抗病毒咀嚼片稳定性考察研究

Stability Study of Film-coating Tablets of Anti-Virus chewable Tablet

目的:考察抗病毒咀嚼片(薄膜衣片)的稳定性,检验确定其贮藏条件和有效期限。方法:以性状、鉴别、重量差异、微生物限度、含量为质量指标,通过影响因素试验、加速试验及长期留样试验观察其质量变化情况。结果:各项考察指标符合药品质量规定。结论:抗病毒咀嚼片在影响因素试验、加速试验和长期试验条件下稳定,因长期试验24个月内其含量无明显变化,可初步确定该制剂有效期为2年。

Objective： Stability study Film-coating Tablets of Anti-Virus chewable Tablet,Preliminary determine its storage conditions and period of validity. Methods：The character,identification,weight variation,microbial limit,content as quality index,Through influential factor test,accelerated testing and long-term retention sample test to observe the quality change. Results： Various indexes meet the provisions of drug quality. Conclusion： Film-coating Tablets of Anti-Virus chewable tablets is stable in the influential factor test,accelerated test and long-term test conditions,Because of the long-term test within 24 months of its content had no significant change,It can be initially confirmed the formulation is valid for a period of 2 years.