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。
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.
作者
王丹丹
昝珂
魏锋
金红宇
马双成
Wang Dandan;Zan Ke;Wei Feng;Jin Hongyu;Ma Shuangcheng(National Institutes for Food and Drug Control,Beijing 100050,China)
出处
《中国药事》
CAS
2020年第11期1281-1298,共18页
Chinese Pharmaceutical Affairs
基金
科技部重大新药创制(编号2018ZX09303-024)。