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宫净灌注剂急性毒性和长期毒性试验研究
引用本文:吕安,张志聪,宫平,张彤,刘艺林,姜晓茜,李德琰,刘凤华.宫净灌注剂急性毒性和长期毒性试验研究[J].中国畜牧兽医,2016,43(8):2143-2149.
作者姓名:吕安  张志聪  宫平  张彤  刘艺林  姜晓茜  李德琰  刘凤华
作者单位:北京农学院动物科学技术学院, 北京 102206
基金项目:国家“十二五”科技支撑计划重点项目(2011BAD34B01)
摘    要:试验旨在观察宫净灌注剂对小鼠急性毒性和大鼠长期毒性作用,评价其安全性,为临床用药提供理论依据。急性毒性试验选取昆明小鼠,以1次最大剂量灌胃宫净灌注剂,测定宫净灌注剂的急性毒性和最大耐受量(maximal tolerance dose, MTD)。长期毒性试验选取80只SD大鼠,分为低、中、高宫净灌注剂组(2.5、5.0、10.0 g/(kg·d))和对照组(给予等体积的蒸馏水),灌胃给药,连续30 d。给药期间每天观察大鼠一般状态、体征、饮食情况及粪便形状,每周称取1次体重并计算进食量。给药30 d后,心脏取血处死动物,检测血液学、血液生化学指标并做病理组织学检查。结果显示小鼠全部存活,未测得LD50,最大耐受量为40 g/kg。在长期毒性试验中,宫净灌注剂低、中、高剂量组与对照组相比,除个别指标外,其余各项指标差异均无统计学意义(P>0.05),未见与药物作用有关的病理变化。由此可见,在本试验条件下,宫净灌注剂对受试动物无明显的急性毒性和长期毒性作用,提示该药临床用药安全无毒。

关 键 词:宫净灌注剂  急性毒性  长期毒性  安全性  
收稿时间:2016-01-13

Experimental Study on Acuet Toxicity and Long-term Toxicity of Gongjing Perfusion
LV An,ZHANG Zhi-cong,GONG Ping,ZHANG Tong,LIU Yi-lin,JIANG Xiao-qian,LI De-yan,LIU Feng-hua.Experimental Study on Acuet Toxicity and Long-term Toxicity of Gongjing Perfusion[J].China Animal Husbandry & Veterinary Medicine,2016,43(8):2143-2149.
Authors:LV An  ZHANG Zhi-cong  GONG Ping  ZHANG Tong  LIU Yi-lin  JIANG Xiao-qian  LI De-yan  LIU Feng-hua
Institution:College of Animal Science and Technology, Beijing University of Agriculture, Beijing 102206, China
Abstract:The purpose of this paper was to study the acute toxicity in mice and long-term toxicity in rats of Gongjing perfusion to evaluate the clinical safety of medication and provide theoretical basis for clinical application.In the acute toxicity experiment,mice were given once the approximate lethal dose of Gongjing perfusion to measure the acute toxicity and the maximal tolerance dose (MTD).In the long-term toxicity observation,80 rats were divided into four groups:low-dose,middle-dose,high-dose test groups of Gongjing perfusion (2.5,5.0,10.0 g/(kg·d)) and control group with distilled water intragastric administration for 30 days.During the experimental period,the appearance,behavior and feces condition of rats were observed and recorded.Each rat was weighted every week,and the average daily gain were calculated.After 30 days,rats were executed and taken blood in their hearts,hematology and blood chemistry were detected.The results showed that the mice were all survived and LD50 was not measured,the MTD was 40 g/kg.In the long-term toxicity test,compared with the control group,there were no significant difference in various index except individual index and the pathological examination revealed that no obvious pathological changes related to drug toxicity.So Gongjing perfusion had not long-term toxicity and acute toxicity under this experiment condition,which suggested Gongjing perfusion had a good clinical safety.
Keywords:Gongjing perfusion  acute toxicity  long-term toxicity  safety  
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