Basic Herbal Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yusung-gu, Daejeon 305-811, Republic of Korea.
Division of Non-clinical Studies, Korea Institute of Toxicology, P.O. Box 123, 100 Jangdong, Yusung-gu, Daejeon 305-343, Republic of Korea.
Regul Toxicol Pharmacol. 2014 Apr;68(3):378-86. doi: 10.1016/j.yrtph.2014.01.008. Epub 2014 Jan 27.
Hwangryunhaedok-tang (Huang-Lian-Jie-Du-Tang in Chinese, Oren-gedoku-to in Japanese) is a traditional herbal medicine with a long history of use for anti-inflammatory purposes. In this study, subchronic toxicity of daily oral administration of a Hwangryunhaedok-tang water extract (HHT) at 0, 250, 750, and 2000mg/kg for 13weeks was examined in rats. Mortality, clinical signs, and changes in body weight, food consumption, clinical signs, ophthalmological examination, urinalysis, hematology, serum biochemistry, gross observation, organ weight, and histopathology were monitored in accordance with Good Laboratory Practice and OECD guidelines. We found no mortality or abnormality in clinical signs, body weight, serum biochemistry, or organ weight in HHT-treated groups in either sex. However, there were significant changes in glucose, bilirubin, urobilinogen, protein (only male) in urine after 2000mg/kg/day HHT treatment for both sexes. In hematological examinations, we found a significant decreased number of red blood cells (RBC), whereas, an increased the mean corpuscular volume, number of platelets, and rate of reticulocyte (RET) after 2000mg/kg/day HHT treatment of male rats. In male and female rats, 750 and 2000mg/kg/day HHT treatment decreased the number of RBC and increased RET. Histopathological examinations revealed stomach mucosal erosion in female rats (2000mg/kg/day). No-observed-adverse-effect levels were established for 750mg/kg HHT in rats under the conditions of this study. However, other toxicological studies are necessary to evaluate the safety of HHT fully.
黄连解毒汤（黄连解毒汤，中文；oren-gedoku-to，日语）是一种具有悠久历史的传统草药，用于抗炎目的。在这项研究中，通过每日口服黄连解毒汤水提取物（HHT），在大鼠中检查了为期 13 周的 0、250、750 和 2000mg/kg 的亚慢性毒性。按照良好实验室规范和 OECD 指南监测死亡率、临床症状以及体重、食物消耗、临床症状、眼科检查、尿液分析、血液学、血清生物化学、大体观察、器官重量和组织病理学的变化。我们没有发现 HHT 治疗组在雌雄两性中的死亡率或临床症状、体重、血清生物化学或器官重量的异常。然而，在雌雄两性中，在 2000mg/kg/天时，尿液中的葡萄糖、胆红素、尿胆素原、蛋白质（仅雄性）有显著变化。在血液学检查中，我们发现红细胞（RBC）数量显著减少，而在雄性大鼠中，平均红细胞体积、血小板数量和网织红细胞（RET）的比例增加。在雄性和雌性大鼠中，750 和 2000mg/kg/天的 HHT 治疗降低了 RBC 数量并增加了 RET。组织病理学检查显示雌性大鼠胃黏膜糜烂（2000mg/kg/天）。在本研究条件下，750mg/kg 的 HHT 确定为无观察到不良效应水平。然而，需要进行其他毒理学研究来全面评估 HHT 的安全性。
