評估紫丁香蘑菌絲體萃取物複方在大鼠二期生殖與發育的毒性

Teratogenic Evaluation of Lepista nuda Mycelia Extract Complex in Rats

林明義(Min-Yi Lin) ； 徐瑞霞(Jui-Hsia Hsu) ； 林建宇(Jian-Yu Lin) ； 陳勁初(Chin-Chu Chen)

《檢驗及品保雜誌》 7卷3期 (2018/07) Pp. 148-156

https://doi.org/10.6573/JTQA.201807_7(3).06

摘要

本試驗探討由含紫丁香蘑(Lepista nuda)菌絲體萃取物、金針菇(Flammulina velutipes)萃取物、N-乙醯基-D-葡萄糖胺(N-acetyl-D-glucosamine)、蔓越莓(Cranberries)萃取物、洛神花萼(Hibiscus sabdariffa)萃取物、穀胱甘肽(glutathione、GSH)、米胚芽萃取物（含神經醯胺：ceramide）及維生素C等含多種美容保健之生物活性物質的之複合組成物（以下簡稱複合物）對SD大鼠生殖與發育二期毒性之影響，結果顯示無論是餵食低劑量組(1,047.2 mg/kg b.w./day)、中劑量組(3,141.6 mg/kg b.w./day)或高劑量組(5,236.0 mg/kg b.w./day)之複合物，與對照組相比之下，試驗動物皆未出現因餵食試驗物質導致之母鼠生殖與胚胎發育之異常現象，證實本試驗物質對懷孕母鼠無生殖毒性；對胚胎發育中之鼠胎亦無發育（致畸胎）之毒 性，對懷孕母鼠之無毒性顯示劑量” no-observed-adverse effect level (NOAEL) 大於5,236 mg/kg/day，可 作為後續人體使用安全性參考之依據。

關鍵字

紫丁香蘑菌絲體萃取物複合物 ； 胚胎發育 ； 無毒性顯示劑量

並列摘要

The purpose of the present study was to evaluate the potential adverse effects in the pregnant rats, after oral administration of a complex formulation containing Lepista nuda mycelia extract, Flammulina velutipe extract, cranberries extract, Hibiscus sabdariffa extract, N-Acetyl-D-glucosamine, glutathione, ceramide and vitamin C. Results indicated that no treatment related maternal or developmental effects were observed at doses 1047.2 (low dose), 3141.6 (mid dose) and 5236.0 mg/kg b.w./day (high dose). Therefore, the no-observable- adverse-effect level (NOAEL) of this complex formulation for pregnant rats and embryo-fetal development is considered to be 5236mg/kg/day.

並列關鍵字

Lepista nuda mycelia extract ； embryofetal development ； no-observableadverse- effect level