度米芬渗透泵片稳定性研究

Investigation on Stability of Domiphen Osmotic Tablet

目的:研究度米芬渗透泵片的稳定性。方法:将度米芬渗透泵片在光照、高温、高湿条件下露置,定时取样,观察样品形态、含量及溶出度。结果:度米芬渗透泵片在光照、高温条件下均稳定;在相对湿度95%条件下放置,含量未发生变化,但释放明显加快,片剂外观有膨胀、吸潮现象。结论:该制剂在光照、高温条件下表现良好的稳定性,在高湿条件下极不稳定,应注意包装材料的隔湿性能。

Objective： To estabilish a method of analysis for stability of Domiphen osmotic tablet（ODT）, and to inviestigate its stability. Methods： ODT was exposed to strong light, high temperature, high moisture of air respectively, and accelerating test was performed. The stability and dissolution of sample were determined by same time. Results： Under strong light, high temperature, the ODT sample had good stability. The dissolution increased at relative humidity 95% and tablet expanded and absorbed moisture except the content didn＇t not change. Conclusion： ODT has good stability under strong light and high temperature, but at high moisture of air it shows extrence unstable. Attention should be paid to the property of moisture insulation of wrapper.