《中华人民共和国药典》与《国际药典》口服剂型收录差异分析

Divergences in oral dosage-form monographs between Chinese Pharmacopoeia (2025 edition) and International Pharmacopoeia (12th edition)

摘要

目的: 对《中华人民共和国药典》2025年版(以下简称“ChP”)与《国际药典》第12版(以下简称“Ph.Int.”,以WHO药物制剂专家委员会发布的技术报告中儿童口服剂型作补充)收载的口服剂型进行分析,为优化我国药典剂型相关内容、促进儿童适宜剂型纳入药典、提升我国药典与国际标准的协调性提供基础研究。方法: 采用文献分析法及比较分析法对两部药典的药品命名方法、口服剂型收载内容进行分析;参照国内外儿童适宜剂型的评价标准,对其收载的口服剂型儿童适宜性进行评价。结果: Ph.Int.纳入药品命名规则,但ChP无相关内容;Ph.Int.剂型收载的内容涵盖了儿童适宜剂型推荐、药品标签/说明书标示应包含内容的建议,ChP未做相关推荐。ChP除中药制剂剂型外共收载口服制剂一级分类9类,二级分类剂型34个;Ph.Int.收载口服制剂一级分类4类,二级分类剂型17个。两部药典收载口服剂型名称和定义基本一致的剂型12个;5个名称一致、定义不同;15个ChP收载Ph.Int.未收载、7个在Ph.Int.中有映射剂型,4个Ph.Int.收载ChP未收载、均在ChP中有映射剂型。Ph.Int.和ChP收载的学龄前及以下年龄儿童适宜性良好的剂型占比分别为47.06%(8/17)、44.12%(15/34),Ph.Int.收载但ChP未收载的4个剂型中,3个剂型对婴幼儿及以上儿童适宜性良好。WHO药物制剂专家委员会发布的技术报告中的儿童适宜口服微片剂型均未被两部药典收载。结论: 建议参照Ph.Int.进一步完善ChP框架及制剂通则收载内容,促进我国学龄前及以下年龄段儿童适宜剂型纳入药典。由职能部门组成联合工作小组,提高药典与临床常用药品指导性政策和目录的协调性,在提升人民群众使用药品可及性的同时增强与Ph.Int.的协调性。

Abstract

Objective: To conduct a comparative analysis of oral dosage forms listed in the Pharmacopoeia of the People's Republic of China 2025 (ChP) and the International Pharmacopoeia 12th edition (Ph.Int.) to generate foundational evidence for optimizing dosage form monographs in the Chinese Pharmacopoeia, facilitating the inclusion of pediatric-appropriate formulations, and enhancing harmonization with international standards. Methods: A systematic literature review and side-by-side comparison were conducted to examine how each compendium names medicinal products and describes oral dosage forms; pediatric suitability was then scored against international and domestic quality criteria for child-appropriate formulations. Results: Compared with the ChP, the Ph.Int. embeds a formal nomenclature rule for drug products and appends explicit guidance on pediatric-appropriate formulations as well as minimum labelling/package-insert requirements-elements entirely absent from the current ChP. The ChP includes nine first-level categories encompassing 34 secondary oral dosage forms except traditional Chinese medicine preparations, whereas the Ph.Int. includes four first-level categories with 17 secondary oral dosage forms. Harmonization analysis revealed 12 dosage forms with concordant nomenclature and definitions; five with identical names but divergent definitions; 15 exclusively in ChP (7 with Ph.Int. mappings); and four exclusively in Ph.Int. (all mapped to ChP counterparts). When judged against international pediatric-usability criteria, 47% (8/17) of Ph.Int. oral monographs and 44% (15/34) of ChP entries are suitable for pre-school children or younger. Strikingly, three of the four Ph.Int.-only formulations demonstrate good acceptability for infants and toddlers, underscoring a ready opportunity for ChP expansion. Conclusion: ChP should draw on Ph.Int. experience to expand its general monographs, rationalize dosage-form classification, and expedite the inclusion of pediatric-friendly oral formulations for children under six. It is suggested to establish a joint working group composed of functional departments to enhance harmonization between the Pharmacopoeia and guidance policies/formularies for clinically commonly used medicines, improve public accessibility to drugs, and concurrently strengthen alignment with the International Pharmacopoeia.

关键词

中华人民共和国药典 / 国际药典 / 口服制剂 / 儿童用药 / 剂型差异

Key words

Chinese Pharmacopoeia / International Pharmacopoeia / oral dosage forms / pediatric medicines / formulation disparity

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基金资助

国家“十三五”科技重大专项增补任务资助项目(2017ZX09304029001001)