• Journal of Physiology & Pathology in Korean Medicine
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• v.28 no.1
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• pp.53-58
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• 2014

The object of this study was to evaluate the single dose toxicity of Choweseuncheng-tang (CWS), a polyherbal formula have been traditionally used as prevention or treatment agent for various diseases as Tae-eumin prescription on Korean medicinal theory, Sasang-euihak, in male and female mice. Aqueous extracts of CWS (yield = 11.00%) 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. As results, we could not find any CWS treatment related mortality and clinical signs, changes in the body and organ weights, gross findings and changes in histopathology of principle organs, except for some dose-independent accidental findings. The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of CWS 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.

• The Korea Journal of Herbology
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• v.33 no.4
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• pp.53-58
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• 2018

Objectives : Kaempferia parviflora Rhizome is black ginger indigenous to Laos and Thailand. It has been used as a folk medicine to improve blood flow and promote vitality and longevity with good health and well being. For these reasons, Kaempferia parviflora Rhizome has been focused on developing it as a food or food supplement. In addition, Kaempferia parviflora Rhizome could be under consideration of new prescription based on its characteristic compounds, polymethoxyflavonoids. However, it needs to be certified as safe before it can be used. Here, a single-oral toxicity test and safety classification was carried out to identity acute information of the toxicity of Kaempferia parviflora Rhizome powder and to make sure of its safety in clinical applications. Methods : Test substance was orally administered to male and female SD-rat at dose levels of 5000 mg/kg to estimate approximate lethal dose(ALD). Based on the acute information of the toxicity, the safety classification was estimated using the HED(human equivalent dose)-based MOS(margin of safety). Results : At 14 days after treatment with test substance. there were no of test substance related with mortalities and clinical signs. In addition, no changes in the body or organ weights and no gross or histopathological findings were observed. Thus, the ALD of Kaempferia parviflora Rhizome powder was considered over 5,000 mg/kg in both female and male mice. Conclusions : Based on the single oral toxicity test using the highest and limit dose, 5,000 mg/kg and the decision guideline for safety classification based on HED-based MOS, it was estimated that Kaempferia parviflora Rhizome powder is classified as "Specified class B" indicating that clinical dose is not limited to patients as safe as food.

• Journal of Physiology & Pathology in Korean Medicine
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• v.27 no.3
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• pp.299-305
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• 2013

This study was to evaluate the single dose toxicity of Arecae Semen (AS) in male and female ICR mice. Aqueous extracts of AS (Yield = 13.15%) were administered 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 principle organs were examined. We could not find any mortality, clinical signs, and changes in the body and organ weight except for diarrhea. Diarrhea were observed in all three different dosage groups of male mice, and in 2000 mg/kg groups of female mice within 48hrs after administration. In addition, no AS extract related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Although the 50% lethal dose and approximate lethal dose of AS aqueous extracts in female and male mice were detected as over 2,000 mg/kg - the limited highest dosage recommended by KFDA guidelines. It should be carefully used in clinics because AS may be induced severe digestive tract disorders.

• Journal of Society of Preventive Korean Medicine
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• v.15 no.2
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• pp.21-38
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• 2011

Objective : This study was to evaluate the single dose toxicity of Bojungikki-tang(Buzhongyiqi-tang, BJIKT) in male and female mice. Method : Aqueous extracts of BJIKT were 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 principle organs were examined. Results : we could not find any mortality, clinical signs, and changes in the body and organ weight. In addition, no BJIKT-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for some sporadic accidental findings. Conclusion : The results obtained in this study suggest that the 50% lethal dose and approximate lethal dose of BJIKT 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.25 no.1
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• pp.122-131
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• 2011

The object of this study was to evaluate the single dose toxicity of Yukmijihwangtanggamibang (YMJHTGMB), a polyherbal formula have been traditionally used as prevention or treatment agent for various lung diseases including chronic obstructive pulmonary disease (COPD), in male and female mice. Aqueous extracts of YMJHTGMB (Yield = 16.33%) wasadministered 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 principle 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 YMJHTGMB 2,000 mg/kg treated two male mice (2/5; 40%) at 1 day after administration. In addition, no YMJHTGMB-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 YMJHTGMB aqueous extracts in both female and male mice were considered as over 2,000 mg/kg, the limited highest dosage recommended by KFDA Guidelines.

• 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.

• The Journal of Korean Medicine
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• v.30 no.6
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• pp.27-34
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• 2009

Objectives: To evaluate the acute toxic effects and approximate lethal dose of Cheonggan extracts (CGX) in SD rats and beagle dogs. Methods: Male and female rats were divided into 4 groups (Control, CGX 1250, CGX 2500, CGX 5000) respectively and male and female dogs were divided into two groups respectively (Control, CGX 5000) respectively. A single oral dose of CGX was treated to the rats and dogs. Mortality, signs of gross toxicity, and behavioral changes were observed over 14 days. All animals were observed every hour for 4 hours after administration and once a day thereafter for 14 days. Body weights were determined at $0_{th}$, $7_{th}$, and $14_{th}$ days. All surviving animals were sacrificed and necrotized. Major organs were inspected visually for gross findings. Results: No animals died in any of the groups during the experimental period (2 weeks), rats or dogs. Body weights of rats and dogs during the experiment continuously increased in all groups but there was no significant change. No abnormal clinical signs were observed for 2 weeks after a single administration of CGX in any dose group of CGX, rats or dogs. No abnormal findings in major organs were observed in any group of rats or dogs. Conclusion: CGX does not have acute toxic effects in rats or dogs. Therefore, an approximate lethal dose is assumed to exceed 5000 mg/kg in both rats and dogs.

• Journal of Pharmacopuncture
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• v.26 no.4
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• pp.348-356
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• 2023

Objectives: Neuralgia-pharmacopuncture (NP) was recently developed as a water-soluble type of pharmacopuncture inspired by CS (care special pain)-pharmacopuncture. I aimed to evaluate the toxic response and approximate lethal dose of when NP when administered intramuscularly to Sprague Dawley rats. Methods: The experimental group was divided into the NP test substance group and the saline control group and administered at a dose of 1.0 mL/animal to the posterior thigh muscles on both sides using a 1 mL syringe; each group consisted of five males and five females. Each rat was monitored for clinical signs and changes in body weight for 14 days after a single intramuscular injection. After completing observation, necropsy findings and localized tolerance at the injection site were assessed via gross necropsy and histopathological examination. Results: No deaths occurred in the NP or control group, regardless of sex. During the observation period, no changes (such as general symptoms, weight change, or visual observation results at the time of autopsy) were judged to be due to the test substance. Histopathological examination showed no changes at the administration site judged to be caused by the test substance in either the male or female test substance administration groups. In addition, mononuclear cell infiltration of the outer membrane of the femoris muscle at the administration site was observed at the same frequency and extent in the control and NP groups, and was judged to be caused by physical stimulation by the injection needle; therefore, it had no toxicological significance. Conclusion: Based on the above results, the approximate lethal dose for a single intramuscular administration of the test substance NP in Sprague-Dawley rats was judged to be > 1.0 mL/animal, and there were no findings that were judged to be due to the test substance at the administration site.

• The Korea Journal of Herbology
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• v.39 no.2
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• pp.19-25
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• 2024

Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats. Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 mg/kg of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD). Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 mg/kg. In addition, no significant necropsy findings related to JGT administration were observed. Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 mg/kg.