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Acute toxicity study of 77 herbal formulas according to GLP guidelines in rats

흰쥐에서 GLP 기준에 의한 한약처방 77종의 단회 투여 급성 독성 연구

  • Hyeun-kyoo Shin (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Woo-Young Jeon (KM Convergence Research Division, Korea Institute of Oriental Medicine) ;
  • Chang-Seob Seo (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Mee-Young Lee (Research Infrastructure Team, Korea Institute of Oriental Medicine)
  • 신현규 (한국한의학연구원 한의과학연구부) ;
  • 전우영 (한국한의학연구원 한의약융합연구부) ;
  • 서창섭 (한국한의학연구원 한의과학연구부) ;
  • 이미영 (한국한의학연구원 비임상연구협력팀)
  • Received : 2023.04.07
  • Accepted : 2023.07.14
  • Published : 2023.09.01

Abstract

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

Keywords

Acknowledgement

본 연구는 한국한의학연구원의 '한방의료기관 한약처방 안전성·유효성 구축 사업 (KSN1823310, KSN1823311)'에 의해 수행되었으며, 이에 감사드립니다.

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