奥沙利铂有关物质的制备.pdf

文档介绍：中国医药工业杂志 Chinese Journal of Pharmaceuticals 2010, 41(10) · 727 ·
奥沙利铂有关物质的制备
单衍强1,赵慧英2,范传文2*
(1. 齐鲁制药(海南)有限公司,海南海口 570314; 2. 齐鲁制药有限公司药物研究院,山东济南 250100)
摘要:为控制奥沙利铂产品质量,分别制备了欧洲药典( EP) 版中所载奥沙利铂的 3 个有关物质——[SP-4-2-(1R-
trans)]-(1,2- 环己二胺-N,N′) 二水合铂(B)、[OC-6-33-(1R-trans)]-(1,2- 环己二胺-N,N′)[ 草酸(2-)-O,O'] 二羟基合铂(C)
和[SP-4-2-(1S-trans)]-(1,2- 环己二胺-N,N′)[ 草酸(2-)-O,O'] 合铂(D)。经 1H NMR 确证结构,其 HPLC 的保留时间与
EP 对照品一致。
关键词:奥沙利铂;有关物质;制备
中图分类号:+1 文献标志码:A 文章编号:1001-8255(2010)10-0727-04
Preparation of the Related Substances of Oxaliplatin
SHAN Yanqiang1, ZHAO Huiying2, FAN Chuanwen2*
(1. Qilu Pharmaceutical (Hainan) Co., Ltd., Haikou 570314;
2. Qilu Pharmaceutical Research Institute, Qilu Pharmaceutical Co., Ltd., Jinan 250100)
ABSTRACT: To perform the quality control of oxaliplatin, three related substances recorded in EP : [SP-4-2-
(1R-trans)]-(1,2-cyclohexanediamine-N,N′)diaquaplatinum(B), [OC-6-33-(1R-trans)]-(1,2-cyclohexanediamine-
N,N′)[ethanedioato(2-)-O,O']dihydroxyplatinum(C)and [SP-4-2-(1S-trans)]-(1,2-cyclohexanediamine-N,N′)
[ethanedioato(2-)-O,O']platinum(D) were prepared. Their structures were confirmed by 1H NMR, and their HPLC
behavior was consistent with that of EP reference.
Key Words: oxaliplatin; related substance; preparation
奥沙利铂(oxaliplatin),化学名为[SP-4-2- 中国药品标准[WS1-(X-104)-2003Z] 对奥沙
(1R-trans)]-(1,2- 环己二胺-N,N')[草酸(2-)-O,O'] 利