摘要
目的:观察复方灵芝降糖胶囊连续给药6个月的长期毒性及停药后的蓄积性毒性反应情况。方法:120只清洁级Wistar种系大白鼠,随机分成4组,正常组(等体积蒸馏水)和复方灵芝降糖高、中、低剂量组(4.14,2.07,0.69 g·kg-1),每组30只,各组每天ig给药1次,连续ig 180 d,并进行停药1个月的恢复期观察,并从一般状况,血液学指标:网织红细胞,红细胞总数(RBC),血小板计数(PLT),血红蛋白总量(Hb),白细胞总数(WBC)及凝血时间,血液生化学指标:丙氨酸氨基转移酶(ALT),天门冬氨酸氨基转移酶(AST),碱性磷酸酶(ALP),尿素氮(BUN),肌酐(Cr),血糖(GLU),总胆红素(T-BIL),总蛋白(TP),总胆固醇(T-CHO),甘油三酯(TG),γ-谷氨酰转移酶(γ-GGT),肌酸磷酸肌酶(CK),对心、肝、脾、肺、肾、肾上腺、甲状腺、睾丸、子宫、脑、前列腺、卵巢、胸腺、附睾等14个脏器组织称重,计算脏器系数。剖取胰腺、胃、十二指肠、回肠、结肠、脑垂体、脊髓、胸骨(骨和骨髓)、淋巴结、膀胱、视神经等共计25个脏器组织进行病理组织学检查,以评价复方灵芝降糖胶囊长期用药的安全性。结果:实验中期(用药90 d),实验末期(用药180 d),恢复期(停药30 d)3次检测结果表明,与正常组比较,复方灵芝降糖胶囊各剂量组对大鼠生长发育,一般状况,血液学指标,血液生化学指标、脏器系数及脏器病理形态均无显著影响。结论:复方灵芝降糖胶囊大剂量长期服用毒性很低,停药后无蓄积性毒性反应,服用比较安全。
Objective： To observe the long-term toxicity of compound Lingzhi Jiangtang capsule after the six-month administration and the accumulative toxicity after the drug discontinuance. Method： Totally 120 cleangrade Wistar rats were randomly divided into four groups： the normal group（ equal volume of distilled water） and compound Lingzhi Jiangtang capsule high,medium and low doses groups（ 4. 14,2. 07,0. 69 g·kg- 1）,with 30 rats in each group. Each group was intragastrically administered with drugs once every day for consecutively 180 days and then stopped giving drugs for one month for observation. The general status,haematological indexes：reticulocyte,erythrocyte total（ RBC）,blood platelet count（ PLT）,total hemoglobin（ Hb）,total white blood cells（ WBC） and blood clotting time,blood biochemical indexes： alanine aminotransferase（ ALT）,aspartate amino transferase（ AST）,alkaline phosphatase（ ALP）,urea nitrogen（ BUN）,creatinine（ Cr）,blood glucose（ GLU）, total bilrubin（ T-BIL）, total protein（ TP）, total cholesterol（ T-CHO）, triglyceride（ TG）,γ-glutamyltransferase（ γ-GGT） and creatine phosphokinase（ CK）,were measured,and heart,liver,spleen,lung,kidney,adrenal gland,thyroid gland,testis,uterus,brain,prostate,ovarian,thymus and epididymis were weighed,in order to calculate organ coefficients. Subsequently,25 organ tissues： pancreas,stomach,duodenum,ileum,colon,pituitary,spinal cord,sternum（ bone and bone marrow）,lymph nodes,bladder and optic nerve,were collected for a histopathologic examination,in order to evaluate the safety of long-term administration of compound Lingzhi Jiangtang capsule. Result： According to the result in the mid-stage of the experiment（ 90 days after the administration）,the late stage of the experiment（ 180 days after the administration） and the recovery period（ 30 days of after the discontinuation）,compared with the normal group,compound Lingzhi Jiangtang capsule groups showed no significant effect o
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2015年第17期146-151,共6页
Chinese Journal of Experimental Traditional Medical Formulae
基金
黑龙江省教育厅项目(11511366)
关键词
复方灵芝降糖胶囊
长期毒性
灌胃
compound Lingzhi Jiangtang capsule
long-term toxicity
intragastric administration
