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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 ,与上述是相一致的
OBJECTIVE To study the stability of DADAD, a prodrug of doxorubicin (DAD), which is used for many years in clinical trials, and to predict the storage period. Methods DADAD was placed in bright light, high humidity, high temperature conditions for the determination of influencing factors, room temperature 3 years left sample observation test and the “simple accelerated test method” study. The results of the basic indicators remain unchanged. Conclusion The result of 3 years sample retention test shows that its storage period can be set as 3 years. It shows its insensitive properties under the conditions of glare, high temperature and high humidity. When it adopts “simple accelerated test method” ℃ and 60 ℃ constant temperature accelerated test, using Q1 0 regression experimental data, obtained at room temperature (25 ℃) storage period of 22 years, showing that it is more stable, consistent with the above