基于2009—2014年国产中药批准情况的数据挖掘  

Data Mining Based on the Approval of Domestic Traditional Chinese Medicine in 2009—2014

作　　者：陈瑞真 陈嘉音[1] 冯霄婵 王宏伟[1] 丁文晴 袁红梅[1] 杨悦[1] CHEN Ruizhen;CHEN Jiayin;FENG Xiaochan;WANG Hongwei;DING Wenqing;YUAN Hongmei;YANG Yue(College of Business Administration,Shenyang Pharmaceutical University,Liaoning Shenyang 110016,China)

机构地区：[1]沈阳药科大学工商管理学院,辽宁沈阳110016

出　　处：《中国医药导刊》2018年第7期442-448,共7页Chinese Journal of Medicinal Guide

基　　金：辽宁省社科规划基金项目(项目编号:L18BFX011;项目名称:基于技术创新的辽宁中药制造业走出去专利法律问题研究)

摘　　要：目的:为推动我国中药现代化发展,了解我国国产中药发展现状,尝试构建适合我国中药继承与发展的创新型管理模式。方法:本研究通过对国家食品药品监督管理总局信息中心提供的2009~2014年国产中药数据库进行数据挖掘,探究目前国产中药的整体情况,对国产中药的剂型、治疗领域分布等进行系统性分析,并结合中药品种保护获批情况识别国产中药核心生产企业。结果:我国中药研发上市存在重复研发同质化严重、中药注射剂型的改良优势与风险、中药生产企业单向化发展问题。结论:建议构建中药创新型审批模式,中药注射剂应注重急重症领域治疗,大小企业应协同发展。Objective：To promote modernization of traditional Chinese medicine in China, and to understand current situation of traditional Chinese medicine, trying to build an innovative management model suitable for the inheritance and development of Chinese traditional medicine. Methods ：Based on the background that traditional Chinese medicine business has been strongly supported by the government, this study analyzed the data through domestic traditional Chinese medicine database of 2009—2014 provided by the CFDA Information Center and explored current situation of domestic traditional Chinese medicine. This study systematically analyzed the distribution of Chinese traditional medicine in dosage form, treatment area, and identified core manufactures of traditional Chinese medicine by combining approval of protection of traditional Chinese medicine. Results ： The development of Chinese medicine had a phenomenon of homogeneity. The treatment of traditional Chinese medicine injections did not show advantages and the development of traditional Chinese medicine manufactures was unilateral. Conclusion ： It is suggested to construct an innovative examination and approval model for traditional Chinese medicine. Traditional Chinese medicine injection should focus on treatment of acute and severe diseases, both large and small manufactures should be developed in coordination.

关 键 词：国产中药 中药品种保护 注射剂 批准文号 

分 类 号：R954.3[医药卫生—药学]