台灣骨碎補粗萃物安全性評估

Safety Evaluations of Davallia Formosana Extraction

"本試驗進行台灣骨碎補（Davallia formosana；DFE）70%酒精萃取物安全性評估。急性毒性試驗結果顯示，DFE酒精萃取物對大鼠口服一半致死劑量大於10 g/kg。90天餵食毒性試驗，雌、雄大鼠每天分別經口投與DFE 0.28、0.83及2.5 g/kg連續90天，結果顯示DFE投與13週期間，對大鼠體重並無影響。DFE對於白血球分類計數、麩氨酸丙氨基轉氨、鹼性磷酸酶、鈉和氯雖有統計上的差異，但仍在正常生理值範圍內或無劑量反應關係。DFE （0.28 g/kg） 使雌鼠脾臟的絕對和相對重量增加，但無劑量反應關係。組織病理檢查沒有發現因DFE的處理引起的組織或器官病理變化。本實驗確立DFE 90天餵食毒性試驗的無明顯效應劑量大於2.5 g/kg。生殖試驗顯示對於母鼠、胎鼠及仔鼠外觀畸型的無明顯效應劑量大於3.8 g/kg。但 DFE明顯減少仔鼠及哺乳母鼠體重的增加。基因毒性試驗包含Ames測試、CHO-K1細胞株染色體異常試驗及微核試驗，三種測試的結果皆顯示DFE並無基因毒性。這些試驗結果提供了DFE安全使用的證據，但禁用於於哺乳婦女。In this study, we evaluated the safety of 70% ethanolic extract of Davallia formosana (DFE). The LD50 value for oral administration of DFE was greater than 10 g/kg. Repeated dosing toxicity study was carried out by orally administering daily doses of 0.28, 0.83, and 2.5 g/kg of DFE to groups of male and female rats for 13 weeks. The mean body weights at weekly intervals were not affected by the administration of DFE during the 13-weeks dosing period. Scattered significant differences in WBC differential count, plasma alanine aminotranferase, alkaline phosphatase, sodium and chloride were found, but all these were still within the range of normal physiological reference or had no dose-correlation. A significant increase was seen in the absolute and relative weight of spleen treated with DFE 0.28 g/kg in female rats, but without dose-correlation. From the microscopic evaluations, there were no treatment-related pathological lesions in the tissue/organs. The no-observed adverse effect level is higher than 2.5 g/kg in rats. Reproductive test study indicated no-effect dose level of DFE was greater than 3.8 g/kg for dams, fetuses, and apparent teratogenicity of offspring. But, DFE markedly reduced the body weight of dams and offsprings in lactating period. The results of three genotoxicity studies, including Ames test, CHO-K1 chromosomal aberration test, and micronucleus test, demonstrated that DFE had no genotoxicity. Our findings provided scientific evidence for the safe use of DFE. But it should be contraindicated in lactating female. "