Interpretation of key quality indicators of phospholipid pharmaceutical excipients and analysis of their impact on drug formulations
10.19778/j.chp.2025.05.005
- VernacularTitle:磷脂类药用辅料关键质量指标解读及其对药物制剂的影响分析
- Author:
Yaowei LI
1
;
Wenqi LIU
;
Lin YANG
;
Fengjiao JIANG
;
Lei CHEN
;
Xinxin ZHANG
;
Yong GAN
Author Information
1. 中国科学院上海药物研究所,上海 201203;南京中医药大学新中药学院,南京 210023
- Publication Type:Journal Article
- Keywords:
phospholipid pharmaceutical excipients;
pharmacopoeia;
quality standard;
content determination;
functionality-related indicators
- From:
Drug Standards of China
2025;26(5):473-481
- CountryChina
- Language:Chinese
-
Abstract:
Phospholipid pharmaceutical excipients are primarily composed of a glycerol backbone,fatty acid chains,and phosphate groups.Due to their amphiphilic structure and unique physicochemical properties,they are commonly used as emulsifiers and carrier materials in pharmaceutical formulations.The pharmacopoeias of various countries have included phospholipid based pharmaceutical excipients and specified the testing methods and limits for their critical quality attributes.This article focuses on the current inclusion status,characteristic indicators,component content determination indicators,and functionality-related indicators determination methods and limits of phospholipid pharmaceutical excipients of various countries,in order to provide references and a basis for the rational applicatione of phospholipid pharmaceutical excipients.
