Abstract：
BACKGROUND: 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.
OBJECTIVE: The aim of the present study was to comprehensively investigate the potential toxicological effects of deer antler extract during the juvenile period.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
OBJECTIVE: The aim of the present study was to comprehensively investigate the potential toxicological effects of deer antler extract during the juvenile period.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：鹿（CervuselaphusLinnaeus）鹿茸提取物传统上已在许多亚洲国家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，因为人类已经长时间暴露于它，并且它已经被用作源自天然存在的产品的滋补药。然而,鹿茸提取物在幼年期的综合毒理学潜力尚未得到调查，其对幼年的安全性仍不清楚。
目的：本研究旨在全面探讨鹿茸提取物在幼年期的潜在毒理学效应。
方法：作为青少年时期安全性评估的一部分，两项独立的研究，青少年毒性研究和子宫营养生物测定，按照良好实验室规范和测试指南进行。在青少年毒性研究中，鹿茸提取物在幼年期间每天以0、500、1000和2000mg/kg的剂量通过口服管饲法给予Sprague-Dawley大鼠，以研究对全身的潜在毒性，发展,和生殖功能。对于子宫营养生物测定，鹿茸提取物在出生后第19-21天每天以0、1000和2000mg/kg的剂量通过口服管饲法给予Sprague-Dawley大鼠，以研究雌激素模拟作用。
结果：结果表明鹿茸提取物无毒，对全身功能无明显不良反应，发育和生殖功能，在幼年期，剂量高达2000mg/kg时，观察到雌激素模拟效应。
结论：这些研究证明了鹿茸提取物的安全性，该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。
目的：本研究旨在全面探讨鹿茸提取物在幼年期的潜在毒理学效应。
方法：作为青少年时期安全性评估的一部分，两项独立的研究，青少年毒性研究和子宫营养生物测定，按照良好实验室规范和测试指南进行。在青少年毒性研究中，鹿茸提取物在幼年期间每天以0、500、1000和2000mg/kg的剂量通过口服管饲法给予Sprague-Dawley大鼠，以研究对全身的潜在毒性，发展,和生殖功能。对于子宫营养生物测定，鹿茸提取物在出生后第19-21天每天以0、1000和2000mg/kg的剂量通过口服管饲法给予Sprague-Dawley大鼠，以研究雌激素模拟作用。
结果：结果表明鹿茸提取物无毒，对全身功能无明显不良反应，发育和生殖功能，在幼年期，剂量高达2000mg/kg时，观察到雌激素模拟效应。
结论：这些研究证明了鹿茸提取物的安全性，该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。
