硝酸异山梨酯滴丸的稳定性实验研究

对新研制的硝酸异山梨酯滴丸进行稳定性实验研究。通过对硝酸异山梨酯滴丸在各影响因素、加速试验及室温留样条件下放置，考察其外观性状、含量、降解产物、溶出度及微生物限度等各项指标随时间变化的规律。采用HPLC测定硝酸异山梨酯含量、溶出度和降解产物，按照微生物限度检查法检查微生物限度。

The Stability Study of Isosorbide Dinitrate Pills

The stability of a new pharmaceutical preparation, isosorbide dinitrate pills, was studied. The appearance, character, content, degradation product, dissolution test and limit of microbes were inspected after placing the pills in various conditions as accelerating study and room temperature to reveal the regularity of changes of the indexes mentioned above with time. The content, dissolution and degradation product of isosorbide dinitrate were determined by HPLC method, and the limit of microbes was determined according to test for the limit of microbes.