湿法制粒压片对格列美脲片溶出行为的影响。 结果 采用粉末直接压片、干法制粒压片、湿法制粒压片工艺制备的格列美脲片溶出行为存在一定差异。结论 采用空 白辅料湿法制粒，外加原料药混合压片制得格列美脲片与参比制剂溶出行为一致，且产品质量稳定，为格列美脲片一致 性评价工作奠定了基础。 关键词：格列美脲片；制备工艺；溶出度 中图分类号：R944.4 文献标志码：B 文章编号：1007-7693(2017)11-1572-04 DOI: 10.13748/ki.issn1007-7693.2017.11.016 引用本文：马莉, 刘兆迅, 王文笙, 等. 制备工艺对格列美脲片溶出行为的影响 [J]. 中国现代应用药学, 2017, 34(11): 1572-1575. Effects of Different Preparation Process on the Dissolution Behavior of Glimepiride Tablets * MA Li, LIU Zhaoxun, WANG Wensheng, TAO Yuanjing (Shandong Dyne Marine Biopharmaceutical Co., Ltd., Rongcheng 264300, China) ABSTRACT: OBJECTIVE To explore the effects of different preparation process on the dissolution behavior of Glimepiride tablets. METHODS Using the dissolution and dissolution curve in pH(7.20±0.05) buffer as index, based on fluidity and compressibility to investigate the effects of power tabletting, dry granulation tabletting and wet granulation tabletting methods on the dissolution behavior of Glimepiride tablets. RESULTS It had different effects on the dissolution of Glimepiride tablets by power tabletting, dry granulation tabletting and wet granulation tabletting. CONCLUSION The Glimepiride tablets, which are made by mixing blank materials wet granulation with raw materials tabletting, has the same dissolution behavior with the reference preparation. And the production quality is stability, which is helpful for the consistency evaluation of Glimepiride tablets. KEY WORDS: G