补肾强筋胶囊的体内安全性评价

In vivo safety evaluation of bushen qiangjin capsules

目的通过动物实验评估中药复方制剂补肾强筋胶囊(BSQJ)的体内安全性,为临床安全用药提供科学和理论依据。方法将40只SPF级SD大鼠按照随机数字表法随机分为Control组和BSQJ组,每组各20只,雌雄各半。BSQJ组按大鼠能耐受的最大给药体积40 mL/(kg·d)为给药标准,1 d内灌胃3次,给药量相当于临床成人用药剂量的20倍,即为32 g/(kg·d)。Control组予灌胃等量0.9%氯化钠溶液。连续灌胃14 d,观察各组大鼠给药前后的急性毒性反应、体重、血常规、生化、溶血实验检测和主要脏器病理组织学表现。结果与Control组相比,BSQJ组雄性大鼠和雌性大鼠给药前后:无死亡现象以及毒性反应;体质量差异无统计学意义(P>0.05);血常规各项指标(WBC、NEUT、NEUT、LY、RBC、Hb、PLT)差异无统计学意义(P>0.05);血生化各项指标(TP、ALT、AST、ALP、Glu、BUN、Scr、UA)差异无统计学意义(P>0.05);未出现溶血现象;心、肝、脾、肺、肾等主要内脏组织进行组织学检查未见异常。结论大剂量补肾强筋胶囊未对大鼠产生急性毒性反应,不影响大鼠血常规、肝肾功能,不发生溶血现象,对主要脏器组织未产生病理性损伤,具有良好的体内安全性。

Objective To evaluate the in vivo safety of Bushen Qiangjin capsule(BSQJ)through animal experiments,in order to provide scientific and theoretical basis for clinical application.Methods Forty SPF SD rats were randomly divided into Control group and BSQJ group according to the random number table method,with 20 rats in each group,half male and half male.In BSQJ group,the maximum drug volume that the rats could tolerate was 40 mL/(kg·d)as the drug standard,and it was gavaged three times per day,and the drug dose was equivalent to 20 times the clinical adult drug dose,which was 32 g/(kg·d).The control group was given an equivalent amount of 0.9% sodium chloride solution by intragastric administration.After continuous gavage for 14 days,the acute toxic reaction,body weight,blood routine,biochemical and hemolytic tests,and histopathological changes of the main organs were evaulated before and after administration.Results Compared with control group,the male and female rats in BSQJ group had no mortality and toxicity(P>0.05);had no difference in body weight(P>0.05);There were no significant differences in blood routine test(WBC,NEUT,NEUT,LY,RBC,HB and PLT)(P>0.05),and biochemical and hemolytic test(TP,ALT,AST,ALP,Glu,Bun,SCR and UA)(P>0.05).No hemolysis or abnormality was found in heart,liver,spleen,lung and kidney.Conclusion Large dose of Bushen Qiangjin capsule had no acute toxic reaction to rats,without affecting blood routine,liver and kidney function,did not produce hemolysis,and caused no pathological damage to the main organs and tissues,which was safe in vivo.