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动物类中药材使用情况及常见质量问题探讨
引用本文:王丹丹,昝珂,魏锋,金红宇,马双成.动物类中药材使用情况及常见质量问题探讨[J].中国药事,2020,34(11):1281-1298.
作者姓名:王丹丹  昝珂  魏锋  金红宇  马双成
作者单位:中国食品药品检定研究院,北京 100050
基金项目:科技部重大新药创制(编号 2018ZX09303-024)
摘    要:目的:动物类中药材在中国具有悠久的应用历史,在中医药宝库中占有重要的地位,但部分动物药材品种在炮制加工、贮藏、使用方法等方面尚存在一定的安全风险。本文梳理了动物类中药材可能存在的质量安全风险点,以期对保障动物类中药材的质量和控制生物安全隐患提供借鉴。方法:本文通过对动物类中药材相关标准及文献的整理研究,发现可能存在的质量安全风险点。结果与结论:目前动物类中药材存在质量标准不完善,药材在运输、保存过程中受污染、变质,缺少相关指导原则的问题。对此,应提高、完善质量标准,加强动物类中药材在贮藏、流通、运输过程的管理,制定相关质控指导原则,保障人民用药安全。

关 键 词:动物类中药材  质量标准  生物安全

A Preliminary Study on the Usage and Common Quality Problems of Animal Traditional Chinese Medicine
Wang Dandan,Zan Ke,Wei Feng,Jin Hongyu,Ma Shuangcheng.A Preliminary Study on the Usage and Common Quality Problems of Animal Traditional Chinese Medicine[J].Chinese Pharmaceutical Affairs,2020,34(11):1281-1298.
Authors:Wang Dandan  Zan Ke  Wei Feng  Jin Hongyu  Ma Shuangcheng
Institution:National Institutes for Food and DrugControl, Beijing 100050 , China
Abstract:Objective: Animal traditional Chinese medicine (animal TCM) has been used for a long history in China and plays an important role in the treasure house of traditional Chinese medicine. However, there are still some safety risks in processing, storage and use of some animal TCM. This article sorted out the possible quality and safety risks of animal TCM to provide references for the quality assurance of animal TCM and the control of biological safety risks. Methods: Through the collation and research on the relevant standards and literature of animal TCM, the possible risk points of quality and safety were found. Results and Conclusion: At present, the quality standard of animal TCM should be improved, the medicinal materials are polluted and deteriorated in the process of transportation and storage, and lack relevant guiding principles. Therefore, we should improve the quality standards, strengthen the management of animal TCM in the process of storage, circulation and transportation, and formulate relevant quality control guidelines to ensure the safety of drug use.
Keywords:
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