| 摘要: |
| 目的:对2025 年版《中国药典》(ChP)与第11 版《欧洲药典》(EP)收载的口服剂型进行分析,为优化我国药典剂型相关
内容、促进儿童适宜剂型研发提供参考。方法:采用文献分析法、对比研究法,对两部药典的剂型分类原则、口服剂型收载内容
进行分析;参照国内外标准对两部药典特有剂型儿童适宜性进行评价。结果:ChP 同时采用给药途径、分散系统、形态和特殊原
料、制备过程为依据,结合实践中的一般习惯进行综合分类。EP 采用分类术语构建分类体系,核心概念包括制药剂型、给药剂
型、基础剂型和物质状态,剂型必备特性分别为释药特性、转化、预期用药部位和给药方法。以ChP 二级分类的34 个剂型为基
础,比较ChP 与EP 收载口服制剂剂型名称、定义,11 个剂型名称、定义基本一致(32. 35%,11/ 34);20 个剂型名称相同、定义不
同(58. 82%,20/ 34);ChP 和EP 的特有剂型分别为3 个(8. 82%,3/ 34) 和40 个;ChP 中13 个剂型(38. 24%,13/ 34) 对应EP 中
39 个剂型。ChP 收载的3 个特有剂型中,无早产儿、足月新生儿、婴幼儿适宜剂型,学龄前儿童适宜性良好的剂型为1 个;EP 收
载的40 个特有剂型中,无早产儿适宜剂型,足月新生儿、婴幼儿、学龄前儿童适宜性良好的剂型分别为10、18、32 个。结论:国
家相关部门可以参考EP,结合我国实际,明确我国剂型分类原则,进一步完善ChP,优化剂型的定义,及时增补和研发新剂型尤
其是低龄段儿童适宜剂型。 |
| 关键词: 中国药典 欧洲药典 口服 剂型 儿童用药 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2026.11.002 |
|
| 基金项目:基金项目:国家“十三五”科技重大专项增补任务,编号2017ZX09304029-001-00 |
|
| Differences in Oral Dosage Forms and Pediatric Suitability Between Chinese Pharmacopoeia (2025 Edition)and European Pharmacopoeia (11th Edition ) |
| Zhang Yunxia, Qin Qianqian, Zhao Ruiling |
| (Children’s Hospital of Shanxi, Taiyuan 030013, China)) |
| Abstract: |
| Objective: To analyze the oral dosage forms included in the 2025 edition of the Chinese Pharmacopoeia (ChP) and the 11th
edition of the European Pharmacopoeia (EP), and to provide references for optimizing the dosage form-related contents of ChP and
advancing the development of child-appropriate dosage forms. Methods: Literature analysis, comparative research were adopted to
analyze the dosage form classification principles and included oral dosage forms of the two pharmacopoeias. The pediatric suitability of
exclusive dosage forms recorded in the two pharmacopoeias was evaluated in accordance with domestic and international evaluation
criteria. Results: The ChP classified a comprehensive classification system based on administration route, dispersion system,
morphology, special raw materials and preparation processes, combined with routine practical conventions. EP established its
classification system via standardized classification terms, with core concepts including pharmaceutical dosage forms, administration
dosage forms, basic dosage forms and physical states; the indispensable characteristics mainly included drug release profiles,
transformation, intended administration site and administration mode. On the basis of 34 secondary classified oral dosage forms stipulated
in ChP, a comparison of nomenclature and definition of oral preparations between ChP and EP was carried out. The nomenclature and
definitions of 11 dosage forms were basically consistent (32. 35%, 11/ 34); 20 dosage forms shared identical names but differed in
definitions (58. 82%, 20/ 34). ChP contained 3 exclusive dosage forms (8. 82%, 3/ 34), while EP included 40 exclusive dosage forms.
Thirteen dosage forms in ChP corresponded to 39 dosage forms in EP (38. 24%, 13/ 34). Among the 3 exclusive dosage forms of ChP,
none were suitable for preterm infants, term neonates or infants, and only 1 dosage form showed good suitability for preschool children.
Among the 40 exclusive dosage forms of EP, no dosage form was applicable to preterm infants; there were 10, 18 and 32 dosage forms with
good suitability for term neonates, infants and preschool children respectively. Conclusion: It is recommended to draw on the experience of
EP and integrate practical conditions in China to clarify the classification principles for domestic dosage forms, further revise and optimize
dosage form definitions, timely add and develop new dosage forms, especially those suitable for children of low age groups. |
| Key words: Chinese Pharmacopoeia European Pharmacopoeia oral dosage forms pediatric medication |
