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作 者:齐卫红[1] 程金伟 王金照 卢难看 王书元[1] 修中飞 王超[1] 霍艳[1] 李芊芊[1] QI Weihong;CHENG Jinwei;WANG Jinzhao;LU Nankan;WANG Shuyuan;XIU Zhongfei;WANG Chao;HUO Yan;LI Qianqian(National Center for Safety Evaluation of Drugs, National Institutes for Food and Drug Control, Key Laboratory of Beifing for Nonelinical Safety Evaluation of Drug, Beifing 100176, China;Xieerxin biological resources research institute of Beifing , Belting 102434, China)
机构地区:[1]中国食品药品检定研究院安全评价研究所,药物非临床安全性评价研究北京重点实验室,北京100176 [2]北京协尔鑫生物资源研究所有限责任公司,北京102434
出 处:《实验动物科学》2018年第1期64-66,71,共4页Laboratory Animal Science
基 金:科技部“十三五”重大新药创制2015年定向择优课题(No.2015ZX09501007-004)
摘 要:GLP(Good Laboratory Practivel)条件下开展药物安全性评价,必须符合AAALAC动物福利要求,所以研究过程中,兽医对动物身体状况的判断,以及对动物疾病的救治都是非常重要的。开展降糖药的研究,可能引起动物脑部损伤致使实验失败,同时动物应有福利得不到保障。本实验主要开展某种胰岛素类降糖药(供试品A)长期毒性研究,采用Beagle犬作为实验动物,每天皮下给予供试品A,连续给药4周,每天进行血糖监测及症状观察,实验过程中,发现Beagle犬出现不同症状的低血糖现象,兽医根据动物出现不同症状给予一定措施,确保了本次实验的完成,同时确保动物得到了应有的福利。GLP conditions to carry out the safety evaluation of drugs must conform to the requirements of the AAALAC animal welfare, so the research process, the veterinary judgment for animal health, as well as to the treatment of animal diseases are very important. Diabetes may cause animal's brain damage that result in the experiment fails and animal welfare doesn't be guaranteed. This experiment is mainly to observe the long-term toxicity research of insulin Amaryl class (A). Using the Beagle dogs as experimental animals, the A was administered subcutaneously every day for 4 weeks, and blood glucose and symptoms were monitored every day. In the course of study, Beagle dogs showed different symptoms of low blood sugar, and veterinary treatment was offered according to the different symptoms to ensure the completion of this experiment and at the same time to ensure the welfare of animals
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