麝香替代品北美巨水鼠香腺體之安全性評估   全文下載

Safety Assessment of Musk Substitute from Nutria of Myocastor Coypus in Mice

麝香味辛、性溫，具開竅、活血、催生、通絡等功效。現今亦為高級香水原料。麝香是採自麝鹿（Moschus moschiferus）之雄性麝香腺，由於以往大都採取殺鹿取材的方式，導致麝鹿瀕於絕種目前已被列入保育動物，有必要研發麝香的替代品。自北美巨水鼠（Myocastor coypus）採集的香腺於台灣民間有充當麝香之用，因此本計畫擬進行該香腺體之成分分析與毒性研究，以評估做為麝香替代品的可行性。北美巨水鼠香腺之動物毒性試驗，包括單一劑量急毒性、重覆劑量亞急毒性和基因毒性試驗，即微生物基因突變分析。由動物實驗之結果顯示，北美巨水鼠Myocastor coypus 泄殖腔附近之腺體之粹取物，在5 g/Kg劑量下並不會造成動物之死亡及明顯之急毒性。而以1 g/Kg劑量連續餵食28天亦無觀察到毒性的產生。然而，處理組雄鼠臨床可見部份雄鼠有互咬現象造成背部受傷且引起發炎，其原因不明。而基因毒性測試結果亦顯示此萃取物不論在Salmonella typhimurium strains TA97, TA98, TA100, TA102 and TA1535皆不具微生物致突變性。本研究顯示北美巨水鼠香腺在安全評估方面尚無發現微生物致突變性或亞急動物毒性，可作為是否適合充當麝香醫療用途之代用品之安全性參考。"

Musk is an important crude drug in Traditional Chinese Medicine and is used in the manufacture of perfume. Traditionally, the gland was picked after killing the male deer. As a highly valued ingredient of Chinese medical remedies, the wide use of this substance has made this animal near the edge of extinction. Hence it is necessary to find a substitute for the same or similar use. The gland from nutria (Myocastor coypus) has been used as a musk substitute in some Taiwan areas. To assess the safety of nutria gland extract (NE), we carried out this study. For the safety evaluation, we have completed the animal toxicity testing including the single dose oral acute and repeated dose subacute toxicity, and genotoxicity. At 5 g/Kg dosage, no lethality and obvious acute toxicity were observed. At repeated treat-ment with NE 1 g/Kg for 28 days, no subacute toxicity was noticed. Genotoxicity was accessed by the Ames test in Salmonella typhimurium strains TA97, TA98, TA100, TA102 and TA1535. Result indicated that NE did not induce revertant increase in bacteria. Results of the current study support the safety of the use of NE, and the acute, subacute toxicity and genotoxicity are not observed in this study.