中国农业科学 ›› 2025, Vol. 58 ›› Issue (14): 2914-2923.doi: 10.3864/j.issn.0578-1752.2025.14.015

• 畜牧·兽医 • 上一篇    下一篇

我国兽用中药创新发展现状与对策:基于2006—2024年获批产品的研究

王建中1(), 颜航1(), 刘静1, 周瑞1, 严英夫2, 李宏全1,*()   

  1. 1 山西农业大学动物医学学院/中兽医药现代化山西省重点实验室,山西太谷 030801
    2 四川省农业农村厅,成都 610041
  • 收稿日期:2024-10-21 接受日期:2025-06-13 出版日期:2025-07-17 发布日期:2025-07-17
  • 通信作者:
    李宏全,E-mail:
  • 联系方式: 王建中,E-mail:jianzhongwang@cau.edu.cn。颜航,E-mail:764385412@qq.com。王建中和颜航为同等贡献作者。
  • 基金资助:
    山西省基础研究计划资助项目(202403021221077); 山西省优秀博士来晋工作奖励(SXBYKY2021047); 山西农业大学博士科研启动项目(2021BQ06)

Current Status and Countermeasures of Innovative in Chinese Veterinary Medicine in China: Based on the Research on Approved Products from 2006 to 2024

WANG JianZhong1(), YAN Hang1(), LIU Jing1, ZHOU Rui1, YAN YingFu2, LI HongQuan1,*()   

  1. 1 Shanxi Key Laboratory for Modernization of TCVM/College of Veterinary Medicine,Shanxi Agricultural University, Taigu 030801, Shanxi
    2 Sichuan Provincial Department of Agricultural and Rural Affairs, Chengdu 610041
  • Received:2024-10-21 Accepted:2025-06-13 Published:2025-07-17 Online:2025-07-17

摘要:

兽用中药及其制剂凭借疗效确切、毒副作用低、不易诱导耐药性等优势,在畜禽疾病防控和健康养殖中的地位日益凸显。自我国农业农村部全面实施“饲料禁抗”政策以来,兽用中药研发与审批进程显著加快,一系列创新产品获批用于动物疾病防治,推动了绿色养殖的发展。然而,当前兽用中药的研发与应用仍面临靶动物覆盖不足(如反刍动物、水产动物及宠物用药稀缺)、质量标准体系不完善、毒性评价方法欠缺、临床数据缺乏系统性等关键挑战,严重制约其现代化和国际化进程。通过系统分析2006年1月至2024年12月我国批准的兽用中药新药及制剂,评估其研发趋势、适应症分布、靶动物覆盖及质量标准等特征,揭示现存问题并提出对策,以促进兽用中药的标准化、现代化与国际化。基于“国家兽药基础数据库”和“农业农村部公告”,收集获批兽用中药数据,从研发趋势、适应症、靶动物和剂型创新等维度进行综合分析,并结合文献与政策评估其创新潜力。得出对兽用中药的研发(1)研发数量持续增长,但靶动物集中于猪、禽(占比>80%),反刍动物、水产及宠物用药不足25%;(2)适应症以呼吸道/消化道疾病及免疫调节为主,抗病毒药物稀缺;(3)生产工艺标准化程度低,原料质量波动大;(4)部分创新产品(如黄芪多糖注射液、连翘提取物制剂)展现较高科学价值,但整体研发水平仍显著落后于化学药物和生物制品。因此,兽用中药在绿色健康养殖中潜力巨大,但需突破以下瓶颈:(1)加强基础研究,阐明药效物质基础;(2)建立全产业链质量控制体系;(3)拓展靶动物范围,开发抗病毒及代谢病新药;(4)构建符合中药特点的毒性评价标准;(5)推动产学研协同创新与国际标准制定。通过整合传统医学理论与现代科技,兽用中药有望构建更安全、高效的动物疾病防控体系,为全球“减抗”行动提供中国方案。

关键词: 兽用中药, 创新研发, 新兽药, 研发

Abstract:

Since the Ministry of Agriculture and Rural Affairs of our country fully implemented the "feed ban on antibiotics" policy, the research and approval process of veterinary traditional Chinese medicine has significantly accelerated. A series of innovative veterinary products have been approved for use in animal disease prevention and treatment, promoting the development of green farming. However, at present, the research and application of veterinary traditional Chinese medicine still face key challenges, such as insufficient coverage of target animals (such as ruminants, aquatic animals, and pet medication is scarce), incomplete quality standard system, lack of toxicity evaluation methods, and lack of systematic clinical data, which seriously restrict its modernization and internationalization process. This study systematically analyzed the new veterinary traditional Chinese medicine drugs and preparations approved in China from January 2006 to December 2024, evaluated their research trends, indication distribution, target animal coverage and quality standards, and revealed existing problems and proposed countermeasures to promote the standardization, modernization and internationalization of veterinary traditional Chinese medicine. Based on the "National Veterinary Drug Basic Database" and "Agriculture and Rural Affairs Department Announcements", this study collected approved veterinary traditional Chinese medicine data, conducted a comprehensive analysis from the dimensions of research trends, indications, target animals and formulation innovation, and combined with literature and policies to assess their innovation potential. The study found: (1) The number of research and development has continued to increase, but the target animals were concentrated on pigs and poultry (accounting for > 80%), while ruminants, aquatic animals and pet medication were less than 25%; (2) The indications were mainly respiratory/digestive tract diseases and immune regulation, and antiviral drugs were scarce; (3) The standardization degree of production processes was low, and the quality of raw materials fluctuated greatly; (4) Some innovative products (such as Astragalus polysaccharide injection, Forsythia extract preparations) showed high scientific value, but the overall research level still lagged significantly behind chemical drugs and biological products. Veterinary traditional Chinese medicine had great potential in green and healthy farming, but it needed to overcome the following bottlenecks: (1) strengthen basic research to clarify the pharmacological basis of the drug; (2) establish a full-chain quality control system; (3)expand the target animal range and develop new drugs for anti-viral and metabolic diseases; (4) build toxicity evaluation standards that conform to the characteristics of traditional Chinese medicine; (5) promote collaborative innovation among industry, academia and research institutions and international standard formulation. By integrating traditional medical theory with modern technology, veterinary traditional Chinese medicine is expected to build a safer and more efficient animal disease prevention and control system, providing a Chinese solution for the global "antibiotic reduction" initiative.

Key words: Chinese veterinary medicine, innovation, new veterinary drugs, research and development