摘要
目的系统分析中药配方颗粒的市场准入特征,探讨标准体系、功能主治、跨省备案及价格竞争等因素对市场准入的影响,为中药配方颗粒行业的高质量发展提供政策和实践层面的实证参考。方法以华润三九医药股份有限公司为样本,采用文档挖掘与价格指数定量分析相结合的混合研究方法,从标准体系、功能主治分布、跨省备案情况与价格竞争4个维度系统分析中药配方颗粒的市场准入特征及其影响因素。结果共纳入样本企业中药配方颗粒品种986个。国标品种占48.2%,备案省超过29个;省标品种占51.8%,备案省分布在17~27个。产品功能主治集中于清热(17.4%)、补虚(15.3%)、活血化瘀(9.1%)等领域,排名前10功能主治品种集中度为83.9%。跨省备案主要集中分布于广东、江苏、安徽等省。集采中标品种的价格竞争,69.5%的集采中标品种价格低于市场中位数。结论中药配方颗粒的市场准入受标准成熟度、临床价值、区域资源与价格机制影响,企业需强化证据与差异化布局,政策应推进标准一体化与价值导向支付,以实现可及性与可持续发展。
Objective To systematically analyze the market access characteristics of Traditional Chinese Medicine(TCM)formula granules,to explore influencing factors such as the standard system,therapeutic indications,inter-provincial registration,and price competition affect market access to provide empirical insights for policy formulation and industry practices and to support the high-quality development of the TCM formula granule sector.Methods Using China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.as the sample enterprise,this study adopts a mixed research method combining document mining and quantitative price index analysis.It examines market access characteristics and influencing factors from four dimensions:standard system,therapeutic indication distribution,inter-provincial registration,and price competition.Results A total of 986 TCM formula granule products were included in the analysis.Among them,48.2%were national standard(GB)products,registered in more than 29 provinces,while 51.8%were provincial standard(SB)products,mainly registered in 17 to 27 provinces.The therapeutic indications were concentrated in areas such as heat-clearing(17.4%),tonifying deficiency(15.3%),and promoting blood circulation(9.1%),with the top ten indications accounting for 83.9%of all products.Inter-provincial registration was primarily concentrated in several provinces,such as Guangdong,Jiangsu,and Anhui.Regarding price competition,69.5%of products selected through centralized procurement were priced below the market median.Conclusions The market access of TCM formula granules is influenced by several factors,including the maturity of quality standards,clinical value,regional resource allocation,and pricing mechanisms.Enterprises should strengthen evidence-based evaluation and differentiated strategies,while policies should accelerate standard harmonization and promote value-based payment to ensure accessibility and sustainable development.
作者
奉艳莲
邱建永
欧阳炜
万欣龙
谢智荣
陈创荣
赖云锋
FENG Yanlian;QIU Jianyong;OUYANG Wei;WAN Xinlong;XIE Zhirong;CHEN Chuangrong;LAI Yunfeng(School of Public Health and Management,Guangzhou University of Chinese Medicine,Guangzhou 510006,China;Department of Pharmacy,Guangdong Provincial Second Hospital of Traditional Chinese Medicine,Guangzhou 510095,China;Department of Science&Technology,Guangzhou University of Chinese Medicine,Guangzhou 510405,China)
出处
《医药导报》
北大核心
2026年第1期149-154,共6页
Herald of Medicine
基金
广东省基础与应用基础研究基金资助项目(2022A1515110662、2022A1515220148)
广州市哲学社会科学发展“十四五”规划2023年度共建课题(2023GZGJ16)
广州中医药大学2024年度人文社会科学培育项目(2024ZDPY02)
广州中医药大学“固本”工程一级学科能力提升项目(GZY2025GB0306)。
关键词
中药配方颗粒
市场准入
影响因素
Traditional Chinese Medicine formula granules(TCMFGs)
Market access
Influencing factors
