男性不育症中药新药研发的瓶颈、策略与思考

中图分类号：R697文献标志码：A文章编号：1003-9783（2025）03-0463-06

doi：10.19378/j.issn.1003-9783.2025.03.016

Bottlenecks，Strategiesand Reflectionson the Researchand Development of Traditional Chinese New Drugs for Male Infertility

LIU Shengjing，WANGFu，GUO Jun（Department of Andrology，Xiyuan Hospital of China Academyof Chinese Medical Sciences，Beijing 100091，China）

Abstract：Traditional Chinese medicine（TCM）has outstanding advantages in treating male infertility，and the researchanddevelopmentofChinesemedicinalpreparations forthetreatmentofmaleinfertilityhasabroad prospectand important strategic significance.The paper focuses on the botlenecksthat exist in the process of researchand development transformationof Chinese materia medica preparation formale infertility，suchasinsufcient standardisationof TCMdiagnosis，single varietyof preparations，and the lack of targeted TCMclinical evaluation methods，etc.Considering the trend of drug research and development，the paper puts forward reflections on the prospectofandchallenges tothe strategyof innovationtransformationof raditional Chinese new drugsfor male infetility with aview to providing more references for the establishment of asafe，efective，andquality-controlled mode of development of innovative traditional Chinese new drugs for male infertility.

Keywords：male infertility；dominant diseases；traditional Chinese new drugs；drug research and development; bottleneck；strategy；reflection

随着全球男性精子质量不断下降，男性不育症已经成为全球性的健康问题[1-2]。（剩余10487字）