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
张程程 1刘翠平 1厉孝广 1潘红娟1
作者信息
- 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
- 折叠
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A1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.
Abstract
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 A1 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A1Key words
1,2-dierucoyl-sn-glycero-3-phosphocholine/dimyristoyl phosphatidylethanolamine/dipalmitoyl phosphatidylglycerol/high performance liquid chromatography/degradation impurity/lysophospholipid/phospholipase A引用本文复制引用
出版年
2023
NETL
NSTL
维普
万方数据