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兽用噬菌体制剂临床应用研究进展与法规解读OA

Research Progress and Regulatory Interpretation of the Clinical Application of Veterinary Bacteriophage Preparations

中文摘要英文摘要

针对当前抗生素滥用引发的多重耐药菌泛滥问题,噬菌体凭借宿主特异性强、绿色无残留、环境友好等突出优势,已成为极具应用潜力的抗生素辅助或替代生物制剂.近年来,全球噬菌体治疗监管体系持续完善,行业规范化发展体系逐步成型,但我国在噬菌体的应用和法规方面仍未形成系统的官方指导文件.本文系统梳理噬菌体在畜禽、水产和宠物领域的研究进展与应用成效,同时汇总并整理了欧美国家最新的噬菌体相关法规、药典和国际标准,以期为我国噬菌体制剂的监管和规模化生产应用提供理论参考,进一步推动噬菌体在养殖领域的应用.

In response to the global spread of multidrug-resistant bacteria caused by antibiotic misuse,bacteriophages have emerged as promising biological agents for antibiotic alternatives or adjunct therapies due to their strong host specificity,residue-free characteristics,and environmental compatibility.In recent years,regulatory frameworks for bacteriophage therapy have been continuously improved worldwide,and standardized development systems have gradually taken shape.However,systematic official guidance documents for the application and regulation of bacteriophage products have not yet been established in China.This review summarizes the research progress and application outcomes of bacteriophages in livestock and poultry,aquatic animals,and companion animals.In addition,the latest bacteriophage-related regulations,pharmacopeias,and international standards from Europe and the United States are reviewed and analyzed.This review aims to provide theoretical references for the regulation,standardized production,and large-scale application of bacteriophage preparations in China,thereby promoting the practical application of bacteriophages in animal production.

闫艳新;潘强;陈婷婷;赵鹏;任慧英;徐洁;刘律;陈姿颐;韩梦;于凌云

青岛诺安百特生物技术有限公司,山东 青岛 266109青岛诺安百特生物技术有限公司,山东 青岛 266109||中国生物工程学会噬菌体专业委员会,北京 朝阳 100101青岛诺安百特生物技术有限公司,山东 青岛 266109青岛诺安百特生物技术有限公司,山东 青岛 266109||广西大学动物科学技术学院,广西 南宁 530004青岛诺安百特生物技术有限公司,山东 青岛 266109||中国生物工程学会噬菌体专业委员会,北京 朝阳 100101青岛诺安百特生物技术有限公司,山东 青岛 266109青岛诺安百特生物技术有限公司,山东 青岛 266109青岛诺安百特生物技术有限公司,山东 青岛 266109青岛诺安百特生物技术有限公司,山东 青岛 266109杭州诺安生防科技有限公司,浙江 杭州 311222

农业科技

噬菌体细菌耐药性减抗替抗产品质量控制生物安全性国际标准国际法规

bacteriophagebacterial resistanceantibiotic reduction and substitutionproduct quality controlbiosafetyinternational standardsinternational regulations

《中国兽医杂志》 2026 (8)

52-57,6

国家重点研发计划(2025YFC3408500)

10.20157/j.cnki.zgsyzz.2026.sf.059

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