三乌胶丸对SD大鼠6个月经口给药的毒性研究  

Study on the toxicity of Sanwu capsules in SD rats after 6 months of oral administration

作　　者：陈琼芳 胡灿 唐海亮 张宗利 周利琴 CHEN Qiongfang;HU Can;TANG Hailiang;ZHANG Zongli;ZHOU Liqin(Hunan Key Laboratory of Efficacy and Safety Evaluation of New Drugs,Hunan Research Center for Drug Safety Assessment,Changsha 410329,China;Yunnan Jinyu Heiyao Pharmaceutical Co.,Ltd.,Qujing 654200,China)

机构地区：[1]湖南省药物安全评价研究中心,新药药效与安全评价湖南省重点实验室,长沙410329 [2]云南金乌黑药制药有限公司,云南曲靖654200

出　　处：《吉林中医药》2023年第11期1327-1332,共6页Jilin Journal of Chinese Medicine

基　　金：云南省重大科技专项计划(202002AA100004)。

摘　　要：目的观察连续6个月经口灌胃给予不同剂量三乌胶丸(SWC)对SD大鼠的毒性反应。方法选用检疫合格的SPF级SD大鼠120只,雌雄各半,随机分为空白组(未加药)、三乌胶丸低剂量组(6.251 g/kg)、三乌胶丸中剂量组(12.458 g/kg)及三乌胶丸高剂量组(24.915 g/kg),每组30只,按15 mL/kg体积灌胃给药,每天1次,连续6个月(26周)。于给药末期(第26周末)及恢复期末(第30周末)每组分别解剖20只、10只SD大鼠,雌雄各半,检查大鼠一般情况、体质量、摄食量、血液学、血液生化学、脏器系数及组织病理学变化。结果三乌胶丸低、中、高剂量组未引起大鼠一般状态、体质量、摄食量及组织病理学异常改变。三乌胶丸低、中、高剂量组大鼠血液学、血液生化学及脏器系数等部分指标与空白组比较有差异,但并无毒理学意义。结论SD大鼠经口灌胃给予三乌胶丸6个月,对大鼠体质量、摄食量、血液学、血液生化学、脏器系数以及组织病理学等无明显毒性反应。Objective To observe the toxic effects of different doses of Sanwu capsules administered by oral gavage to SD rats for 6 consecutive months.Methods One hundred and twenty quarantine-free SPF SD rats,half male and half female,were randomly divided into a blank group(no drug),a SWC low-dose group(6.251 g crude drug/kg),a SWC medium-dose group(12.458 g crude drug/kg)and a SWC high-dose group(24.915 g crude drug/kg),with 30 rats in each group.The drug was administered by gavage at the volume of 15 mL/kg once a day for 6 months(26 weeks).At the end of administration(26 weeks)and the end of recovery(30 weeks),20 and 10 SD rats in each group were dissected,half male and half female,respectively.The general condition,body weight,food intake,hematology,blood biochemistry,organ coeficient and histopathological changes of the rats were examined.Results There were no abnormal changes in the general state,body mass,food intake and histopathology in rats of the low-,mediumand high-dose groups of Sanwu capsules.There were differences in some indicators such as hematology,blood biochemistry,and organ coefficient in rats between the low-,medium-and high-dose groups of Sanwu capsules and the blank group,but there was no toxicological significance.Conclusion Oral administration of SWC to SD rats for 6 months shows no significant toxic effects on their body weight,food intake,hematology,blood biochemistry,organ coefficient,and histopathology.

关 键 词：三乌胶丸 毒性 大鼠 血液学 血液生化学 脏器系数 组织病理学 

分 类 号：R965.3[医药卫生—药理学]