摘要
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(4 500 lx±500 lx)照射10 d、高温(60℃)存放10 d、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.
出处
《中国药业》
CAS
2011年第1期3-5,共3页
China Pharmaceuticals
基金
国家科技型中小企业技术创新项目
项目编号:05C26215301434
昆明市科技计划重点项目
项目编号:08G100110
关键词
铂类抗癌药物
奥沙利铂
原料药
稳定性
platinum-based anticancer drug
oxaliplatin
raw material
stability
