• 대한한방내과학회지
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• 제32권4호
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• pp.599-609
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• 2011

Objectives : The aim of this study was to evaluate the single oral dose toxicity and safety of Bojungikgi-tang (Buzhongyiqi-tang) and fermented Bojungikgi-tang (Buzhongyiqi-tang) extracts in male and female ICR mice. Methods : In the single oral dose toxicity study, non-fermented and fermented Bojungikgi-tang (Buzhongyiqi-tang) were administered to male and female ICR mice as an oral dose of 1250, 2500 and 5000 mg/kg. Changes of body weights, general behaviors, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, serum chemistry, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There was no mortality or sign of toxicity in the single oral dose toxicity study. There were also no significant differences in body weights, organ weights, and hematological parameters, serum chemistry values between treatment and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of fermented Bojungikgi-tang (Buzhongyiqi -tang) in both female and male mice can be considered as well over 5,000 mg/kg, so these medicines can be safe in clinics.

• 대한한방내과학회지
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• 제32권3호
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• pp.334-344
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• 2011

Objectives : Sipjeondaebo-tang is a medicine traditionally prescribed as a restorative. The aim of this study was to investigate the single oral dose toxicity and safety of extract of fermented Sipjeondaebo-tang in ICR mice. Methods : In single oral dose toxicity study, non-fermented or fermented Sipjeondaebo-tang were administered by oral gavage to ICR mice (5 males, 5 females) at single doses of varying concentrations: 1250, 2500 and 5000 mg/kg. Changes of body weight, general behavior, adverse effects and mortality were determined throughout the experimental period. Hematological parameters, organ weights and necropsy findings were evaluated at the end of the experiment. Results : There were no mortality or signs of toxicity in single oral dose toxicity studies. There were also no significant differences in body weight, organ weight, or hematological parameters between the treatment and control groups. Conclusions : Fermented Sipjeondaebo-tang did not cause remarkable adverse effects in ICR mice. The oral lethal dose of fermented Sipjeondaebo-tang is more than 5000 mg/kg and no-observed-adverse-effect level (NOAEL) of the extract for both male and female mice is 5000 mg/kg.

• 대한한의학방제학회지
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• 제30권4호
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• pp.281-291
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• 2022

Objectives : In this study, acute oral toxicity test of pomace Schisandra chinensis extracts was conducted in order to up-cycling to a high value-added industry using by-products discarded in the production process of Schisandra chinensis products and active ingredients such as dibenzocyclooctadiene lignans in Schisandra chinensis. Methods : Pomace Schisandra chinensis extracts were orally administered to SD-rats(female, n=3) without a control group according to the 'OECD guidelines'. After, mortality and clinical signs were observed, and the deceased animals were subjected to an autopsy. In addition, acute oral toxicity test was sequentially performed in step I (300 mg/kg), step II(300 mg/kg), step III(2,000 mg/kg), and step IV(2,000 mg/kg) according to the mortality. Results : There were no abnormalities caused by pomace Schisandra chinensis extracts in step I and step II. However, one animal each died in step III and step IV. In addition, clinical signs(salivation, decrease in food intake, prone position, decrease of locomotor activity, loss of locomotor activity, convulsion, hypothermia, lacrimation, staining around mouth, soiled perineal region, reddish urine, chromaturia, decrease of fecal volume, lying on side, blackish stool, no stool, compound-colored stool, refusal to feed, excitement, hypersensitivity, rigidity, dorsal position, etc.) were observed. But, no clinical signs were observed from 5th day, and experiment animals recovered completely. Conclusions : As a result of this study, pomace Schisandra chinensis extracts may exhibit acute toxicity at concentrations of 2,000 to 5,000 mg/kg, and the GHS classification was designated as 'Category 5'.

• 사상체질의학회지
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• 제22권1호
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• pp.59-65
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• 2010

1. Objectives: The aim of this study is data analysis for acute toxicity and safety of Cheongsimyeonja-tang. 2. Methods: We investigated the acute toxicity for water-extracted Cheongsimyeonja-tang. Fifty five male and female mice were observed for 14 days after one day oral administration of Cheongsimyeonja-tang at the respective doses of 0 (control group), 2560, 3200, 4000 and 5000 mg/kg. 3. Results: We observed survival rates, general toxicity, change of body weight and autopsy. In animals administered with Cheongsimyeonja-tang, there were nither dead animals nor significant changes of body weights. In addition, no differences were found between control and treated groups in clinical sign and autopsy. 4. Conclusion: The data confirmed that Cheongsimyeonja-tang is free from the toxicity and safety problems in treated groups. Compared with the control group, we could not find any toxic alteration in all treated groups(2560, 3200, 4000 and 5000 mg/kg). Lethal Dose 50 (LD50) value for mice was more than 5000 mg/kg per oral for both male and females. It suggest that Cheongsimyeonja-tang in mice is considered to be safe.

• 한국지역사회생활과학회지
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• 제27권3호
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• pp.437-449
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• 2016

To provide information on the safety of crude antifungal compounds produced by Bacillus subtilus SN7 isolated from Meju, we carried out an acute (single) oral dose toxicity test and 4 week repeated oral dose determination test on crude antifungal compounds in male and female Sprague Dawley rats. In the acute toxicity test, rats were treated with crude antifungal compounds produced by Bacillus subtilus SN7 orally at increasing dose levels (500, 1,000, and 2,000 mg/kg) and observed for 2 weeks. In the repeated-dose 28-day oral dose determination study, rats were orally administered doses of 500, 1,000, and 2,000 mg/kg daily for 4 weeks. There were no test article-related deaths or abnormal clinical signs in the two studies. In the 4 week repeated oral dose determination test, there were also no significant differences in clinical signs, body and organ weight changes, or any other hematological and biochemical parameters between the control and treated groups. The results suggest that the crude antifungal compounds produced by Bacillus subtilus SN7 up to a dosage level of 2,000 mg/kg are not toxic in male and female rats.

• 대한한방부인과학회지
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• 제26권4호
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• pp.1-13
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• 2013

Objectives: In this study, it was carried out to evaluate the acute oral toxicity of Root of Polygala teunifolia Willd. in Sprague-Dawley (SD) rats. Methods: Male and female rats were administered orally with Root of Polygala teunifolia Willd. water extract of 1,000 mg/kg (low dosage group), 2,000 mg/kg (middle dosage group) and 4,000 mg/kg (high dosage group). We daily observed number of deaths, clinical signs and gross findings for 7 days. After 7 days, we measured body and organs weight. Also we analyzed hematological changes. Results: No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. But we found out histopathological changes in liver fat tissues of female. In addition, there were no significant changes of gross body and individual organs weight. Conclusions: These results suggest that water soluble extract of Root of Polygala teunifolia Willd. has not acute oral toxicity and oral $LD_{50}$ value was over 4,000 mg/kg in SD rats.

• 한방안이비인후피부과학회지
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• 제26권4호
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• pp.15-25
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• 2013

Objectives : This study was carried out to evaluate the acute oral toxicity of Alismatis Rhizoma in Sprague-Dawley(SD) rats. Methods : male and female rats were administered orally with Alismatis Rhizoma water extract of 1,000 mg/kg (low dosage group), 2,000 mg/kg(middle dosage group) and 4,000 mg/kg(high dosage group). We daily observed number of deaths, clinical signs and gross findings for 7 days. After 7 days, we measured body and organs weight. Also we analyzed hematological changes. Results : No dead SD rats and no clinical signs were found during the experiment period. Also other specific changes were not found between control and treated groups in hematology and serum biochemistry. In addition no significant changes of gross body and individual organs weight. Conclusions : These results suggest that water soluble extract of Alismatis Rhizoma has not acute oral toxicity and oral $LD_{50}$ value was over 4,000 mg/kg in SD rats.

• 셀메드
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• 제11권1호
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• pp.2.1-2.8
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• 2021

The clinical condition Amnesia causes difficulty in learning new information and the inability to recall past events. It is primarily concerned with recent memory loss. Majoon-e-Nisyan (MJN) is a polyherbal Unani formulation, present in a semi-solid form. It is widely used potent drug of the Unani System of Medicine (USM) for treating Nisyan (amnesia). In the present study polyherbal Unani formulation, MJN has been studied for its quality control and acute toxicity. Standardization (quality control) of drugs deals with drug identity, drug quality and purity determination. Standardization of MJN had been done as per the Unani pharmacopoeial parameters approved by World Health Organization (WHO) - Pharmacognostical parameters, Physico-chemical parameters, high-performance thin-layer chromatography (HPTLC), microbial load, aflatoxin, and heavy metals. Solvents and chemicals used in the study were of analytical grade and used instrument were calibrated. By conducting an acute oral toxicity study in rats, the safety of MJN was assessed. The limit test method of OECD guideline 425 was followed in the study. Results of standardization and standard operating procedures (SOPs) for preparation of MJN may serve as the standard reference in the future. The data generated in the study for the quality control of MJN proved the quality of formulation and shows that MJN is not toxic in rats following acute dosing up to 2000 mg/kg bw. The data obtained in the paper for MJN may be used as a standard guideline for preparation of the formulation which can save time, cost, and resources for future research endeavours.

• 한국한의학연구원논문집
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• 제13권1호통권19호
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• pp.161-164
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• 2007

SsangHwaTang has been traditionally prescribed a medicine as a restorative. In this study, We investigated the acute toxicity about water-extracted SsangHwaTang. Twenty-five mice completed 14 days of oral SsangHwaTang at the respective doses of 0(control group), 2560, 3200, 4000 and 5000mg/kg. And then we observed survival rates, general toxicity, change of body weight, and autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (2560, 3200, 4000 and 5000mg/kg). In conclusion, LD50 of SsangHwaTang was over 5000mg/kg and it is very safe to ICR mice.

• Toxicological Research
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• 제13권4호
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• pp.349-352
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• 1997

Scopoliae rhizoma is a perennial herb which has a similar effect with atropine on the cardiovascular system. It is also known to have a seditive and anticonvulsant activity on the central nerve system. In order to evaluate an acute toxicity of Scopoliae rhizoma, the present study was performed after administration the Scopoliae rhizoma prepared by both decoctional and frozen dried extract through three different routes (oral; 5,000 mg/kg, intraperitoneal; 2,000 mg/kg, subcutaneous; 5,000 mg/kg) to the female ICR mice. In the group treated intraperitoneally with a frozen dried extract, abnormal clinical signs such as decreased activity, crouch, potosis and abnormal walking were observed for 40 rain after administration. With regard to WBC, decreased number of lymphocyte and increased number of monocyte and granulocyte were also observed in the animals received intraperitoneally with Scopoliae rhizoma extract. Taken together, what toxicity of Scopoliae rhizoma was shown differently depending on its type for administration may be resulted in the differency of administered dose. The results provided here support a pharmacological and toxicological consideration for its clinical use in the regard of oriental medicine.