Lee Kyungjin, Choi Ho-Young
Department of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Republic of Korea.
Evid Based Complement Alternat Med. 2019 Apr 11;2019:8104951. doi: 10.1155/2019/8104951. eCollection 2019.
Studies on the safety of herbal medicine are essential for the development of new drugs. The aim of this study was to evaluate the no-observed-adverse-effect-level (NOAEL) of HVC1 (Gamisamhwangsasim-tang, a 30% ethanol extract of a mixture of Pruni Cortex, Scutellariae Radix, Coptidis Rhizoma, and Rhei Rhizoma) and identify its target organs after oral administration to Sprague-Dawley (SD) rats repeatedly for 13 weeks. Three test groups were treated with HVC1 at a dose of either 500 (low-dose), 1,000 (middle-dose), or 2,000 (high-dose) mg/kg/day. Another group received high-dose HVC1 and was observed for 4 weeks following treatment to examine recovery from the effects of the extract. All treatment groups were compared to a vehicle control group. During the study, mortality, clinical signs, body weight changes, food consumption, abnormal lesions in the eye, urinary parameters, hematological parameters, blood coagulation time, blood biochemical parameters, changes in organ weight, gross findings, and histopathological changes were examined. No systemic toxicity related to HVC1 was observed in any group, and it was concluded that the NOAEL of HVC1 was 2,000 mg/kg/day. No target organ was identified.
草药安全性研究对新药开发至关重要。本研究旨在评估HVC1（加味三黄四物汤，由黄柏、黄芩、黄连和大黄混合而成的30%乙醇提取物）的无观察到有害作用水平（NOAEL），并确定其对Sprague-Dawley（SD）大鼠连续口服给药13周后的靶器官。三个试验组分别以500（低剂量）、1000（中剂量）或2000（高剂量）mg/kg/天的剂量给予HVC1。另一组接受高剂量HVC1治疗，并在治疗后观察4周以检查提取物作用后的恢复情况。所有治疗组均与溶剂对照组进行比较。在研究期间，检查了死亡率、临床症状、体重变化、食物消耗、眼部异常病变、尿液参数、血液学参数、凝血时间、血液生化参数、器官重量变化、大体检查结果和组织病理学变化。在任何组中均未观察到与HVC1相关的全身毒性，得出结论HVC1的NOAEL为2000 mg/kg/天。未确定靶器官。
