• 생명과학회지
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• 제26권2호
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• pp.204-211
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• 2016

본 실험에서는 유산균발효 독활의 마우스 단회 경구 투여 독성 자료를 얻기 위해 식품의약품안전청 고시 제 2013-121 “의약품 등의 독성시험 기준”에 의거하여, 설치류 투여 한계 용량인 2,000 mg/kg을 최고 투여군을 설정하고 공비 2로 1,000 및 500 mg/kg 투여군을 중간 및 저용량 투여군으로 설정하여 실험을 실시하였으며, 그 결과는 독활 열수 추출물 2,000 mg/kg 암수 투여군 및 암수 매체 대조군과 비교 평가 하였다. 본 실험의 결과, 설치류 투여한계 용량인 2,000 mg/kg 투여군까지, 유산균발효 독활 열수 추출물 투여와 관련된 사망례, 임상증상, 체중, 장기중량, 육안부검 및 조직병리학적 소견이 인정되지 않았다. 따라서 유산균발효 독활 열수 추출물의 마우스에 대한 단회 경구 투여 반수 치사량 및 개략적 치사량은 암수 각각 2,000 mg/kg이상으로 산출되었으며, 특정 임상증상 및 표적 장기 역시 없는 것으로 판단되어, 유산균발효 독활은 매우 안전한 물질로 판단된다. 또한 독활 열수 추출물 2,000 mg/kg 투여와 관련된 사망례, 임상 증상, 체중, 장기중량, 육안 및 조직병리학적 변화 역시 인정되지 않았다. 이러한 결과는 독활의 활용도를 증대시키는 기초 자료가 될 것으로 사료된다.

• Toxicological Research
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• 제21권1호
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• pp.51-55
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• 2005

To investigate the acute toxicity of adventitious roots extract derived from wild ginseng, it was orally administered to beagle dogs with a single dose. In acute toxicity test, three groups (9 beagle dogs of male) were administered with different dosages of adventitious roots extract (prepared by Biopia Corp.) 500 mg/kg (G2), 1,000 mg/kg (G3), 2,000 mg/kg (G4) and one group (G1, 2 beagle dogs of male) were received by only capsule without the extract according to the Regulation on Korea Food and Drug Administration (1999. 12. 22). There were vomitus for a time and mucous stool at the day, and anorexia and mucous stool at the first day in the group of 2,000 mg/kg administration. There were mucous stool in one and anorexia for a while in two beagle dogs at the first day in the 1,000 mg/kg administration. But no death or abnormal clinical sign was observed through the study period. Therefore, the adventitious roots extract derived from wild ginseng is considered not to have the acute toxicity in the beagle dogs. These results suggest that LD/sub 50/ value of the test substance was considered to be more than 2,000 mg/kg in the beagle dogs.

• 대한한방내과학회지
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• 제33권2호
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• pp.145-159
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• 2012

Objectives : The object of this study was to obtain acute toxicity information (single oral dose toxicity) of Armeniacae Semen (AS), a medicinal herb used for treating constipation and various respiratory diseases, in rats. Methods : In order to observe the $LD_{50}$ (50% lethal dose), approximate lethal dosage (ALD) and target organs, AS aqueous extracts were orally administered once to female and male Sprague Dawley rats at dose levels of 2,000, 1,000, 500 and 0 (control) mg/kg (body weight). The mortality, changes in the body weight, clinical signs and gross observation were monitored for 14 days after single oral treatment of AS extracts, and the organ weights and histopathological findings of principle organs were observed after sacrifice. Results : After single oral treatment of AS 2,000 and 1,000 mg/kg, all (5/5; 100%) female and male rats died within 30 minutes after treatment, while no mortalities were observed in the female and male rats treated with 500 mg/kg of AS extract. Therefore, $LD_{50}$ in female and male rats was calculated as 741.95 mg/kg. Seizure, loss of locomotion, salivation, increases of respiration and heart-beat were observed after AS extract treatment, which were observed in all rats including the lowest dosage group, 500 mg/kg in the present study. In addition, lung congestion was visible in all mortal rats with AS 2,000 and 1,000 mg/kg, respectively. Conclusions : The results obtained in this study suggest that AS extract ranges in Class III, because the $LD_{50}$ and ALD in both female and male rats were calculated as 741.95 mg/kg and 500~1,000 mg/kg, respectively. However, AS extract should be carefully treated at clinical applications, because salivation, increase of respiration and heart-beat were also observed in the lowest dosage group, 500 mg/kg in the present study.

• 한국수산과학회지
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• 제34권3호
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• pp.173-178
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• 2001

저분자 alginate인 HAG-10, HAG-50, HAG-100 및 alginate를 랫드에 35일간 섭취시켰을 때, 혈청중의 지질성분과 동맥경화지수의 측정으로 특성이 가장 좋은 저분자 alginate인 HAG-50의 안전성을 확보하기 위해 랫드에 경구급성독성실험을 실시하였다. 혈청중 total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides 및 phospholipid 함량과 동맥경화지수는$5\%$ 와 $10\%$HAG-50에서 모두 유의적으로 뚜렷히 감소하여 지질대사 개선효과를 나타내었다. HAG-50의 경구급성독성실험을 검토한 결과, 투여할 수 있는 최고 용량인 랫드 체중 kg당 5.0g의 용량에서도 암$\cdot$수 모두 일반상태의 이상 반응과 폐사 및 병리$\cdot$조직학적 이상을 나타내는 예는 전혀 관찰되지 않아서 $LD_{50}$치의 산출이 불가능하였으므로 HAG-50은 아주 안전한 제재임이 검증되었다. 이상의 결과를 종합해 볼 때, 평균분자량 50,000 정도의 저분자 alginate인 HAG-50이 가장 우수한 지질대사 개선효과의 기능적 특성을 발휘하였으며, 경구급성독성실험 에서도 독성이 전혀 없었고, alginate가 가지고 있는 고유의 생리적 기능을 유지 향상시키면서 이용에 제한이 되고 있는 점성을 줄이고 용해도를 높혀서 alginate의 이용성을 높일 수 있는 새로운 형태의 식품소재라고 사료된다.

• Toxicological Research
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• 제23권1호
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• pp.79-86
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• 2007

The isolated plantamajoside from Plantago asiatica that is often used as a marker compound in chemotaxonomic studies has various bioactivites such as the inhibitions of cyclic AMP phosphodi-esterase and 5-lipoxygenase, microbial growth and inflammation, and currently demands the generation of toxicity data. The purpose of this study was to examine the toxicities of the single and 14 days repeated dose toxicity in Sprague-Dawley rats orally administrated with plantamajoside at dose levels of 0, 500, 1000, and 2000 mg of dried material/kg body weight/day. The results showed that there was no difference in body weight change, food intake, water consumption, or relative organ weight among different dose groups. Also we observed no death and abnormal clinical signs were observed during the experimental period. Between the groups orally administered Plantago asiatica and the control group, there was no statistical significance in hematological test or serum biochemical values. There were no gross findings at final sacrifice. There was no evidence of histopathological alteration mediated by 14 days treatment with Plantago asiatica. These results suggest that no observed adverse effect level (NOAEL) of the oral application was considered to be more than 2000 mg/kg in rats under the conditions employed in this study. Another observation was performed to investigate the safety of Plantago asiatica in respect of genotoxicity. This substance was examined that Salmonella typhimurium reversion assay (Ames test) in strain TA98, TA100, TA1535. In the reverse mutation test, Plantago asiatica did not induce mutagenicity in Samonella typhimurium with and without metabolic activation. These results indicated that Plantago asiatica had no genotoxicity.

• 생약학회지
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• 제20권3호
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• pp.180-187
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• 1989

Systematic pharmacological studies on powdered whole part of unossified antler obtained from Cervus nippon Temminck var. mantchuricus have been carried out in mice and rats. Powdered antler, with a single oral administration, showed a very weak acute and subacute toxicity; its MLD being >5g/kg orally in mice. On daily oral treatments of the antler for 14 days, it did not cause any significant differences in body weight gain, various organ weights and serum transaminase activities compared to those of the control rats. Powdered antler, with a single oral administration, showed a remarkable analgesic activity as evaluated by writhing syndrome and tail-pressure test, a weak CNS depressant activity as well as a weak immunopotentiating action as evaluated by carbon clearance test in mice. Powdered antler, with repeated treatments, showed a moderate antifatigue effect against immobilized stress and showed significant increases in both adrenal weight and its ascorbic acid content in rats, suggesting that the mode of antifatigue effect of antler is related to adrenal and its components.

• 생약학회지
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• 제41권3호
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• pp.210-215
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• 2010

Acute toxicity on the polysaccharide fraction of Pueraria lobata was examined using male and female Sprague-Dawley rats. The polysaccharide fraction of Pueraria lobata was orally administered at a dose of 5 mg/kg, 50 mg/kg, 500 mg/kg, 2,000 mg/kg and 5,000 mg/kg and observed for two weeks. No mortality and abnormal clinical signs were observed at the doses used. There were not any significant differences in parameters of blood biochemical values and urinalysis by the treatment of test material. All rats were appeared to be healthy and normal throughout the observation period. Also there was no difference in net body weight gain and gross pathological findings among the groups rats treated with different doses of the polysaccharide fraction with Pueraria lobata.

• 한국식품위생안전성학회지
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• 제26권4호
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• pp.377-382
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• 2011

살균소독제, 라미아-킬(benzalkonium chloride(20%), citric acid(20%))에 대하여 랫드와 토끼를 이용하여 급성경구독 성과 피부 자극성 평가를 각각 수행하였다. 랫드에 라미아-킬 2,000 mg/kg 농도를 최고농도로 하여 단회 투여 후, 14일간 관찰한 결과, 사망, 이상증상 및 체 중변화 등은 관찰되지 않아, 라미아-킬의 $LD_{50}$은 2,000 mg/kg 이상으로 추정되었다. 토끼의 등 부위의 털을 제거하고 찰과부위와 비찰과 부위에 여러 농도로 라미아-킬을 도포 한 후, 피부 자극성을 확인한 결과, 라미아-킬의 l차 자극 지수가 0.50으로 비자극성 물질로 분류되었다. 따라서, 본 연구를 통하여, 라미아-킬은 급성경구독성 시 안전한 물질이며, 피부 자극성을 야기하지 않는 물질로 평가되었다.

• 사상체질의학회지
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• 제9권2호
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• pp.203-225
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• 1997

Jihwangbakhotang(地黃白虎楊) is made by Li Je Ma, the creator of the Four Constitutional Medicine. Single and 13 weeks oral repeated dose toxicity studies were conducted in Sprague Dawley rats of both sexes to elucidate the potential acute and subchronic toxicity of JBT extract and reversibility of any effects. In the single dose study, JBT extract was administered orally to rats with the dose of 2 g/kg and 8 g/kg. In the long term administration of 13 weeks, the JBT extract of 125 mg/kg/day, 500 mg/kg/day, 2000 mg/kg/day was administered to rats. The change of blood weight, urine volume, electrolyte in urine, hematological change, the change of blood chemistry, autopsy finding, and histological observation were researched, the results were as follows; 1. The lethal dose of JBT extract seems to be over 10 g/kg, the single administration of JBT extract 8 g/kg showed no toxical signs except little increase of urine volume. 2. The change of body weight had the trend of decrease in the group of, but has no significance, and also the consumption of food and water had no changes. 3. The hematological changes induced by the 13 weeks administration of JBT extract showed the significance in the item of Hb, MCH, MCV, WBC in the group of 125 mg/kg/day. 4. In the test of blood chemistry, total cholesterol showed little decrease and A/G ratio showed little increase, but the change was not clear, and the standard error was large. So the result was obtained insignificantly and the toxicity of JBT extract was not observed. 5. In the male group after recovery period, the level of cholesterol and triglyceride decreased slightly, but the result was not significant. 6. In the urine test, the little change of electrolyte was appeared, but it seemed not to be the result induced by the toxicity of JBT extract. 7. In each group of male and female rats, the weight change of organ and the serum histological changes was observed, but the result did not showed the dose dependent toxicity. So the toxicity of JBT extract was not regarded. In the conclusion, the toxicity of JBT extract was not observed in the single dose treatment and long term repetitive administration of JBT extract.

• Toxicological Research
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• 제23권1호
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• pp.87-96
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• 2007

Single and repeated-dose toxicity of anti-diabetic herb extract microcapsule (ADHEM) were evaluated according to Toxicity Test Guidelines of Korea Food and Drug Administration using Sprague-Dawley rats. For single-dose toxicity test, kneading ADHEM with sterilized water were administered orally once at dose levels of 0 and 2,000 mg/kg and examined for 14 days. No dead animals, clinical signs and abnormal necropsy findings were observed and also no significant difference in body weights was found. Therefore, the $LD_{50}$ of ADHEM was considered to be higher than 2,000 mg/kg in both male and female rats. For repeated-dose toxicity test, ADHEM were mixed with powder fodder and administerd orally for 28 days at dose levels of 0, 500, 1000 and 2000 mg/kg/day. No dead animals, clinical signs and significant difference in body weights were found. In hematology and serum biochemistry, all values were included within the normal ranges. In relative organ weights, kidney or liver were significantly increased in the 500, 1000 or 2000 mg/kg/day male groups, uterus was significantly increased in the 500 mg/kg/day female group and left adrenal glands were significantly decreased in the 2000 mg/kg/day female group. In histopathological examinations, vacuolation and microgranuloma in the liver, chronic progressive nephropathy and inflammation in the kidney were observed in the 500, 1000 or 2000 mg/kg/day both male and female groups. Therefore, the no observed adverse effect level (NOAEL) of ADHEM was considered to be lower than 500 mg/kg/day in both male and female rats.