银杏丹参软胶囊毒理学实验观察  

The toxicity experiment observation of soft capsules for yinxing-danshen

作　　者：李中炼[1] 刘昌英[2] 戴黎光 周明[2] 周银平[2] 刘琳[2] 刘志勇[2] 

机构地区：[1]江西中医学院,南昌330006 [2]江西省劳动卫生职业病防治研究所医学实验动物中心,南昌330006

出　　处：《江西中医学院学报》2010年第3期53-56,共4页Journal of Jiangxi College of Traditional Chinese Medicine

摘　　要：目的:了解和观察银杏丹参软胶囊产品的毒性,为进一步开发积累资料。方法:按食品安全性毒理学评价程序和方法进行实验。结果:根据急性毒性(LD50)剂量分级及标准,银杏丹参软胶囊制剂的急性经口毒性结果属无毒级。对小鼠骨髓微核试验、小鼠精子畸形试验均为阴性。银杏丹参软胶囊以2.5、5.0、10.0ml/kgBW的剂量(以5倍浓缩液计)灌胃大鼠30天,动物生长活动正常,被毛浓密有光泽。各剂量组动物体重、食物利用率、主要脏体比与对照组比较差异无显著性意义(P>0.05)。对照组和各剂量组的白细胞计数及其分类、红细胞计数、血红蛋白及各项生化指标(谷丙转氨酶、谷草转氨酶、尿素氮、肌酐、胆固醇、甘油三酯、血糖、总蛋白、白蛋白)均在正常值范围内。未发现该受试物对各剂量组被检动物的大体解剖与主要脏器产生有意义的病理变化。结论:实验建立了银杏及丹参为主的软胶囊制剂的毒理学资料,为其作为保健食品提供了毒理学依据。Objective：To comprehend the acute toxic effects of soft capsules for yinxing-danshen（CYXDS） which accumulated the data for further development. Method：toxicology estimate sequence and methods of food safety were adopted. Result：The acute toxicity showed that CYXDS was nonvenomous. Micronucleus tests and sperm malformation test was negative after oral administration of CYXDS in mice. The sub-acute toxicity in the rats was carried out with 2.5,5,10mg/kg b.wt for 30 d.All animals vegetative activity was normal,clothing hair thickening and glossing. The weight,food utilization rate and organ /body were no difference（P〉0.05） between dosage. The biochemical parameters and blood cell count parameters were in range of normal values at all dosages rats. Histopathologic examination showed no significent in this part. Conclusion：Our studies establishes toxicology data for CYXDS that provide CYXDS toxicologic information for health food.

关 键 词：银杏丹参软胶囊 急性毒性 安全评价 

分 类 号：R992[医药卫生—毒理学]