放射性药物化学前体的药学研究技术要求探讨

Discussion on Pharmaceutical Research Technical Requirements of Chemical Precursors for Radiopharmaceutical Preparation

关键词:  放射性药物  放射性药物化学前体  药学研究  技术要求

Key words:  radiopharmaceuticals  chemical precursors for radiopharmaceutical preparation  pharmaceutical research  technical requirements

摘要:

放射性药物一般由放射性核素和非放射性成分2个部分组成，两者结合后可将其递送至体内特定部位，并利用前者的辐射属性发挥诊断和治疗作用。本文中放射性药物化学前体是指通过化学合成制备的非放射性物质（以下简称化学前体），用于制备放射性药物药盒和PET放射性药物等。目前中国无化学前体的概念，尚无包括化学前体在内的放射性药物药学研究技术指导原则或技术要求，不利于放射性药物的研发。本文拟通过对欧洲药品管理局（European Medicines Agency，EMA）化学前体相关技术要求的介绍，探讨中国化学前体药学研究相关技术要求，为此类药物的研发提供参考。

Abstract:

Radiopharmaceuticals generally contain two kinds of components, i.e. radionuclides and non-radioactive fractions, which combine with each other to deliver the former to their targeted site, where the former play the diagnostic and therapeutic role by taking advantage of their radiation attribute. In this paper, chemical precursors of radiopharmaceuticals refer to non-radioactive fractions mentioned above, which are manufactured by chemical synthesis (hereinafter as chemical precursors for short) and dedicated to prepare radiopharmaceutical products, such as radiopharmaceutical kits and PET radiopharmaceuticals etc. At present, there is a lack of formal definition for chemical precursors, and technical guidelines or regulations for radiopharmaceuticals' research and development as well as chemical precursors in China, which have restricted the development of the industry. This paper aim to discuss the technical requirements of pharmaceutical research on chemical precursors by introducing related published guidelines of European Medicines Agency(MEA) to provide suggestions for this kind of pharmaceuticals' research and development in China.