中国医用同位素的制备现状及展望

    Current Status and Future Prospect of Medical Radioisotopes Production in China

    • 摘要: 医用同位素是指用于疾病诊断、治疗及医学研究的放射性同位素,是放射性药物及核医学的基石,在心脑血管、神经退行性疾病、恶性肿瘤等临床诊疗方面具有不可替代的作用。我国医用同位素研究已有近70年的历史,从131I、32P、99Mo到18F、68Ga、225Ac,研发出数十种同位素满足了临床使用需求。2021年6月,国家原子能机构等八部门联合发布《医用同位素中长期发展规划(2021—2035年)》,为我国医用同位素的未来发展指出明确的发展方向,促进了医用同位素的研发、生产与应用。本文对近年来国内医用同位素的制备技术研究进展进行总结,并对未来医用同位素的发展提出建议。

       

      Abstract: This study examines the current state of medical radioisotope production in China. It aims to evaluate production technologies, industrial applications, and clinical impacts of diagnostic and therapeutic radioisotopes. The work identifies barriers to progress, including limited infrastructure and a reliance on imported materials. It proposes solutions to enhance self-sufficiency and scalability. The ultimate goal is to strengthen nuclear medicine for diagnosing and treating diseases like cancer, heart conditions, and neurological disorders. A systematic literature review was performed, covering peer-reviewed articles, industry reports, and government documents from 2015 to 2025. Radioisotopes were categorized into diagnostic isotopes for single-photon emission computed tomography(SPECT), such as 99Tcm, 123I, and 201Tl; diagnostic isotopes for positron emission tomography(PET), including 68Ga, 64Cu, and 89Zr; and therapeutic isotopes, such as 131I, 177Lu, 90Y, 225Ac, and 211At. For each isotope, key parameters such as half-life, decay type, and production method were reviewed. The historical progress in isotope development was summarized, and efforts in the preparation of specific radioisotopes were evaluated. Additionally, the availability of target materials and the role of production infrastructure, including cyclotrons, research reactors, and generator systems, were analyzed to assess scalability. China has achieved significant progress in medical radioisotope production. 99Tcm and 68Ga production increases due to advanced generator technologies, 64Cu, and 89Zr has achieved scale production. These isotopes support widespread use in cancer imaging and molecular diagnostics. Several β-emitting therapeutic isotopes, including 125I, 89Sr, and 90Y, have achieved partial domestic production, marking progress toward reducing reliance on imported radioisotopes. The output of carrier-free 177Lu has also advanced, enabling its application in targeted radionuclide therapies for neuroendocrine tumors. Alpha-emitting isotopes, such as 225Ac and 211At, demonstrate strong therapeutic potential in oncology. However, their development remains constrained by limited production capacity and supply chain challenges. Over 90% of target materials(e.g., 160Gd, 176Yb) are imported. High-energy accelerators and reactors remain insufficient. Despite these challenges, national policies have played a critical role in promoting research and investment, including the 《Medium- and Long-Term Development Plan for Medical Radioisotopes(2021–2035)》 and the 《Three-Year Action Plan for High-Quality Development of Nuclear Technology Applications(2024–2026)》. China’s medical radioisotope sector is experiencing rapid growth, driven by policy support and increasing clinical needs. However, reliance on imported materials and insufficient infrastructure hinder progress. Solutions include expanding high-energy cyclotron and reactor capacity, localizing the production of target materials, and integrating automation for quality control. Artificial intelligence enhances process optimization and data analysis. Investment in research, workforce training, and international collaboration is critical. These steps ensure a sustainable and self-reliant radioisotope supply, thereby improving access to nuclear medicine and advancing healthcare outcomes in China.

       

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