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박화용,황윤환,장두례,하정호,정기연,마진열,Park, Hwayong,Hwang, Youn-Hwan,Jang, Doorye,Ha, Jeong-Ho,Jung, Kiyoun,Ma, Jin Yeul 대한한의학방제학회 2012 大韓韓醫學方劑學會誌 Vol.20 No.2
Objectives : Traditional medicine Gumiganghwal-tang (GT) has been used in Asia to treat inflammatory diseases including common cold, pain, fever, and algor. In this study we investigated the acute toxicity and safety of GT and fermented GT (FGT). Methods : Acute toxicity and safety were evaluated in male and female ICR mice orally administered 0 (control) and 2,000 mg/kg of GT and FGT. After the administration of GT and FGT, we observed mortality, body weight, clinical symptoms. After necropsy, organ weights were measured and blood analysis was performed. Results : There was no mortality and clinical symptoms according to the administration of GT and FGT. Comparing with control group, there were no significant alterations on the organ weight, complete blood cell count and biochemical parameters. Conclusions : Median lethal dose of GT and FGT considered to be over 2,000 mg/kg in both male and female mice, and recognized as safe with no toxicity.
Single, repeated dose toxicity and genotoxicity assessment of herb formula KIOM2012H
박화용,황윤환,마진열 한국한의학연구원 2017 Integrative Medicine Research Vol.6 No.4
Background: Traditional medicine and herbal prescriptions are becoming more popular, and they account for a large share of the world’s healthcare research studies, developments, and market demands. Increasing scientific evidence of the substantive efficacies such as preventive health keeping pharmaceutical materials and dietary supplements can be found elsewhere. Above all, safety should be the critical premise for considering developmental materials such as pharmaceuticals without side effects and toxicity. Methods: The authors formulated KIOM2012H (K2H) using four herbs that were reported to have medicinal effects—including anticancer, antiaging, antimicrobial, inflammation, and neuroprotective properties. In order to examine the toxicity, single and repeated dose toxicity, and genotoxicities of bacterial mutation, micronucleus, and chromosomal aberration assays were conducted. Results: All experimental observations and results showed normal findings. Toxicities or abnormal signs were not observed in all experimental assays, including oral administration, animal behavior, clinical findings, and changes in body weight in vivo. In vitro bacterial cultures produced no revertant colonies, and no increased numbers of structural or numerical aberrant metaphases were found in the metaphase chromosomes examined. Moreover, no significant increased frequency of micronucleus was observed in any of the doses used. Overall, no acute toxicity or genotoxicity was found in all analysis parameters in all the assays conducted. Conclusion: Reviewing the results as a whole, K2H extract was regarded as a safe material with no toxicity, and can be applied for the research and development of complementary and alternative medicines with improved efficacy in current therapeutic healthcare, based on traditional medicine and herb resources.
박화용,황윤환,하정호,정기연,마진열,Park, Hwayong,Hwang, Youn-Hwan,Ha, Jeong-Ho,Jung, Kiyoun,Ma, Jin Yeul 대한한의학방제학회 2013 大韓韓醫學方劑學會誌 Vol.21 No.1
Objectives : Traditional medicine Oryeong-san (ORS) has been prescribed for a long time to treat light fever, thirst, dysuria, and accompanying edema. However, the acute toxicity and safety were not reported. In this study, we evaluated the potent acute toxicity and safety of ORS. Methods : ICR mice were used to evaluate acute toxicity and safety by oral administration of 0, 500, 1,000, 2,000mg/kg of ORS. Mortality, body weight, and clinical symptoms were observed, and organ weight and blood biochemical parameters were analyzed after necropsy. Results : We found no mortality and no toxic or abnormal clinical symptoms by administration of ORS. Comparing with control group, no significant alterations in organ weight and blood biochemical parameters were observed. Conclusions : ORS recognized as safe and non-toxic medicinal material, and median lethal dose considered to be over 2,000 mg/kg in both male and female ICR mice.
Acute toxicity and genotoxicity of fermented traditional medicine oyaksungi-san
박화용,황윤환,마진열 한국한의학연구원 2017 Integrative Medicine Research Vol.6 No.2
Background: The traditional medicine oyaksungi-san (OY) has been prescribed in East Asia for hundreds of years for the treatment of stroke, paralysis, and ataxia. OY also has therapeutic effects on arthralgia, myalgia, and rheumatoid arthritis, and recent studies have shown its protective effects against apoptosis of hippocampal cells and its anti-inflammatory effects on the peripheral blood cells of patient with cerebral infarction. Many studies have explored the use of traditional medicine and herb materials in the development of safe, novel, and effective pharmaceuticals with fewer side effects. These efforts commonly adopt a bioconversion tool for fermentation with beneficial microbes. However, only pharmaceuticals with high levels of safety and low levels of toxicity can be used in healthcare system. Methods: OY water extract was fermented with Lactobacillus and assayed for acute toxicity and genotoxicity. Single dose acute toxicity, bacterial reverse mutation, chromosome aberrations, and micronucleus were observed and assayed in rats, histidine/tryptophan auxotrophic bacteria, Chinese hamster ovary fibroblast cells, and mice bone marrow cells, respectively. Results: All the experimental animals showed no abnormal behavior, clinical signs, body weight increases, or mortality. In the bacterial cultures, no revertant colonies were observed. Morphological and numerical chromosomal aberrations were not found in all metaphases examined. Frequency of induced micronuclei was not significantly increased in all doses applied. Conclusion: As a whole, no acute toxicity or genotoxicity were observed in all the assays examined. Therefore, fermented OY is considered to be a safe material that can be used for development of complementary and alternative medicine using bioconversion.