我国中成药通用名称的命名问题研究--基于2009-2014年中成药批准数据的统计分析

Research on the Naming of Generic Name of Proprietary Chinese Medicines——Based on Statistical Analysis of Proprietary Chinese Medicines approval Data from 2009 to 2014

目的:为进一步加强我国中成药通用名称命名的规范化、书面化、系统化管理提供参考性建议。方法:采用Excel软件,以我国最新出台的《中成药通用名称命名技术指导原则》为统计依据,对来源于国家食品药品监督管理总局信息中心的2009—2014年批准的中成药数据"药品名称"项进行分类统计,以了解我国中成药命名的基本现状,并在指导原则系列文件相关规定的基础上深入分析我国在规范中成药通用名称的制度建设上的不足之处。结果:监管机构未制定药品通用名称审核标准,对于某些命名方式未考虑文化因素,实行"一刀切"策略,未明确制药企业在名称规范工作中的主体责任,对于更名工作的有效开展未设立约束措施。结论与建议:建议将百年药企的文化性、知名商标与驰名商标企业的信誉性、中药材的道地性以及古典名方纳入考虑范畴,建立科学的名称审核标准,以药品功效为实际考察指标实行分类管理,明确企业责任,制定配套约束措施,从根本上实施对药品名称的规范管理。

Objective ： To provide reference for further normalized, written and systematical management of the generic names of proprietary Chinese medicines. Methods：By using Excel software, the basic principles of 《The guiding principle of generic name of proprietary Chinese medicines 》 pronmlgated recently in China was used as the statistical basis. The data of proprietary Chinese medicines approved in 2009-2014 from China Data Center for Food ＆ Drug Adnfinistration were made classified statistics of ＂Drug name＂ in order to understand the basic status quo of the nanfing of proprietary Chinese medicines in China. Based on the relevant provisions of the ＂Guiding Principles＂ series of documents, the author analyzed the deficiencies in system construction of standardizing generic names of proprietary Chinese medicines. Results：Regulators have not set a standard for drug generic name review, and did not consider cultural factors for certain nanfing methods, implemented a ＂one-size-fits-all＂ strategy, did not specify the main responsibilities of the pharmaceutical companies in naming, and did not establish a binding mechanism for guaranteeing the effective condnct of renaming work. Conclusion：Proposed that century enterprise culture, the credibility of well-known trademarks and famons brand firms, the authenticity of Chinese herbal medicines and classical names should betaken into account, and should set the scientific name review standards, use the efficacy of the drug as the actual inspection index for classified management, clarify the responsibility of enterprises, formulate supporting constraints, and ultimately implement standardized management of drug names.