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: Mee-Young Lee, Chang-Seob Seo, Yong-Bum Kim, Hyeun-Kyoo Shin
• Journal: Regulatory toxicology and pharmacology : RTP (Regul Toxicol Pharmacol) Vol. 73 Issue 2 Pg. 485-93 (Nov 2015) ISSN: 1096-0295 [Electronic] Netherlands
• PMID: 26432010 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2015 Elsevier Inc. All rights reserved.

Chemical References

• Drugs, Chinese Herbal

Topics

• Animals
• Body Weight (drug effects, physiology)
• Dose-Response Relationship, Drug
• Drugs, Chinese Herbal (chemistry, toxicity)
• Eating (drug effects, physiology)
• Female
• Male
• No-Observed-Adverse-Effect Level
• Organ Size (drug effects, physiology)
• Rats
• Rats, Sprague-Dawley
• Toxicity Tests, Subchronic (methods)