评估菇类菌丝复合性饮品之大鼠致畸试验

Prenatal Developmental Toxicity Study for a Mushroom Mycelia Complex Drink in Rats

摘要: 本試验依据卫生福利部公告之健康食品安全性评估方法，对大鼠胚胎发育之影响及造成畸胎的可能性；测试之菇类菌丝复合性饮品，是以樟芝菌丝体发酵全液为主体，添加各1% (v/v)的巴西蘑菇菌丝体浓缩发酵滤液、云芝菌丝体浓缩发酵滤液、舞茸子实体浓缩萃取液及桑黄子实体浓缩萃取液，经调整糖酸比后制成。共设置4组试验组，为对照组、低、中及高剂量组，投予剂量分别为180、360及720 mL/kg Body Weight (B.W.)，分别为人体每日建议口服剂量(人体每日360 mL/60kg B.W.)之30倍、60倍及120倍。每组各使用20只完成配种的雌性Sprague-Dawley (SD)品系母鼠，以口服管喂方式分别于怀孕第6至15天投予试验物质，并于怀孕第20天将各组怀孕母鼠安乐死后以帝王切开术进行解剖检查。试验结果显示，各剂量组与对照组比较，母鼠子宫重量、胚胎着床数、胚胎着床前损失率、胚胎着床后损失率及胎数体重在统计上均无明显差异(p > 0.05)；胎鼠之外观、内脏及骨骼检查，各剂量组及对照组胎鼠均未显示明显之畸胎现象。综合以上实验结果，菇类菌丝复合性饮品于本试验设计条件下，对大鼠胚胎发育不会造成不良影响；其投予剂量最高可达720 mL/kg B.W.，为人体建议摄取量(每日360 mL/60kg B.W.)之120倍。

Abstract: This study was conducted to assess the prenatal developmental toxicity of a mushroom mycelia complex drink according to the safety assessment guideline of Health Food announced by Ministry of Health and welfare, Executive Yuan of Taiwan. Concentrated aqueous extract (1% v/v) from Grifola frondosa fruit body, Agaricus blazai mycelia, Phellinus linteus fruit body and Coriolus versicolor mycelia was added to the mycelium fermentation broth of Antrodia cinnamomea to produce a mushroom mycelia complex drink after the adjustment of the sweet and sour ratio. A total of 4 test groups were established in this present study: a negative control group, a low dose group, a medium dose group, and a high dose group. Rats in the low, medium and high dose groups were administered the test article at doses of 180 mL/kg B.W., 360 mL/kg B.W., and 720 mL/kg B.W., respectively and the doses mentioned above were the 30×, 60× and 120× compared with the recommended daily intake og 360 mg/60kg B.W. A total of 20 successfully conceiving female Sprague-Dawley (SD) rats were used for each group. The test article was administered orally to female rats between days 6 and 15 of their pregnancy. On the 20th day og pregnancy, the rats were euthanized, caesarean sections were performed, and macroscopic examinations were conducted. Results indicated that weight of uterus, fetal body weight, number of corpora lutea, implantation sites, pre-implantation loss, post-implantation loss of the test groups and negative control group exhibited no statistical differences. According to the results of the fetal external, organ and skeletal examination, no fetal deformations were caused by the test article. Therefore, the results of the present study indicated that administering the maximum dosage of the mushroom mycelia complex drink (The dose of 720 mg/kg/day was the 120× compared with recommended daily intake of 360 mg/60kg B.W.) results in no deformations or negative influences on rat fetal development.