目的 考察铂类抗癌药物奥沙利铂原料药的稳定性.方法 分别在强光(45001x±5001x)照射10d、高温(60℃)存放10d、高湿(25℃,相对湿度90%±5%)存放10 d、加速试验(40℃±2℃,相对湿度75%±5%)6个月、长期试验(25℃±2℃,相对湿度60%±10%)12个月后,考察奥沙利铂原料药的性状、鉴别以及溶液的外观、pH、比旋度、有关物质、杂质D、干燥失重和含量变化.结果 经光照试验、高湿试验、高温试验、加速试验和长期试验后,奥沙利铂原料药的各项指标均符合质量标准要求.结论 奥沙利铂原料药稳定性较好.%Objective To investigate the stabilities of oxaliplatin raw material medicine of platinum- based anticancer drug. Methods The raw material of oxaliplatin was respectively treated with highlight(4 500 lx ±500 lx) for 10 d, high temperature (60 ℃ ) for 10 d, high wet (25 ℃, RH 90％ ±5％ ) for 10 d, accelerating testing(40℃ ±2 ℃, RH 75％ ±5％ ) for 6 months, and a long term testing (25 ℃ ± 2 ℃, RH 60％ ± 10％ ) for 12 months. Then the changes of characters, identification, appearance of solution, acidity, specific optical rotation, related substance, impurity D, weight loss by drying and content under different storage conditions were observed. Results All of the tested indexes of the samples were consistent with the quality standards after the series tests. Conclusion The tested material is better stable.
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