男性不育症是中医优势病种，研发治疗男性不育症的中药制剂具有广阔前景及重要战略意义。该文围绕 男性不育症中药制剂研发转化过程中存在的中医诊断标准化不足、制剂品种单一、缺乏针对性中医临床评价方 法等瓶颈问题，结合药物研发趋势，对男性不育症的中药新药研发策略的前景及挑战提出思考，以期为建立安 全、有效、质量可控的男性不育症中药新药研创模式提供更多参考。

Traditional Chinese medicine （TCM） has outstanding advantages in treating male infertility， and the research and development of Chinese medicinal preparations for the treatment of male infertility has a broad prospect and important strategic significance. The paper focuses on the bottlenecks that exist in the process of research and development transformation of Chinese materia medica preparation for male infertility， such as insufficient standardisation of TCM diagnosis， single variety of preparations， and the lack of targeted TCM clinical evaluation methods， etc. Considering the trend of drug research and development， the paper puts forward reflections on the prospect of and challenges to the strategy of innovation transformation of traditional Chinese new drugs for male infertility with a view to providing more references for the establishment of a safe， effective， and quality-controlled mode of development of innovative traditional Chinese new drugs for male infertility.

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北京市自然科学基金青年项目（7254520）；宁夏自然科学基金项目（2024AAC03715）；国家中医药管理局高水平中医药重点学科 建设项目（zyyzdxk-2023238）；国家自然科学基金面上项目（82174392）