灵芝颗粒的毒理学安全性研究

Toxicology and Safety Studies of Lingzhi Granule

目的研究灵芝颗粒的毒性作用,为灵芝颗粒的安全用量和功能学研究提供参考。方法通过急性毒性试验、遗传毒性试验(Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验)和30d喂养试验进行毒理学研究。结果急性毒性试验结果为MTD>20g/(kg·BW)(以样品计),折算成品为100g/(kg·BW),相当于成人日推荐量的600倍,根据急性毒性分级属于无毒级;遗传毒性试验(Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验)均为阴性;30d喂养试验表明,该受试物在4.17、8.33、16.7g/(kg·BW)(以成品计,分别相当于推荐人群日摄入量的25、50、100倍)剂量时,对SD大鼠的临床检查、血液学、血生化学和脏器重量和系数以及病理组织形态等指标均无明显不良影响。结论灵芝颗粒按推荐的食用量具有较好的食用安全性。

OBJECTIVE To study the toxic effects of Lingzhi granule and provide reference for it＇s safe dosage and functional study. METHODS Study the toxicology by acute toxicity test,genetic toxicity test（ Ames test,micronucleus test of bone marrow cells in mice,mice sperm malformation test） and 30 d feeding trials. RESULTS Result of acute toxicity test showed MTD 20 g /（ kg·BW）（ calculated in sample） and converted to finished product,it was100 g /（ kg·BW）,600 times equivalent to recommended adult daily serving size. According to the acute toxicity of class,it belongs to non-toxic class; Genetic toxicity test（ Ames test,micronucleus test of bone marrow cells in mice,mice sperm malformation test） were all negative; 30 d feeding test showed that indexes of clinical examination,hematology,blood biochemistry,viscera weight coefficient and pathological indicators of SD rats were no significant adverse effects when the test samples in the levels of 4. 17,8. 33,16. 7g /（ kg·BW）（ respectively equal to 25,50,100 times of the recommended daily intake of adults in the finished product）. CONCLUSION Lingzhi granule had good edible safety taken by the recommended dosage.