协和医学杂志2025，Vol.16Issue(4)：867-873,7.DOI:10.12290/xhyxzz.2025-0505
优化标准体系,规范临床实践:《医用锗[68Ge]/镓[68Ga]发生器及镓[68Ga]放射性药物质量标准》和《医用镥[177Lu]及其放射性药物的质量标准》解读
Optimizing Standardization Systems and Standardizing Clinical Practice:Interpretation of Quality Standards for Medical 68 Ge/68 Ga Generators and 68 Ga Radiopharmaceuticals and Quality Standards for Medical 177 Lu and Its Radiopharmaceuticals
摘要
Abstract
On January 1,2022,the China International Association for the Promotion of Science and Technology(CIAPST)officially implemented two pivotal standards:Quality Standards for Medical Germanium-68/Gallium-68(68 Ge/68 Ga)Generators and Gallium-68 Radiopharmaceuticals(T/CI 046-2021)and Quality Standards for Medical Lutetium-177(177 Lu)and Its Radiopharmaceuticals(T/CI 047-2021).These standards introduce innovative requirements for quality control and clinical application of radiopharmaceuticals,marking a significant advancement in China's regulatory framework for nuclear medicine.This article provides a compre-hensive analysis of the technical rationale,QC protocols,and clinical implications outlined in the standards.Against the backdrop of China's evolving nuclear medicine landscape,we further identify challenges in imple-mentation(e.g.,production consistency,regulatory compliance)and propose actionable strategies to optimize radiopharmaceutical quality management systems.Our perspective aims to support the standardization and global integration of China's radiopharmaceutical industry.关键词
镓-68标记物/镥-177标记物/放射性药物/团体标准Key words
Gallium-68/Lutetium-177/radiopharmaceuticals/group standard分类
医药卫生引用本文复制引用
赖毓昕,彭雨萌,王国昌..优化标准体系,规范临床实践:《医用锗[68Ge]/镓[68Ga]发生器及镓[68Ga]放射性药物质量标准》和《医用镥[177Lu]及其放射性药物的质量标准》解读[J].协和医学杂志,2025,16(4):867-873,7.基金项目
国家自然科学基金(82402315) （82402315）
福建省自然科学基金(2024J08171) （2024J08171）
福建省科技创新联合资金项目(2023Y9084) （2023Y9084）
福建省级临床重点专科建设项目(2023SZDZK-HYXK) National Natural Science Foundation of China(82402315) （2023SZDZK-HYXK）
Natural Science Foundation of Fujian Province(2024J08171) （2024J08171）
Joint Funds for the Innovation of Science and Technology of Fujian Province(2023Y9084) （2023Y9084）
Fujian Provincial Clinical Key Specialty Construction Project(2023SZDZK-HYXK) （2023SZDZK-HYXK）
