Park Jong-Hun, Ra Jong-Sung, Kwon Jeong Eun, Her Yang-Mi, Choe Tae Hwan, Lee Yoon-Seo, Suh Hee Ju, Shin Seung-Yeon, Park Dae Won, Kwak Ho-Hyun, Woo Heung-Myong, Jeon Hyelin, Kang Se Chan
College of Veterinary Medicine and Institute of Veterinary Science, Kangwon National University, 1, Kangwondaehak-gil, Chuncheon-si, Gangwon-do 24341 Republic of Korea.
Department of Oriental Medicine Biotechnology, Kyung Hee University, 1732, Deogyong-daero, Giheung-gu, Yongin-si, Gyeonggi-do 17104 Republic of Korea.
Toxicol Res. 2020 Apr 14;36(4):367-406. doi: 10.1007/s43188-020-00042-5. eCollection 2020 Oct.
(AP) and (RG) are traditional medicinal plants. The bioflavonoid composition standardized by HPLC analysis was named APRG64. Despite many studies reported to beneficial bioactivities of AP and RG, very limited range of toxicity tests have documented. So, we did experiment diversely on the toxicity tests of the substance APRG64. Genotoxicity (mammalian chromosomal aberration test, micronoucleus test) against APRG64, acute and sub-chronic toxicity test from rodent/non-rodent, and systemic safety pharmacology test were conducted. As a result of the test, genotoxicity against APRG64 was not observed. The NOAEL of rodents was confirmed as 2000 mg/kg/day and non-rodents was confirmed as 500 mg/kg/day. In addition, systemic safety pharmacological toxicity (effects on respiratory system, central nervous system, cardiovascular system) following administration of APRG64 was not observed. Finally, we accomplished ten potential toxicity tests and evaluated extensive safety of APRG64. Consequently, APRG64 may be a promising material for nutraceuticals and natural medicines.
(AP)和(RG)是传统药用植物。通过高效液相色谱分析标准化的生物类黄酮成分被命名为APRG64。尽管有许多研究报道了AP和RG的有益生物活性，但记录的毒性测试范围非常有限。因此，我们对物质APRG64进行了多种毒性测试实验。针对APRG64进行了遗传毒性（哺乳动物染色体畸变试验、微核试验）、啮齿动物/非啮齿动物的急性和亚慢性毒性试验以及全身安全药理学试验。测试结果显示，未观察到APRG64的遗传毒性。啮齿动物的无观察到有害作用水平（NOAEL）被确认为2000毫克/千克/天，非啮齿动物为500毫克/千克/天。此外，未观察到APRG64给药后的全身安全药理学毒性（对呼吸系统、中枢神经系统、心血管系统的影响）。最后，我们完成了十项潜在毒性测试并评估了APRG64的广泛安全性。因此，APRG64可能是一种有前途的营养保健品和天然药物材料。
