| A 90-day repeated-dose oral toxicity study on Flos lonicerae extract in Fischer 344/N rats |
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Zhong-Ze Han, Hu-Song Zhang, Sang-Chul Kang, Ki-Hyun Gil, Kwang-Han Kong, Do-Hyung Kim, Tae-Hwan Ahn, Jin-Sook Bae, Hyeon-Kyu Go, Myoung-Kyu Han, Hak-Soo Kim, Hyun-Suk Heo, Eun-Mi Park, Si-Whan Song, Kap-Ho Kim, Chan-Koo Park, Hyun-Kul Lee |
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Preclinical Research Center |
| 금은화(Flos lonicerae) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험 |
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한충택, 장호송, 강상철, 길기현, 공광한, 김도형, 안태환, 배진숙, 고현규, 한명규, 김학수, 허현숙, 박은미, 송시환, 김갑호, 박찬구, 이현걸 |
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켐온 전임상 연구센터 |
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| Abstract |
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This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established. |
| Key Words:
F344/N rats, Flos lonicerae, repeated dose toxicity test |
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