基于《中成药通用名称命名技术指导原则》分析我国已上市中成药命名存在的问题与改进建议

Analysis of the Problems in the Naming of Commercially Available Chinese Patent Medicine in China and Improvement Suggestions Based on the Naming Technical Guidelines for Generic Name of Chinese Patent Medicines

目的:了解我国已上市中成药命名现状及存在问题,并提出改进建议。方法:选取截至2017年12月31日国家食品药品监督管理总局(CFDA)公布的国家编码药品共计169 601种,采用Excel 2013软件筛选出国药准字"Z"中成药35 513种和进口注册证"Z"中成药68种。基于《中成药通用名称命名技术指导原则》(以下简称"《指导原则》")对国产中成药的不合规情况进行汇总,并对不合规国产中成药的剂型、特殊人群用药、地区等分布情况进行统计、分析。结果:不符合《指导原则》命名的国产中成药共5 091种,占国产中成药总数的14.34%,命名问题主要集中在夸大式命名(1 723种,占33.84%)、剂型不位于命名最后(1 118种,占21.96%)、采用濒危受保护动植物等命名(851种,占16.72%)、采用药理学等相关用语命名(848种,占16.66%),体现"传统文化特色"命名比例不高(1 324种,占4.35%)。命名不合规国产中成药的剂型前5位分别为片剂(1 203种,占23.63%)、胶囊剂(821种,占16.13%)、合剂(802种,占15.75%)、丸剂(706种,占13.87%)、颗粒剂(448种,占8.80%);命名不合规国产中成药的特殊人群用药问题集中在儿童用药(608种,占11.94%);命名不合规国产中成药所属生产企业所在地区主要集中在广东(613种,占12.04%)、广西壮族自治区(371种,占7.29%)、吉林(265种,占5.21%)、陕西(245种,占4.81%)、北京(233种,占4.58%)。结论:我国已上市国产中成药命名问题较多,集中反映在命名类型、剂型、儿童药等方面,且体现"传统文化特色"品种较少。笔者建议可从强化并完善我国特色药名审查管理制度、突出中国传统特色文化的命名管理、保护传统经典品牌等方面入手,进一步规范中成药命名。

OBJECTIVE:To investigate the situation and existing problems of the naming of commercially available Chinese patent medicine(CPM)in China,and to put forward the improvement suggestions.METHODS:Announced in Dec.31,2017 by CFDA,there were totally 169 601 kinds of national coded drugs.Total of 35 513 kinds of CPM with drug approval number“Z”and 68 kinds of imported CPM with importing registration certificates“Z”was screened by using Excel 2013 software.Based on Naming Technical Guidelines for Generic Name of Chinese Patent Medicines(hereinafter referred to as the Guidelines),the unqualified situation of domestic CPM were summarized,and unqualified domestic Chinese patent medicine were analyzed statistically in respects of dosage form,special population medication and area.RESULTS:There were 5 091 kinds of drugs named nonconformity with the“Guidelines”,accounting for 14.34% of domestic CPM.The problems of naming mainly focused on exaggerated naming(1 723 kinds,33.84%),dosage form un-located after naming(1 118 kinds,21.96%),naming by endangered protected animals and plants(851 kinds,16.72%),naming by pharmacology and other related terms(848 kinds,16.66%).Names emboding“traditional cultural features”(1 324 kinds,4.35%)took the lower proportion.Top 5 dosage forms of domestic CPM with unqualified naming were tablets(1 203 kinds,23.63%),capsules(821 kinds,16.13%),mixture(802 kinds,15.75%),pills(706 kinds,13.87%),granules(448 kinds,8.80%).The problems of special population medication for domestic CPM with unqualified naming concentrated on children’s medication(608 kinds,11.94%).The main manufacturers of domestic CPM with unqualified naming came from Guangdong(613 kinds,12.04%),Guangxi Zhuang Autonomous Region(371 kinds,7.29%),Jilin(265 kinds,5.21%),Shaanxi(245 kinds,4.81%)and Beijing(233 kinds,4.58%).CONCLUSIONS:There are many problems in naming of commercially available domestic CPM in China,mainly reflecting as naming type,dosage form,pediatric drugs,etc.There are fewer names emboding“traditional cultural features”.It is suggested that we should further standardize the naming of CPM by strengthening and perfecting the management and examination system of CPM,highlighting the naming principles of Chinese traditional culture and protecting traditional classical brands.