【摘要】 研究了5-单硝酸异山梨醣控释片的处方组成和制备工艺,并对不同处方进行了体外溶出试验,证实体外释药可维持10 h以上。体外释药速率与HPMC的粘度及其在处方中的比例有关,与溶出介质的pH值无关,体外释药过程,符合Higuchi方程,经稳定性实验考察,证实本制剂在37℃、RH 75%的条件下保存三个月后,其含量、溶出度、外观、硬度、脆碎度均无变化。更多还原

【Abstract】 A controlled release tablet was developed in order to reduce the side effects of the drug. A UV spectrophotometric method for the determination of isosorbide-5-monoitrate was established. The drug dissolution behaviors can be described by Higuchi Equation. The factors influencing the drug dissolution were studied. The stability of the tablets was investigated by FDA method (37℃, RH 75%). No obvious changes in its appearance, hardness, content and dissolution profile were observed.更多还原