中成药说明书“主治”项规范化表述探析  

Research on the standardization of“Indications”in package inserts for Chinese patent medicines

作　　者：张美微 李可千 姚克宇 朱彦[2] ZHANG Meiwei;LI Keqian;YAO Keyu;ZHU Yan(School of Medical Information,Changchun University of Chinese Medicine,Changchun 130117,China;Research Laboratory for Application Methodology of Digital Traditional Chinese Medicine,Institute of Traditional Chinese Medicine Information,Chinese Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]长春中医药大学医药信息学院,长春130117 [2]中国中医科学院中医药信息研究所数字中医药应用方法学研究室,北京100700

出　　处：《中国药房》2025年第5期513-518,共6页China Pharmacy

基　　金：国家自然科学基金项目(No.82174534);中国中医科学院科技创新工程课题(No.CI2021A05306);中国中医科学院基本科研业务费优秀青年科技人才培养专项达标课题(No.ZZ13-YQ-126)。

摘　　要：目的促进中成药说明书“主治”表述的规范化,保障临床和患者合理用药。方法检索并收集2020年版《中国药典》(一部)和各类、各级标准中对应中成药的【功能主治】信息,建立中成药说明书“主治”表述中证候、病机、病名、症状术语识别标准,借助Microsoft Office Access 2021软件建立查询表并对术语要素进行人工提取,并构建“主治”表述3级分类体系,进而通过量化分析得出“主治”表述规范化模板。结果与结论共纳入9851份有效中成药说明书,其中包含症状术语的中成药说明书数量最多(7991份),其次是病名、病机(分别有5867、5167份);在病名术语中,包含西医病名的最多(4446份),其次为中医病名(2018份);有6962份中成药说明书【功能主治】项内容的表述与现有要求相符。“主治”表述二级分类中的“病名”和三级分类中的“病名+症状”“症状”不符合既定要求。从病机和证候着手所建的“主治”表述规范化模板有2个,即“病机+病名+症状”“病名+证候+症状”。建议“主治”表述信息应当完整且准确,“主治”表述的格式应规范化,并使用适当的连接词和标点符号,将非处方药中中成药的药品说明书分为专业版和患者版等,从而促进“主治”规范表述,推动中成药说明书撰写的规范化进程。OBJECTIVE To promote the standardization of the“Indications”section in package inserts for Chinese patent medicines and ensure rational clinical and patient use.METHODS The“Function and Indications”information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia(VolumeⅠ)and various national and regional standards.Identification criteria were established for syndrome,pathogenesis,disease name,and symptom terminology in the“Indications”section.Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements,followed by the construction of a three-tier classification system for“Indications”descriptions.A standardized template for“Indications”was developed through quantitative analysis.RESULTS&CONCLUSIONS A total of 9851 valid package inserts for Chinese patent medicines were included.Among these,the majority(7991)contained symptom terminology,followed by disease names(5867)and pathogenesis descriptions(5167).Within disease name terminology,Western medical disease names predominated(4446),followed by traditional Chinese medicine disease names(2018).The“Function and Indications”content of 6962 package inserts complied with existing requirements.Notably,the secondary classifications of“disease name”,as well as the tertiary classification of“disease name+symptoms”and“symptoms”,failed to meet established standards.Two standardized templates for“Indications”were formulated based on pathogenesis and syndrome:“pathogenesis+disease name+symptoms”and“disease name+syndrome+symptoms”.The“Indications”section should provide complete and accurate information,adhere to standardized formatting,and employ appropriate conjunctions and punctuation.For non-prescription Chinese patent medicines,package inserts should be categorized into professional and patient versions.These measures will facilitate the standardization of“Indications”descriptions and advance

关 键 词：中成药 说明书 主治 规范化表述 模板 

分 类 号：R95[医药卫生—药学] R288