符合中药特点的致癌风险评价方法  

Cancer Risk Assessment Methods in Accordance with the Characteristics of Traditional Chinese Medicine

作　　者：文海若 闫明 宋捷[1] 鄂蕊 耿兴超[1] 胡燕平[1] 王雪[1] Wen Hairuo;Yan Ming;Song Jie;Ao Rui;Geng Xingchao;Hu Yanping;Wang Xue(National Center for Safety Evaluation of Drugs,National Institutes for Food and Drug Control,Key Laboratory of Beijing for Nonclinical Safety Evaluation Research of Drugs,Beijing 100176,China;China Pharmaceutical University,Nanjing 210009,China)

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,药物非临床安全评价研究北京市重点实验室,北京100176 [2]中国药科大学,南京210009

出　　处：《中国药事》2020年第7期829-835,共7页Chinese Pharmaceutical Affairs

基　　金：国家自然科学基金(编号81503068);国家“重大新药创制”科技重大专项(编号2018ZX09201017-001)。

摘　　要：如何对中药的致癌性风险作出科学而合理的评价是毒理学研究的难点之一。因中药成分和配伍的复杂性,现有的常规遗传毒性评价方法在评价中药方面有所局限。在原有试验原理基础上开发高通量筛选方法,以及利用新型生物标志物和基于新原理的试验技术已在中药毒性预测和评价领域显露一定的应用价值。本文聚焦适合大量成分毒性筛选及靶器官毒性评价的试验方法,包括改良的传统试验方法、自动化检测手段、生物标志物、三维组织培养技术和计算机毒理学的引入等,为中药致癌性评价提供借鉴思路。To make a scientific and reasonable assessment for the carcinogenic risk of traditional Chinese medicine(TCM)is one of the chanllenges in toxicology evaluation.However,conventional genotoxicity evaluation methods are limited in the evaluation of TCMs due to the complexity and the compatibility of their components.The development of high throughput screening method based on the original principles and the use of new biomarkers and techniques based on novel principles have shown certain application value in the fields of toxicity prediction and evaluation of TCMs.This article focuses on the test methods that are feasible for the toxicity screening of a large number of components and the target organ toxicity evaluation,including improved traditional test methods,automated detection methods,the introduction of biomarkers,three-dimensional tissue culture techniques and computer toxicology,etc.,which shall provide references for the carcinogenicity evaluation of TCMs.

关 键 词：中药 致癌性 评价方法 高通量 构效分析 

分 类 号：R991[医药卫生—毒理学]