参知健脑胶囊单次灌胃给予小鼠的毒性试验  

Acute toxicological study of Shenzhi Jiannao Capsule by a single oral gavage on mice

作　　者：舒忻[1] 马大勇[2] 林彬[1] 韩振蕴[1] 

机构地区：[1]北京中医药大学东方医院脑病科,北京100078 [2]北京中医药大学东直门医院脑病科,北京100700

出　　处：《中国医药导报》2012年第12期135-137,共3页China Medical Herald

基　　金：国家科技重大专项"重大新药创制"项目(项目编号:2009ZX09103-401)

摘　　要：目的观察单次灌胃给予参知健脑胶囊供试品后动物所产生的毒性反应,为临床前反复给药的毒性研究和临床研究提供动物试验参考资料。方法试验用4～5周龄昆明小鼠40只,随机分为两组,分别为灭菌注射用水阴性对照组和供试品组,每组20只动物,雌雄各半。给药途径为灌胃给药,给药容量为25 mL/kg,给药频率为单次给药。供试品组给药剂量为5 000 mg/kg,对照组给予等容量的灭菌注射用水。给药后进行临床观察,观察期为14 d;给药后每周测定动物体重和食量;观察期结束后,将动物安乐死,进行大体解剖观察。结果试验期间没有发现动物死亡和濒死,所有动物的临床观察均未见异常反应。与同期同性别对照组相比,各检测时间点动物体重、食量未见明显差异。所有动物大体解剖均未见异常变化。结论在本试验条件下,参知健脑胶囊单次灌胃给予昆明小鼠,在5 000 mg/kg的剂量下,未见毒性反应。按体重计算,此剂量相当于临床拟用剂量的286倍。Objective To observe the acute toxicity reaction of mice after poured Shenzhi Jiannao Capsule into their stomachs,which might provide reference for toxicity study of dosing repeatedly before clinical research and clinical research.Methods Forty Kunming mice which were four to five week-old were divided randomly into two groups,including sterile water for injection with negative control group and tests administration group,each group had 20 animals,the male and female were in half.The drug administration was oral gavage.The administrated drug volumes were 25 mL/kg and the frequency was a single administration.The dosages of the administration group was 5 000 mg/kg,and the control group were given sterile water of equal volume.There was a 14-day clinical observation after dose,and among that period,the animals′weight and appetite were observed.After clinical observation,all the mice were euthanized,and observed for the gross anatomy.Results In the period of test,there wasn′t animal death or articulo mortis found;there wasn′t abnormal clinical reaction found in all of animals.The control group in same sex and same period were compared,there was no obvious difference at each test time of their weight and appetite.There was no change abnormal found in the gross anatomy of all the animals.Conclusion In this experimental condition,there is no toxic reaction at the dose of single gavage of Shenzhi Jiannao Capsule for Kunming mice under 5 000 mg/kg.According to the calculation of weight,this dose is equivalent 286 times of clinical dose.

关 键 词：参知健脑胶囊 小鼠 单次灌胃 急性毒理 

分 类 号：R977[医药卫生—药品]