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作 者:昝珂[1] 王丹丹 李耀磊[1] 金红宇[1] 魏锋[1] 王莹[1] 马双成[1] Zan Ke;Wang Dandan;Li Yaolei;Jin Hongyu;Wei Feng;Wang Ying;Ma Shuangcheng(National Institutes for Food and Drug Control,Beijing 100050,China)
出 处:《中国药事》2020年第11期1275-1280,共6页Chinese Pharmaceutical Affairs
基 金:科技部重大新药创制(编号2018ZX09303-024,2018ZX09735-006)。
摘 要:目的:对动物类中药材的生物安全现状进行总结并提出相应建议,为动物类中药材的质量控制及其监管提供参考。方法:通过查阅国内相关法规、文献、质量标准及炮制规范,进行归纳分析,提出动物类中药材的生物安全防控原则。结果与结论:动物类中药材的基原动物较多,部分品种的基原动物有相关规定,但仍有部分品种缺乏对生物安全方面的研究和监管规定。动物类中药材中细菌、病毒和寄生虫存在较大隐患,应研究制订相关品种的具体控制规则,加强生物安全监管,保障人民用药安全。Objective: To summarize the current situation of biosecurity of animal traditional Chinese medicine in recent years and put forward corresponding suggestions, so as to provide references for the quality control and supervision of animal traditional Chinese medicine. Methods: By summarizing and analyzing the relevant domestic laws and regulations, literature, quality standards, processing standards and biosecurity prevention, the control principles of animal traditional Chinese medicine were put forward. Results and Conclusion: There were many protozoa from animal traditional Chinese medicine, some had relevant regulations, but some lacked research and regulatory regulations on biosecurity. There are great hidden dangers in bacteria, viruses and parasites in animal traditional Chinese medicine. It is necessary to study and formulate specific control rules for related varieties in order to strengthen biosecurity supervision of animal traditional Chinese medicine and ensure the safety of drug use.
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