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[短缺进口药材质量监管的现状与思考]

[Status and thinking of quality supervision on imported medicinal materials in shortage].

作者信息

Zhu Jian-Guang, Duan Jin-Ao, Li Wen-Lin, Zhou Wei, Yang Li-Li

机构信息

School of Pharmacy, Henan University of Chinese Medicine, Zhengzhou 450046, China.

School of Pharmacy, Nanjing University of Chinese Medicine, Nanjing 210023, China.

出版信息

Zhongguo Zhong Yao Za Zhi. 2018 Jun;43(12):2628-2632. doi: 10.19540/j.cnki.cjcmm.20180322.011.

DOI:10.19540/j.cnki.cjcmm.20180322.011
PMID:29950087
Abstract

With the continuous development of traditional Chinese medicine business, the types and amounts of Chinese materia medica resources are increasingly reduced. By reviewing the origins, trading sources, and existing quality standards of the available common Chinese madicinal materials in shortage, it was found that the large amount of imported medicinal materials in domestic market or clinical application were not due to the traditional paths such as envoys presenting tribute, business trade, war conflict, national migration, and tourist travel, but due to the shortage of resources in domestic origins. Meanwhile, the former quality control standard on traditional imported medicinal materials was out of date, and the new imported medicinal materials quality control standard was in absence, resulting in unclear origins, unknown origins and processing methods, as well as more and more prominent problems on mixed use of the different varieties with same name and the same varieties from different origins. On the one hand, this situation once again sounded the alarm for the development of Chinese medicine industry from the resource perspective. On the other hand, the confusion of new varieties in Chinese herbal medicine market has also brought a serious threat to the efficacy of Chinese medicine. It is pointed out that it is an effective way to ensure the drug safety of imported medicinal materials through strengthening quality supervision of shortage of traditional Chinese medicines based on the new pharmacopoeia standards.

摘要

随着中医药事业的不断发展,中药材资源的种类和数量日益减少。通过梳理现有短缺常用中药材的产地、贸易来源及现行质量标准,发现国内市场或临床应用中大量进口药材并非源于朝贡、商贸、战争冲突、民族迁徙、人员往来等传统途径,而是国内产地资源短缺所致。同时,以往传统进口药材质量控制标准陈旧,新的进口药材质量控制标准缺失,导致产地不明、来源及炮制方法不清,同名异物、同物异名混用问题日益突出。这一方面从资源角度再次为中医药产业发展敲响警钟;另一方面,中药材市场新品种混乱也给中药疗效带来严重威胁。指出基于新的药典标准加强短缺中药材质量监管是保障进口药材用药安全的有效途径。

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