我国特殊医学用途配方食品蛋白质原料使用状况分析  

Analysis of the use of protein materials in formula food for special medical purposes

作　　者：王星 WANG Xing(Center for Food Evaluation,State Administration for Market Regulation,Beijing 100070,China)

机构地区：[1]国家市场监督管理总局食品审评中心,北京100070

出　　处：《中国食品卫生杂志》2023年第11期1631-1636,共6页Chinese Journal of Food Hygiene

摘　　要：目的探讨分析蛋白质原料在特殊医学用途配方食品中的使用状况,为特殊医学用途配方食品研发中蛋白质原料的选择、产品的注册管理及临床使用提供参考。方法结合特殊医学用途配方食品的注册审评情况,从法规标准、蛋白质原料特征及其在不同类型特殊医学用途配方食品中的使用等进行汇总分析。结果蛋白质在特殊医学用途配方食品中具有重要的营养作用,常用的原料包括乳清蛋白、酪蛋白、大豆分离蛋白、水解蛋白及氨基酸等。基于不同的适用人群,蛋白质在全营养配方食品、蛋白质组件及特定全营养配方食品中具有相应的使用要求和临床应用特点。结论基于目前的注册审评情况及文献查询情况,针对蛋白质原料和人体对蛋白质营养需求的相关研究较为成熟,但针对蛋白质原料在特殊医学用途配方食品中使用的研究仍较为有限。建议进一步加强蛋白质原料在特殊医学用途配方食品中使用的基础研究、标准法规的完善以及上市后产品临床使用情况的数据收集等工作。Objective This study aimed to discuss the use of protein materials in formula food for special medical purposes to provide a reference for the selection of the protein materials,product registration management,and clinical use in the development and design of formula food for special medical purposes.Methods This study summarized and analyzed the requirements of the protein in terms of the regulations and standards,the characteristics of protein materials,and their use status in different types of formula food for special medical purposes from the perspective of evaluation.Results Protein plays an essential role in formula food for special medical purposes.The commonly used protein materials include whey proteins,casein and soybean protein isolates,hydrolyzed protein,and amino acids.Based on the different applicable people,proteins have different characteristics and clinical applications in nutritionally complete formulas,protein modules,and nutritionally complete formulas for a specific disease.Conclusion Following the current requirements of registration and standards and the literature review,studies on the characteristics of protein materials and human protein nutritional requirements are relatively well-established,but studies on proteins used in formula food for special medical purposes are still limited.Paying more attention to the basic research on the use of protein materials in formula foods for special medical purposes and the collection of data used in clinical studies is crucial.

关 键 词：特殊医学用途配方食品 蛋白质 食品安全 临床营养 

分 类 号：R155[医药卫生—营养与食品卫生学]