长白山有机灵芝破壁孢子粉的毒理学安全性评价

目的对长白山有机灵芝破壁孢子粉作为保健食品进行毒性实验研究。方法采用小鼠急性毒性试验、遗传毒性试验,以及大鼠30 d喂养实验来评价长白山有机灵芝破壁孢子粉的毒理学安全性。结果样品给药后,ICR种雌、雄小鼠的最大耐受剂量(MTD)大于20.00 g/kg·bw,属于无毒级;遗传毒性试验结果中Ames试验、小鼠骨髓嗜多染红细胞微核试验及小鼠精子畸形试验均表现为阴性;大鼠30 d喂养实验中,动物生长发育良好,各剂量组体重、食物利用率、血常规指标、血生化指标、脏器重量和系数以及病理组织学等指标均未见毒性作用。结论长白山有机灵芝破壁孢子粉均未见明显毒副作用,具有服用安全性。

Toxicological safety evaluation of sporoderm-broken spore powders of organic Ganoderma lucidum of Changbai mountain

Objective To investigate the toxicity of sporoderm-broken spore powders of organic Ganoderma lucidum of Changbai mountain as a kind of health food. Methods The toxicological safety of sporoderm-broken spore powders of organic Ganoderma lucidum of Changbai mountain was evaluated by taking acute toxicity test of mice, genetic toxicity test, and 30 d rat feeding trial. Results Maximum tolerated dose (MTD) of female and male mice of ICR species were greater than 20.00 g/kg?bw after gavage, which indicated that samples were non-toxic product. Ames test, micrinucleus test of bone marrow cells in mice and mouse sperm malformation test were all showed negative in genetic toxicity test. In 30 d rat feeding test, animal growth and development were normal, weight, food utilization, blood routine, blood biochemistry, organ weights and pathological indexes also had no toxicity in each dose group. Conclusion Sporoderm-broken spore powders of organic Ganoderma lucidum of Changbai mountain is safe for taking, and it has no significant side effects.