奥沙利铂杂质研究进展  

Progress on the impurities in Oxaliplatin

作　　者：牛冲[1] 刘桂花 张中湖[1] 

机构地区：[1]山东省食品药品检验所,山东济南250101 [2]山东瑞中医药有限公司,山东济宁272000

出　　处：《药学实践杂志》2012年第6期412-414,436,共4页Journal of Pharmaceutical Practice

基　　金：国家重大科技专项重大新药创制--输液生产线关键工艺在线监控技术平台建设课题(2009ZX09313-023)

摘　　要：以近年来国内外研究文献为基础,对奥沙利铂及其制剂杂质来源、杂质控制、制剂的稳定性等进行综述。奥沙利铂及其制剂的主要杂质为草酸、杂质B、C、D以及杂质E。杂质由合成工艺带入,同时原料及制剂在放置过程中均可降解产生上述杂质。为确保临床用药的安全有效,奥沙利铂及其制剂的杂质需要分别进行控制。The research progress on the preparation and impurities of Oxaliplatin were summarized based on the recent documents, which generalize the impurity organization, impurity controlling and preparation stability. The principal impurities in Oxaliplatin were oxalic acid, impurity B, impurity C, impurity D and impurity E. All of the impurities were produced during the syntheses and also could be degraded from Oxaliplatin and its preparation. The impurities in Oxaliplatin and its preparation must be controlled respectively to ensure the security and effect of the drugs.

关 键 词：奥沙利铂 杂质 有关物质 抗癌药物 

分 类 号：R979.1[医药卫生—药品]