盐酸二甲双胍混合材料骨架缓释片的研制与功能性分析  

Preparation and Functional Analysis of Metformin Hydrochloride Matrix Sustained-release Tablets

作　　者：孙秀娟 赵英霞 汤丽丽 Sun Xiu-juan;Zhao Ying-xia;Tang Li-li

机构地区：[1]寿光富康制药有限公司,山东潍坊262700

出　　处：《化工设计通讯》2023年第10期210-212,共3页Chemical Engineering Design Communications

摘　　要：目的:分析二甲双胍混合材料骨架缓释片的研制方法与功能性。方法:本药品研制使用EC作为骨架材料,完成对盐酸二甲双胍骨架缓释片的制作,通过实验分析影响释药的因素,如EC规格、黏合剂类型、润滑剂添加量、技术工艺、释放介质pH。根据上述研究结果,对处方进行筛选,由此选取最佳的二甲双胍混合材料缓释片的研制、介绍药品功能性。结果:盐酸二甲双胍骨架混合材料缓释片的体外释药满足回归方程,EC规格、制片压力对盐酸二甲双胍释放造成的影响小,而黏合剂种类、润滑剂用量与制片工艺对药物释放造成的影响大。结论:以二甲双胍混合材料为骨架,添加其他辅料研制出的缓释片具有良好功能性,缓释片的释放速率适当,并且工艺简单、安全性较高。Objective:To analyze the preparation method and functionality of Metformin matrix sustained-release tablets.Methods:EC was used as the matrix material in the development of this drug to complete the preparation of Metformin hydrochloride matrix sustained-release tablets.The factors affecting the drug release were analyzed through experiments,such as EC specification,adhesive type,lubricant addition,technical process,and pH of the release medium.According to the above research results,the prescription was screened to select the best Metformin mixed material sustained-release tablets and introduce the drug functionality.Results:The in vitro release of Metformin hydrochloride matrix mixed material sustained-release tablets met the regression equation.EC specification and production pressure had little effect on the release of Metformin hydrochloride,while the type of adhesive,the amount of lubricant and the production process had great effect on the release of metformin hydrochloride.Conclusion:The sustained-release tablets prepared with Metformin mixture as the skeleton and other excipients have good functionality,appropriate release rate,simple process,high safety.

关 键 词：盐酸二甲双胍 混合材料骨架 研制方法 性能分析 

分 类 号：TB34[一般工业技术—材料科学与工程]