药品剂型标准术语的比较研究

doi:10.19803/j.1672-8629.20220444

摘要/Abstract

摘要： 目的为我国药物警戒活动中剂型的规范化和国际化发展提供参考。方法分析欧洲药品质量管理局（EDQM）剂型的概念模型、分类体系、术语特点和扩展应用,对比《中华人民共和国药典》（2020版）（简称“《中国药典》”）,结合我国剂型术语使用现状,提出发展建议。结果 EDQM剂型标准术语是国际人用药品注册技术协调会（ICH）官方术语,我国支持采用其填写个例安全性报告。该术语集遵循医药产品说明书（IDMP）标准的核心概念模型,使用分类术语构建分类体系,并应用于药事建模。剂型经编码、定义、4项特性标识,语义可跨语种、地区保持一致。《中国药典》剂型则以综合分类法分类,可部分映射至EDQM剂型术语,两者的用途、标准、范围等均有差异。我国剂型使用中仍可见标注不精确,术语、编码和分类多样等现象。结论我国可改进EDQM剂型翻译成果,将其与《中国药典》结合使用;完善《中国药典》剂型和更新效率,推进药品剂型术语标准化进程。

关键词: 药物警戒, 剂型, 术语, 欧洲药品质量管理局, 中国药典, 分类, 模型, 半结构化

Abstract: Objective To provide reference for standardization and internationalization of pharmaceutical dose forms of pharmacovigilance in China. Methods The conceptual model, classification system, characteristics of terms, and expanded applications of pharmaceutical dose forms in European Directorate for the Quality of Medicines (EDQM) standard terms were analyzed and compared with dosage forms in the Chinese Pharmacopoeia 2020 Edition. Based on the current applications of terms of dose forms in China, proposals were raised. Results Pharmaceutical dose forms are part of EDQM standard terms, which are an online semi-structured database maintained by European Directorate for the Quality of Medicines. Pharmaceutical dose forms in EDQM are accepted as preferred terms by ICH, and recognized worldwide. China National Medical Products Administration has supported their use in individual case safety reports as well. EDQM terminologies for dose forms are constructed on the basis of IDMP developed by ISO, especially the core conceptual model. There is a unique code, a definition, and 4 characteristics for each term, so that its meaning remains the same across languages and regions. Using taxonomy terms, a 3-level classification system and several auxiliary classifications are constructed, where terminologies for dose forms are at the third level. Dosage forms also play a role in complex concept modeling, such as combined pharmaceutical dose forms. Another reference for pharmaceutical dose forms of pharmacovigilance is Chinese Pharmacopoeia(CP) in China. It constructs a 3-level classification system for dose forms as well, but without taxonomy terms. Terminologies in it can be partially mapped to EDQM. There are differences in applications, accreditation criteria, and coverage between dose forms from Chinese Pharmacopoeia and EDQM. Inaccurate labelling of dose forms, and variations in terminologies, codes and classifications exist in the applications of dose forms of CP. Conclusion There is a need to improve Chinese translation of EDQM pharmaceutical dose forms so as to use them in combination with CP. China could consider completing terminologies for dose forms in CP, promoting standardization, and including new dose forms with reference to EDQM's experience.

Key words: pharmacovigilance, dosage form, term, European Directorate for the Quality of Medicines(EDQM), Chinese Pharmacopoeia, classification, schema, semi-structured

中图分类号:

R954
R994.11

张雨琪, 徐昕怡, 朱兰, 朱彦. 药品剂型标准术语的比较研究[J]. 中国药物警戒, 2023, 20(8): 904-910.

ZHANG Yuqi, XU Xinyi, ZHU Lan, ZHU Yan. Comparison standard terminology for pharmaceutical dose forms[J]. Chinese Journal of Pharmacovigilance, 2023, 20(8): 904-910.

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