基于中药监管科学创新技术体系破解国家中药类产品集中带量采购难点  

A New Idea of Cracking the Difficulties in National Centralized Procurement of Traditional Chinese Medicine Products Based on A Platform for Scientific Innovation Standards of Traditional Chinese Medicine Supervision

作　　者：魏胜利[1,2,3,4] 李大宁 徐安龙 WEI Sheng-li;LI Da-ning;XU An-long(Beijing University of Chinese Medicine;Institute of Regulatory Science for Traditional Chinese Medicine,National Medical Products Administration;Engineering Research Center of Good Agricultural Practice for Chinese Crude Drugs of Ministry of Education;Expert Committee of Sanming Procurement Alliance for Provincial Traditional Chinese Medicine(Materials)Procurement Alliance)

机构地区：[1]北京中医药大学 [2]国家药品监督管理局中药监管科学研究院 [3]中药材规范化生产教育部工程研究中心 [4]三明采购联盟省际中药(材)采购联盟专家组委员会

出　　处：《中国食品药品监管》2024年第1期108-117,共10页China Food & Drug Administration Magazine

基　　金：国家自然科学基金项目(32070357);北京市科技计划创新品种及平台培育项目(Z201100005420005)。

摘　　要：在国家推动药品集中带量采购(以下简称集采)工作常态化背景下,中成药大品种在全国范围内的集采已经落地开展,中药饮片的省际联合采购也正在进行,而未来中药配方颗粒纳入集采也是大势所趋。然而,中药不同于化学药品,其原料来源于天然资源,组成成分复杂、功效主治多样,是一个多功效、多组分的复杂体系,加之中药类产品生产过程复杂,产品质量良莠不齐,生产成本相差悬殊,如何在中药类产品集采中科学评价产品质量,体现优质优价,以及如何科学评估中药类产品的生产成本,制定合理的最高限价,都是中药集采工作执行中亟待解决的难点问题。针对上述难点,笔者提出基于中药监管科学体系,创新制定中药类产品质量等级标准以及构建全产业链溯源与供应保障平台,从而确保中药类产品集采保质、提级、稳供、高质量发展的新思路。With the continuous push for the normalization of drug volume-based procurement,the nationwide procurement of major categories of Chinese patent medicines and the inter-provincial joint procurement of Chinese medicinal decoction pieces are in progress.The inclusion of traditional Chinese medicine particles in centralized procurement is also anticipated.However,traditional Chinese medicine(TCM)differs from chemical medicine as its raw materials are derived from natural resources,comprising complex components and diverse therapeutic effects.In addition,the production process of TCM products is complicated,resulting in varying product quality and substantial differences in production costs.Scientifically evaluating product quality to reflect high quality and reasonable pricing,as well as assessing the production costs of TCM products to establish rational maximum price limits,are critical challenges that urgently need resolution in the implementation of Chinese medicine procurement.Addressing these challenges,this paper proposes an innovative approach based on the scientific regulatory system for TCM.It suggests the development of quality grading standards for TCM products,and the establishment of a comprehensive supply chain traceability and assurance platform.These measures aim to ensure the quality,upgrading,stability,and high-quality development of TCM products in centralized procurement.

关 键 词：中药集采 中成药 中药饮片 精准药材 精准饮片 

分 类 号：R95[医药卫生—药学]