已获批特殊医学用途婴儿配方食品营养成分含量与《新国标》（GB 25596-2025）比较研究

doi:10.12372/jcp.2025.25e0568

摘要/Abstract

摘要：

国家卫生健康委员会联合国家市场监督管理总局于2025年3月16日共同发布《食品安全国家标准特殊医学用途婴儿配方食品通则》（GB 25596-2025）（简称《新国标》）。《新国标》涉及宏量营养素（蛋白质、碳水化合物和脂肪），维生素和矿物质等微量元素以及可选择成分等指标范围、含量要求及检测方法的优化调整，同时产品类别从原有6类扩增至13类，并配套相应技术指标要求。目前已获批特殊医学用途婴儿（简称特医婴）配方食品均按照《食品安全国家标准特殊医学用途婴儿配方食品通则》（GB 25596-2010）（简称《旧国标》）要求生产。本文将重点围绕必需成分和可选择性成分的指标变化，比较研究已获批产品与《新国标》的符合程度，帮助临床儿科医师准确把握《新国标》修订的核心内容，从而为特定疾病状态婴儿提供更加科学合理的营养支持方案。

关键词: 特殊医学用途婴儿配方食品, 国家标准, 已获批, 比较研究

Abstract:

The National Health Commission and the State Administration for Market Regulation jointly promulgated the "National Food Safety Standard: General Standard for Infant Formula for Special Medical Purposes" (GB 25596-2025, hereinafter referred to as the "New Standard") on March 16, 2025. The New Standard introduces comprehensive optimizations regarding the reference ranges, content requirements, and testing methods for macronutrients (proteins, carbohydrates, and fats), vitamins, minerals, and other optional components. Additionally, it expands the product categories from the original 6 to 13 types, with corresponding technical specifications established for each category. Currently, all approved infant formula products for special medical purposes (hereinafter referred to as "FSMP for infants") in the market are manufactured in compliance with the 2010 version of the standard (GB 25596-2010, "Old Standard"). This article will focus on analyzing the changes in mandatory and optional component requirements, while evaluating the compliance status of approved products with the New Standard. The findings aim to assist clinical pediatricians in accurately understanding the key revisions of the New Standard, thereby enabling more scientifically appropriate nutritional support plans for infants with special medical conditions.

Key words: infant formula foods for special medical purposes, new standards, approved, comparative study

中图分类号:

郭卓雨. 已获批特殊医学用途婴儿配方食品营养成分含量与《新国标》（GB 25596-2025）比较研究[J]. 临床儿科杂志, 2025, 43(11): 837-844.

GUO Zhuoyu. A comparative study on the nutritional content of approved special medical purpose infant formula food with the "New National Standard (GB 25596-2025)"[J]. Journal of Clinical Pediatrics, 2025, 43(11): 837-844.

图/表 4

表1

特医婴配方食品必需成分新旧国标对比"

类别	营养成分	指标要求				检验方法
		每100 kJ		每100 kcal		检验方法
		《旧国标》	《新国标》	《旧国标》	《新国标》	《旧国标》	《新国标》
蛋白质、脂肪和碳水化合物指标	蛋白质/g	0.45~0.70	0.43↓~0.84↑	1.88~2.93	1.8↓~3.5↑	GB 5009.5	GB 5009.5
	脂肪/g	1.05~1.40	0.84↓~1.43↑	4.39~5.86	3.5↓~6.0↑	GB 5413.3	GB 5009.6
	亚油酸/g	0.07~0.33	0.07~0.33	0.29~1.38	0.3~1.4	GB 5413.27	GB 5009.168
	α-亚麻酸/mg	12~NS	12~NS	50~NS	50~NS	GB 5413.27	GB 5009.168
	亚油酸与α-亚麻酸比值	5∶1~15∶1	5∶1~15∶1	5∶1~15∶1	5∶1~15∶1	－	－
	碳水化合物/g	2.2~3.3	2.2~3.3	9.2~13.8	9.0~14.0	－	－
维生素指标	维生素A/μg RE	14~43	14~43	59~180	60~180	GB 5413.9	GB 5009.82
	维生素D/μg	0.25~0.60	0.48↑~1.20↑	1.05~2.51	2.0↑~5.0↑	GB 5413.9	GB 5009.296
	维生素E/mg α-TE	0.12~1.20	0.12~1.20	0.50~5.02	0.5~5.0	GB 5413.9	GB 5009.82
	维生素K₁/μg	1.0~6.5	0.96²⁾~6.45²⁾	4.2~27.2	4.0²⁾~27.0²⁾	GB 5413.10	GB 5009.158
	维生素B₁/μg	14~72	14~72	59~301	60~300	GB 5413.11	GB 5009.84
	维生素B₂/μg	19~119	19~120²⁾	80~498	80~500²⁾	GB 5413.12	GB 5009.85
	维生素B₆/μg	8.5~45.0	8.4²⁾~41.8↓	35.6~188.3	35²⁾~175↓	GB 5413.13	GB 5009.154
	维生素B₁₂/μg	0.025~0.360	0.024²⁾~0.359²⁾	0.105~1.506	0.10²⁾~1.50²⁾	GB 5413.14	GB 5009.285
	烟酸(烟酰胺)/μg	70~360	96↑~359²⁾	293~1 506	400↑~1 500²⁾	GB 5413.15	GB 5009.89
	叶酸/μg	2.5~12.0	2.4²⁾~12.0	10.5~50.2	10²⁾~50²⁾	GB 5413.16	GB 5009.211
	泛酸/μg	96~478	96~478	402~2 000	400~2 000	GB 5413.17	GB 5009.210
	维生素C/mg	2.5~17.0	2.4²⁾~16.7²⁾	10.5~71.1	10²⁾~70²⁾	GB 5413.18	GB 5413.18
	生物素/μg	0.4~2.4	0.36²⁾~2.39²⁾	1.5~10.0	1.5~10.0	GB 5413.19	GB 5009.259
	胆碱/mg¹⁾	1.7~12.0	4.8↑~23.9↑	7.1~50.2	20↑~100↑	GB/F 5413.20	GB 5413.20
矿物质指标	钠/mg	5~14	NS~20↑	21~59	NS~84	GB 5413.21	GB 5009.91
	钾/mg	14~43	17↑~54↑	59~180	70~225	GB 5413.21	GB 5009.91
	铜/μg	8.5~29.0	8.4²⁾~28.7²⁾	35.6~121.3	35~120	GB 5413.21	GB 5009.13
	镁/mg	1.2~3.6	1.2~3.6	5.0~15.1²⁾	5.0~15.0	GB 5413.21	GB 5009.241
	铁/mg	0.10~0.36	0.10~0.48↑	0.42~1.51	0.42~2.00↑	GB 5413.21	GB 5009.90
	锌/mg	0.12~0.36	0.12~0.36	0.50~1.51	0.50~1.50	GB 5413.21	GB 5009.14
	锰/μg	1.2~24.0	0.24↓~23.90²⁾	5.0~100.4	1.0↓~100.0²⁾	GB 5413.21	GB 5009.242
	钙/mg	12~35	12~43↑	50~146	50~180↑	GB 5413.21	GB 5009.92
	磷/mg	6~24	6~26↑	25~100	25~110↑	GB 5413.22	GB 5009.87
	钙磷比值	1∶1~2∶1	1∶1~2∶1	1∶1~2∶1	1∶1~2∶1	－	－
	碘/μg	2.5~14.0	3.6↑~14.1²⁾	10.5~58.6	15↑~59²⁾	GB 5413.23	GB 5009.267
	氯/mg	12~38	NS~52↑	50~159	NS~218↑	GB 5413.24	GB 5009.44
	硒/μg	0.48~1.90	0.48~2.06↑	2.01~7.95	2.0~8.6↑	GB 5009.93	GB 5009.93

表1

表2

表3

已获批特医婴配方食品必需成分与《新国标》差异对比"

指标	类别	特医婴配方食品		无乳糖或低乳糖配方		乳蛋白部分水解配方		乳蛋白深度水解或氨基酸配方		早产/低出生体重配方		母乳营养补充剂		氨基酸代谢障碍配方
指标	类别	个数	达标率 %	个数	达标率 %	个数	达标率 %	个数	达标率 %	个数	达标率 %	个数	达标率 %	个数	达标率 %
蛋白质、脂肪和碳水化合物	蛋白质	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	脂肪	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	亚油酸	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	α-亚麻酸	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	亚油酸与α-亚麻酸比值	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	碳水化合物	57	100	14	100	11	100	5	100	19	100	5	100	3	100
维生素	维生素A	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素D	21	36.84	0	0	0	0	0	0	16	84.21	5	100	0	0
	维生素E	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素K₁	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素B₁	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素B₂	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素B₆	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素B₁₂	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	烟酸(烟酰胺)	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	叶酸	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	泛酸	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	维生素C	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	生物素	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	胆碱¹⁾	17	29.82	3	21.43	5	45.45	0	0	6	31.58	1	20	2	66.67
矿物质指标	钠	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	钾	55	96.49	14	100	11	100	5	100	17	89.47	5	100	3	100
	铜	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	镁	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	铁	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	锌	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	锰	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	钙	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	磷	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	钙磷比值	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	碘	38	66.67	5	35.71	6	54.55	2	40	17	89.47	5	100	3	100
	氯	57	100	14	100	11	100	5	100	19	100	5	100	3	100
	硒	57	100	14	100	11	100	5	100	19	100	5	100	3	100

表3

表4

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可选择成分	指标要求				检验方法
可选择成分	《旧国标》/100 kJ^-1	《新国标》/100 kJ^-1	《旧国标》/100 kcal^-1	《新国标》/100 kcal^-1	《旧国标》	《新国标》
胆碱/mg¹⁾	1.7~12.0	4.8↑~23.9↑	7.1~50.2	20↑~100↑	GB/T 5413.20	GB 5413.20
铬/μg	0.4~2.4	0.4~2.4	1.5~10	1.5~10.0	－	GB 5009.123
钼/μg	0.4~2.4	0.4~2.4	1.5~10	1.5~10.0	－	GB 5009.297
肌醇/mg	1.0~9.5	1.0~9.6²⁾	4.2~39.7	4~40²⁾	GB 5413.25	GB 5009.270
牛磺酸/mg	NS~3	0.8~4.0↑	NS~13	3.5~16.7↑	GB 5413.26	GB 5009.169
左旋肉碱/mg	0.3~NS	0.3~NS	1.3~NS	1.3~NS	－	GB 5009.300
DHA/mg³⁾	NS~0.5	3.6~9.6↑	NS~0.5	15~40↑	GB 5413.27	GB 5009.168
AA/ARA/mg³⁾	NS~1	NS~19.1↑	NS~1	NS~80↑	GB 5413.27	GB 5009.168