专题论文

动物实验替代技术研究进展

  • 程树军
展开
  • 广东出入境检验检疫局技术中心, 广州 510623
程树军,研究员,研究方向为动物实验替代方法研发及标准化,电子信箱:chengsj@126.com

收稿日期: 2017-10-10

  修回日期: 2017-11-27

  网络出版日期: 2017-12-29

基金资助

广东省科技计划项目(2015A030402005)

Technology progress of alternative to animal testing

  • CHENG Shujun
Expand
  • Guagdong Inspection and Quarantine Technology Center, Guangzhou 510623, China

Received date: 2017-10-10

  Revised date: 2017-11-27

  Online published: 2017-12-29

摘要

综述了动物实验替代技术的发展及法规接受情况。介绍了替代动物实验的历史,阐述了在21世纪毒性测试新观念(TT21C)、有害结局通路(AOP)、整合测试等理论的指导下,组织重建和多器官人体芯片技术、干细胞技术、组学技术、非生物测试技术、高通量和高内涵技术等新技术对动物实验替代方法的促进分析了标准化的替代方法和个性化的体外方法在化学品、化妆品、药品和生物制品等健康相关产品评估中的应用。分析表明,替代技术不仅是实验动物学科的重要分支,也是一类研发和实验用的创新性工具,同时具有产业化的前景。

本文引用格式

程树军 . 动物实验替代技术研究进展[J]. 科技导报, 2017 , 35(24) : 40 -47 . DOI: 10.3981/j.issn.1000-7857.2017.24.004

Abstract

This paper reviews the technological progresss and the regulatory acceptance of alternative methods, including the development of the concept of alternative to the animal test, which can be divided into three phases as the starting accumulation, the regulation acceptance and the accelerated development.. The focus is on the theories of the Toxicity Testing in the Twenty-First Century (TT21C), the Adverse Outcome Pathway(AOP) and the integrated testing strategy, The new technologies include the reconstructed tissues and the multiorgans-on-chip, the stem cells, the " omics-"technology, and the non-testing approaches, and the high throughput and the high content screening are integrated into the alternative methods, with obvious interdisciplinary features. The standardized alternative methods and the personalized in vitro methods are applied in the assessment of health related products of chemicals,cosmetics,medicals and other biological products. It is concluded that the technology of the alternative to the animal testing is not only an important part of lab animal science, but also an innovative tool for scientific progress and with the prospect of industrialization.

参考文献

[1] Michael Balls. 3R和仁慈准则[M]. 程树军, 译. 北京:科学出版社, 2014:32-87. Balls M. The three Rs and the humanity criterion[M]. Cheng Shujun, trans. Beijing:Science Press, 2014:32-87.
[2] 程树军, 焦红. 实验动物替代方法原理与应用[M]. 北京:科学出版社, 2010:285-304. Cheng Shujun, Jiao Hong. The principle and application of experimen-tal animal substitution method[M]. Beijing:Science Press, 2010:285-304.
[3] Scott L, Eskes C, Hoffmann S, et al. A proposed eye irritation testing strategy to reduce and replace in vivo studies using Bottom-Up and Top-Down approaches[J]. Toxicol in Vitro, 2010, 24(1):1-9.
[4] 黄健聪, 秦瑶, 程树军, 等. 牛角膜浑浊渗透试验方法预测眼刺激性的研究[J]. 中国卫生检验杂志, 2014, 24(14):1980-1983. Huang Jiancong, Qin Yao, Cheng Shujun, et al. Eye irritation prediction using bovine corneal opacity and permeability alternative method[J]. Chinese Journal of Health Laboratory Technology, 2014, 24(14):1980-1983.
[5] OECD. OECD new guidance document on an integrated approach on testing and assessment (IATA) for skin corrosion and irritation[S]. Par-is:OECD, 2013.
[6] 瞿小婷, 程树军, 刘超, 等. 国际化学品安全评价动物替代测试法规趋势[J]. 日用化学品科学, 2016, 39(2):11-16. Qu Xiaoting, Cheng Shujun, Liu Chao,et al. Global regulation trend of alternative methods for chemical safety evaluation on animals[J]. Deter-gent & Cosmetics, 2016, 39(2):11-16.
[7] 程树军. 化妆品评价替代方法标准实施指南[M]. 北京:中国标准出版社, 2017:75-207. Cheng Shujun. Guides of alternative methods standards for cosmetics as-sessment[M]. Beijing:China Standards Press, 2017:75-207.
[8] OECD. OECD guideline for testing of chemicals No.437:Bovine corne-al opacity and permeability test method for identifying i) Chemicals in-ducing serious eye damage and ii) Chemicals not requiring classifica-tion for eye irritation or serious eye damage[S]. Paris:OECD, 2013:1-27.
[9] 秦瑶, 程树军, 黄健聪, 等. 整合CAMVA和BCOP方法检测化妆品的眼刺激[J]. 中国比较医学杂志, 2014, 24(6):78-82. Qin Yao, Cheng Shujun, Huang Jiancong, et al. Integrated CAMVA and BCOP methods to predict eye irritation caused by cosmetics[J]. Chinese Comparative Medicine, 2014, 24(6):78-82.
[10] 柯逸晖, 陈彧, 程树军, 等. 直接多肽结合试验组合人细胞系活化试验预测皮肤致敏物的探讨[J]. 中国实验动物学报, 2016, 24(6):611-617. Ke Yihui, Chen Yu, Cheng Shujun, et al. Preliminary study for inte-grating DPRA with h-CLAT to predict skin sensitizers[J]. Acta Labora-torium Animal Sinica, 2016, 24(6):611-617.
[11] National Research Council (NRC). Toxicity Testing in the twenty-first century:A vision and a strategy[R]. Washington, DC:National Acade-my of Sciences, 2007.
[12] 瞿小婷, 程树军, 秦瑶, 等. 有害结局通路指南及毒性测试应用分析[J]. 中国日用化学工业, 2016, 46(8):473-478. Qu Xiaoting, Cheng Shujun, Qin Yao, et al. Adverse outcome pathways guide and toxicity test applications[J]. China Surfactant Detergent & Cosmetics, 2016, 46(8):473-478.
[13] OECD. Guidance document on developing and assessing adverse out-come pathways[S]. Paris:OECD, 2013.
[14] 陈彧, 喻欢, 程树军, 等. 基于有害结局通路原理的皮肤致敏测试替代方法进展[J]. 日用化学品科学, 2016, 39(4):4-9. Chen Yu, Yu Huan, Cheng Shujun, et al. Development of alternative test strategy for the AOP-Based skin sensitization[J]. Detergent & Cos-metics, 2016, 39(4):4-9.
[15] 陈彧, 喻欢, 程树军, 等. 结合组织学评分的牛角膜浑浊和渗透性方法研究[J]. 日用化学工业, 2016, 46(2):107-110. Chen Yu, Yu Huan, Cheng Shujun, et al. Research on bovine corneal opacity and permeability test integrating with histopathological evalua-tion[J]. China Surfactant Detergent & Cosmetics, 2016, 46(2):107-110.
[16] 秦瑶, 柯逸晖, 程树军, 等. 牛角膜浑浊和渗透性实验应用于个人护理产品评价的案例分析[J]. 日用化学品科学, 2017, 40(3):13-18. Qin Yao, Ke Yihui, Cheng Shujun, et al. Case analysis of BCOP in evaluation of personal care products[J]. Detergent & Cosmetics, 2017, 40(3):13-18.
[17] 秦瑶, 柯逸晖, 徐宏景, 等. 鸡胚尿囊膜模型在化妆品毒性和功效评估中的应用[J]. 日用化学品科学, 2016, 39(7):15-18. Qin Yao, Ke Yihui, Xu Hongjing, et al. Application of chicken chorio-allantoic membrane model in toxicity and efficacy assessment of cos-metics[J]. Detergent & Cosmetics, 2016, 39(7):15-18.
[18] Jaworska J S, Natsch A, Ryan C,et al. Bayesian integrated testing strat-egy (ITS) for skin sensitization potency assessment:A decision sup-port system for quantitative weight of evidence and adaptive testing strategy[J]. Arch Toxicol, 2015, 89(12):2355-2383.
[19] Walters R M, Gandolfi L, Mack C M, et al. In vitro assessment of skin irritation potential of surfactant-based formulations by using a 3-D skin reconstructed tissue model and cytokine response[J]. Altern Lab Anim, 2016, 44(6):523-532.
[20] Patlewicz G, Ball N, Booth E D, et al. Use of category approaches, read-across and (Q) SAR:General considerations[J]. Regul Toxicol Pharmacol, 2013, 67(1):1-12.
[21] 程树军, 秦瑶, 喻欢, 等. 胚胎干细胞试验预测胚胎毒性替代方法进展[J]. 中国比较医学杂志, 2016, 26(1):81-85. Cheng Shujun, Qin Yao, Yu Huan, et al. Progress for alternatives methods predict the embrytoxicity by embryonic stem cell test[J]. Chi-nese Comparative Medicine, 2016, 26(1):81-85.
文章导航

/