Non-clinical safety assessment of Hwangryunhaedok-tang: 13-week toxicity in Crl:CD Sprague Dawley rats.
Hwangryunhaedok-tang (Huang-Lian-Jie-Du-Tang in Chinese, Oren-gedoku-to in Japanese) is a traditional herbal medicine with a long history of use for anti-inflammatory purposes. In this study, subchronic toxicity of daily oral administration of a Hwangryunhaedok-tang water extract (HHT) at 0, 250, 750, and 2000mg/kg for 13weeks was examined in rats. Mortality, clinical signs, and changes in body weight, food consumption, clinical signs, ophthalmological examination, urinalysis, hematology, serum biochemistry, gross observation, organ weight, and histopathology were monitored in accordance with Good Laboratory Practice and OECD guidelines. We found no mortality or abnormality in clinical signs, body weight, serum biochemistry, or organ weight in HHT-treated groups in either sex. However, there were significant changes in glucose, bilirubin, urobilinogen, protein (only male) in urine after 2000mg/kg/day HHT treatment for both sexes. In hematological examinations, we found a significant decreased number of red blood cells (RBC), whereas, an increased the mean corpuscular volume, number of platelets, and rate of reticulocyte (RET) after 2000mg/kg/day HHT treatment of male rats. In male and female rats, 750 and 2000mg/kg/day HHT treatment decreased the number of RBC and increased RET. Histopathological examinations revealed stomach mucosal erosion in female rats (2000mg/kg/day). No-observed-adverse-effect levels were established for 750mg/kg HHT in rats under the conditions of this study. However, other toxicological studies are necessary to evaluate the safety of HHT fully.
Basic Herbal Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yusung-gu, Daejeon 305-811, Republic of Korea.
Mee-Young
MY
Lee
Basic Herbal Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yusung-gu, Daejeon 305-811, Republic of Korea.
Chang-Seob
CS
Seo
Division of Non-clinical Studies, Korea Institute of Toxicology, P.O. Box 123, 100 Jangdong, Yusung-gu, Daejeon 305-343, Republic of Korea.
Young-Bum
YB
Kim
Basic Herbal Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yusung-gu, Daejeon 305-811, Republic of Korea.
In-Sik
IS
Shin
Basic Herbal Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yusung-gu, Daejeon 305-811, Republic of Korea. Electronic address: hkshin@kiom.re.kr.
Hyeun-Kyoo
HK
Shin
D000818:Animals; D001663:Bilirubin / Q000652:urine; D004365:Drugs, Chinese Herbal / Q000633:toxicity*; D004906:Erythrocyte Count; D004909:Erythrocyte Indices / Q000187:drug effects; D005260:Female; D006029:Glycosuria / Q000139:chemically induced; D007668:Kidney / Q000187:drug effects / Q000473:pathology; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D011507:Proteinuria / Q000139:chemically induced; D017207:Rats, Sprague-Dawley; D013270:Stomach / Q000187:drug effects / Q000473:pathology; D059550:Toxicity Tests, Subchronic; D014558:Urobilinogen / Q000652:urine
D004365:Drugs, Chinese Herbal; C061676:oren gedoku to; D014558:Urobilinogen; D001663:Bilirubin
Hwangryunhaedok-tang; Safety; Subchronic; Toxicity; Traditional herbal medicine