银杏苁蓉配方急性毒性和亚慢性毒性实验研究

Acute and sub-chronic toxicity of Ginkgo biloba and Cistanche tubulosaformula on rats

目的观察银杏苁蓉配方的毒性。方法按照《保健食品检验与评价技术规范》2003年版中的相关规定,进行银杏苁蓉片的急性毒性实验和90d喂养实验。结果银杏苁蓉配方的大鼠最大耐受剂量(MTD)大于15g·kg^(-1)·bw^(-1),属无毒级;将受试物掺入饲料中,自由摄取连续90d,大鼠体质量和食物利用率均无异常改变,各项血常规和生化指标均在本实验室正常指标值范围内,高剂量组和对照组动物各脏器的病理组织检查亦未见明显病变,未观察到有害作用(NOAEL),剂量为0.7g·kg^(-1)·bw^(-1)。结论可以判断银杏苁蓉配方为无毒物,未见急性毒性和亚慢性毒性。

Objective To study the toxicity of Ginkgo biloba and Cistanche tubulosaformula.Methods The acute test and 90 dfeeding test were applied and analyzed in rats in accordance with Procedures and Methods for Toxicological Assessment of Food Safety.Results Its acute toxicity test showed that the maximum tolerated dose（MTD）was greater than 15g·kg^-1·bw^-1.The 90 d feeding test showed that body weight and food utilization rate were similar in each group;the parameters of blood routine examination and biochemical index were in normal range;the formula did not cause significant pathological changes in the organs of high dosage group and control group.The no observed adverse effect level（NOAEL）was estimated as 0.7g·kg^-1·bw^-1.Conclusion Ginkgo biloba and Cistanche tubulosaformula is a non-toxic product and has no sub-chronic toxicity as well.