中国新药杂志

非人灵长类动物胚胎-胎仔毒性实验阳性药物的选择

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崔艳君 ¹ , 田义超 ¹ , 周莉 ²^,³ , 孙祖越 ²^,³

中国新药杂志 | 重大新药创制专项巡礼 2021,30(14): 1266-1273

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中国新药杂志 |重大新药创制专项巡礼 2021 , 30 (14) : 1266 -1273

非人灵长类动物胚胎-胎仔毒性实验阳性药物的选择

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崔艳君¹, 田义超¹, 周莉²^,³, 孙祖越²^,³

作者信息

¹湖北天勤生物科技有限公司武汉分公司，武汉　430075

²上海市计划生育科学研究所药理毒理研究室，中国生育调节药物毒理检测中心，上海　200032

³复旦大学生殖与发育研究院，上海　200032

通讯作者:

孙祖越，男，研究员，博士生导师，主要从事药物生殖与发育毒理学研究。E-mail：sunzy64@163.com。

作者简介:

崔艳君，女，硕士研究生，助理研究员，主要从事药物非临床安全性评价。E-mail：cuiyanjun1981@163.com。

Selection of teratogenic drugs for reproductive and developmental toxicity test in non-human primates

Yan-jun CUI¹, Yi-chao TIAN¹, Li ZHOU²^,³, Zu-yue SUN²^,³

Affiliations

¹Hubei Topgene Biotechnology Co., Ltd., Wuhan Branch, Wuhan 430075, China

²Shanghai Institute of Planned Parenthood Research, National Evaluation Center for Toxicology of Fertility Regulating Drugs, Shanghai 200032, China

³Reproductive and Developmental Research Institute of Fudan University, Shanghai 200032, China

出版时间: 2021-07-30

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摘要

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生物技术药物研发的蓬勃发展促使越来越多的生物制品需要进行非人灵长类动物生殖与发育毒性研究，而国内开展该实验项目的机构和案例均较少，如何成功建立该实验体系，阳性药物的选择至关重要。对于大小鼠、家兔可引起胚胎畸形的药物积累了很多案例和经验，而非人灵长类动物的实验及案例报道较少，本文针对可引起非人灵长类动物胚胎发育畸形的药物展开综述。

关键词

非人灵长类 / 生殖与发育毒性 / 模型 / 阳性药物

Abstract

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The reproductive and developmental toxicity evaluation on non-human primates is required urgently as the booming of biotechnological drugs. The selection of positive drugs is vital for establishment of the test system when there is less experience in domestic safety evaluation centers. There are different kinds of teratogens reported to both human and animals such as rodents, rabbits, but less on non-human primates. In this paper the potential teratogens to non-human primates were reviewed according to the literature.

Key words

non-human primate / reproductive and developmental toxicity / model / teratogenic drugs

引用本文

崔艳君, 田义超, 周莉, 孙祖越. 非人灵长类动物胚胎-胎仔毒性实验阳性药物的选择. 中国新药杂志, 2021 , 30 (14) : 1266 -1273 .

Yan-jun CUI, Yi-chao TIAN, Li ZHOU, Zu-yue SUN. Selection of teratogenic drugs for reproductive and developmental toxicity test in non-human primates[J]. Chinese Journal of New Drugs, 2021 , 30 (14) : 1266 -1273 .

基金

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国家“重大新药创制”科技重大专项资助项目(2018ZX09201017-002)

参考文献

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2021年第30卷第14期

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首发时间：2026-10-28
出版时间：2021-07-30

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录用日期：2021-05-18

基金

国家“重大新药创制”科技重大专项资助项目(2018ZX09201017-002)

作者信息

¹湖北天勤生物科技有限公司武汉分公司，武汉　430075

²上海市计划生育科学研究所药理毒理研究室，中国生育调节药物毒理检测中心，上海　200032

³复旦大学生殖与发育研究院，上海　200032

通讯作者:

孙祖越，男，研究员，博士生导师，主要从事药物生殖与发育毒理学研究。E-mail：sunzy64@163.com。

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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