title: Acute toxicity and genotoxicity study of fermented traditional herb formula Guibi-tang.
abstract: BACKGROUND
  Guibi-tang (Guipi-tang in Chinese and Kihi-to in Japanese) is a multi-herb traditional medicine commonly prescribed to treat psychoneurosis in East Asia. Although this medicine has been widely used, there is little available information on the safety and toxicity of Guibi-tang, especially on the fermented one.
  
  
  METHODS
  Guibi-tang, composed of 12 herbs, was fermented with bacteria and lyophilized. Single dose acute toxicity in rats was observed for 14 days after administration. Genetic toxicity of fermented Guibi-tang was evaluated on bacterial reverse mutation in Salmonella and Escherichia spp., chromosome aberrations in Chinese hamster ovary cells, and micronucleus formation in mice. Ingredients in FGBT were identified and quantified by high performance liquid chromatography-mass spectrometry.
  
  
  RESULTS
  In acute oral toxicity study, behavior, clinical signs and body weight changes were normal observing in all experimental animals. No revertant colonies were found in any bacterial cultures examined. Morphological or numerical anomalies and significant increased number of aberrant metaphases were not observed. Micronucleus assay showed no significant increases in the frequency of inducing micronuclei in any dose examined. Decursinol, decursin, glycyrrhizin, and 6-gingerol in fermented Guibi-tang were identified and quantitated. As a whole, no acute and genotoxic effects were found in all the assays and parameters analyzed.
  
  
  CONCLUSIONS
  Fermented Guibi-tang was recognized as safe and non-toxic, and therefore can be used for applications of traditional medicine in modern complementary and alternative therapeutics and health care.
authors.affiliation: KM-based Herbal Drug Development Group, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 305-811, Republic of Korea. Electronic address: uofaz@kiom.re.kr.
authors.forename: Hwayong
authors.initials: H
authors.lastname: Park
authors.affiliation: KM-based Herbal Drug Development Group, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 305-811, Republic of Korea. Electronic address: hyhhwang@kiom.re.kr.
authors.forename: Youn-Hwan
authors.initials: YH
authors.lastname: Hwang
authors.affiliation: KM-based Herbal Drug Development Group, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 305-811, Republic of Korea. Electronic address: hjyang@kiom.re.kr.
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Yang
authors.affiliation: Nutraceutical Food R&D center, Kolmar BNH, 22-15 Sandan-gil, Jeonui-myeon, Sejong 339-851, Republic of Korea. Electronic address: hkkim@kolmarbnh.co.kr.
authors.forename: Hyun-Kyu
authors.initials: HK
authors.lastname: Kim
authors.affiliation: Korea Conformity Laboratories, 8 Gaetbeol-ro 145beon-gil, Yeonsu-gu, Incheon 406-840, Republic of Korea. Electronic address: songks@kcl.re.kr.
authors.forename: Kyung Seuk
authors.initials: KS
authors.lastname: Song
authors.affiliation: KM-based Herbal Drug Development Group, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 305-811, Republic of Korea. Electronic address: jyma@kiom.re.kr.
authors.forename: Jin Yeul
authors.initials: JY
authors.lastname: Ma
mesh_terms: D000818:Animals; D001835:Body Weight / Q000187:drug effects; D016466:CHO Cells; D002460:Cell Line; D002869:Chromosome Aberrations / Q000139:chemically induced*; D003412:Cricetulus; D004365:Drugs, Chinese Herbal / Q000009:adverse effects*; D004925:Escherichia / Q000187:drug effects; D005260:Female; D005285:Fermentation; D008297:Male; D051379:Mice; D015162:Micronucleus Tests / Q000379:methods; D009152:Mutagenicity Tests / Q000379:methods; D009154:Mutation / Q000187:drug effects; D010936:Plant Extracts / Q000009:adverse effects*; D010946:Plants, Medicinal / Q000009:adverse effects*; D051381:Rats; D017207:Rats, Sprague-Dawley; D012475:Salmonella / Q000187:drug effects
chemical_list: D004365:Drugs, Chinese Herbal; D010936:Plant Extracts; C578965:guipi
keywords: Fermentation; Genotoxicity; Guibi-tang; Traditional medicine