健脑丸对大鼠的重复给药毒性试验研究  

Study on toxicity test of repeated administration of Jiannao Pills in rats

作　　者：张力涵 潘嘉[2] 何甜甜 刘洁[2] 黄吉 ZHANG Li-han;PAN Jia;HE Tian-tian;LIU Jie;HUANG Ji(School of Clinical Medicine,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan;Institute of Traditional Chinese Medicine Pharmacology and Toxicology,Sichuan Academy of Traditional Chinese Medicine,Chengdu 610041,Sichuan;School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,Sichuan)

机构地区：[1]成都中医药大学临床医学院,四川成都611137 [2]四川省中医药科学院中药药理毒理研究所,四川成都610041 [3]成都中医药大学药学院,四川成都611137

出　　处：《中药与临床》2023年第1期42-46,共5页Pharmacy and Clinics of Chinese Materia Medica

基　　金：四川省省级科研院所基本科研业务专项(A-2021N-20);四川省中医药管理局中医药基础研究项目(2021MS449)。

摘　　要：目的:考察健脑丸重复给药对大鼠的毒性反应及恢复情况,评价药物安全性,为临床用药提供依据。方法:30只大鼠随机分为给药组和空白对照组,每组15只,雌雄各半,给药组每日以健脑丸临床剂量的50倍(2 mL/100 g,1.875 g·kg^(-1))灌胃1次,对照组每日以蒸馏水(2 mL/100g)灌胃1次,每周6天,连续26周。停药后每组处死2/3大鼠,分别观察各项指标及基本情况;剩余大鼠继续喂养4周后取材,并观察停药后动物各项指标及基本情况。结果:连续给药26周以及停药恢复4周各组大鼠的外观、行为活动等一般生命体征状况良好,极少数检测指标有统计学上的差异;两组病理检测个别大鼠个别脏器有轻微病变,但各组之间无明显差异,以上变化可能均为大鼠的自发病变,与药物无关。结论:健脑丸以相当于临床剂量的50倍对SD大鼠灌胃给药26周及停药恢复4周,均未出现明显的毒性反应,故该药物重复给药安全性良好。Objective:To investigate the toxicity and recovery in rats with repeated administration of Jiannao Pills and evaluate the drug safety,so as to provide a basis for its clinical medication.Method:Thirty rats were randomly divided into the administration group and the blank control group,with 15 rats in each group consisting of half male and half female.The administration group was given 50 times of the clinical dose of Jiannao Pills(2 mL·100 g^(-1),1.875 g·kg^(-1))by gavage once a day,and the control group was given distilled water(2 mL·100g^(-1))by gavage once a day,6 times a week,for 26 weeks.After drug withdrawal,two thirds of the rats in each group were sacrificed to observe the indexes and basic conditions.The remaining rats were sacrificed after continued feeding for 4 weeks to observe the indexes and basic conditions after drug withdrawal.Result:The appearance,behavior and other general vital signs of the rats with continuous administration for 26 weeks and with subsequent recovery for 4 weeks after withdrawal were all good,and only a few indexes were statistically different.The pathological examination of the two groups showed that there were slight pathological changes in some organs of some rats,but there was no significant difference between the two groups,which may be spontaneous pathological changes in rats and not related to the drugs.Conclusion:There is no obvious toxicity in SD rats with intragastric administration of Jiannao Pills with 50 times of the clinical dose for 26 weeks and with subsequent recovery for 4 weeks after withdrawal.Therefore,repeated administration of the drug is safe.

关 键 词：健脑丸 大鼠 重复给药毒性试验 

分 类 号：R285.5[医药卫生—中药学]