Developmental and Reproductive Toxicology Research Group, Korea Institute of Toxicology, Daejeon, Republic of Korea; Laboratory Animal Medicine, College of Veterinary Medicine, Chungnam National University, Daejeon, Republic of Korea.
R&D Headquarters, Korea Ginseng Corp, Daejeon, Republic of Korea.
J Ethnopharmacol. 2024 Jan 30;319(Pt 1):117094. doi: 10.1016/j.jep.2023.117094. Epub 2023 Aug 28.
Deer (Cervus elaphus Linnaeus) antler extract has been traditionally used in many Asian countries to prevent and treat various diseases. Deer antler extract is generally considered to be safe because humans have been exposed to it for a long time and it has been used as a tonic medicine originating from naturally occurring product. However, the comprehensive toxicological potential of deer antler extract during the juvenile period has not been investigated and its safety for juveniles remains unclear.
The aim of the present study was to comprehensively investigate the potential toxicological effects of deer antler extract during the juvenile period.
As part of a safety assessment of the juvenile period, two separate studies, a juvenile toxicity study and a uterotrophic bioassay, were conducted in accordance with Good Laboratory Practice regulations and test guidelines. In the juvenile toxicity study, deer antler extract was administered daily by oral gavage to Sprague-Dawley rats at doses of 0, 500, 1000, and 2000 mg/kg during the juvenile period to investigate potential toxicities on general systemic, developmental, and reproductive functions. For the uterotrophic bioassay, deer antler extract was administered daily by oral gavage to Sprague-Dawley rats at doses of 0, 1000, and 2000 mg/kg on postnatal days 19-21 to investigate the estrogen-mimicking effects.
The results showed that deer antler extract was non-toxic and no observable adverse effects on general systemic function, developmental and reproductive function, and estrogen-mimetic effects were observed with dosing up to 2000 mg/kg during the juvenile period.
The safety of deer antler extracts was demonstrated in these studies and the results of this study can be used to evaluate human risk or determine the maximum recommended starting dose of deer antler extract for further clinical trials.
鹿茸提取物在许多亚洲国家传统上被用于预防和治疗各种疾病。鹿茸提取物通常被认为是安全的,因为人类长期接触它,并且它被用作源自天然产物的滋补药物。然而,在幼年期鹿茸提取物的综合毒理学潜力尚未得到研究,其对幼年期的安全性仍不清楚。
本研究旨在全面研究幼年期鹿茸提取物的潜在毒理学效应。
作为幼年期安全性评估的一部分,按照良好实验室规范和测试指南进行了两项独立的研究,一项是幼毒性研究,另一项是子宫增重生物测定。在幼毒性研究中,通过口服灌胃给予 Sprague-Dawley 大鼠鹿茸提取物,剂量分别为 0、500、1000 和 2000mg/kg,以研究对一般全身、发育和生殖功能的潜在毒性。对于子宫增重生物测定,通过口服灌胃给予 Sprague-Dawley 大鼠鹿茸提取物,剂量分别为 0、1000 和 2000mg/kg,在产后第 19-21 天,以研究雌激素模拟作用。
结果表明,鹿茸提取物在幼年期最高剂量达 2000mg/kg 时,无毒性,对一般全身功能、发育和生殖功能无明显不良影响,也无雌激素模拟作用。
在这些研究中证明了鹿茸提取物的安全性,并且本研究的结果可用于评估人类风险或确定鹿茸提取物的最大推荐起始剂量,以进行进一步的临床试验。