Wu Jing-Yi, Li Can, Wu Chen-Yue, Hu Hao-Bin, Jin Hong-Yu, Wei Feng, Xu Zeng-Lai, Zhou Yue-Hua
Center for Drug Evaluation, National Medical Products Administration Beijing 100022, China.
Jiangsu Institute for Food and Drug Control Nanjing 210019, China.
Zhongguo Zhong Yao Za Zhi. 2021 Nov;46(22):6004-6010. doi: 10.19540/j.cnki.cjcmm.20210702.601.
To learn the current situation and strengthen the management of national standards for Chinese medicinal materials, we sorted out the relevant national standards. According to incomplete statistics, there are 1 185 kinds of Chinese medicinal materials, including 1 024 kinds of plant medicines, 106 kinds of animal medicines, and 54 kinds of mineral medicines, in addition to ethnic medicinal materials with different functions. The relevant standards include 819 Pharmacopoeia standards, 342 standards issued by the Ministry of Health or National Medicinal Products Administration, 7 standards for new medicinal materials, and 17 standards for imported medicinal materials. In this paper, the sources of standards as well as the distribution of families and genera and the distribution of medicinal parts of medicinal materials are analyzed. The suggestions are as follows:(1)to improve the coordination among different national standards of Chinese medicinal materials;(2)to improve the standardization and controllability of relevant standards;(3)to revise the issued standards for Chinese medicinal materials(including Tibetan, Uygur, and Mongolian medicinal materials).
为了解中药材国家标准现状并加强管理，我们对相关国家标准进行了梳理。据不完全统计，中药材有1185种，其中植物药1024种、动物药106种、矿物药54种，另有具有不同功效的民族药材。相关标准包括819项药典标准、342项由卫生部或国家药品监督管理局发布的标准、7项新药材标准以及17项进口药材标准。本文对标准来源以及药材的科属分布和药用部位分布进行了分析。建议如下：（1）加强中药材不同国家标准间的协调；（2）提高相关标准的规范性和可控性；（3）修订已发布的中药材标准（包括藏药、维吾尔药和蒙药标准）。
