title: A toxicological study of HangAmDan-B in mice.
abstract: The aim of the study was to define the toxicity of HangAmDan-B (HAD-B) in mice over the short and long term. HAD-B was studied in 1-week single and 5-week repeated oral dose toxicity tests on male Imprinting Control Region mice. Doses used in 1 week single oral dose toxicity tests were 0, 0.2, 1, 5, and 25 g/kg/day and those of repeated toxicity test were 0, 0.04, 0.2, 1, and 2 g/kg/day. Blood and urine samples were assayed and their morphology observed. Numerical data were compared using Mann-Whitney U test and analysis of variance. Significantly decreased red blood cell levels in mice from S2-HAD-B, S3-HAD-B, S4-HAD-B, and S5-HAD-B groups were observed in single oral dose toxicity tests. Hemoglobin, hematocrit, and mean cell hemoglobin values in mice from the S4-HAD-B and S5-HAD-B groups were also significantly decreased. No mortalities or significant differences in all factors were observed during the dosing period of the repeated dose toxicity test. Administering 2 g/kg/day of HAD-B in mice over a 5-week period showed no significant hematological changes. However, risk of anemia with more than 5 g/kg/ day administration of HAD-B was found. In general, HAD-B appears to be safe and nontoxic, and a no observed adverse effect level in mice was established at 2 g/kg/ day. This data serves as satisfactory preclinical evidence for the safety of HAD-B should a future clinical trial for HAD-B be launched. Further studies are required to confirm these safety results and to carry out a safety trial in humans.
authors: East-West Cancer Center, College of Oriental Medicine, Daejeon University, Daejeon, Korea. altyhs@dju.ac.kr
authors: Hwa-Seung
authors: HS
authors: Yoo
authors: Hyo-Jae
authors: HJ
authors: Lee
authors: Jung-Sun
authors: JS
authors: Kim
authors: Jeungwon
authors: J
authors: Yoon
authors: Grace H
authors: GH
authors: Lee
authors: Yeon-Weol
authors: YW
authors: Lee
authors: Chong-Kwan
authors: CK
authors: Cho
mesh_terms: D000704:Analysis of Variance; D000740:Anemia / Q000209:etiology*; D000818:Animals; D002417:Cattle; D032661:Cordyceps; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal / Q000633:toxicity*; D004906:Erythrocyte Count; D006400:Hematocrit; D006454:Hemoglobins / Q000378:metabolism*; D019684:Magnoliopsida; D008297:Male; D055670:Medicine, Korean Traditional; D051379:Mice; D008815:Mice, Inbred Strains; D018709:Statistics, Nonparametric
chemical_list: D004365:Drugs, Chinese Herbal; D006454:Hemoglobins