目的 比较分析我国与欧盟儿童非处方药（OTC） （化学药品单方制剂）相同活性成分对应剂型与规格的异同，为我国儿童OTC（化学药品单方制剂）适宜剂型和规格的科学补充与完善提供参考和建议。方法 检索国家药品监督管理局（NMPA）官网，梳理出我国儿童OTC（化学药品）清单，并从中筛选出单方制剂的活性成分；以筛选出的活性成分为检索对象，从欧洲药品管理局总部（HMA）官网、药智网、药物在线网站中检索欧盟儿童OTC；采用描述性统计分析方法，比对我国与欧盟具有相同活性成分的儿童OTC（化学药品单方制剂）剂型与规格的异同，为进一步优化我国儿童OTC提供借鉴。结果 我国儿童OTC（化学药品单方制剂）对应的活性成分共计72个，其中17个活性成分检索到了欧盟儿童OTC单方制剂。对我国与欧盟17个相同活性成分对应的剂型与规格进行梳理。在剂型方面，欧盟儿童OTC中涉及剂型17种，其中独有剂型4种，咀嚼胶囊为我国儿童OTC（化学药品）缺失剂型；我国儿童OTC（化学药品单方制剂）涉及剂型25种，其中独有剂型13种。在规格方面，欧盟儿童OTC规格为53个，其中独有规格33个；我国儿童OTC（化学药品单方制剂）规格为90个，其中独有规格70个。此外，少数活性成分对应的剂型与规格在我国未纳入儿童OTC，而欧盟已纳入。结论 与欧盟相比，我国儿童OTC（化学药品单方制剂）剂型与规格种类更加丰富，特别是口服固体制剂种类繁多；欧盟部分独有剂型具有儿童使用优势，其独有的单剂量包装规格提高了儿童用药安全性。我国相关部门应借鉴欧盟先进经验，加大对儿童OTC适宜剂型与规格的开发。

Objective To compare and analyze the similarities and differences in the corresponding dosage forms and specifications of the same active ingredients in over-the-counter (OTC) (chemical single-ingredient preparation) for children between China and European Union, in order to provide reference and suggestions for the scientific supplementary opinions and improvement of suitable dosage forms and specifications for OTC (chemical single-ingredient preparation) for children in China. Methods The official website of the National Medical Products Administration (NMPA) was searched to sort out the list of OTC (chemical drugs) for children in China, and the active ingredients of single-ingredient preparation were screened from it; Using the screened active ingredients as the search object, EU children's OTC were searched from the European Medicines Agency (HMA), Yaozh website, and Drug future website; Using descriptive statistical analysis methods, the similarities and differences were compared in dosage forms and specifications of OTC (chemical single-ingredient preparation) for children with the same active ingredients between China and European Union, and provide reference for further optimizing OTC for children in China. Results There are 72 active ingredients of OTC (chemical drugs) single-ingredient preparation for children in China, of which 17 active ingredients were retrieved from OTC singleingredient preparation for children in European Union. Sort out the dosage forms and specifications corresponding to 17 identical active ingredients in China and European Union. In terms of dosage forms, 17 dosage forms are involved in these 17 active ingredients of OTC for children in European Union, including four exclusive dosage forms, and chewing capsules are lacking in OTC (chemical singleingredient preparation) for children in China; 25 dosage forms are involved in OTC (chemical single-ingredient preparation) for children in China, including 13 exclusive dosage forms. In terms of specifications, there are 53 drug specifications in European Union, including 33 unique specifications; There are 90 specifications in China, including 70 unique specifications. Dosage forms and specifications corresponding to a few active ingredients have not been included in OTC (chemical single-ingredient preparation) of children in China, while OTC (chemical single-ingredient preparation) of children in European Union has included them. Conclusion Compared to the European Union, China offers a more diverse range of OTC (chemical single-ingredient preparation) formulations and specifications for children, particularly with a wide variety of oral solid dosage forms. Some unique dosage forms in the European Union have advantages for children, and the unique single-dose packaging specifications improve the safety of pediatric drugs. Relevant departments in China can learn from the advanced experience of European Union and research more suitable dosage forms and specifications of OTC for children.

R283.6

中国非处方药物协会自我药疗教育专业委员会课题（CMNASMEC-2021-03）