# 功能性食品中生物活性肽（BAPs）：从生产与验证到商业化、监管壁垒及未来前景 - 生物通

*Источник: 生物通*
*Дата: 2026-10-01*
*Язык: zh*

**Кратко:** ¡¶JOURNAL OF FOOD SCIENCE¡·£ºBioactive Peptides in Functional Foods: From Production and Validation to Commercialization, Regulatory Hurdles, and Future Prospects
        
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1 Introduction
ÉúÎï»îÐÔëÄ£¨BAPs£©ÊÇÇ×±¾µ°°×ÖÐÎÞ»îÐÔ¡¢ÊÍ·Åºó²úÉúÉúÀíÐ§Ó¦µÄ2¨C20¸ö°±»ùËá£¨AA£©Æ¬¶Î£¬À´Ô´º¸ÇÈé¡¢Èâ¡¢µ°¡¢´ó¶¹¡¢¹ÈÎï¡¢¶¹Àà¼°ÓãÔå¡£Æä½á¹¹¨C»îÐÔ¹ØÏµÓÉAA×é³É¡¢ÐòÁÐ¡¢µçºÉ¡¢ÊèË®ÐÔºÍÁ½Ç×ÐÔµÈ¾ö¶¨£¬¹¦ÄÜ°üÀ¨¿¹¸ßÑªÑ¹¡¢¿¹Ñõ»¯¡¢¿¹¾ú¡¢ÃâÒßµ÷½Ú¡¢¿¹ÌÇÄò²¡µÈ¡£ValorizationÍÆ¶¯¸±²úÎï×ª»¯Îª¸ßÖµÅäÁÏ¡£±¾×ÛÊöÆÀ¹À´ÓÉú²ú¡¢ÑéÖ¤µ½ÉÌÒµ»¯¡¢¼à¹ÜºÍÇ°¾°¡£
2 The Discovery and Validation of BAPs: A Critical Assessment
2.1 Generation of Bioactive Peptides
2.1.1 Conventional Approaches
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2.1.2 Emerging Production Technologies and Their Industrial Potential
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2.2 Isolation, Purification, and Characterization
2.2.1 Advanced Separation Methodologies
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2.2.2 Peptide Identification and Sequencing Techniques
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2.3 A Multi-Tiered Approach to Bioactivity Validation
2.3.1 In Silico Prediction
in silicoÊý¾Ý¿â¡¢·Ö×Ó¶Ô½Ó¡¢·Ö×Ó¶¯Á¦Ñ§¼°ÈË¹¤ÖÇÄÜ£¨AI£©/»úÆ÷Ñ§Ï°£¨ML£©ÓÃÓÚÔ¤²â»îÐÔºÍ´ÓÍ·Éè¼Æ¡£
2.3.2 In Vitro Screening
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2.3.3 Cellular and In Vivo Models
Caco-2ºÍRAW264.7ÓÃÓÚÎüÊÕ¡¢»úÖÆºÍ¿¹Ñ×£¬×Ô·¢ÐÔ¸ßÑªÑ¹´óÊó£¨SHRs£©¡¢DrosophilaºÍ°ßÂíÓãÓÃÓÚÌåÄÚ¡£ÌåÍâÊý¾ÝÓëÈËÌåÁÆÐ§ÍÑ½Ú£¬EFSAÒªÇóÈËÌåÊÔÑé¡£×ª»¯ÊÇÐò¹áËðºÄ£¬Éæ¼°ëÄÃ¸½µ½â¡¢PepT1±¥ºÍ¡¢ÎüÊÕÍ¨Â·¡¢¸ÎÊ×¹ýºÍÉöÇå³ý£¬ÐèÄ£ÄâÏû»¯¡¢LC-MS/MS¶¨Á¿¡¢Ò©´úºÍ·Ö²ãÊÔÑé¡£
2.4 Mechanistic Basis of Major Biological Activities
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3 BAP Commercialization
3.1 Technical Hurdles in Product Formulation
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3.1.1 Oral Absorption, Systemic Stability, and Tissue Distribution
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3.1.2 Sensory and Matrix Constraints
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3.2 Innovative Formulation and Delivery Strategies
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3.2.1 Comparative Nano- and Micro-Delivery Platforms
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3.2.2 Allergenicity and Safety Considerations of BAPs
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3.3 Manufacturing Scale-Up, Quality Control, and Industrial Implementation
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3.4 Case Studies of Commercial Products
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4 Navigating Regulatory Landscape and Health Claims
4.1 The Global Regulatory Landscape: An Overview
FDA¡¢EFSA¡¢¼ÓÄÃ´óÎÀÉú²¿¡¢ÈÕ±¾ÌØ¶¨±£½¡ÓÃÊ³Æ·£¨FOSHU£©¡¢ÖÐ¹úÊ³Æ·Ò©Æ·¼à¶½¹ÜÀí×Ü¾Ö£¨CFDA£©µÈÌåÏµ¾ùÒªÇóÇ¿¿ÆÑ§Ö¤¾Ý£¬ÓÈÆäÈËÌåÊÔÑé¡£
4.2 FDA (Us) vs. 1924/2006ÒªÇóEFSAÓªÑø¡¢ÐÂÊ³Æ·ºÍÊ³Æ·¹ýÃôÔ×¨¼Ò×é£¨NDA£©ÆÀ¹À£¬Ðè¶àÏîËæ»ú°²Î¿¼Á¶ÔÕÕÈËÌåÊÔÑéÒ»ÖÂÖ¤¾Ý¡£PeptiStrong»ñFDA GRASÎÞÒìÒé£¬µ°Ä¤½ºÔëÄ»ñEFSA»ý¼«°²È«Òâ¼û¡£
4.3 Regulatory Pathways in Asia-Pacific Markets
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4.4 Key Hurdles to Regulatory Approval
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5 Future Prospects and Research Gaps
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6 Conclusions
BAPsÇ±Á¦´ó£¬µ«´æÔÚÁÙ´²Ç°¨CÁÙ´²ÍÑ½Ú¡¢GIÎÈ¶¨ÐÔºÍ¸Ð¹ÙÕÏ°¡£ÄÉÃ×°ü·âµÈ¿É½â¾ö²¿·ÖÎÊÌâ£¬Î´À´ÒÀÀµ¸ßÖÊÁ¿ÁÙ´²ÑÐ¾¿¡¢AIÉè¼ÆºÍ¸öÐÔ»¯ÓªÑø¡£

¡¶JOURNAL OF FOOD SCIENCE¡·£ºBioactive Peptides in Functional Foods: From Production and Validation to Commercialization, Regulatory Hurdles, and Future Prospects
        
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1 Introduction
ÉúÎï»îÐÔëÄ£¨BAPs£©ÊÇÇ×±¾µ°°×ÖÐÎÞ»îÐÔ¡¢ÊÍ·Åºó²úÉúÉúÀíÐ§Ó¦µÄ2¨C20¸ö°±»ùËá£¨AA£©Æ¬¶Î£¬À´Ô´º¸ÇÈé¡¢Èâ¡¢µ°¡¢´ó¶¹¡¢¹ÈÎï¡¢¶¹Àà¼°ÓãÔå¡£Æä½á¹¹¨C»îÐÔ¹ØÏµÓÉAA×é³É¡¢ÐòÁÐ¡¢µçºÉ¡¢ÊèË®ÐÔºÍÁ½Ç×ÐÔµÈ¾ö¶¨£¬¹¦ÄÜ°üÀ¨¿¹¸ßÑªÑ¹¡¢¿¹Ñõ»¯¡¢¿¹¾ú¡¢ÃâÒßµ÷½Ú¡¢¿¹ÌÇÄò²¡µÈ¡£ValorizationÍÆ¶¯¸±²úÎï×ª»¯Îª¸ßÖµÅäÁÏ¡£±¾×ÛÊöÆÀ¹À´ÓÉú²ú¡¢ÑéÖ¤µ½ÉÌÒµ»¯¡¢¼à¹ÜºÍÇ°¾°¡£
2 The Discovery and Validation of BAPs: A Critical Assessment
2.1 Generation of Bioactive Peptides
2.1.1 Conventional Approaches
Ã¸½â¸ßÌØÒì¡¢ÎÂºÍ¡¢Ê³Æ·¼¶£¬µ«Ã¸¹ó¡¢²úÂÊ¿ÉÄÜµÍ£»Î¢ÉúÎï·¢½Í³É±¾µÍµ«¿ØÖÆ²î£»»¯Ñ§ºÏ³ÉºÍÖØ×é±í´ï¿É¾«È·¿ØÖÆÐòÁÐ£¬ÊÊºÏ¸ßÖµ¶ÌëÄ£¬µ«³É±¾¡¢´¿»¯ºÍGMP¸ºµ£¸ß¡£
2.1.2 Emerging Production Technologies and Their Industrial Potential
³¬Éù¸¨ÖúÌáÈ¡£¨UAE£©¡¢¸ß¾²Ë®Ñ¹£¨HHP£©¡¢Âö³åµç³¡£¨PEF£©¡¢Å·Ä·¼ÓÈÈ¡¢Î¢²¨ºÍÑÇÁÙ½çË®µÈÍ¨¹ý¸Ä±äµ°°×½á¹¹±©Â¶ÇÐ¸îÎ»µã£¬¶à×÷ÎªÃ¸½âÔ¤´¦ÀíÌá¸ß²úÂÊ£»µ«´æÔÚ·Ç¾ùÒ»ÐÔ¡¢ÈÈËðÉË¡¢×Ê±¾³É±¾ºÍ¸ßÄÜºÄ£¬Ñ¡ÔñÓ¦»ùÓÚ²úÆ·¶ø·Ç½ö²úÂÊ¡£
2.2 Isolation, Purification, and Characterization
2.2.1 Advanced Separation Methodologies
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2.2.2 Peptide Identification and Sequencing Techniques
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2.3 A Multi-Tiered Approach to Bioactivity Validation
2.3.1 In Silico Prediction
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2.3.2 In Vitro Screening
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2.3.3 Cellular and In Vivo Models
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2.4 Mechanistic Basis of Major Biological Activities
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3 BAP Commercialization
3.1 Technical Hurdles in Product Formulation
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3.1.1 Oral Absorption, Systemic Stability, and Tissue Distribution
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3.1.2 Sensory and Matrix Constraints
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3.2 Innovative Formulation and Delivery Strategies
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3.2.1 Comparative Nano- and Micro-Delivery Platforms
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3.2.2 Allergenicity and Safety Considerations of BAPs
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3.3 Manufacturing Scale-Up, Quality Control, and Industrial Implementation
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3.4 Case Studies of Commercial Products
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4 Navigating Regulatory Landscape and Health Claims
4.1 The Global Regulatory Landscape: An Overview
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4.2 FDA (Us) vs. EFSA (Eu)
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4.3 Regulatory Pathways in Asia-Pacific Markets
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4.4 Key Hurdles to Regulatory Approval
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5 Future Prospects and Research Gaps
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6 Conclusions
BAPsÇ±Á¦´ó£¬µ«´æÔÚÁÙ´²Ç°¨CÁÙ´²ÍÑ½Ú¡¢GIÎÈ¶¨ÐÔºÍ¸Ð¹ÙÕÏ°¡£ÄÉÃ×°ü·âµÈ¿É½â¾ö²¿·ÖÎÊÌâ£¬Î´À´ÒÀÀµ¸ßÖÊÁ¿ÁÙ´²ÑÐ¾¿¡¢AIÉè¼ÆºÍ¸öÐÔ»¯ÓªÑø¡£

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