烟酸缓释片的研制及其释药特性的研究

目的:制备烟酸缓释片,并对其释药性质进行了研究.方法:分别采用不同粒度烟酸和不同粒度、粘度、含量的羟丙甲纤维素以及不同压力的方法制备烟酸缓释片,在不同pH值释放介质中测定其释放度,并与国外同类缓释片进行比较.结果:HPMC的粒度、粘度、压片压力对本制剂的释药影响不大.随着烟酸粒度的减小,HPMC用量的增加和释放介质的pH值增高,释药速率减慢.结论:烟酸缓释片的释药过程符合Higuchi方程,影响药物释放的主要因素是烟酸的粒度、HPMC的用量和释放介质的pH值;研制的烟酸缓释片与国外样品体外释放速率相近.

Study on niacin sustained-release tablets and the release property

OBJECTIVE To prepare niacin sustained-release tablets and study their release characteristics. METHODS Different particle size of niacin and HPMC, different viscosity grades and amount of HPMC and pressure were used to prepare niacin sustained-release tablets. The drug release was determined in different pH medium and compared with the control samples abroad. RESULTS The HPMC particle size, viscosity grade and pressure used had little influence on drug release. The smaller particle size of niacin, the larger amount of HPMC and the higher pH medium used, the slower release rate was resulted. CONCLUSIONS The releasing behavior of the niacin sustained-release tablets followed Higuchi-kinetics and the main factors affecting drug release were particle size of niacin, the content of HPMC and pH of medium. The release kinetics was similar to that of the control samples produced abroad.