灵芝蒜颗粒毒理实验研究

Study on Toxicology of Lingzhisuan Granules

目的:探讨评价灵芝蒜颗粒的安全性,为其应用提供毒理学安全依据。方法:采用小鼠急性经口毒性实验、Ames实验、小鼠骨髓嗜多染红细胞微核实验和小鼠精子畸形实验及大鼠30 d喂养实验。结果:灵芝蒜对小鼠急性经口毒性实验结果大于20 000 mg/kg,体内体外致突变实验结果均为阴性,30 d喂养实验,0.84 g/kg,1.67 g/kg,3.33 g/kg(分别相当成人日用量的25、50、100倍)3个剂量组的样品灌胃30 d,实验期间动物生长发育良好,各剂量组的动物体重、增重量和进食量及食物利用率与对照组比较,差异均无统计学意义(P>0.05);各剂量组血常规和生化检测指标、脏器重量及脏器/体重比值与对照组比较,差异均无统计学意义(P>0.05);病理组织学检查结果,各实验组大鼠肝、肾、胃肠、脾、睾丸和卵巢等组织均未见有病理改变。结论:灵芝蒜颗粒属实际无毒级,未见遗传毒性,长期服用是安全的。

Objective：To investigate the edible safety of Lingzhisuan Granules（LZS） through the toxicology tests.Methods：The acute oral toxicity test,Ames test,micronuclers test of bone marrow,sperm shape abnormality test in mice and 30-day feeding test in rats were conducted.Results：The oral LD50 of LZS in mice was more than 20.0 g/kg BW.The results of Ames test,micronucleus test of bone marrow,sperm shape abnormality test in mice and 30-day feeding test in rats were negative.With LZS giving rats for 30-day,no behavioral changes were observed and no significant alterations were exhibited in body weight,food consumption,blood routine,clinical biochemistry,organ weight and organ/body ratios and histopathology.Conclusion：LZS is classified as non-toxic.Toxicity test of LZS results show no obvious heredity toxicity.LZS is safe for edibility.