穿心莲内酯磺化物注射液急性毒性及长期毒性研究  

Acute toxicity and long-term toxicity of andrographolide sulfonate injection

作　　者：陈磊 董可 吴禹熹 余佳欣 杨涵月 殷勤[2] 张敏[2] 李旭廷[2] CHEN Lei;DONG Ke;WU Yuxi;YU Jiaxin;YANG Hanyue;YIN Qin;ZHANG Min;LI Xuting(Sichuan Yuqiang Herbal Biotechnology Co.,Ltd.,Chengdu Sichuan 611135,China;Sichuan Academy of Animal Husbandry Sciences,Chengdu Sichuan 611135,China)

机构地区：[1]四川育强本草生物技术有限公司,四川成都611135 [2]四川省畜牧科学研究院,四川成都611135

出　　处：《中兽医医药杂志》2024年第6期64-69,F0003,F0002,共8页Journal of Traditional Chinese Veterinary Medicine

基　　金：国家现代农业产业技术体系四川省兽药创新团队项目(SCCXTD-2020-18);四川省“十四五”川猪重大科技专项子课题(2021ZDZX0010-2)。

摘　　要：观察穿心莲内酯磺化物注射液的急性毒性及长期毒性反应,为临床安全用药提供参考。急性毒性试验选取40只SPF级昆明(KM)小鼠,雌雄各半,随机分为4组,每组10只,分别以5000 mg/kg、3968 mg/kg、3150 mg/kg、2500 mg/kg的剂量给药,每天2次,给药时间间隔2.5 h,末次给药完毕后,第2天起,连续7 d观察小鼠急性毒性反应。长期毒性试验选取80只SD大鼠,随机分为空白对照组及穿心莲内酯磺化物低剂量组、中剂量组、高剂量组,3个剂量组分别以LD50的1/10、1/50、1/100剂量对大鼠进行灌胃给药,连续给药30 d,各组大鼠自由采食、饮水,观察大鼠对穿心莲内酯磺化物长期毒性反应。结果显示,除死亡小鼠病理学检查出现部分异常,急性毒性试验各组小鼠多个脏器病理学检查无明显异常;与空白对照组相比,长期毒性试验各试验组大鼠体质量、采食量均正常,病理检查未见与药物毒性相关的主要脏器组织形态学改变。穿心莲内酯磺化物对小鼠半数致死量为4454.20 mg/kg,95%可信区间为4157.19~4773.09 mg/kg,急性毒性显示低毒,无长期毒性,临床治疗用药拥有较大的安全剂量。The purpose was to study the acute toxicity and long-term toxicity of andrographolide sulfonate injection,so as to provide reference for clinical safe medication.In the acute toxicity test,40 SPF Kunming(KM)mice,half male and half female,were randomly divided into four groups with 10 in each group.They were administered at doses of 5000 mg/kg,3968 mg/kg,3150 mg/kg,and 2500 mg/kg,respectively,twice daily,with an interval of 2.5 h.After the last administration,the acute toxicity in mice was observed for continuous 7 days.In the long-term toxicity test,80 SD rats were randomly divided into blank group and low,medium and high dose groups of andrographolide sulfonate.The rats were given intragastric administration with 1/10,1/50,1/100 doses of LD50 for 30 days.The rats in each group were free to feed and drink water to observe the long-term toxicity of andrographolide sulfonate.In the acute toxicity test,except for some abnormalities in the pathological examination of dead mice,there were no obvious abnormalities in the pathological examination of multiple organs in the remaining non-dead mice.Compared with the blank group,the body weight and feed intake of rats in each experimental group were normal in the long-term toxicity test.It is concluded that the median lethal dose LD50 of andrographolide sulfonate is 4454.20 mg/kg,and the 95%confidence interval is 4157.19-4773.09 mg/kg.It showed low acute toxicity,no long-term toxicity,and a large safe dose in clinical treatment.

关 键 词：穿心莲内酯磺化物 急性毒性 长期毒性 

分 类 号：S853.7[农业科学—临床兽医学]