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目的 :对新研制的卡铂栓进行稳定性实验研究。方法 :通过影响因素 ,加速和自然留样实验 ,采用HPLC测定卡铂栓的含量和降解产物 ,并观察外观性状变化。结果 :卡铂栓剂为脂溶性基质时 ,室温光照高湿度条件包装情况下稳定性好。结论 :本方法测定快速、简便、准确 ,表明卡铂栓应于避光干燥 ,2 5℃以下保存。
Objective: To study the stability of newly developed carboplatin suppository. Methods: The content of carboplatin and the degradation products were determined by HPLC with influencing factors, accelerated and natural samples retention experiments, and the changes of appearance and appearance were observed. Results: Carboplatin suppository was a fat-soluble matrix with good stability under ambient light and humidity conditions. Conclusion: The method is rapid, simple and accurate, indicating that carboplatin suppository should be kept in dark and dry, and kept below 25 ℃.