Journal of Applied Biological Chemistry

The Korean Society for Applied Biological Chemistry (한국응용생명화학회)
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4-week dose range finding toxicity test of Magnoliae Flos extract in Sprague-Dawley rats

Sprague-Dawley 랫드를 이용한 신이 추출물의 4주 반복 용량 결정 독성시험

  • Received : 2021.12.17
  • Accepted : 2022.01.25
  • Published : 2022.03.31
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Abstract

Medicinal herb demonstrated in many pharmacological effects and recognized to be safe has been used for a long time. However, side effects including safety of medicinal herb have not been identified yet. The aim of the study was to estimate safety evaluation of Magnoliae Flos used for the treatment of pain, rhinitis, and pneumonia in Korea, China and Japan through four-week dose range finding toxicity test in male and female Sprague-Dawley rats. Magnoliae Flos was orally administered to male and female SD rats once a day for 28 days at 1,500 and 3,000 mg/kg. The safety evaluation was determined to examine clinical signs, mortality, body weight, food intake, hematology, serum biochemistry and relative organ weights and there were no significant changes related toxicity. Consequently, these findings indicates that Magnoliae Flos did not show any side effects including toxicity in dose range finding toxicity test and the no observed adverse effect level for Magnoliae Flos was estimated as more than 3,000 mg/kg.

많은 약리학적 효과가 입증되고 안전하다고 인정되는 생약제를 포함한 천연물은 오랫동안 사용되어 왔다. 다만 생약제로 사용되는 천연물의 안전성 등 부작용은 명확하게 확인되지 않았다. 이번 연구의 목적은 통증, 비염, 폐렴 치료에 사용되는 신이의 안정성 평가를 확인하기 위하여 SD 랫드 동물모델을 이용하여 4주 반복 용량 결정 독성시험으로 신이의 독성평가를 수행하였다. 수컷과 암컷 SD 랫드에 신이추출물을 28일 동안 1,500, 3,000 mg/kg의 농도로 하루 1회 경구 투여하였다. 신이추출물의 안정성 평가는 일반증상관찰, 체중 및 사료섭취량 측정, 혈구 및 혈액생화학 분석, 부검소견 관찰 및 상대적 장기무게 측정으로 판단하였으며 실험기간동안 신이추출물의 투여로 독성 관련 유의미한 변화는 나타나지 않았다. 따라서 이러한 연구결과는 4주 반복 용량 결정 독성시험에서 신이추출물이 독성 등 부작용은 나타나지 않았으며, 신이추출물의 독성이 나타나지 않는 최대무독성량은 3,000 mg/kg 이상으로 추정되었다.

Keywords

Acknowledgement

본 연구는 산림청(한국임업진흥원) 산림과학기술 연구개발사업 '2021373B10-2123-BD02'의 지원에 의하여 이루어진 것입니다.

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