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