养阴益气胶囊长期毒性实验  

Long-term Toxicity of Yangyin Yiqi Capsule

作　　者：唐颖馨 姚达宝 聂璐薇 刘娜[1] TANG Yingxin;YAO Dabao;NIE Luwei;LIU Na(Department of Neurology,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,China)

机构地区：[1]华中科技大学同济医学院附属同济医院神经内科,武汉430030

出　　处：《医药导报》2023年第10期1442-1446,共5页Herald of Medicine

摘　　要：目的 评价养阴益气胶囊对大鼠灌胃给药6个月的长期毒性情况。方法 90只SD大鼠随机分为3组:养阴益气胶囊大剂量组(每日灌胃给药剂量相当于生药20 g·kg^(-1))、养阴益气胶囊小剂量组(每日灌胃给药剂量相当于生药5 g·kg^(-1))和空白对照组(每日灌胃等容量纯化水),灌胃容量均为5 mL·kg^(-1),给药时间均为180 d。观察指标为大鼠外观体征、进食、行为活动、排便、体质量、血液学及血生化指标,以及病理检查。停药后继续进行可逆性观察2周。结果 小剂量组和大剂量组大鼠体质量增加,但稍低于空白对照组(P>0.05);两组大鼠血液学指标均在正常范围内,与空白对照组之间差异无统计学意义(P>0.05);大剂量组血尿素氮高于空白对照组(P<0.05),但仍在正常范围内,其余血生化指标各组间差异无统计学意义(P>0.05)。各组动物系统尸解、组织病理学检查及可逆性观察均未见异常,脏器系数及生殖腺系数组间差异均无统计学意义(P>0.05)。结论 养阴益气胶囊给大鼠灌胃给药6个月的安全剂量为相当于生药20 g·kg^(-1),相当于临床用药剂量的60倍。Objective To evaluate the long-term toxicity of Yangyin Yiqi capsule on rats administered by gavage for six months.Methods Ninety SD rats were randomly divided into three groups:high dose group of Yangyin Yiqi capsule(daily gavage dosage of crude drug of 20 g·kg^(-1)),low dose group of Yangyin Yiqi capsule(daily gavage dosage of crude drug of 5 g·kg^(-1)),and blank control group(daily gavage of equal volume of distilled water).All animals were administered by gavage with volume of 5 mL·kg^(-1) and lasted 180 days.The appearance,feeding,physical signs,behavioral activities,bowel movements,weight,hematological and biochemical indicators,and pathological examination of rats were observed and detected.Reversible observation for 2 weeks was conducted after drug withdrawal.Results The weight gain of two experimental groups of rats was slightly lower than that of the blank control group,but there was no statistically significant difference among all groups(P>0.05).The hematological indicators of two experimental groups were all within the normal range,and there were no statistically significant difference compared to the blank control group(P>0.05).Blood urea nitrogen of high-dose group was higher than that in blank control group(P<0.05),but was still within the normal range.There were no statistical significance in other blood biochemical indexes among all groups(P>0.05).No abnormality was found in system autopsy,histopathological examination and reversible observation of animals in each group.There were no statistically significant difference in organ coefficient and gonadal coefficient among all groups(P>0.05).Conclusion The safe dose of Yangyin Yiqi capsule administered by gavage to rats for six months is 20 g·kg^(-1)(crude drug),which is equivalent to 60 times of the clinical dosage.

关 键 词：养阴益气胶囊 脑卒中 糖尿病 灌胃给药 长期毒性 

分 类 号：R965[医药卫生—药理学]