摘要
2017年底,原国家食品药品监督管理总局颁布了《中药资源评估技术指导原则》,其目的是为了通过中药资源评估这项工作,让更多药品上市许可持有人或中药生产企业树立起"企业生产中成药、饮片等,应以保障中药资源产量和质量为前提"的理念,并最终达到促进中药资源可持续利用的战略目的。该文在"总量不减,保障供应"的总体思想指导下,着重介绍了基于"总量不减"的中药资源"家底评估"和基于"保障供应"的中药资源"供需平衡评估"2种评估方法,通过论述全国中药资源普查与中药资源评估的区别与联系,最终提出了基于"保障供应"的中药资源"供需平衡评估"基本策略,为业内开展相关工作提供参考依据。
At the end of 2017,the former China Food and Drug Administration promulgated " the Guiding Principles for the Assessment of Chinese Medicine Resources" whose purpose is establishing the concept of " the production of Chinese traditional medicines,herbal pieces and etc. should be based on the premise of ensuring the production and quality of Chinese medicine resources" for a licensed holder of a drug listing or a production enterprise of Chinese Medicine by assessing this work through the resources of Chinese Medicine which finally achieves the strategic significance of promoting the sustainable utilization of Chinese medicine resources. Under the guidance of the overall idea of " the total amount is not reduced and the supply is guaranteed",this paper focuses on the following two methods of assessment:(1) " family property assessment" of Chinese medicine resources based on " fixed total amount".(2) " Supply and demand balance assessment" of Chinese medicine resources based on " supply guarantee". In this paper,we discuss the difference and relationship between the national survey of Chinese medicine resources and the assessment of Chinese medicine resources. Finally,we put forward a basic strategy called " supply and demand balance assessment" of Chinese medicine resources based on " supply guarantee" that will guide the Industrial production of traditional Chinese medicine.
作者
张泽坤
张小波
杨光
王海南
郭兰萍
ZHANG Ze-kun;ZHANG Xiao-bo;YANG Guang;WANG Hai-nan;GUO Lan-ping(State Key Laboratory Breeding Base of Dao-di Herbs,National Resource Center for Chinese Materia Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China;China National Drug Administration,Beijing 100620,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2018年第15期3223-3227,共5页
China Journal of Chinese Materia Medica
基金
中央本级重大增减支项目(2060302)
国家重点研发计划项目(2017YFC1701603)
国家“重大新药创制”科技重大专项(2018ZX09201009)
科技基础性工作专项(2013FY114500)
中国中医科学院重点领域专项(ZZ10-027)
关键词
普查
中药资源
评估
消耗量
可获得量
潜在风险
可持续利用
national investigation
Chinese medicine resources
assessment
consumption
amount of available
potential risks
sustainable utilization