竺黄醒脑胶囊的急性和长期毒性动物实验研究  

Experimental Study on Acute and Long-term Toxicity of Zhuhuang Xingnao Capsules in Animals

作　　者：闫国强[1] 李宝芬[1] 董晶晶[1] 张俊艳 张倩[1] 金颖慧 YAN Guo-qiang;LI Bao-fen;DONG Jing-jing;ZHANG Jun-yan;ZHANG Qian;JIN Ying-hui(Department of Pharmaceutical Affairs for Traditional Chinese Medicine,Cangzhou Hospital of Integrated Traditional and Western Medicine,Cangzhou,Hebei 061001,China)

机构地区：[1]沧州中西医结合医院中药药事科,河北沧州061001

出　　处：《解放军医药杂志》2017年第12期76-80,共5页Medical & Pharmaceutical Journal of Chinese People’s Liberation Army

基　　金：河北省卫生和计划生育委员会重点科技研究计划(20150540)

摘　　要：目的对竺黄醒脑胶囊进行急性和长期毒性实验研究,为临床安全用药提供依据。方法以昆明种小鼠40只和Wistar大鼠80只为研究对象。急性毒性实验将40小鼠随机分为对照组和给药组,每组20只。给药组给予竺黄醒脑胶囊灌胃,剂量为20.0 g/kg;对照组给予等容量纯净水。两组均给药前、给药第7和14天观察小鼠的一般状态、体重和进食量。长期毒性实验将80只大鼠随机分高、中、低剂量组(竺黄醒脑胶囊灌胃剂量分别为5.0 g/kg、2.5 g/kg、1.25 g/kg)和对照组,每组20只。对照组给予等容量纯净水。连续给药13周处死并检测10只大鼠,剩余10只大鼠停药2周后处死并检测,观察各组大鼠的一般状况、体重、摄食量,检测血液学、血液生化学、脏器系数和病理组织学变化。结果小鼠急性毒性实验显示,受试动物无一死亡,未发现明显毒性反应。大鼠长期毒性实验显示,各剂量组个别血液学检测指标较对照组有所差异,但均在正常生理范围内,无明显毒性反应。各剂量组未见由药物中毒所导致的脏器组织病理形态学改变。结论竺黄醒脑胶囊灌胃给药对小鼠和大鼠均未见明显的毒性反应。Objective To study acute and long-term toxicity of Zhuhuang Xingnao Capsules in order to evaluate clinical safety.Methods A total of40healthy Kunming species mice and80Wistar rats were recruited in this study.The40mice were randomly divided into dose group(n=20)and control group(n=20)for acute toxicity experiment,and dose group was lavaged with Zhuhuang Xingnao Capsules(20.0g/kg),while control group was lavaged with same volume of purified water.General conditions,body weight and food intake were observed before administration and at the7th d and14th d of administration.The80Wistar rats were randomly divided into large(5.0g/kg),medium(2.5g/kg),small(1.25g/kg)dosages groups by Zhuhuang Xingnao Capsules intragastric administration and control group(n=20for each group)for long-term toxicity experiment,while control group was lavaged with same volume of purified water.After continous13weeks administration,in each group,10rats were sacrificed firstly,and then other10rats were sacrificed in2weeks after stopping administration for detection.General conditions,body weight and food intake were observed,and hematological,blood biochemistry and organ indexes and histopathological changes were detected.Results Acute toxicity experiment showed that none of death mice and obviously toxic reaction were found.Long-term toxicity experiment showed that there were differences in some hematological indexes between each dosages group and control group,but the differences were in the normal range without obviously toxic reaction.No histopathological lesions of organs induced by drug were observed in dosages groups.Conclusion Zhuhuang Xingnao Capsules show no obvious toxicity by intragastric administration.

关 键 词：竺黄醒脑胶囊 毒性试验 急性 毒性试验 慢性 小鼠 大鼠 WISTAR 

分 类 号：R994.1[医药卫生—毒理学] R-332[医药卫生—药学]