Deshpande Pallavi O, Mohan Vishwaraman, Pore Mukul P, Gumaste Shailesh, Thakurdesai Prasad A
Department of Scientific affairs, Indus Biotech Private Limited, Kondhwa, Pune, Maharashtra, India.
Intox Pvt. Ltd, Urawade, Mulshi, Pirangut, Pune, Maharashtra, India.
Pharmacogn Mag. 2017 Jan;13(Suppl 1):S135-S141. doi: 10.4103/0973-1296.203978. Epub 2017 Apr 7.
Glycoside-based standardized fenugreek seed extract (SFSE-G) demonstrated promising efficacy in animal models of immune-inflammatory conditions.
The present study was aimed at embryo-fetal development toxicity evaluation of SFSE-G in Wistar rats as per guideline No. 414 of the Organization for Economic Co-operation and Development (OECD).
Mated female rats were randomized into four groups of 30 each and received oral doses of either SFSE-G at 250, 500, and 1000 mg/kg or vehicle (water) during the period of gestation (postconception) from gestational day 5 (GD5, an implantation day) until 1 day before cesarean sections (GD19). Maternal food consumption, body weights, and clinical signs were monitored throughout gestation. Cesarean sections were performed on GD20 and fetal observations (gravid uterine weight, implantation sites, early and late resorptions, live and dead fetuses) were recorded. Live fetuses were weighed and examined for external, visceral, and skeletal variations and malformations.
None of the SFSE-G-treated groups showed maternal and embryo-fetal toxicity. Occasional and incidental skeletal and visceral malformations were observed and found to be spontaneous and unrelated to the treatment.
Oral exposure of SFSE-G during the prenatal period did not show significant maternal and embryo-fetal toxicity up to a dose of 1000 mg/kg in rats. Therefore, the no-observed-adverse-effect level for SFSE-G for prenatal oral exposure was considered to be 1000 mg/kg.
Prenatal toxicity of glycoside-based standardized fenugreek seed extract (SFSE-G) was evaluated.SFSE-G was orally gavaged to rats on gestational days 5-19 with a limit dose of 1000 mg/kg.SFSE-G did not show maternal or developmental toxicity.SFSE-G showed NOAEL of 1000 mg/kg for prenatal exposure in female rats. CPCSEA: Committee for the Purpose of Control and Supervision of Experiments on Animals; GD: Gestational day; GRAS: Generally recognized as safe; HED: Human equivalent dose; NOAEL: No-observed adverse effect levels; OECD: Organization for Economic Co-operation and Development; SFSE-G: glycoside-based standardized fenugreek seed extract.
基于糖苷的标准化胡芦巴籽提取物（SFSE-G）在免疫炎症性疾病的动物模型中显示出有前景的疗效。
本研究旨在按照经济合作与发展组织（OECD）第414号指南对Wistar大鼠进行SFSE-G的胚胎-胎儿发育毒性评估。
将交配后的雌性大鼠随机分为四组，每组30只，在妊娠期间（受孕后）从妊娠第5天（GD5，着床日）至剖宫产术前1天（GD19），分别给予250、500和1000 mg/kg的SFSE-G口服剂量或赋形剂（水）。在整个妊娠期监测母鼠的食物消耗量、体重和临床体征。在GD20进行剖宫产，并记录胎儿观察结果（妊娠子宫重量、着床部位、早期和晚期吸收、活胎和死胎）。对活胎进行称重，并检查其外部、内脏和骨骼的变异及畸形情况。
所有接受SFSE-G治疗的组均未显示出母鼠和胚胎-胎儿毒性。观察到偶尔出现的骨骼和内脏畸形，发现这些畸形是自发的，与治疗无关。
在大鼠中，产前口服SFSE-G直至1000 mg/kg剂量均未显示出显著的母鼠和胚胎-胎儿毒性。因此，SFSE-G产前口服暴露的未观察到不良反应水平被认为是1000 mg/kg。
评估了基于糖苷的标准化胡芦巴籽提取物（SFSE-G）的产前毒性。在妊娠第5 - 19天对大鼠口服灌胃给予SFSE-G，极限剂量为1000 mg/kg。SFSE-G未显示出母鼠或发育毒性。SFSE-G对雌性大鼠产前暴露的未观察到有害作用水平为1000 mg/kg。 CPCSEA：动物实验控制和监督委员会；GD：妊娠日；GRAS：一般认为安全；HED：人体等效剂量；NOAEL：未观察到不良反应水平；OECD：经济合作与发展组织；SFSE-G：基于糖苷的标准化胡芦巴籽提取物
