基于中、欧、美三部药典的肿瘤类PET药物质量控制标准比较

doi:10.5246/jcps.2021.03.020

中国药学(英文版) ›› 2021, Vol. 30 ›› Issue (3): 246-252.DOI: 10.5246/jcps.2021.03.020

基于中、欧、美三部药典的肿瘤类PET药物质量控制标准比较

朱亦紫, 李华君, 张钰渤, 赵超然, 卢帅, 范明暄, 韩梅^*()

北京师范大学化学学院放射性药物教育部重点实验室, 北京 100875

收稿日期:2020-12-15 修回日期:2021-01-22 接受日期:2021-02-04 出版日期:2021-03-29 发布日期:2021-03-29
通讯作者: 韩梅
作者简介:
+ Tel.: +86-13601152898, E-mail: hanmei@bnu.edu.cn
基金资助:
National Key Research and Development Plan (Grant No. 2017YFC0113305).

Comparison of quality control standards of PET radiopharmaceuticals for tumor in Pharmacopoeia of Europe, the United States and People’s Republic of China

Yizi Zhu, Huajun Li, Yubo Zhang, Chaoran Zhao, Shuai Lu, Mingxuan Fan, Mei Han^*()

Key Laboratory of Radiopharmaceuticals of Ministry of Education, School of Chemistry, Beijing Normal University, Beijing 100875, China

Received:2020-12-15 Revised:2021-01-22 Accepted:2021-02-04 Online:2021-03-29 Published:2021-03-29
Contact: Mei Han

摘要/Abstract

摘要：

为完善肿瘤类PET药物质量控制标准相关方法提供思路和降低该类药物临床应用风险, 对比分析中国药典(ChP2020)、欧洲药典(EP8.0)、美国药典(USP39)中肿瘤类PET药物的质量控制标准异同, 重点从鉴别(鉴定方法)、检查(pH、残留溶剂、细菌内毒素、无菌、杂质)、含量测定(放射性核纯度、放射化学纯度、放射性浓度)这3个方面进行比较分析。ChP2020对肿瘤类PET药物的质量控制标准均不低于USP39, 但与EP8.0相比更宽松。综合来看, EP8.0对肿瘤类PET药物的质量控制标准最为全面严格。中国药典对肿瘤类PET药物的质量控制标准可以借鉴国际标准, 尤其是欧洲药典, 进行完善和提高。

关键词: PET药物, 质量控制, 药典

Abstract:

To improve the relevant methods of the quality control standards of tumor Positron Emission Computed Tomography (PET) radiopharmaceuticals and to reduce the clinical application risks of such drugs, this article compares and analyzes the similarities and differences of the quality control standards of tumor PET radiopharmaceuticals in the Pharmacopoeia of People’s Republic of China (ChP2020), European Pharmacopoeia (EP8.0) and United States Pharmacopoeia (USP39), focusing on comparing and analyzing the identification (identification method), inspection (pH, residual solvent, bacterial endotoxin, sterility, and impurities), and content determination (radionuclear purity, radiochemical purity, and radioactive concentration) of tumor PET radiopharmaceuticals. The quality control standards of ChP2020 for tumor PET radiopharmaceuticals are relatively equivalent to the quality control standards of USP39 but are not as stringent as those of EP8.0. In general, EP8.0 has the most comprehensive and strict quality control standards for tumor PET radiopharmaceuticals. The quality control standards of tumor PET radiopharmaceuticals in the Chinese Pharmacopoeia can be improved by referring to international standards, especially the European Pharmacopoeia.

Key words: PET radiopharmaceuticals, Quality control, Pharmacopoeia

Supporting:

朱亦紫, 李华君, 张钰渤, 赵超然, 卢帅, 范明暄, 韩梅. 基于中、欧、美三部药典的肿瘤类PET药物质量控制标准比较[J]. 中国药学(英文版), 2021, 30(3): 246-252.

Yizi Zhu, Huajun Li, Yubo Zhang, Chaoran Zhao, Shuai Lu, Mingxuan Fan, Mei Han. Comparison of quality control standards of PET radiopharmaceuticals for tumor in Pharmacopoeia of Europe, the United States and People’s Republic of China[J]. Journal of Chinese Pharmaceutical Sciences, 2021, 30(3): 246-252.

图/表 4

Table 1. Comparison of 18F-FDG in Quality Control Standards of ChP2020, EP8.0 and USP39[1,2,3].

Table 2. Comparison of 18F-NaF in Quality Control Standards of EP8.0 and USP39[2,3].

Table 3. The Quality Control Standards of 11C-ACEATE and 18F-FMISO in EP8.0[2,11].

Figure 1. Legal basis for registration of radiopharmaceuticals in the United States[16,17,18].

参考文献 21

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基于中、欧、美三部药典的肿瘤类PET药物质量控制标准比较

Comparison of quality control standards of PET radiopharmaceuticals for tumor in Pharmacopoeia of Europe, the United States and People’s Republic of China

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