鲑降钙素喷鼻剂稳定性考察

Stability of salmon calcitonin nasal spray

目的考察鲑降钙素喷鼻剂的稳定性,为制定其合理的有效期、储存条件提供依据。方法采用高效液相色谱法,分别测定在强光、高温、高湿条件下放置5 d和10 d,在25℃加速试验的条件下放置6个月,在(5±3)℃的条件下放置3个月的鲑降钙素喷鼻剂的含量、有关物质等的含量变化情况。结果鲑降钙素喷鼻剂在40℃、25℃和强光条件下,含量及有关物质均发生明显变化,在(5±3)℃及高湿度条件下则未发生明显变化,各储存条件下的pH值及外观装量等均无明显变化。结论鲑降钙素的有效期可暂定24个月,其合适储存条件为低温(2～8℃)、避光贮存。

Objective To investigate the stability of salmon calcitonin nasal spray to establish the useful life and storage conditions.Method HPLC was used to determine the salmon calcium nasal＇s content and related substances,which were placed five days and ten days under the conditions of high temperature、high humidity and strong light respectively,half a year under the condition of 25 ℃,three months under the condition of（5±3） ℃.Result The contents of salmon calcium in nasal spray declined under the 40 ℃,25 ℃,strong light condition and related substances increased obviously.While there were no obvious changes in relevant substances under the conditions of（5±3） ℃ and high humidity,and in the pH,appearances and capacities under all tested conditions.Conclusion The useful life of the salmon calcium nasal spray is tentatively set for two years and the storage should be at low temperature（2-8 ℃） and avoiding light.