title: Safety assessment of Guibi-tang: Subchronic toxicity study in Crl:CD SD rats.
abstract: Guibi-tang (Kihi-To in Japanese and Qui-Pi-Tang in Chinese) is a multiherbal traditional Korean medicinal formula used for treatment of amnesia, fatigue, poor memory or forgetfulness, anemia, insomnia, and necrosis. The aim of the present study was to investigate potential safety, if any, of subchronic administration of Guibi-tang aqueous extract (GBT) in laboratory animals. For this study, 0, 1000, 2000, and 5000 mg/kg/day of GBT was administered to Crl:CD Sprague Dawley rats (10/sex/group) for 13 weeks via oral gavage. Administration of the GBT did not result in any mortality, body weight, food consumption, hematology, serum biochemistry, clinical or ophthalmological signs or changes in urinalysis, gross findings, or organ weight. However, histopathology revealed forestomach hyperplasia and duodenum mucosal hyperplasia in rats of both sexes at the highest dose of GBT, 5000 mg/kg/day. Therefore, the no-observed-adverse-effect level in rats was established for GBT at 2000 mg/kg/day under the conditions of this study.
authors.affiliation: Herbal Medicine Formulation Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yuseong-gu, Daejeon 305-811, Republic of Korea.
authors.forename: Mee-Young
authors.initials: MY
authors.lastname: Lee
authors.affiliation: Herbal Medicine Formulation Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yuseong-gu, Daejeon 305-811, Republic of Korea.
authors.forename: Chang-Seob
authors.initials: CS
authors.lastname: Seo
authors.affiliation: Division of Non-clinical Studies, Korea Institute of Toxicology, P.O.Box 123, 100 Jangdong, Yuseong-gu, Daejeon 305-343, Republic of Korea.
authors.forename: Yong-Bum
authors.initials: YB
authors.lastname: Kim
authors.affiliation: Herbal Medicine Formulation Research Group, Korea Institute of Oriental Medicine, 483 Expo-ro, Yuseong-gu, Daejeon 305-811, Republic of Korea. Electronic address: hkshin@kiom.re.kr.
authors.forename: Hyeun-Kyoo
authors.initials: HK
authors.lastname: Shin
mesh_terms: D000818:Animals; D001835:Body Weight / Q000187:drug effects / Q000502:physiology; D004305:Dose-Response Relationship, Drug; D004365:Drugs, Chinese Herbal / Q000737:chemistry / Q000633:toxicity*; D004435:Eating / Q000187:drug effects / Q000502:physiology; D005260:Female; D008297:Male; D019055:No-Observed-Adverse-Effect Level; D009929:Organ Size / Q000187:drug effects / Q000502:physiology; D051381:Rats; D017207:Rats, Sprague-Dawley; D059550:Toxicity Tests, Subchronic / Q000379:methods*
chemical_list: D004365:Drugs, Chinese Herbal
keywords: Guibi-tang; Kihi-To; NOAE; Qui-Pi-Tang; Subchronic