中国药业2011,Vol.20Issue(1):3-5,3.
铂类抗癌药物奥沙利铂原料药的稳定性研究
Study on Stability of Raw Material of Oxaliplatin as Platinum-Based Anticancer Drug
摘要
Abstract
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.关键词
铂类抗癌药物/奥沙利铂/原料药/稳定性分类
医药卫生引用本文复制引用
彭娟,普绍平,栾春芳,张志荣,刘祝东..铂类抗癌药物奥沙利铂原料药的稳定性研究[J].中国药业,2011,20(1):3-5,3.基金项目
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. ()