儿科用中药发育毒理学研究及评价进展  

Progress in study and evaluation of developmental toxicology for pediatrics traditional Chinese medicine

作　　者：周莉[1,2,3] 郭隽 孙祖越 ZHOU Li;GUO Jun;SUN Zu-yue(National Evaluation Center for Toxicology of Fertility Regulating Drugs,Shanghai Institute of Planned Parenthood Research,Shanghai 200032,China;Institute of Reproduction and Development,Fudan University,Shanghai 200032,China;Key Lab of Reproduction Regulation of National Population and Family Planning Commission,Shanghai 200032,China)

机构地区：[1]上海市计划生育科学研究所,中国生育调节中药毒理检测中心,上海200032 [2]复旦大学生殖与发育研究院,上海200032 [3]国家人口和计划生育委员会计划生育药具重点实验室,上海200032

出　　处：《中国药理学与毒理学杂志》2020年第8期568-574,共7页Chinese Journal of Pharmacology and Toxicology

基　　金：国家科技重大专项(2018ZX09201017-002)。

摘　　要：自古医家便有重视小儿用药的“不药之药”、“谨慎用药”等合理用药和安全用药的原则,结合幼龄动物毒理学试验(Juvenile animal study)等现代医学模式对中药开展深入研究,有助于了解儿科用中药发育毒理学特点。在开展儿科用中药安全性评价时,需要设定更为全面的发育毒理学评价指标,结合儿童发育特性、中药特色以及现代医学法规,关注临床相关指标,开展儿科用中药毒动学研究。同时还需要考虑儿童生理基础和药物代谢特点以及不同发育阶段影响药动学等因素。国家立法和监管是完善真正属于中药安全性评价科学体系的重要保障;呼吁中西医结合联动研发,调动药物研发和安全性评价人员的积极性,促使儿科用中药的非临床安全性评价工作步入正轨,以推动儿科用药研发的发展。Since ancient times,medical professionals have attached importance to the principles of rational and safe use of medicines for children,such as"non-medicine treatment"and"cautions of medication".In-depth studies on traditional Chinese medicine(TCM),combined with modern medical models such as Juvenile animal study,can advance our understanding of the characteristics of devel⁃opmental toxicology of pediatric TCM.When evaluating the safety of pediatric TCM,it is necessary to set the indexes for comprehensive developmental and toxicological evaluation in line with the develop⁃mental characteristics of children,the characteristics of TCM,modern medical regulations and laws,and to focus on clinically relevant indexes in order to carry out toxicokinetic studies of pediatric TCM.The characteristics of children′s physiology,drug metabolism,and factors influencing pharmacokinetics at different developmental stages need to be taken into account.National legislations and regulations are an important guarantee for the scientific system of TCM safety evaluation.It is recommended that TCM be combined with Western medicine for collaborated research and that those engaged in drug development and safety evaluation show more initiative so that the non-clinical safety evaluation of TCM for pediatric use can be put on the right track to promote pediatric drug research and development.

关 键 词：儿童 中药 儿科 发育毒理 安全性评价 

分 类 号：R285.1[医药卫生—中药学]