药学研究
藥學研究
약학연구
JOURNAL OF PHARMACEUTICAL RESEARCH
2014年
11期
651-653,660
,共4页
单硝酸异山梨酯%缓释片%稳定性
單硝痠異山梨酯%緩釋片%穩定性
단초산이산리지%완석편%은정성
Isosorbide mononitrate%Sustained-release tablets%Stability
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。
目的：製備單硝痠異山梨酯緩釋片，併對其進行穩定性研究。方法以羥丙甲纖維素為骨架材料，與參比製劑（ Imdur，阿斯利康）進行體外釋放度比較，採用均勻設計法優化單硝痠異山梨酯緩釋片處方，併攷察緩釋片在（40±2）℃、相對濕度75%±5%條件下的穩定性。結果經f2（相似因子）判斷單硝痠異山梨酯緩釋片釋放麯線，與參比製劑相似。在（40±2）℃、相對濕度75%±5%條件下6箇月的穩定性良好。結論單硝痠異山梨酯緩釋片製備工藝簡單易行，質量可控，符閤大規模生產要求。
목적：제비단초산이산리지완석편，병대기진행은정성연구。방법이간병갑섬유소위골가재료，여삼비제제（ Imdur，아사리강）진행체외석방도비교，채용균균설계법우화단초산이산리지완석편처방，병고찰완석편재（40±2）℃、상대습도75%±5%조건하적은정성。결과경f2（상사인자）판단단초산이산리지완석편석방곡선，여삼비제제상사。재（40±2）℃、상대습도75%±5%조건하6개월적은정성량호。결론단초산이산리지완석편제비공예간단역행，질량가공，부합대규모생산요구。
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.
