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, Beijing 100700, China.
State Key Laboratory of Innovative Natural Medicine and Traditional Chinese Medicine Injections, Ganzhou 341000, China.
Zhongguo Zhong Yao Za Zhi. 2018 Dec;43(23):4735-4740. doi: 10.19540/j.cnki.cjcmm.20180820.001.
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.
动物类中药在中国有着悠久的应用历史,其临床应用非常广泛。由于动物类中药化学成分复杂,化学研究基础相对薄弱,导致许多动物类中药的成分及毒性成分不明确,动物类中药的药效成分与毒性成分之间的关系尚未阐明。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、遗传毒性实验等,必要时还需要进行致癌性等实验研究。目前动物类中药的临床前安全性研究主要基于对有毒性动物类中药的研究,大多数动物类中药尚未开展系统的临床前和临床安全性研究,研究方法主要集中在急性毒性试验。有必要对动物类中药开展系统的临床前安全性研究,阐明不同动物类中药可能产生的不良反应及其特点、毒性靶器官、中毒剂量及中毒机制。最后,本文建议在动物类中药临床前安全性研究中,应结合化学物质基础、产地、采收季节等进行深入研究和比较,必要时对“无毒”动物类中药开展安全性研究。此外,有必要合理运用毒理学研究的前沿技术和方法,全面阐明动物类中药的临床前安全性信息。