Biotoxtech. Co. Ltd, Cheongju, 13000, South Korea.
International Ginseng and Herb Research Institute, Geumsan, 312-804, South Korea.
Regul Toxicol Pharmacol. 2019 Jun;104:157-162. doi: 10.1016/j.yrtph.2019.03.010. Epub 2019 Mar 21.
Korean red ginseng and its extract have been used as traditional medicines and functional foods in countries worldwide. Pectin lyase-modified red ginseng extract (GS-E3D) was newly developed as a dietary supplement for obesity, diabetes-related renal dysfunction, etc. In this study, the safety of GS-E3D on acute toxicity and genotoxicity was evaluated. For acute study, Sprague-Dawley rats were administrated by oral gavage at a dose of 5000 mg/kg GS-E3D. To evaluate genotoxicity of GS-E3D, we conducted three-battery tests, which are Ames test using Escherichia coli (WP2uvrA pKM101) and Salmonella typhimurium strains (TA98, TA100, TA1535 and TA1537), chromosomal aberration test -using Chinese hamster lung cells, and micronucleus test using ICR mice. In acute toxicity studies, there were no dead animals or abnormal necropsy findings in the control group and GS-E3D (5000 mg/kg) treated group. GS-E3D did not induce mutagenicity in the bacterial test, chromosomal aberrations in Chinese hamster lung cells and micronuclei in bone marrow cells of mice. Conclusively, the approximate lethal dose of GS-E3D was greater than 5000 mg/kg bw and GS-E3D has no genotoxic potential in the three-battery tests on genotoxicity.
高丽红参及其提取物已被世界各国用作传统药物和功能性食品。果胶裂解酶修饰的红参提取物（GS-E3D）是新开发的一种用于肥胖症、糖尿病相关肾功能障碍等的膳食补充剂。在这项研究中，评估了 GS-E3D 的急性毒性和遗传毒性安全性。在急性研究中，Sprague-Dawley 大鼠经口灌胃给予 5000mg/kg GS-E3D。为了评估 GS-E3D 的遗传毒性，我们进行了三项测试，即使用大肠杆菌（WP2uvrA pKM101）和鼠伤寒沙门氏菌（TA98、TA100、TA1535 和 TA1537）的艾姆斯试验、中国仓鼠肺细胞的染色体畸变试验和 ICR 小鼠的微核试验。在急性毒性研究中，对照组和 GS-E3D（5000mg/kg）处理组均无动物死亡或异常尸检发现。GS-E3D 未在细菌试验、中国仓鼠肺细胞染色体畸变和小鼠骨髓细胞微核中诱导致突变性。总之，GS-E3D 的近似致死剂量大于 5000mg/kg bw，并且在遗传毒性的三项测试中，GS-E3D 没有遗传毒性潜力。
