Che Jeong-Hwan, Yun Jun-Won, Kim Yun-Soon, Kim Seung-Hyun, You Ji-Ran, Jang Ja-June, Kim Hee Chan, Kim Hyeon Hoe, Kang Byeong-Cheol
Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea; Biomedical Center for Animal Resource and Development, Bio-Max Institute, Seoul National University, Seoul, Republic of Korea.
Department of Experimental Animal Research, Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
Regul Toxicol Pharmacol. 2015 Apr;71(3):379-87. doi: 10.1016/j.yrtph.2015.01.012. Epub 2015 Jan 30.
Although Sophorae radix (SR) has been traditionally used as a treatment for various clinical symptoms, a comprehensive investigation of its safety has not yet been carried out. Therefore, we present an evaluation of the toxicity of the SR extract that was performed according to the Organization for Economic Cooperation and Development test guidelines for subchronic toxicity and genotoxicity. In an oral subchronic study for 13 weeks, the repeated treatment of rats with 429 or 1500 mg/kg of the SR extract induced a dose-related change in body weight. In particular, the SR extract was observed to exert a significant increase in liver weight along with an increase in serum alkaline phosphatase and alanine transaminase. A small but statistically significant reductions in red blood cell, hemoglobin, and hematocrit levels in the SR extract-treated rats suggest the possibility that anemia, accompanied by liver injury, was at least partially induced. These findings indicate the no-observed-adverse-effect-level for the SR extract was considered to be 10mg/kg/d. And, the data obtained from the chromosome aberration assay showed that SR extract might be considered to be a weak clastogen although no significant micronucleus induction was observed in vivo. Despite the benefits that SR extract can exhibit, this study indicates that SR extract may possess hepatotoxic and genotoxic potential.
尽管苦参传统上被用于治疗各种临床症状，但尚未对其安全性进行全面研究。因此，我们根据经济合作与发展组织的亚慢性毒性和遗传毒性试验指南，对苦参提取物的毒性进行了评估。在一项为期13周的口服亚慢性研究中，用429或1500mg/kg的苦参提取物反复处理大鼠，导致体重出现剂量相关变化。特别是，观察到苦参提取物会使肝脏重量显著增加，同时血清碱性磷酸酶和谷丙转氨酶也增加。苦参提取物处理的大鼠红细胞、血红蛋白和血细胞比容水平虽有小幅但具有统计学意义的降低，这表明至少部分诱导了伴有肝损伤的贫血。这些结果表明，苦参提取物的未观察到不良反应水平被认为是10mg/kg/d。并且，从染色体畸变试验获得的数据表明，尽管在体内未观察到明显的微核诱导，但苦参提取物可能被认为是一种弱断裂剂。尽管苦参提取物可能具有益处，但本研究表明其可能具有肝毒性和遗传毒性潜力。
