{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T02:26:06Z","timestamp":1787970366527,"version":"build-2784847793"},"reference-count":26,"publisher":"MDPI AG","issue":"13","license":[{"start":{"date-parts":[[2022,6,24]],"date-time":"2022-06-24T00:00:00Z","timestamp":1656028800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100003718","name":"Korea Institute of Oriental Medicine","doi-asserted-by":"publisher","award":["KSN2013310"],"award-info":[{"award-number":["KSN2013310"]}],"id":[{"id":"10.13039\/501100003718","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100003718","name":"Korea Institute of Oriental Medicine","doi-asserted-by":"publisher","award":["KSN2022310"],"award-info":[{"award-number":["KSN2022310"]}],"id":[{"id":"10.13039\/501100003718","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>Siryung-tang (SRT) is a traditional herbal prescription containing Oryeong-san and Soshiho-tang that is used to treat digestive system diseases. We performed safety evaluations of SRT based on genotoxicity and developed an assay for quality control using high-performance liquid chromatography with a photodiode array detector. Genotoxicity was evaluated based on bacterial reverse mutation (Salmonella typhimurium TA1535, TA98, TA100, and TA1537, and Escherichia coli WP2 uvrA), chromosomal aberration (Chinese hamster lung cells), and micronucleus (mouse) tests. Quality control analysis was conducted using a SunFire C18 column and gradient elution with a distilled water\u2013acetonitrile mobile phase system containing 0.1% (v\/v) formic acid for 12 markers (5-(hydroxy-methyl)furfural, 3,4-dihydroxybenzaldehyde, liquiritin apioside, liquiritin, coumarin, baicalin, wogonoside, cinnamaldehyde, baicalein, glycyrrhizin, wogonin, and atractylenolide III). SRT showed no genotoxicity in three tests. Ames tests showed that SRT at 313\u20135000 \u03bcg\/plate did not significantly increase the number of revertant colonies with or without metabolic activation among five bacterial strains. Moreover, in vivo micronucleus testing showed that SRT did not increase the frequency of bone marrow micronuclei. The number of chromosomal aberrations associated with SRT was similar to that observed in the negative controls. The 12 markers were detected at 0.04\u201316.86 mg\/g in a freeze-dried SRT sample and completely eluted within 45 min. The extraction recovery was 95.39\u2013104.319% and the relative standard deviation value of the precision was \u22642.09%. Our study will be used as basic data for the safety and standardization of SRT.<\/jats:p>","DOI":"10.3390\/molecules27134066","type":"journal-article","created":{"date-parts":[[2022,6,26]],"date-time":"2022-06-26T21:01:41Z","timestamp":1656277301000},"page":"4066","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["In Vitro and In Vivo Genotoxicity Assessments and Phytochemical Analysis of the Traditional Herbal Prescription Siryung-Tang"],"prefix":"10.3390","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8156-446X","authenticated-orcid":false,"given":"Chang-Seob","family":"Seo","sequence":"first","affiliation":[{"name":"KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mi-Sook","family":"Jung","sequence":"additional","affiliation":[{"name":"Advanced Toxicity Evaluation Team 2, Biotoxtech Co., Ltd., Cheongju 28115, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyeun-Kyoo","family":"Shin","sequence":"additional","affiliation":[{"name":"KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7337-2460","authenticated-orcid":false,"given":"Mee-Young","family":"Lee","sequence":"additional","affiliation":[{"name":"KM Convergence Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2022,6,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1016\/S1674-6384(17)60071-6","article-title":"LC\u2013MS\u2013based metabolomics in traditional Chinese medicine research: Personal experiences","volume":"9","author":"Mao","year":"2017","journal-title":"Chin. Herbal Med."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2113","DOI":"10.1002\/jssc.200800134","article-title":"Traditional Chinese medicine and separation science","volume":"31","author":"Liu","year":"2008","journal-title":"J. Sep. Sci."},{"key":"ref_3","first-page":"1779","article-title":"Case report of post-herpetic neuralgia by Siryung-tang (chailing-tang)","volume":"20","author":"Yun","year":"2006","journal-title":"Korean J. Orient. Physiol. Pathol."},{"key":"ref_4","unstructured":"Heo, J. (2007). Donguibogam, Namsandang."},{"key":"ref_5","unstructured":"(2021, August 23). Saireito. Available online: https:\/\/kampo.ca\/herbs-formulas\/formulas\/saireito\/."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"98","DOI":"10.1159\/000235999","article-title":"The traditional herbal medicine Saireito exerts its inhibitory effect on murine oxazolone-induced colitis via the induction of Th1-polarized immune responses in the mucosal immune system of the colon","volume":"151","author":"Watanabe","year":"2010","journal-title":"Int. Arch. Allergy Immunol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1248\/bpb.33.142","article-title":"The inhibitory effect of ergosterol, a bioactive constituent of a traditional Japanese herbal medicine Saireito on the activity of mucosal-type mast cell","volume":"33","author":"Wang","year":"2010","journal-title":"Biol. Pharm. Bull."},{"key":"ref_8","first-page":"110","article-title":"Suppression of murine colitis by Kampo medicines, with special reference to the efficacy of Saireito","volume":"26","author":"Endo","year":"2009","journal-title":"J. Trad. Med."},{"key":"ref_9","first-page":"611","article-title":"Effects of Shiryung-tang extract on the liver injury induced by ethanol in rats","volume":"27","author":"Kim","year":"2013","journal-title":"Korean J. Orient. Physiol. Pathol."},{"key":"ref_10","first-page":"161","article-title":"A study of Kampo medicines in a diabetic nephropathy model","volume":"18","author":"Nakagawa","year":"2001","journal-title":"J. Trad. Med."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1007\/BF01973686","article-title":"Effect of Sairei-to on gentamicin nephrotoxicity in rats","volume":"67","author":"Ohno","year":"1993","journal-title":"Arch. Toxicol."},{"key":"ref_12","first-page":"1","article-title":"Genotoxicity of extracts of Japanese traditional herbal medicines (Kampo)","volume":"24","author":"Katami","year":"2002","journal-title":"Environ. Mutagen Res."},{"key":"ref_13","unstructured":"OECD (1998). Principles of Good Laboratory Practice, Organization for Economic Co-Operation and Development: ENV\/MC\/CHEM(98)17."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Kato, S., Hayashi, S., Kitahara, Y., Nagasawa, K., Aono, H., Shibata, J., Utsumi, D., Amagase, K., and Kadowaki, M. (2015). Saireito (TJ-114), a Japanese traditional herbal medicine, reduces 5-fluorouracil-induced intestinal mucositis in mice by inhibiting cytokine-mediated apoptosis in intestinal crypt cells. PLoS ONE, 10.","DOI":"10.1371\/journal.pone.0116213"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"3707058","DOI":"10.1155\/2021\/3707058","article-title":"Saireito improves lymphatic function and prevents UVB-induced acute inflammation and photodamage in HR-1 hairless mice","volume":"2021","author":"Oyama","year":"2021","journal-title":"Evid. Based Complement. Alternat. Med."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"2960","DOI":"10.1016\/j.phytochem.2007.06.028","article-title":"Phytochemistry and pharmacology","volume":"68","author":"Phillipson","year":"2007","journal-title":"Phytochemistry"},{"key":"ref_17","first-page":"6610793","article-title":"Genetic toxicology and safety pharmacological evaluation of forsythin","volume":"2021","author":"Han","year":"2021","journal-title":"Evid. Based Complent. Alternat. Med."},{"key":"ref_18","first-page":"427","article-title":"The in vitro chromosomal aberration test using Chinese hamster lung (CHL) fibroblast cells in culture","volume":"5","author":"Ishidate","year":"1985","journal-title":"Prog. Mutat. Res."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1016\/0165-1218(85)90069-2","article-title":"Is there a continuing role for the intraperitoneal injection route of exposure in short-term rodent genotoxicity assays?","volume":"156","author":"Ashby","year":"1985","journal-title":"Mutat. Res."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"1084","DOI":"10.1038\/nprot.2007.77","article-title":"Cytokinesis-block micronucleus cytome assay","volume":"2","author":"Fenech","year":"2007","journal-title":"Nat. Protoc."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/S0027-5107(00)00064-6","article-title":"The Ames Salmonella\/microsome mutagenicity assay","volume":"455","author":"Mortelmans","year":"2000","journal-title":"Mutat. Res."},{"key":"ref_22","unstructured":"Lee, K.H. (2013). The Dispensatory on the Visual and Organoleptic Examination of Herbal Medicine, National Institute of Food and Drug Safety Evaluation."},{"key":"ref_23","doi-asserted-by":"crossref","unstructured":"Seo, C.S., and Shin, H.K. (2020). Simultaneous determination of 12 marker components in Yeonkyopaedok-san using HPLC\u2013PDA and LC\u2013MS\/MS. Appl. Sci., 10.","DOI":"10.3390\/app10051713"},{"key":"ref_24","unstructured":"OECD (2020). Guidelines for the Testing of Chemicals, 471, Bacterial Reverse Mutation Test, Organisation for Economic Co-Operation and Development."},{"key":"ref_25","unstructured":"OECD (2016). Guidelines for the Testing of Chemicals, 473, In Vitro Mammalian Chromosomal Aberration Test, Organisation for Economic Co-Operation and Development."},{"key":"ref_26","unstructured":"OECD (2016). Guidelines for the Testing of Chemicals, 474, Mammalian Erythrocyte Micronucleus Test, Organization for Economic Co-Operation and Development."}],"container-title":["Molecules"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1420-3049\/27\/13\/4066\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T23:39:19Z","timestamp":1760139559000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1420-3049\/27\/13\/4066"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,6,24]]},"references-count":26,"journal-issue":{"issue":"13","published-online":{"date-parts":[[2022,7]]}},"alternative-id":["molecules27134066"],"URL":"https:\/\/doi.org\/10.3390\/molecules27134066","relation":{},"ISSN":["1420-3049"],"issn-type":[{"value":"1420-3049","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,6,24]]}}}