单硝酸异山梨酯缓释片的制备及稳定性研究

目的制备单硝酸异山梨酯缓释片,并对其进行稳定性研究。方法以羟丙甲纤维素为骨架材料,与参比制剂(Imdur,阿斯利康)进行体外释放度比较,采用均匀设计法优化单硝酸异山梨酯缓释片处方,并考察缓释片在(40±2)℃、相对湿度75%±5%条件下的稳定性。结果经f2(相似因子)判断单硝酸异山梨酯缓释片释放曲线,与参比制剂相似。在(40±2)℃、相对湿度75%±5%条件下6个月的稳定性良好。结论单硝酸异山梨酯缓释片制备工艺简单易行,质量可控,符合大规模生产要求。

Study oN tHe preparatioN aNd stability of Isosorbide MoNoNitrate SustaiNed-release Tablets

Objective To prepare Isosorbide Mononitrate Sustained-release Tablets,and to investigate the stability of the tablets. MetHods The formulation of sustained-release tablets of isosorbide mononitrate was optimized by uniform de-sign,and hydroxypropyl methycellulose（ HPMC）as matrix material. The release profile was compared with that of Im-dur. The stability of tablets was studied under conditions of（40 ± 2）℃ and relative humidity 75% ± 5% exposure. Results The samples had the similar sustained-release property with that of Imdur. The tablets were stable to the temperature and relative humidity conditions of（40 ± 2）℃ and 75% ± 5% for 6 months. CoNclusioN Preparation process of Isosor-bide Mononitrate Sustained-release Tablets was simple and the quality can be controlled,which met the requirement for large scale production.