阿西美辛缓释片的研制及释药因素考察

目的:制备阿西美辛缓释片并对释药因素进行考察.方法:采用湿法制粒工艺,以羟丙基甲基纤维素(HPMC)为骨架材料,制备阿西美辛缓释片;运用正交设计法筛选确定速释部分的处方;对HPMC规格和用量、润湿剂浓度、制片压力等影响释药的因素进行考察,并在此基础上进行处方的筛选.结果:阿西美辛缓释片的体外释药行为符合Higuchi方程,HPMC用量、润湿剂浓度、制片压力对释药几乎无影响,而HPMC规格对药物的释放产生一定的影响.结论:采用HPMC作为基本骨架材料,结合其他辅料,可制备日服1次的阿西美辛缓释片.

Study on the Factors Influencing Acemetacin Release from Sustained Release Tablets and the Optimization of Formulation

Objective:To prepare the acemetacin sustained release tablets(Ac-S RT )and study the influencing factors.Methods:The Ac-SRT were prepared by the wet granulation method,using HPMC as skeleton material.The effects of the viscosity and amount of HPMC and the concentration adhesive on the release of Ac-SRT were observed.On the basis of pharmaceutical preformulation studies,the preparation technique and optimized formulation of Ac-SRT were designed.Results:The release behavior of the tablets follows the Higuchi equation. Amount of HPMC and the co ncentration of adhesive has no significant effects on the release of Ac-SRT,whi le the viscosity of HPMC influence the release of Ac-SRT to some degree.Conclus ion:Combining with other filters,a sustained release tablet(SRT)of once daily ad ministration is prepared by using hydropropyl methylcellulose as the basic matri x material.