己酮可可碱葡萄糖注射液中杂质的研究  

Research on Impurity of Pentoxifylline and Glucose Injection

作　　者：杜碧莹[1] 王自[1] 

机构地区：[1]广东省广州市药品检验所,广州510160

出　　处：《中国药学杂志》2014年第9期773-775,共3页Chinese Pharmaceutical Journal

摘　　要：目的研究己酮可可碱葡萄糖注射液中杂质、杂质的结构确证及产生的原因。方法通过LC-MS,推断杂质可能结构,并以可可碱与1,3二溴丙烷为起始原料,制备目标化合物,用IR,LC-MS,1H-NMR,13C-NMR进行结构鉴定。结果确证该杂质为1,1'-(丙烷-1,3-二基)双(3,7-二甲基-3,7-二氢-1H-嘌呤-2,6-二酮)。结论本实验为己酮可可碱葡萄糖注射液生产工艺中杂质的控制及质量评价提供依据。OBJECTIVE To study the impurity of pentoxifylline and glucose injection and confirm its structure and source. METHODS LC-MS was used to speculate the structure of the impurity. The impurity was synthesized by using theobromine and 1,3-di bromopropane as the starting materials and the structure was identified by IR, LC-MS, I H-NMR, and ^13 C-NMR. RESULTS The impurity was identified to be l, 1 ＇- （ propane-1,3-diyl ） his （ 3,7-dimethyl-3,7-dihydro-lH-purine-2,6-dione ）. CONCLUSION The study provides theoretical basis for the control of impurity in the production process and quality assessment of pentoxifylline and glucose injection.

关 键 词：己酮可可碱葡萄糖注射液 杂质 合成 结构鉴定 

分 类 号：R917[医药卫生—药物分析学]