小叶榕干浸膏小鼠单次给药毒性的安全性研究  

Single dose toxicity of Ficus microcarpa in mice

作　　者：高展旺 张昕 莫尊汇 王羚郦[1] 易智彪 GAO Zhanwang;ZHANG Xin;MO Zunhui;WANG Lingli;YI Zhibiao(School of Pharmaceutical Sciences,Guangzhou University of Chinese Medicine,Guangzhou Guangdong 510006,China;Mathematical Engineering Academy of Chinese Medicine,Guangzhou University of Chinese Medicine,Dongguan Guangdong 523808,China)

机构地区：[1]广州中医药大学中药学院,广东广州510006 [2]广州中医药大学中医药数理工程研究院,广东东莞523808

出　　处：《中国药物警戒》2022年第3期265-269,274,共6页Chinese Journal of Pharmacovigilance

基　　金：广东省科技厅产学研合作项目(2014B09090-2002);广东省中医药建设专项资金项目(20174003)。

摘　　要：目的通过考察经小叶榕干浸膏给药后,小鼠单次给药毒性的病理学、血液学及生化指标的变化,确定小叶榕干浸膏的半数致死量(LD_(50))或最大耐受量(MTD),以评价小叶榕干浸膏的安全性。方法LD_(50)实验将小鼠随机分为6组,分别以不同剂量进行灌胃给药,观察7 d后小鼠的一般情况和肉眼观察脏器形态学变化;MTD实验将小鼠按体重随机分为3组,分别以不同药物、不同剂量进行3次灌胃给药。观察统计14 d内小鼠的毒性反应、病理学变化、血液学及生化指标的变化。结果LD_(50)实验无小鼠死亡情况,无法确定小叶榕干浸膏的LD_(50)值;MTD实验结果按生药量计算为70.40 g·kg^(-1);经观察,各组小鼠头颈部及体表等处均正常,各个脏器未见颜色加深的病变或明显损伤,器官的组织细胞未见炎症细胞浸润、结构异常扩张或收缩改变等病理反应,且未见与药物相关的异常变化,血液学指标及生化指标与空白组相比均未见统计学差异(P>0.05),未见小叶榕干浸膏引起明显的单次给药毒性反应和死亡情况。结论小叶榕干浸膏具有良好的安全性。Objective To study the changes of indexes of pathology,hematology and biochemistry under single-dose toxicity in mice treated with a median lethal dose(LD_(50))or maximum tolerance dose(MTD)of Ficus microcarpa so as to evaluate the safety of Ficus microcarpa.Methods In LD_(50) tests,the mice were randomly divided into 6 groups and given by gavage different doses of Ficus microcarpa.The general condition of mice and the morphological changes of viscera were observed after 7 days.In MTD experiments,the mice were randomly divided into 3 groups and given three times by gavage different drugs at different doses.The changes in toxic reactions and in hematological and biochemical indexes were observed and recorded within 14 days.Results There was no death of mice in LD_(50) tests,suggesting that LD_(50) could not be calculated.The MTD was calculated as 70.4 g·kg^(-1) by the crude dose.In addition,histopathological observations revealed that the organs of mice in each group did not exhibit pathological reactions.And compared with the blank control group and the equivalent dose group,there was no statistical difference in hematological or biochemical index in the maximum tolerance dose group(P>0.05),and no obvious acute toxic reactions or death caused by Ficus microcarpa were observed.Conclusion Ficus microcarpa is quite safe.

关 键 词：小叶榕干浸膏 单次给药毒性 最大耐受量 组织病理学 

分 类 号：R994.1[医药卫生—毒理学]