• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.6
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• pp.1019-1026
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• 2010

The object of this study was to evaluate the single dose toxicity of Iijintanggami-bang (IJTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various digestive disorders including reflux esophagitis, in male and female mice. Aqueous extracts of IJTGMB (Yield = 8.45%) was administered to female and male ICR mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 12 principal organs were examined. As results, we could not find any mortality, clinical signs, and changesin the body and organ weight except for soft feces restricted to IJTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no IJTGMB-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of IJTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.

• The Journal of Korean Obstetrics and Gynecology
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• v.27 no.1
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• pp.28-40
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• 2014

Objectives: This study was to evaluate the single dose toxicity of Sobokchuko-tang (SBC) in male and female mice. Methods: Aqueous extract of SBC (yield=6.60%) was administered to female and male mice as an oral dose of 2,000, 1,000 and 500 mg/kg (body weight) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines. Animals were monitored for the mortality and changes in body weight, clinical signs and gross observation during 14 days after dosing, upon necropsy; organ weight and histopathology of 14 principle organs were also examined. Results: we could not find any SBC treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for pharmacological immunomodulatory effects related findings including significant increases of submandibular lymph node weights, hypertrophy and hyperplasia of lymphoid cells in the submandibular lymph nodes restrictly detected in 2,000 mg/kg treated female and male mice with some sporadic accidental findings. Conclusions: The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of SBC aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines, and can be safety used in clinics.

• Journal of Physiology & Pathology in Korean Medicine
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• v.23 no.5
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• pp.1145-1153
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• 2009

The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.

• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.2
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• pp.186-194
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• 2014

The object of this study was to obtain acute toxicity information (single-dose oral toxicity) of Woohwangchungshim-won (WHCSW), a pill type herbal medicine used in Korean Medicine (KM) for treating stroke. In order to obtain the 50% lethal dose (LD50), approximate lethal dosage (ALD) and target organs, WHCSW powders were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.) according to the recommendation of Korea Food and Drug Administration (KFDA) Guidelines (Notification No. 2009-116). The mortality and changes in the body weight, clinical signs and gross observation were monitored for 14 days after single-dose oral administration of WHCSW according to KFDA Guidelines with organ weights and histopathological changes were observed in 12 principle organs. After single-dose oral administration of WHCSW, we could not find any mortality and toxicological evidences up to 2,000 mg/kg-administered group, except for some accidental findings and dose-independent increases of body weight gains in female 1,000 and 500 mg/kg-administered female mice. The results obtained in this study suggest that the LD50 and ALD of WHCSW in both female and male mice after single-dose oral administration were considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg that was the highest dose recommended by KFDA and Organization for Economic Co-Operation and Development (OECD), and can be safely used in clinics.

• The Journal of Internal Korean Medicine
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• v.34 no.1
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• pp.46-58
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• 2013

Objectives : The object of this study was to obtain acute information (single oral dose toxicity) of Scutellariae Radix Aqueous Extracts (SR; yield = 27.20%) which traditionally have been used in Korean medicine for treating various diseases including inflammatory diseases. Methods : In order to observe the 50% lethal dose ($LD_{50}$), approximate lethal dosage (ALD) and target organs, SR Aqueous Extracts were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight.) according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after single oral treatment of SR according to KFDA Guidelines with organ weights and histopathological observations of 14 types of principle organs. Results : After single oral treatment of SR, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents, on the body and organ weights, clinical signs, gross and histopathological observations, except for some accidental findings. Conclusions : The results obtained in this study suggest that the $LD_{50}$ and ALD of SR in both female and male mice after single oral treatment be considered as over 2,000 mg/kg because no mortalities were detected up to 2,000 mg/kg that was the highest dose recommended by KFDA and OECD, and can be safely used in clinics.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.1
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• pp.124-133
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• 2010

The object of this study was to obtain acute information single oral dose toxicity of Mahwangbujaseshin-tang extracts, with mouse bone marrow cell micronucleus test for detecting possible genotoxicity. In order to observe the 50% lethal dose, approximate lethal dosage, maximum tolerance dosage and target organs, test articles were once orally administered to ICR mice at dose levels of 2000, 1000, 50 mg/kg according to the recommendation of KFDA Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing according to KFDA Guidelines with organ weights of 12 types of principle organs. In addition, after twice oral treatment of Mahwangbujaseshin-tang extracts 2000, 1000 and 500 mg/kg, we checked the changes on the number of MNPCE. We could not find any mortality, clinical signs, changes in the body weight and gross findings upto 2000 mg/kg treated group. The limited dosages in rodents except for increases of lymphoid organ weights and hypertrophy encounted as results from pharmacological effects of Mahwangbujaseshin-tang extracts, immune modulator effects with some sporadic accidental findings not toxicological signs. No evidence of increases of MNPCE numbers were also detected in all three different dosages of Mahwangbujaseshin-tang extracts treated mice. The results obtained in this study suggest that the LD50 and ALD of Mahwangbujaseshin-tang extracts in mice were considered as over 2000 mg/kg because no mortalities were detected upto 2000 mg/kg that was the highest dose recommended by KFDA and OECD. And the results of mouse bone marrow micronucleus test of Mahwangbujaseshin-tang extracts is negative results.

• KSBB Journal
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• v.18 no.2
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• pp.90-93
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• 2003

Six heavy metals (lead, copper, cadmium, chromium, mercury and arsenic) were analyzed in 9 oriental medical materials(Paeoniae Radix Alba, Zizyphi Fructus, Cnidii Rhizoma, Rehmanniae Radix Preparata, Angelicae Gigantis Radix, Astragali Radix, Glycyrrhizae Radix, Cinnamomi Cortex Spissus, and Zingiberis Rhizoma Crudus) by inductively coupled plasma atomic emission spectrometry (ICP-AES). The heavy metal contents of Zingberis Rhizoma Crudus and Angelicae Gigantis Radix were 44.0 and 37.3 mg/kg, respectively, which were 1.47 and 1.24 times higher than the guideline set by the Korean Food and Drug Administration (KFDA). Washing with deionized water lowered the heavy metal contents by 20-38%, and reduced levels to below the guidelines set by KFDA.

• Journal of Food Hygiene and Safety
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• v.23 no.1
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• pp.19-25
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• 2008

We analyze the HACCP Prerequisites of National Veterinary Research and Quarantine Service (NVRQS), Korea Food and Drug Administration(KFDA), and US Food Safety and Inspection Service (FSIS) and recommend contents and ranges to be complemented and used for the preparation of guidelines. We used the HACCP Notice of the Processing Livestock Act, the HACCP Application Manual for Livestock Processing Plants, the HACCP Notice of the Food Sanitation Act, US GPO 9 CFR and 21 CFR, US FSIS Directive 11,000.1, and HACCP-based Inspection reference guide of Consumer Services, North Carolina Department of Agriculture. The Prerequisites of NVRQS and KFDA are composed of 66 and 84 items respectively, without detailed guidelines for their application. This may decisively affect the application in the field and the evaluation activities. Water supplies, washing and disinfection monitoring tools, and examining and correcting plan are required to be improved. If the standards of compliance of each Prerequisite item as well as performance guidelines are given, the application and evaluation will be performed more effectively. The evaluation items should be associated with Prerequisite operations such as non-compliance complement, self-evaluation, and record keeping. Hazards found during official inspection should be promptly controlled not to contaminate the work places and processing items. As the HACCP is expected to spread from farms to tables, the standardized Prerequisite program among the official governments should be prepared.

• Korean Journal of Food Science and Technology
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• v.43 no.1
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• pp.1-5
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• 2011

It is possible that veterinary medicines remain in livestock food products, according to the use of many and various veterinary medicines to protect against disease when livestock animals are breed in limited space. Concentrated and continuous monitoring of residues is needed due to increases in resistance to antibiotics and side effects by eating livestock food products. We developed an analysis method for detecting streptomycin, dihydrostreptomycin, neomycin, gentamicin and spectinomycin in meat using LC/MS/MS and measured sensitivity, precision, accuracy, linearity and recovery according to CODEX guidelines to acquire confidence in the analysis method. Based on the results, we acquired good sensitivity compared to the maximum residue limit (MRL) as limits of detection (LOD) were 0.002-0.016 mg/kg and limits of quantification (LOQ) were 0.006-0.050 mg/kg. The analysis method satisfied the CODEX guidelines. The linearity ($r^2$) values of aminoglycoside antibiotics were 0.9936-0.9980, recoveries were 60-110% and relative standard deviations (RSD) were within 15%. As a result of monitoring for residues in a total 250 samples of livestock foods such as pork, chicken, and beef by the confirmed method, dihydrostreptomycin and gentamicin were detected in 5 pork samples. The residues of these antibiotics were within the MRLs. Thus, the detection ratio was 2% as 5 samples were identified from 250 samples.

• Proceedings of the PSK Conference
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• 2003.10a
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• pp.28-28
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• 2003

After approval, the drug should be manufactured and maintained with uniform quality. To assure the quality of drugs, the drug companies should comply with GMP guidelines and regulatory authorities should assess their compliance. In this article, I want to review the definition of drugs as well as the quality surveillance system. To be controlled as drugs, they ought to have their own specifications and test methods. (omitted)