The Korea Journal of Herbology (대한본초학회지)

The Korea Association of Herbology (대한본초학회)
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A 13-Week Repeated Oral Dose Toxicity Test and a 4-Week Recovery Test of Standardized Cornus officinalis and Psoralea corylifolia L . in Sprague-Dawley Rats

산수유(山茱萸)와 보골지(補骨脂) 복합추출물의 Sprague-Dawley 랫드를 이용한 13 주 반복경구투여 독성시험 및 4 주 회복시험

  • Sim, Seo-Ah (Department of Pharmacology, College of Korean Medicine, Sangji University) ;
  • Kang, Sung-Chul (Department of Pharmacology, College of Korean Medicine, Sangji University) ;
  • Jin, Bo-Ram (Department of Pharmacology, College of Korean Medicine, Sangji University) ;
  • Kim, Min-jeong (Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Sangji University) ;
  • Yeo, Sujung (Department of Meridian & Acupoint, College of Korean Medicine, Sangji University) ;
  • Park, In-hwa (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Sangji University) ;
  • Jerng, Ui Min (Department of Internal Medicine, College of Korean Medicine, Sangji University) ;
  • Cha, Yun-yeop (Department of Rehabilitation Medicine of Korean Medicine, College of Korean Medicine, Sangji University) ;
  • Ahn, Ji-Hye (Department of Oriental Pharmacy, College of Pharmacy, Woosuk University) ;
  • An, Hyo-Jin (Department of Pharmacology, College of Korean Medicine, Sangji University)
  • 심서아 (상지대학교 한의과대학 약리학교실) ;
  • 강성철 (상지대학교 한의과대학 약리학교실) ;
  • 진보람 (상지대학교 한의과대학 약리학교실) ;
  • 김민정 (상지대학교 한의과대학 침구의학교실) ;
  • 여수정 (상지대학교 한의과대학 경혈학교실) ;
  • 박인화 (상지대학교 한의과대학 한의학과 재활의학과) ;
  • 정의민 (상지대학교 한의과대학 내과) ;
  • 차윤엽 (상지대학교 한의과대학 한의학과 재활의학과) ;
  • 안지혜 (우석대학교 약학대학 한약학과) ;
  • 안효진 (상지대학교 한의과대학 약리학교실)
  • Received : 2021.10.12
  • Accepted : 2021.11.25
  • Published : 2021.11.30
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Abstract

Objectives : In the current study, we performed the 13-week repeated oral dose toxicity test and a 4-week recovery test of standardized Cornus officinalis Sieb. et Zucc. and Psoralea corylifolia L. 30 % ethanol extract (SCP) in Sprague-Dawley (SD) rats owing to aims for verifying no observed adverse effect level (NOAEL). Methods : The animal study was performed according to OECD guidelines for the testing of chemicals section 4 health effects test No.408 repeated dose 90-day oral toxicity study in rodents (03 October 2008). In the repeated dose toxicity study, SCP was orally administered to female and male rats at dose levels of 1,000, 2,000, and 4,000 mg/kg/day for 13-week. The control group and high dose (4,000 mg/kg/day) group were then monitored for 4 extra weeks to determine recovery time after the study period. 1) Results : Compared with the control group, there were no treatment-related adverse effects in clinical signs, body weight, hematology, serum biochemistry (Aspartate aminotransferase, Alanine aminotransferase, Alkaline phosphatase, 𝛾-Glutamyl transpeptidase, Blood urea nitrogen, Creatinine, Glucose, Total cholesterol, Total protein, Creatine phosphokinase, Albumin, Total bilirubin, Triglyceride, Inorganic phosphorus, Albumin/Globulin ratio, Calcium ion, Sodium ion, Potassium ion, Chloride ion), necropsy findings and organ weight (Ovary, Adrenal gland, Pituitary, Thymus, Prostate, Testis, Epididymis, Spleen, Kidney, Heart, Lung, Brain, Liver) at any dose tested. Conclusions : Taken together, these results suggest that the NOAEL of SCP in both genders was considered as over 4,000 mg/kg. Results from this study provide scientific evidence for the safety of SCP.

Keywords

Acknowledgement

이 연구는 2020년 상지대학교 교내과제 지원사업 및 상지대학교 대학원 지원에 의하여 수행되었음

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