营养型脂肪乳剂仿制药药学研究的相关考虑

Some considerations on the study of nutritional fat emulsions

营养型脂肪乳剂通常系以动植物提取油类作为油相,以磷脂作为乳化剂、添加等渗剂和注射用水,经乳化制得的水包油型乳剂,可提供必需脂肪酸,能够维持细胞结构和功能,是肠外营养理想的供能物质。鉴于该类品种原料药组分相对复杂、生产工艺要求较高、质量控制需进一步完善,本文结合品种特点、审评经验和现行国内外的法规要求提出一些研究考虑,旨在为后续的研发提供一些参考。

Nutritional fat emulsions are usually oil-in-water emulsions prepared by emulsifying oils extracted from animals and plants as the oil phase,phospholipids as emulsifiers,supplemented with isotonic agents and water for injection.As an ideal energy supply substance for parenteral nutrition,nutritional fat emulsions can provide essential fatty acids and maintain cell structure and functions.Thus,quality control of nutritional fat emulsions requires further improvements considering the complex composition of their APIs and high requirements for production process.In order to provide guidance for future research and development,this article addresses some research considerations based on the characteristics of nutritional fat emulsions,drug evaluation experience,and current domestic and foreign regulatory requirements.