非那雄胺缓释片的稳定性研究

Studies on the stability of finasteride sustained-release tablets

目的 :考察非那雄胺缓释片的稳定性。方法 :按照《中国药典》2 0 0 0年版二部 (附录 C稳定性试验 )规定 ,进行影响因素试验、加速试验及室温留样考察 ,用相似因子法评价释放度的稳定性。结果 :缓释片各项指标均符合规定 ,释放度相似因子 f2 均较大。结论 :可认为缓释片稳定性良好。

bject: To study the stability of finasteride susta ined -release tablet s. Methods: According to the requirements of stability test on appendix ⅩⅨ C of China Pharmacopoeia (2000.Vol Ⅱ), test for influencing factor, accelerat ed testand samples kept at room temperature were studied. The release stability was ev aluated using similar factor analysis. Results: All the indexes accorded with th e standard. Conclusion: Sustained-release tablets have a good stability.