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Abstract：
Withania somnifera (Ashwagandha) also called as Indian ginseng, a revered herb from Indian traditional system of medicine is a rejuvenator and tonic (Rasayana) used for its varied benefits. The roots of ashwagandha exhibit properties like anti-inflammatory, aphrodisiac, anthelmintic, astringent, diuretic, stimulant and thermogenic. However, data of ashwagandha on its mutagenic effects are lacking. In the present study, in-vitro genotoxicity tests were used to evaluate the mutagenic potential of Ashwagandha Root Extract (ARE). Concentrations of 0.156 to 5.00 mg/plate ARE were used for conducting Bacterial reverse mutation test (BRMT). For chromosome aberration (CA) test ARE was used in concentrations of 0.25 to 2.00 mg/ml, and for micronucleus (MN) tests ARE concentrations of 500/1000/2000 mg/kg were used. Acute oral toxicity was conducted in Wistar rats (n = 25) as per the OECD guideline (#423) with doses of 500/1000/2000 mg/kg body weight in male Swiss albino mice for morbidity and mortality for 3 days. The BRMT and CA tests were conducted with and without metabolic activation (S9). The study was approved by the institutional ethics committee (IEC) and institutional animal ethics committee (IAEC). ARE failed to show any mutagenic effects up to a dose of 5 mg/plate in BRMT. Also, ARE did not show any clastogenic activity in doses up to 2 mg/ml in CA test and in micronucleus test up to 2000 mg/kg body weight. These results were observed with and without metabolic activation (S9) under the stated experimental conditions. No mortality, morbidity, or any clinical signs were observed up to 3 days following ARE administration. Ashwagandha root extract failed to show any mortality in doses up to 2000 mg/kg oral dosage and did not show any mutagenic (genotoxic) effects in high concentrations.
摘要：
Withaniasomnifera（Ashwagandha）也被称为印度人参，来自印度传统医学系统的一种受人尊敬的草药是一种恢复活力和补品（Rasayana），用于其各种好处。ashwagandha的根表现出抗炎等特性，壮阳药,驱虫药,收敛,利尿剂,兴奋剂和产热。然而,缺乏ashwagandha诱变作用的数据。在本研究中,体外遗传毒性试验用于评估Ashwagandha根提取物（ARE）的诱变潜力。使用浓度为0.156至5.00mg/板的ARE进行细菌回复突变试验(BRMT)。对于染色体畸变（CA）测试，ARE以0.25至2.00mg/ml的浓度使用，对于微核（MN）测试，ARE浓度为500/1000/2000mg/kg。根据OECD指南（＃423），在Wistar大鼠（n=25）中进行急性口服毒性，在雄性瑞士白化病小鼠中的剂量为500/1000/2000mg/kg体重，持续3天的发病率和死亡率。在有和没有代谢激活的情况下进行BRMT和CA测试(S9)。该研究得到机构伦理委员会(IEC)和机构动物伦理委员会(IAEC)的批准。ARE在BRMT中高达5mg/板的剂量下未能显示任何诱变作用。此外，在CA试验和在2000mg/kg体重的微核试验中，ARE在高达2mg/ml的剂量下均未显示任何致裂活性。在所述实验条件下,在有和没有代谢活化(S9)的情况下观察到这些结果。没有死亡,发病率，或在ARE给药后3天内观察到任何临床体征。Ashwagandha根提取物在高达2000mg/kg口服剂量的剂量下未能显示任何死亡率，并且在高浓度下没有任何诱变（遗传毒性）作用。
