Page 7 - 《中国药房》2022年21期

·药事管理·

国内外儿童非处方药（化学药品）剂型与规格的比较分析 Δ

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张金芬 ，佟若菲 ，黄 涛 ，王森怡 ，杨 琳 ，王洋洋 ，马新玲 ，王晓玲 ，孙燕燕 （1.天津市儿童医院/天津大
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学儿童医院药剂科，天津 300134；2.首都医科大学附属北京儿童医院药学部，北京 100045）
中图分类号 R95 文献标志码 A 文章编号 1001-0408（2022）21-2561-05
DOI 10.6039/j.issn.1001-0408.2022.21.01
摘 要 目的 对国内外儿童非处方药（OTC）（化学药品）剂型与规格的现状进行比较分析，为新增我国儿童OTC剂型与规格提
供参考。方法 梳理我国儿童OTC单方制剂的活性成分，比较我国与世界卫生组织（WHO）发布的第8版《WHO儿童基本药物示
范目录》（WHO EMLc）及美/英/欧（本文指欧盟国家）/日具有相同活性成分的儿童OTC剂型与规格的异同并进行分析。结果 我
国儿童OTC单方制剂对应的活性成分共计72个，涉及34种剂型、216个规格；在WHO EMLc及美/英/欧/日儿童OTC中共检索到
39个相同活性成分，涉及38种剂型、258个规格。在39个相同活性成分对应的儿童OTC中，我国的特有剂型有10种，WHO EMLc
及美/英/欧/日的特有剂型共计16种，后者收录的部分具有儿童使用优势的剂型（咀嚼软糖、局部皮肤用凝胶剂、口服液体喷雾剂
等）在我国暂未收录；我国的特有规格有107个，WHO EMLc及美/英/欧/日的特有规格共计214个，后者药品规格适用年龄段的划
分更为细致。此外，少数活性成分（如布洛芬、盐酸西替利嗪等）对应的剂型与规格在我国未纳入儿童 OTC，而英/欧已纳入。
结论 WHO EMLc及美/英/欧/日儿童OTC的剂型与规格在整体上较我国更丰富和灵活。我国相关部门应借鉴WHO和国外先进
经验，加大对儿童OTC剂型与规格的研发。
关键词 儿童；非处方药；活性成分；剂型；规格

Comparative analysis of the dosage forms and specifications of OTC （chemical drugs） for children at
home and abroad
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ZHANG Jinfen ，TONG Ruofei ，HUANG Tao ，WANG Senyi ，YANG Lin ，WANG Yangyang ，MA Xinling ，
WANG Xiaoling ，SUN Yanyan（1. Dept. of Pharmacy，Tianjin Children’s Hospital/Tianjin University Children’s
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Hospital，Tianjin 300134，China；2. Dept. of Pharmacy，Beijing Children’s Hospital Affiliated to the Capital
Medical University，Beijing 100045，China）
ABSTRACT OBJECTIVE To compare the dosage forms and specifications of over-the-counter drug（OTC）（chemical drugs）
for children at home and abroad，and to provide reference for the addition of new dosage forms and specifications of OTC for
children in China. METHODS Data analysis was used to comb the active ingredients of OTC single-ingredient preparation for
children in China. The similarities and differences of the dosage forms and specifications of OTC for children with the same active
ingredients among China and 8th edition of WHO Model List of Essential Medicines for Children（WHO EMLc）and US/UK/EU（this
article refers specifically to EU countries）/Japan were analyzed by comparative analysis. RESULTS There were 72 active
ingredients of OTC single-ingredient preparation for children in China，corresponding to 34 dosage forms and 216 specifications；
39 same active ingredients of OTC for children were retrieved in WHO EMLc and US/UK/EU/Japan，corresponding to 38 dosage
forms and 258 specifications. Among OTC for children corresponding to 39 active ingredients，there were 10 unique dosage forms
in China，and 16 unique dosage forms in WHO EMLc and US/UK/EU/Japan，of which some dosage forms have advantages for
children（such as chewing gums，gels for external use，spray for oral liquid，etc.），were included in the latter while not included
in China. There were 107 unique specifications in China，and 214 unique specifications in WHO EMLc and US/UK/EU/Japan，of
which the division of applicable age groups for specifications was more detailed. In addition，the dosage forms and specifications
corresponding to a few active ingredients（such as ibuprofen，cetirizine hydrochloride）were not included in OTC for children in
China， while included in UK/EU. CONCLUSIONS The
Δ 基金项目 中国非处方药物协会自我药疗教育专业委员会课题
dosage forms and specifications of OTC for children in WHO
（No.CMNASMEC-2021-03）
EMLc and US/UK/EU/Japan are generally more abundant and
＊第一作者 药师，硕士。研究方向：药剂学。电话：022-87787305。
E-mail：zjfyouyou@163.com flexible than in China. Relevant departments in China should
# 通信作者 主任药师，硕士生导师，硕士。研究方向：药事管理。 learn from the advanced experience of WHO and foreign
电话：022-87787305。E-mail：syytjcn@sina.com countries and increase the research and development of dosage

中国药房 2022年第33卷第21期 China Pharmacy 2022 Vol. 33 No. 21 ·2561·