Content and Composition of Phospholipids, Fatty Acids and Sterols in Commercial Natural Phospholipid Excipients

Author:

Zheng Luxia1ORCID,Shen Xiong2ORCID,Wang Yingchun1,Liang Jian2,Xu Mingming3,Fang Xinxin3,Chen Gang3,Chen Guilliang1

Affiliation:

1. Shanghai Institute of Pharmaceutical Industry, China State Institute of Pharmaceutical Industry, 285 Gebaini Road, Shanghai 200040, China

2. Department of Pharmacy, Zhongshan Hospital, 180 Fenglin Road, Shanghai 200032, China

3. NMPA Key Laboratory for Quality Control of Therapeutic Monoclonal Antibodies, Shanghai Institute for Food and Drug Control, 1500 Zhangheng Road, Shanghai 201203, China

Abstract

Background: Phospholipids are widely used in food and pharmaceutical industry as functional excipients. In spite of the many analytical methods reported, there are very limited reports concerning systematic research and comparison of phospholipid excipients. Objective: To present a comprehensive evaluation of commercial natural phospholipid excipients (CNPEs). Methods: Seventeen batches of CNPEs from five manufacturing enterprises, isolated either from soybean or egg yolk, were investigated. The content and composition of phospholipids, fatty acids and sterols as a whole were considered as the evaluative index of CNPEs. Eight kinds of phospholipids were determined by Supercritical Fluid Chromatography (SFC), twenty-one kinds of fatty acids were determined by Gas Chromatography (GC) after boron trifluoride-methanol derivatization, and nine kinds of sterols were determined by High Performance Liquid Chromatography (HPLC) after separation and derivatization of the unsaponifiable matter. Cluster analysis was employed for the classification and identification of the CNPEs. Results: The results showed that each kind of CNPEs had its characteristic content and composition of phospholipids, fatty acids and sterols. Seventeen batches of samples were divided into eight groups in cluster analysis. CNPEs of the same type from different source (soybean or egg yolk) or enterprises presented different content and composition of phospholipids, fatty acids and sterols. Conclusion: Each type of CNPEs had its characteristic content and composition of phospholipid, fatty acid and sterol. The compositions of phospholipid, fatty acid and sterol as a whole can be applied as an indicator of the quality and characteristics for CNPEs.

Funder

National Science Foundation of China

Publisher

Bentham Science Publishers Ltd.

Subject

Pharmaceutical Science,Molecular Medicine,Biochemistry,Biophysics

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