DEPC、DMPE和DPPG合成磷脂降解杂质的初步研究  

Preliminary Study of Synthetic Phospholipid Degradation Impurities of DEPC,DMPE and DPPG

作　　者：张程程 刘翠平 厉孝广 潘红娟[1] ZHANG Chengcheng;LIU Cuiping;LI Xiaoguang;PAN Hongjuan(State Key Lab.of New Drug and Pharmaceutical Process,Shanghai Institute of Pharmaceutical Industry,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]中国医药工业研究总院上海医药工业研究院,创新药物与制药工艺国家重点试验室,上海201203

出　　处：《中国医药工业杂志》2023年第11期1652-1659,共8页Chinese Journal of Pharmaceuticals

摘　　要：分别建立了HPLC-电雾式检测器(CAD)法分析二芥酰磷脂酰胆碱(DEPC)、二肉豆蔻酰磷脂酰乙醇胺(DMPE)和二棕榈酰磷脂酰甘油(DPPG)中的有关物质,监测这3种合成磷脂的降解杂质。采用LC-MS法、专一性磷脂酶A_(1)酶解试验结合ACD/Labs软件(Version 2021)辅助,鉴定3种合成磷脂主要的降解杂质结构,发现上述3种磷脂降解产生了Sn-1-溶血磷脂和Sn-2-溶血磷脂及脂肪酸等共性杂质,并确定了Sn-1-溶血磷脂为优势降解物,为合成磷脂类药用辅料的质量控制和制剂工艺研究提供了参考。An HPLC-charged aerosol detector(CAD)method for the analysis of the related substances of 1,2-dierucoyl-sn-glycero-3-phosphocholine(1),dimyristoyl phosphatidylethanolamine(2)and dipalmitoyl phosphatidylglycerol(3)was established respectively,and the main phospholipid degradation impurities of three synthetic phospholipids were identified as Sn-1-lysophospholipids,Sn-2-lysophospholipids and fatty acids by LC-MS method and specialized phospholipase A_(1)combined with ACD/Labs software(version 2021),and identified in which the Sn-1-lysophospholipids was found as the dominant degradation product.The results provided a reference for the quality control and preparation process of synthetic phospholipid pharmaceutical excipients.

关 键 词：二芥酰磷脂酰胆碱 二肉豆蔻酰磷脂酰乙醇胺 二棕榈酰磷脂酰甘油 高效液相色谱法 降解杂质 溶血磷脂 磷脂酶A_(1) 

分 类 号：R917[医药卫生—药物分析学]