摘要
本研究制定了规范的^(68)Ga-PSMA-11注射液制备流程,并参考国内外药典要求拟定了适用于本机构的^(68)Ga-PSMA-11注射液质量控制标准。回顾2020—2022年度本机构316批次的^(68)Ga-PSMA-11注射液的制备和质量控制结果,发现所有批次均成功制备得到^(68)Ga-PSMA-11注射液,质量控制结果均符合拟定的标准。^(68)Ga-PSMA-11的标记率为(85.3±11.4)%,受^(68)Ge/^(68)Ga发生器淋洗总体积的显著影响,随着淋洗总体积的增加而降低,而淋洗间隔时间对标记率影响很小。本研究有望指导核医学从业人员规范进行^(68)Ga-PSMA-11注射液的制备和质量控制,从而提升该药物的质量与安全,并为其相关行业标准的制定提供参考。
In this study,a standardized preparation process for ^(68)Ga-PSMA-11 injection was developed by optimizing the labeling conditions,and the quality control standards of ^(68)Ga-PSMA-11 injection applicable to our institution were formulated by combining domestic and international pharmacopoeias.Reviewing the preparation and quality control results of a total of 316 batches of ^(68)Ga-PSMA-11 injections from 2020—2022,it was found that all batches were successfully prepared to obtain ^(68)Ga-PSMA-11 injections,and the quality control results were in full compliance with the proposed standards.The labeling rate of ^(68)Ga-PSMA-11 was(85.3±11.4)%,and it was decreased significantly with increasing total elution volume of ^(68)Ge/^(68)Ga generator,while the elution interval time had little effect on the labeling rate.This study is expected to guide nuclear medicine practitioners to standardize the preparation and quality control process of ^(68)Ga-PSMA-11 injection,thus improving the quality and safety of the drug,and providing a reference for related industry standards.
作者
叶佳俊
张明如
王佳
祝子范
康飞
杨卫东
汪静
YE Jiajun;ZHANG Mingru;WANG Jia;ZHU Zifan;KANG Fei;YANG Weidong;WANG Jing(Department of Nuclear Medicine,The First Affiliated Hospital of Air Force Military Medical University,Chinese People’s Liberation Army,Xi’an 710032,China)
出处
《同位素》
CAS
2023年第4期407-415,共9页
Journal of Isotopes
基金
国家自然科学基金(92259304,91959208,81971646,82171977,82122033)
基础加强计划重点基础研究项目(2017-JCJQ-ZD-051-04)
陕西省重点产业创新链项目(2022ZDLSF04-12)。
