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.
Zhongguo Zhong Yao Za Zhi. 2018 Aug;43(15):3223-3227. doi: 10.19540/j.cnki.cjcmm.20180528.009.
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.
2017年底,原国家食品药品监督管理总局颁布了《中药资源评估指导原则》,其目的是通过对中药资源评估工作,树立药品上市许可持有人或中药生产企业“中药及饮片等生产应以保障中药资源生产与质量为前提”的理念,最终达到促进中药资源可持续利用的战略意义。在“总量不减、供应保障”总体思路指导下,本文重点阐述以下两种评估方法:①基于“总量固定”的中药资源“家底评估”;②基于“供应保障”的中药资源“供需平衡评估”。本文探讨了中药资源全国普查与中药资源评估的区别与联系。最后提出基于“供应保障”的中药资源“供需平衡评估”基本策略,以指导中药产业生产。