同位素 ›› 2020, Vol. 33 ›› Issue (4): 226-233.DOI: 10.7538/tws.2019.33.04.0226

• 放射性药物与标记化合物 • 上一篇    下一篇

放射性药品质量标准浅析

刘胜兰;邓启民   

  1. 成都云克药业有限责任公司,成都610041
  • 出版日期:2020-08-20 发布日期:2020-09-12

Analysis of Quality Standards for Radiopharmaceuticals

LIU Shenglan;DENG Qimin   

  1. Chengdu Yunke Pharmaceutical Co., Ltd, Chengdu 610041, China
  • Online:2020-08-20 Published:2020-09-12

摘要:

完善的药品质量标准是药品检验工作的基础和保证,其有效性、合理性直接关系着检验结果的准确性和用药的安全性。放射性药品中含有放射性核素,其结构和特性与非放射性药物不同,质量标准中的检定项目和检定方法通常与普通药物存在较大差异。为了解放射性药品质量标准的制定原则和放射性药品检定方法,文章通过对《中国药典》(ChP2015)、《美国药典》(USP42-NF37)和《欧洲药典》(EP9.0)中收载的与放射性药品质量控制相关的指导原则和检定方法进行分析,并对各国药典收载的放射性药品质量标准中的放射性检定项目做对比分析,总结了放射性药品质量控制的内容和方法,以及国内外放射性药品质量标准的差异。就目前而言,我国药典中收载的放射性药品质量控制指导原则局限性较大,放射性检定方法不够完善,质量标准与国外药典相比有一定的差距。希望对放射性药品开发过程中的质量控制以及生产企业内控质量标准的制定提供参考。

关键词: 药品质量标准, 放射性药品, 药典, 放射性检定

Abstract:

A consummate drug quality standard is the basis and guarantee for drug quality control. Its effectiveness and rationality are directly related to the accuracy of the test results and the safety of medication. Due to the presence of radionuclides in the radiopharmaceuticals, their structures and characteristics are different from those of non-radioactive drugs. The testing items and methods in quality standards are usually quite different from those of common pharmaceuticals. In order to understand the formulation principles of quality standards and assay methods of radiopharmaceuticals. In this article, the testing methods and guiding principles related to the quality control of radiopharmaceuticals contained in the Chinese Pharmacopoeias (ChP2015), United States Pharmacopoeia/National Formulary (USP42-NF37) and European Pharmacopoeia (EP9.0) were analysed, and the radioactive assay items in the quality standards of radiopharmaceuticals contained in the three pharmacopoeia were compared, and the contents and methods of radiopharmaceutical quality control and the differences in quality standards of radiopharmaceuticals domestically and abroad were summarized. At present, the guiding principles for the quality control of radiopharmaceuticals contained in the ChP2015 are more restrictive, the radioactive assay methods are defective, and the quality standards of radiopharmaceuticals have a certain gap compared with foreign pharmacopoeias. It is expected to provide a reference for the quality control in the development process of radiopharmaceuticals and the formulation of internal quality standards for manufacturing enterprises.

Key words: drug quality standards, radiopharmaceutical, pharmacopoeia, radioactive assay