甘蓝强骨片急性毒性和长期毒性试验  

Study on acute and long-term toxicity of Ganlanqianggu Tablets

作　　者：周泽璇 张婷 梁国栋 刘卫东 肖云峰[3] ZHOU Zexuan;ZHANG Ting;LIANG Guodong;LIU Weidong;XIAO Yunfeng(Inner Mongolia Datang Medicine Co.,Ltd.,Huhhot 010010,China;Inner Mongolia Enterprise Key Laboratory of Innovative Mongolian Medicine Research,Huhhot 010010,China;The Center for New Drug Safety Evaluation and Research of Inner Mongolia Medical University,Huhhot 010110,China)

机构地区：[1]内蒙古大唐药业股份有限公司,内蒙古自治区呼和浩特010010 [2]内蒙古自治区蒙药新药研发企业重点实验室,内蒙古自治区呼和浩特010010 [3]内蒙古医科大学新药安全评价研究中心,内蒙古自治区呼和浩特010010

出　　处：《药学研究》2022年第2期83-87,121,共6页Journal of Pharmaceutical Research

基　　金：内蒙古重大专项:蒙医药现代化关键技术研究及蒙药产业化。

摘　　要：目的研究甘蓝强骨片对小鼠单次给药以及对大鼠重复给药的毒性试验,为临床安全用药提供依据。方法采用单次给予小鼠最大剂量的甘蓝强骨片33.86 g·(kg·d)^(-1),给药后观察14 d动物的一般临床症状、体重、摄食量、饮水量和剖检进行大体病理学检查。采用大鼠进行重复给药毒性试验研究,80只动物分为甘蓝强骨片22.50、11.25、0.45 g·(kg·d)^(-1)和羧甲基纤维素钠溶剂对照4组,每天灌胃给药,连续30 d,每天观察记录动物反应,每周测定体重及进食量。给药30 d结束后,测定血液学指标、血液生化学指标、观察主要脏器的组织病变情况、计算脏器系数及组织病理学检查。结果小鼠单次给药33.86 g·kg^(-1),给药后动物自主活动、摄食量略有减少,进行大体病理学检查,肉眼观察组织、器官未发现异常或病变。甘蓝强骨片22.50、11.25、0.45 g·(kg·d)^(-1)重复给药30 d,与溶剂对照组比较,大鼠体重、摄食量,大体病理学检查、肉眼观察组织、器官均无明显异常。结论在试验条件下,甘蓝强骨片灌胃给药小鼠最大给药剂量为33.86 g·kg^(-1),灌胃给药大鼠无毒反应剂量为22.50 g·(kg·d)^(-1)。Objective To study the toxicity test of Ganlanqianggu Tablets for single administration in mice and repeated administration in rats,and provide the basis for clinical safe drug use.Methods The maximum dose of Ganlanqianggu Tablets were given to mice once 33.86 g·(kg·d)^(-1).The general clinical symptoms,body weight,food intake,water intake and necropsy of the animals were observed 14 days after administration for gross pathological examination.The toxicity test of repeated administration was carried out in rats.Eighty animals were divided into four groups:Ganlanqianggu Tablets 22.50,11.25,0.45 g·(kg·d)^(-1)and sodium carboxymethyl cellulose control group.The animals were intragastric administrated daily for consecutive 30 days,and their reactions were observed and recorded daily.After 30 days of administration,hematology indexes and blood biochemistry indexes were determined,pathological changes of main organs were observed,organ coefficients were calculated and histopathological examinations were performed.Results Mice were given 33.86 g·kg^(-1)in a single dose,and the animals′autonomous activity and food intake were slightly reduced after administration.Gross pathological examination was conducted,and no abnormal or pathological changes were found in tissues and organs by gross observation.After repeated administration of Ganlanqianggu Tablets at 22.50,11.25 and 0.45 g·(kg·d)^(-1)for 30 days,compared with the solvent control group,there was no obvious abnormality in body weight,food intake,gross pathology examination,gross observation of tissues and organs of rats.Conclusion Under experimental conditions,the maximum dose of Ganlanqianggu Tablets to fill the stomach was 33.86 g·kg^(-1)in mice,and the non-toxic reaction dose to fill the stomach was 22.50 g·(kg·d)^(-1)in rats.

关 键 词：甘蓝强骨片 单次给药 小鼠 重复给药 大鼠 

分 类 号：R285.5[医药卫生—中药学]