阿魏酸钠注射液的稳定性研究

Study of the Stability on Sodium Ferulate Injection

目的 :考察不同pH值及强光、高温等因素对阿魏酸钠注射液稳定性的影响 ,并对阿魏酸钠注射液进行加速试验考察。方法 :将不同pH值的阿魏酸钠注射液在 10 0℃恒温中静置 3 0分钟 ,观察其降解率随时间变化情况 ;分别在 450 0lx强光照射及 40℃、60℃高温条件下放置 10天 ,观察阿魏酸钠注射液的各项指标变化情况 ;在3 0℃加速试验条件下放置 3个月 ,考察阿魏酸钠注射液的稳定性。结果 :药液pH值升高 ,阿魏酸钠的降解速度加快 ;强光及高温条件下放置 10天 ,阿魏酸钠注射液的pH值、含量及有关物质均有不同程度的改变 ;3 0℃加速试验 3个月 ,其pH值略有上升 ,含量有较明显改变。结论 :阿魏酸钠注射液的稳定性受pH值影响 ,且在光照及高温下不稳定。本品应避免光照及高温受热 。

Objective:To study th e effects of different pHs, intense light and high temperature on the stability o f Sodium Ferulate Injection. The accelaration experiment was adopted in this stu dy. Methods:Sodium Ferulate Injection of different pHs stayed a t 100℃ for 30 min. The rate of degradation following time was observed. Its app ropriate attributes changes were observed at 4 500 lx and 40℃、60℃ storage con ditions for ten days, and the accelerated testing stability was studied at 30℃ under storage conditions for three months. Results:The studies showed that degradation was increased with the pH value raised. Its pH value, co ntent and related substances changed when stored under intense light and high te mperature condition. The Accelerated testing indicated that concentration of Sod ium Ferulate Injection was obviously changed. Conclusion:Sodium Ferulate Injection is sensitive to heat and light, and it must be stored at low temperature and protected from light.