Safety Evaluations of Davallia Formosana Extraction

遗传毒性 加药 后代 毒性 体重 生理学 生殖毒性 未观察到不良反应水平 口服 医学 微核 毒理 微核试验 药理学 动物科学 内科学 生物 怀孕 遗传学
作者
Jiunn-Wang Liao,Jhaol-Huei Wu,Wen-Chuan Lin
出处
期刊:中醫藥雜誌 卷期号:20: 119-135
标识
DOI:10.6940/jcm.200912_20(3_4).03
摘要

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.
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