摘要
动物类中药在我国应用历史悠久,临床运用广泛。由于动物类中药物质基础较复杂,化学研究基础相对薄弱,导致很多动物类中药的有效成分、毒性成分尚不清楚,有效成分与有毒成分的关系也未阐明。动物类中药的非临床安全性评价主要包括急性毒性、长期毒性、安全药理学、生殖毒性、遗传毒性实验,必要时还需进行致癌性等实验研究。我国当前对动物类中药的临床前安全性研究主要以有毒动物类中药的研究为主,绝大多数动物类中药没有进行过系统的临床前和临床安全性研究,其研究方法也主要以急性毒性试验为主。有必要对动物类中药进行系统的临床前安全性研究,搞清楚不同的动物类中药有可能产生的毒副作用及其特点、毒性靶器官、中毒剂量以及中毒机制等。最后,该文建议在动物类中药的临床前安全性研究中,应结合化学物质基础、产地、采集季节以及加工方法等进行深入的研究和比较,必要时开展"无毒"动物类中药的安全性研究,另外需合理借助毒理学研究的前沿技术和方法,以全面充分阐明动物类中药的临床前安全性信息。
Animal traditional Chinese medicine has a long history of application in China, and its clinical application is very extensive. Due to the complex chemical composition in animal traditional Chinese medicine, the basis of chemical research is relatively weak, which leads to the unclear composition and toxic components of many animal Chinese medicines. The relationship between the medicinal and toxic components of animal Chinese medicine has not yet been elucidated. The non-clinical safety evaluation of animal traditional Chinese medicine mainly includes acute toxicity, long-term toxicity, safety pharmacology, reproductive toxicity, genotoxicity experiments, and experimental studies such as carcinogenicity are needed when necessary. The current preclinical safety research on animal traditional Chinese medicine is mainly based on the study for toxic animal traditional Chinese medicines. Most animal Chinese medicines have not carried out systematic preclinical and clinical safety studies. The research method is mainly focused on acute toxicity test. It is necessary to carry out systematic preclinical safety studies on animal traditional Chinese medicines, to clarify the possible side effects and its characteristics, its toxic target organs, toxic doses and poisoning mechanisms induced by different animal traditional Chinese medicines. Finally, this paper suggests that in the preclinical safety study of animal traditional Chinese medicine, in-depth research and comparison should be carried out in combination with chemical substance foundation, origin, and collection season, and the safety of "non-toxic" animal traditional Chinese medicine should be carried out when necessary. In addition, it is necessary to rationally use the cutting-edge technologies and methods of toxicology research to fully clarify the preclinical safety information of animal Chinese medicines.
作者
易艳
赵雍
李春英
张宇实
潘辰
刘素彦
蒋春红
梁爱华
YI Yan;ZHAO Yong;LI Chun-ying;ZHANG Yu-shi;PAN Chen;LIU Su-yan;JIANG Chun-hong;LIANG Ai-hua(Key Laboratory of Beijing for Identification and Safety of Chinese Medicine,Institute of Chinese Materia Medica,China Academy of Chinese Medical Sceiences,Bering 100700,China;State Key Laboratory of Innovative Natural Medicine and Traditional Chinese Medicine Injections,Ganzhou 341000,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2018年第23期4735-4740,共6页
China Journal of Chinese Materia Medica
基金
国家“重大新药创制”科技重大专项(2014ZX09201022,2015ZX09501004)
北京科学技术专项(Z161100004916025,Z151100000115012)
中国中医科学院自主选题项目(Z2014036,ZZ2014023,ZXKT15031,ZZ10-025)
关键词
动物类中药
临床前安全性研究
不良反应
毒理学
animal traditional Chinese medicine
preclinical safety studies
adverse reactions
toxicology
