• 동의생리병리학회지
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• 제24권6호
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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.

• Toxicological Research
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• 제20권4호
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• pp.325-328
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• 2004

The present study was carried out to investigate the potential acute toxicity of Balbusae caulis in taeniam by a single oral dose in Sprague-Dawley rats. Twenty rats of each sex were randomly assigned to four groups of 5 rats each and were administered singly by gavage at dose levels of 0, 1250, 2500, and 5000 mg/kg body weight. Mortalities, clinical findings, and body weight changes were monitored for the 14-day period following administration. At the end of 14-day observation period, all animals were sacrificed and complete gross postmortem examinations were per-formed. Throughout the study period, no treatment-related deaths were observed. There were no adverse effects on clinical signs, body weight, and gross finding at any dose tested. The results showed that the single oral administration of Balbusae caulis in taeniam did not cause any toxic effect at the dose levels of 5000 mg/kg or lower in rats and the minimal lethal dose was considered to be over 5000 mg/kg body weight for both sexes.

• Journal of Acupuncture Research
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• 제31권1호
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• pp.105-110
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• 2014

Objectives : The objective of this study is to analyze the single-dose toxicity of horse placenta hydrolysate extracts. Methods : Sprague-Dawley rats were chosen for the study. Doses of horse placenta hydrolysate extracts, 2,000 mg/kg, 1,000 mg/kg and 500 mg/kg, were administered to the experimental group, and the same doses of normal saline solution were administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results : In all 4 groups, no deaths occurred, and the horse placenta hydrolysate extracts administered by oral was over 2,000 mg/kg. No significant changes in the weight between the control group and the experimental group were observed. To check for abnormalities in organs and tissues, we used microscopy to examine representative histological sections of each specified organ, the results showed no significant differences in any organs or tissues. Conclusions : The above findings suggest that treatment with horse placenta hydrolysate extracts is relatively safe. Further studies on this subject should be conducted to yield more concrete evidence.

• 한국자원식물학회지
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• 제28권4호
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• pp.371-381
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• 2015

The object of this study was to obtain single oral dose toxicity of Arisaema Rhizome (Arisaema amurense f. serratum (Nakai) Kitag) aqueous extracts. Arisaema Rhizome (Chunnamsong in Korean) is one of the most important folk remedy plants used in Asia. In the study, a 28-day rat oral gavage study has been conducted with the extracts from Arisaema Rhizome at dose of 1,250, 2,500 and 5,000 ㎎/㎏/day. The following endpoints were evaluated: clinical observations, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Based on the analysis of these endpoints, it was estimated that NOEL (no observed effect level) for male rats and NOAEL (no observed adverse effect level) for female rats are 5000 ㎎/㎏/day of the water-extracts from Arisaema Rhizome.

• Toxicological Research
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• 제21권3호
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• pp.255-261
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• 2005

Gami-Samhwang-San, a herbal prescription for obesity treatment, is composed of seven crude herbs such as Rehmanniae Radix Preparata, Ephedrae Herba, Scutellariae Radix, Acori Gramineri Rhizoma, Polygalae Radix, Typhae Pollen, Armeniacae Semen, Menthae Herba. In this study, marker substances in n-butanol fraction (SH-21-B) from Gami-Samhwang-San were analyzed by high performance liquid chromatography (HPLC) and acute toxicity of standardized SH-21-B was evaluated by good laboratory practices (GLP) guideline of Korea Food and Drug Administration. Therefore we confirmed that there were baicalin of 15.92%, amygdalin of 6.57% and ephedrine of 2.49% in SH-21-B. SH-21-B was administered in rats at dose of 0 mg/kg, 2,000 mg/kg, and 5,000mg/kg. Clinical signs of both sexes of rats were observed daily for 14 days after single oral administration. Two female rats one administered at 2,000 mg/kg and the other administered at 5,000 mg/kg, died, but no dead animal was observed among male rats. Therefore $LD_{50}$ in the female rat is observed to be 8,710 mg/kg, and MLD (Minimun Lethal Dose) of the male rat is observed to be more than 5,000 mg/kg.

• 한방비만학회지
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• 제17권2호
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• pp.96-100
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• 2017

Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.

• 대한한방부인과학회지
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• 제27권1호
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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.

• 대한한의학회지
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• 제44권3호
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• pp.29-38
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• 2023

Objectives: This study aimed to investigate the acute oral toxicity of 77 herbal formulas and performed in male and female Sprague-Dawley (SD) rats as per the guidelines mentioned in Ministry of Food and Drug Safety. Methods: Each sex of SD rat were administered a single dose (2000 or 5000 mg/kg) of 77 herbal formulas via oral gavage; the control group received vehicle only. After administration, the mortality, clinical signs, gross findings, and body weight were followed up for 15 days. Results: After administration of 77 herbal formulas, mortality, clinical signs, body weight changes, and gross findings related to the test substances were not observed in both male and female groups. Conclusion: Our results demonstrate the single-dose oral administration of 77 herbal formulas produced no mortality indicating the approximate lethal dose is greater than 2000 or 5000 mg/kg body weight.

• 한국독성학회:학술대회논문집
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• 한국독성학회 2003년도 추계학술대회
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• pp.132-132
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• 2003

In this GLP study, 4 study groups of 12 Sprague-Dawley (SD) rats/sex were given vehicle, or 1,000, 1,500, or 2,000 mg/kg/day Sophora Japonica Linne Seed Extract (SE) for 13 weeks. Standard endpoints in this study included mortality, clinical observations, body weight, food and water consumption, ophthalmoscopic examination, urinalysis, hematology, serum biochemistry, organ weights, gross anatomic pathology and histopathology.(omitted)

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제41권2호
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• pp.90-96
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• 2015

Necrotizing fasciitis (NF) is an infection that spreads along the fascial planes, causing subcutaneous tissue death characterized by rapid progression, systemic toxicity, and even death. NF often appears as a red, hot, painful, and swollen wound with an ill-defined border. As the infective process continues, local pain is replaced by numbness or analgesia. As the disease process continues, the skin initially becomes pale, then mottled and purple, and finally, gangrenous. The ability of NF to move rapidly along fascial planes and cause tissue necrosis is secondary to its polymicrobial composition and the synergistic effect of the enzymes produced by the bacteria. Treatment involves securing the airway, broad-spectrum antimicrobial therapy, intensive care support, and prompt surgical debridement, repeated as needed. Reducing mortality rests on early diagnosis and prompt aggressive treatment.