肾康灵胶囊的急性毒性和亚急性毒性实验研究  

Experimental Study on the Acute and Subacute Toxicity of Shenkangling Capsule

作　　者：洪海棉 肖淋[1] 吴梅玲 吴梅花[1] 陈成辉[1] 肖钦[1] HONG Haimian;XIAO Lin;WU Meiling;WU Meihua;CHEN Chenghui;XIAO Qin(Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine,Fuzhou,Fujian 350004,China)

机构地区：[1]福建中医药大学附属人民医院,福建福州350004

出　　处：《福建中医药》2024年第6期21-24,39,共5页Fujian Journal of Traditional Chinese Medicine

基　　金：福建省科技厅引导性课题(2021Y0033)。

摘　　要：目的通过肾康灵胶囊对小鼠和大鼠进行急性和亚急性毒性研究,初步评价肾康灵胶囊的安全性,为其临床安全用药提供必要的毒理学依据。方法急性毒性实验选用8周龄的SPF级昆明种小鼠20只,采用最大耐受剂量法,即一次性灌胃127.6 g/kg肾康灵胶囊后,连续观察14 d,记录中毒表现、死亡情况、心、肝、肾、胃、十二指肠等器官组织病理变化。亚急性毒性实验选用8周龄的SPF级SD大鼠80只,雌雄各半,按性别分别随机分为低、中、高剂量组和对照组,低、中、高剂量组分别灌胃10.2、20.4、30.6 g/kg肾康灵混悬液,每天1次,连续灌胃30 d,分别于第0、7、14、21、28天观察记录4组大鼠的一般情况、进食量和体质量,大鼠处死后检测红细胞、血红蛋白、白细胞、中性粒细胞、淋巴细胞和血小板等血液指标,检测白蛋白(ALB)、总蛋白(TP)、丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、总胆红素(TBIL)、甘油三酯(TG)、总胆固醇(TC)、肌酐(Cr)、尿素氮(BUN)和血糖(Glu)等血清生化指标,测定心、肝、肾、胃和十二指肠的脏器系数,并行HE染色观察组织形态学改变。结果①急性毒性实验中,未发现动物死亡,一般情况良好,心、肝、肾、胃、十二指肠等脏器未见明显异常,小鼠最大耐受给药量为127.6 g/kg。②亚急性毒性实验中,4组大鼠的体质量、红细胞、血红蛋白、白细胞、中性粒细胞、淋巴细胞、ALB、ALT、AST、TC、BUN及心、胃、十二指肠的脏器系数比较,差异无统计学意义(P>0.05),部分组别的血小板、TP、TG、Cr、Glu、肝、肾的脏器系数差异有统计学意义(P<0.05),但无剂量-反应关系;与对照组比较,高剂量组TBIL显著升高,差异有统计学意义(P<0.05)。结论肾康灵胶囊在最大耐受剂量下单次给药对小鼠无毒副作用,低、中剂量用药30 d对大鼠没有明显毒性,但高剂量用药时可能对大鼠的胆红素代谢有�Objective:To make a preliminary safety evaluation of Shenkangling capsule,and provide the necessary toxicological basis for its clinical medication safety by conducting acute and subacute toxicity studies on mice and rats.Methods:In the acute toxicity experiment,208-week-old SPF Kunming strain mice were selected and administrated by the maximum tolerated dose method,i.e,127.6 g/kg Shenkangling capsule was given by gavage at one time,and the toxic manifestations,death status,histopathological changes of heart,liver,kidney,stomach,duodenum were recorded consecutively for 14 days.In the subacute toxicity experiment,808-week-old SPF SD rats(half male and half female)were randomly divided into low dose,medium dose,high dose and control group,the low,medium,and high dose groups were gavaged with 10.2,20.4,and 30.6 g/kg Shenkangling suspension respectively,once a day,for 30 days.The general conditions,food intake,and body weight of the rats in the 4 groups were observed and recorded on days 0,7,14,21,and 28.After the rats were sacrificed,the hematological indexes such as red blood cells,hemoglobin,white blood cells,neutrophils,lymphocytes,and platelets were detected,serum biochemical indexes including albumin(ALB),total protein(TP),alanine aminotransferase(ALT),aspartate aminotransferase(AST),total bilirubin(TBIL),triglycerides(TG),total cholesterol(TC),creatinine(Cr),blood urea nitrogen(BUN),and blood glucose(Glu)were detected.The organ coefficients of heart,liver,kidney,stomach and duodenum were measured,and the HE staining was performed to observe histomorphological changes.Results:1)In the acute toxicity experiment,no animal death were observed,and the general conditions were good.No significant abnormalities were found in organs such as the heart,liver,kidney,stomach,and duodenum,and the maximum tolerated dose for mice was 127.6 g/kg.2)In the subacute toxicity experiment,there were no significant differences in body weight,red blood cells,hemoglobin,white blood cells,neutrophils,lymphocytes,ALB,ALT,AST,TC,BUN,and o

关 键 词：肾康灵胶囊 毒理学 急性毒性 亚急性毒性 安全性评价 

分 类 号：R285.5[医药卫生—中药学]