二乙酰二脱水卫矛醇(DADAD)的稳定性研究

Studies on the stability of 3,4-Diacety1-1,2;5,6 Dianhydrogalactitol(DADAD)

目的 将临床多年使用的抗癌新药卫康醇 (DAD)的前体药物 DADAD进行稳定性研究 ,预测贮存期。方法 将 DADAD置于强光、高湿、高温条件下进行影响因素的测定、室温 3年留样观察试验和“简便加速试验法”的研究。结果 各项指标基本保持不变。结论 3年留样试验结果表示其贮存期可定为 3年 ;在规定的强光、高温、高湿条件下 ,显示出其不敏感的特性 ;当其采用“简便加速试验法”,经 85℃和 6 0℃恒温的简便加速试验 ,用 Q1 0 法回归处理实验数据 ,求得室温 (2 5℃ )贮存期为 2 2年 ,显示出其较稳定 。

Objective To study on the stability of DADAD Methods\ The Influential factors were determinated by placing the DADAD under strong light,high temperature and humidity The storage life of the sample reserving in tree years was also examined by the simple and convenient accelerative test Results\ All targets are not Change Conclusion\ Its storage life is determinated in three years The it's stability is basically identical with that by Q\-\{10\} method \ \