尼可地尔胃漂浮型缓释片的研制

Preparation of Nicorandil Gastric-floating Sustained-release Tablets

开发一种基于粉末直压工艺制备尼可地尔胃漂浮型缓释片。以HPMC K100M与Kollidon SR为骨架通道,以累计释放度、起漂时滞与总漂浮时长为评价指标,成功制备出尼可地尔胃漂浮型缓释片。该缓释片体外释放时间可达24 h,起漂时滞为3 min,总漂浮时长超过12 h。对制备的尼可地尔胃漂浮型缓释片进行质量评价,片重差异、硬度以及脆碎度均符合药典要求,片重差异为3.5%,硬度均在10~12 kg,脆碎度减失差重为0.34%。

A preparation of nicorandil gastric floating sustained-release tablets based on powder direct pressure process was developed.Using HPMC K100M and Kollidon SR as the skeleton channels,the cumulative release degree,floating time lag and total floating time as the evaluation index,nicorandil gastric floating sustained-release tablets were successfully prepared.The extended-release tablet had an in vitro release time of up to 24 h,a floating time lag of 3 min,and a total floating time of more than 12 h.The quality evaluations of the prepared nicorandil gastric floating sustainedrelease tablets were carried out,and the difference in tablet weight,hardness and brittleness met the requirements of the pharmacopoeia,the difference in tablet weight was 3.5%,the hardness was 10~12 kg,and the brittleness minus weight was 0.34%.