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

다국어 초록 (Multilingual 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.

참고문헌 (Reference)

1 진보람, "산수유, 보골지 복합추출물의 Sprague-Dawley rat를 이용한단회경구투여 독성시험" 대한본초학회 34 (34): 31-36, 2019

2 Ministry of Food and Drug Safety, "Standards for managing toxicity testing of medicines"

3 노종현, "Sprague-Dawley Rats을 이용한 결명자 물 추출물의 26주 반복 경구투여 독성시험 및 4주 회복시험" 한국약용작물학회 26 (26): 157-169, 2018

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5 Oriental Medicine Dictionary Compilation Committee, "Oriental Medicine Dictionary" Jungdam 587-588, 2018

6 "Ministry of Food and Drug safety"

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9 황보현, "Corni Fructus attenuates testosterone-induced benign prostatic hyperplasia by suppressing 5α-reductase and androgen receptor expression in rats" 한국영양학회 12 (12): 378-386, 2018

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11 Wei Ma, "Bioactive compounds from Cornus officinalis fruits and their effects on diabetic nephropathy" 153 : 840-845, 2014

12 Jin BR, "Anti-Proliferative Effects of HBX-5 on Progression of Benign Prostatic Hyperplasia" 23 (23): 2683-, 2018