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Evaluation of genetic toxicity, acute and sub-chronic oral toxicity and systemic safety of Agrimonia pilosa and Rhus gall 50% ethanolic extract mixture (APRG64) in vitro and in vivo (rodent and non-rodent animal models)

Toxicological Research 2020년 36권 4호 p.367 ~ 406
박종헌, 나종성, 권정은, 허양미, 최태환, 이윤서, 서희주, 신승연, Park Dae-Won, 곽호현, 우흥명, 전혜린, 강세찬,
소속 상세정보
박종헌 ( Park Jong-hun ) - Kangwon National University College of Veterinary Medicine
나종성 ( Ra Jong-Sung ) - Kyung Hee University Department of Oriental Medicine Biotechnology
권정은 ( Kwon Jeong-Eun ) - Kyung Hee University Department of Oriental Medicine Biotechnology
허양미 ( Her Yang-Mi ) - Kyung Hee University Department of Oriental Medicine Biotechnology
최태환 ( Choe Tae-Hwan ) - Kyung Hee University Department of Oriental Medicine Biotechnology
이윤서 ( Lee Yoon-Seo ) - Kyung Hee University Department of Oriental Medicine Biotechnology
서희주 ( Suh Hee-Ju ) - Kyung Hee University Department of Oriental Medicine Biotechnology
신승연 ( Shin Seung-Yeon ) - Kyung Hee University Department of Oriental Medicine Biotechnology
 ( Park Dae-Won ) - Kyung Hee University Department of Oriental Medicine Biotechnology
곽호현 ( Kwak Ho-Hyun ) - Kangwon National University College of Veterinary Medicine
우흥명 ( Woo Heung-Myong ) - Kangwon National University College of Veterinary Medicine
전혜린 ( Jeon Hye-Lin ) - Genencell Co. Ltd.
강세찬 ( Kang Se-Chan ) - Kyung Hee University Department of Oriental Medicine Biotechnology

Abstract


Agrimonia pilosa (AP) and Rhus gall (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.

키워드

Agrimonia pilosa; Rhus gall; Genotoxicity; Systemic safety pharmacological toxicity; Potential toxicity tests; Natural medicines; NOAEL

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