• 제목/요약/키워드: single oral toxicity test

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Single Oral Dose Toxicity Study of an Alcohol Extract of Bombus ignitus pupae in Rats

  • Ahn, Mi-Young;Han, Jea-Woong;Yoon, Hyung-Ju;Hwang, Jae-Sam;Park, Hae-Chul;Seo, Yun-Jung;Chung, Wan-Tae
    • International Journal of Industrial Entomology and Biomaterials
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    • 제19권1호
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    • pp.175-180
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    • 2009
  • Recently, as the male silkworm pupae, bee pupae have the potential that strengths men's vitality on vascular endothelial nitric oxide in endothelial cells. Especially we prepared alcohol extract of pupae of bumblebee, native bee named Hobakbul, Bombus ignitus. The alcohol extract of pupae of B. ignitus was administered to rats at doses of 0, 0.04, 0.2, 1 or 2 g/kg as a single oral dose. There were no observed clinical signs or deaths related to treatment in all the groups tested. Therefore, the approximate lethal dose of the alcohol extract B. ignitus pupae was considered to be higher than 2 g/kg in rats. Mild decreases in body weight gain in male were observed dose-dependently within B. ignitus pupae alcohol extract treated groups in dose response manner over 2 weeks. Throughout the administration periods, no significant changes in diet consumption, ophthalmologic findings, clinical pathology (hematology, clinical chemistry and coagulation) or gross pathology were detected. Minor changes in male and female rats were found in hematological parameters for all or partial of B. ignitus pupae extract treated groups but all the changes observed were within the physiological range. From these results, it was concluded that there was no-evidence of specific toxicity related to the ingestion of alcohol extract of B. ignitus pupae.

태음조위탕(太陰調胃湯)의 마우스 단회투여 독성시험 (Single Oral Dose Toxicity Test of Taeumjowi-tang in ICR Mice)

  • 김종대
    • 동의생리병리학회지
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    • 제23권5호
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    • pp.993-1002
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    • 2009
  • The object of this study was to evaluate the single dose toxicity of Taeumjowui-tang(TUJWT), a polyherbal formula have been traditionally used as prevention or treatment agent for obesity, in male and female mice. Aqueous extracts of TUJWT (Yield = 10.5%) was administered to female and male ICR mice as an oral dose of 2000, 1000 and 500 mg/kg (body wt.) according to the recommendation of 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 changes in the body and organ weight except for diarrhea restricted in TUJWT 2000 mg/kg treated one male mouse at 1 day after administration, and increases of popliteal lymph node weights in all TUJWT administered groups. In addition, no TUJWT-treatment related abnormal gross findings and changes in histopathology of principle organs were detected except for increases of the frequency of hypertrophy and hyperplasia of lymphoid cells in the popliteal lymph nodes in all TUJWT treatment groups with some sporadic accidental findings. These increases of popliteal lymph node weights with hypertrophy and hyperplasia of lymphoid cells were considered that related to the immune modulate effect of TUJWT not toxicological signs. The results obtained in this study suggest that the TUJWT does not cause any toxicological signs. The 50% lethal dose and approximate lethal dose of TUJWT aqueous extracts in both female and male mice were considered as over 2000 mg/kg.

황벽나무, 두충나무 추출물 등을 포함한 천연 추출물의 항균력 및 안전성 (Antimicrobial Activity and Safety Test of Natural extract including Phellodendro namurense, Eucommia ulmides Oliv extracts)

  • 노대영;조수현;양형욱;한동균;김진홍;김동욱
    • Korean Chemical Engineering Research
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    • 제54권6호
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    • pp.762-766
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    • 2016
  • 본 연구에서는 황벽나무, 두충나무, 귀룽나무 추출물 등을 포함하는 천연추출물에대해 항균활성 효과 및 안전성에 대해 검토하였다. 항균활성은 기회 병원성균인 Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli 및 Candida albicans에 대해 실험되었다. 안전성 시험으로는 세포독성실험, 단회 경구투여 독성시험, 단회 흡입투여 독성시험, 반복 흡입투여 독성시험, 안점막 자극시험이 실시되었다. 항균력효과시험 결과 추출물은 Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candida albicans 4가지 균 모두에 대해 우수한 항균활성을 보여주었다. 천연추출물의 단회 경구투여 독성시험, 단회 흡입투여 독성시험 및 반복 흡입투여 독성시험, 안점막 자극시험의 결과 독성은 관찰되지 않았다. 따라서 황벽나무, 두충나무, 귀룽나무 추출물 등을 포함한 천연추출물은 뛰어난 안전성과 항균력이 있음을 확인하였다.

총명탕(聰明湯) 열수(熱水) 추출물의 마우스 단회 경구투여 독성 실험 (Mouse Single Oral Dose Toxicity Test of Chongmyung-tang Aqueous Extracts)

  • 황하연;장우석;백경민
    • 대한한방내과학회지
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    • 제35권1호
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    • pp.37-49
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    • 2014
  • 목적 및 방법 : 본 연구에서는 한의학에서 전통적으로 신경보호 약물로 사용되어온 총명탕 물 추출물의 급성 독성증상을 관찰하기 위하여 한국식품의약품안전청 고시 제 2009-116호에 따라 암수 ICR마우스 단회 경구투여 독성 실험을 실시하였다. 반수치사량, 개략적치사량, 표적장기 등을 관찰하기 위하여, 수율 9.70% 총명탕 물 추출물 2,000, 1,000 및 500 mg/kg을 암수 마우스에 단회 경구 투여하고, 투여 후 14일 동안의 임상증상, 사망례, 체중 및 증체량의 변화 및 부검소견을 관찰하였으며, 투여 14일 후 14개 주요 실질 장기에 대한 중량 및 조직병리학적 관찰을 실시하였다. 또한 별도의 암수 매체 대조군을 두어 그 결과를 비교하였다. 결 과 : 본 실험의 결과, 설치류 최대 한계투여 용량인 2,000 mg/kg까지 총명탕 물 추출물 투여와 관련된 사망례가 인정되지 않았으며, 암수 매체 대조군을 포함하여, 모든 실험군에 걸쳐 산발적으로 관찰된 일부 우발적인 육안부검 및 조직병리학적 소견을 제외하고, 총명탕 물 추출물 투여와 관련된 임상증상, 체중 및 장기 중량의 변화, 14개 주요장기에 대한 육안부검 및 조직병리학적 소견이 인정되지 않았다. 결 론 : 따라서 마우스 단회 경구투여 독성실험에서 총명탕 물 추출물의 반수치사량 및 개략적 치사량은 각각 설치류 투여 한계용량인 2,000 mg/kg 이상으로 관찰되어, 매우 안전한 약물로 판단되며, 임상사용에는 별 다른 문제를 일으키지는 않을 것으로 판단된다.

천남성 추출물의 Sprague-Dawley 랫드를 이용한 28일 반복 경구투여 DRF독성시험 (A 28 Day Repeated Dose-Oral Toxicity Studies of Arisaema Rhizome Aqueous Extracts in Sprague-Dawley Rats)

  • 김민경;이지선;박영철;최선미;이상훈
    • 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.

Single Oral Dose Toxicity Study of Water Extracts of Picrorrhiza Rhizoma In ICR Mice

  • Lee Hyeung-Sik;Lee Ik-Gu;Ku Sae-Kwang
    • Toxicological Research
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    • 제22권2호
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    • pp.117-126
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    • 2006
  • This study was conducted to obtain the acute information of the oral dose toxicity of lyophilized water extract of Picrorrhiza Rhizoma (PR) - dried underground stem of Picrorrhiza kurroa, having various pharmacological effects, in male and female mice. In order to calculate 50% lethal dose ($LD_{50}$), approximate lethal dose and target organs, test article was administered once by oral gavage to male and female ICR mice at 2000, 1000, 500 and 250 mg/kg. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after dosing with organ weight and histopathology of 12 types of principle organs. As the results, we could not find any mortality, clinical signs, changes in the body weight and gross findings except for hair loss, a significantly (p<0.05) increase of body weight gains in 2000mg/kg of PR extracts-dosing male group and some sporadic gross findings. In addition, no meaningful changes on the organ weight and histopathology of 12 types of principle organs were detected in the present study except for significantly (p<0.05) but dose independent changes on thymus, spleen and popliteal lymph nodes weights, and some sporadic accidental histopathological findings. The results obtained in this study suggest that the PR extract is non-toxic in mice and is therefore likely to be safe for clinical use. The $LD_{50}$ and approximate lethal dose of PR extracts in both female and male mice were considered as over 2000 mg/kg.

방풍갈근탕(防風葛根湯)의 항알레르기효과에 관한 연구 (Study on Anti-allergic Effect and Safety of Bangpung-galgeun-tang)

  • 이주은;박성하;강경화;이용태
    • 동의생리병리학회지
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    • 제21권5호
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    • pp.1118-1126
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    • 2007
  • The purpose of this study was to examine the anti allergic effect in vivo and in vitro, and to observe single and four weeks repeated toxicity in mice of Bangpung-galgeun-tang (BGT). We investigated anti DNP IgE-mediated passive cutaneous anaphylaxis in rodents and compound 48/80-induced active systemic anaphylatic shock in mice after oral administration with BGT of 0.4 g/kg and 0.8 g/kg for 8 days, and also examined MTT assay, ${\beta}-hexosaminidase$ activity, IL-4 and $TNF-{\alpha}$ from RBL-2H3 and $TNF-{\alpha}$ from Raw264.7 after pre-treatment with BGT of 0.25 mg/ml, 0.5 mg/ml, 1 mg/ml and 2 mg/ml. To ascertain safety and toxicity of BGT, we divided into single and four weeks repeated administration test. In single test, three groups were administrated different dosages and routes (2 g/kg/i.p., 4 g/kg/i.p. and 15 g/kg /p.o.) of BGT, and in four weeks repeated test, 0.8 g/kg BGT was administrated. Control groups were administrated with only saline according to on Korean Food and Drug Administration, respectively. We observed attentively motality, abnormal clinical sign, body weight change, organ weight, AST and ALT of mice after BGT administration. BGT inhibited passive cutaneous anaphylaxis and active systemic anaphylatic shock by oral administration. All the concentrations of BGT from 0.25 to 2 mg/ml didn't have an effect on cell viability and cytotoxicity. In RBL-2H3, ${\beta}-hexosaminidase$ release, IL-4 and $TNF-{\alpha}$, and in Raw264.7, $TNF-{\alpha}$ were significantly reduced by treated all concentrations of BGT. During toxicity experiment period, there was no difference in body weight change, organ weight, AST and ALT among different dose groups. Death were found 3 mice from day 2 to day 3 in single test i.p. group. (2 g/kg, 4 g/kg). Several individuals of single test i.p. group were observed that decreased locomotor activity, exophthalmos, bloodshot eyes, loss of eyesight and so on in early period after administration. But there was no difference in clinical signs among p.o. group. These results indicate that BGT have inhibition effects on allergy and suggest that no observable effect level of the test orally administration was considered to be more than 2 g/kg in mice under the conditions employed in this study.

편백 정유의 마우스에 대한 급성경구독성 (Acute Oral Toxicity Test of Chamaecyparis obtusa Essential Oil on ICR Mice)

  • 임창우;손송이;이후장
    • 한국식품위생안전성학회지
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    • 제33권3호
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    • pp.214-219
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    • 2018
  • 본 연구는 세균과 진균에 대한 항균작용, 살충작용, 항아토피 활성, 항염증 효과, 혈압강하 및 스트레스 완화 효과 등이 있는 것으로 알려진 편백 정유를 이용하여, 마우스에서의 급성경구독성시험을 수행하였다. 편백 정유를 마우스에 0, 125, 250, 500, 1,000, 2,000 mg/kg body weight의 농도로 각각 1회 경구투여한 결과, 마우스 암 수 모두 2,000 mg/kg에서 모두 생존하였으며, 모든 투여군의 체중 및 모든 혈액학적 혈액생화학적 지표값들이 대조군과 비교하여 통계적으로 유의적인 차이를 보이지 않았다. 따라서 편백 정유의 마우스에서의 $LD_{50}$은 2,000 mg/kg body weight 이상으로 확인되었다.

황벽나무, 두충나무 등을 포함하는 복합수목추출물의 항균활성 및 안전성 시험 (Antimicrobial Activity and Safety Test of Mixed Plant Extracts Including Phellodendron Amurense and Eucommia Ulmides Oliv)

  • 김현우;신혜진;황단비;이지은;박만춘;김진홍;김동욱
    • Korean Chemical Engineering Research
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    • 제51권5호
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    • pp.536-539
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    • 2013
  • 본 연구에서는 황벽나무, 두충나무 등을 포함하는 복합수목추출물의 항균활성 효과 및 안전성에 대해 검토하였다. 항균활성은 피부상재균이며 기회 병원성균인 Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli 및 Candida albicans에 대해 disc 확산법으로 실험되었다. 안전성 시험으로는 단회 경구투여 독성시험, 단회투여 흡입독성 시험, 반복투여 흡입독성시험이 실시되었다. 항균력효과시험 결과 추출물은 Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans에 대해 우수한 항균활성을 보여주었으나, Escherichia coli에서는 항균활성이 없었다. 복합수목추출물의 단회 경구투여 독성시험, 단회투여 흡입독성시험 및 반복투여 흡입독성시험의 결과 독성은 관찰되지 않았다. 따라서 황벽나무, 두충나무 등을 포함한 복합수목추출물은 천연 항살균제로서 상업화 가능성이 매우 높음을 알 수 있었다.

육미지황탕(六味地黃湯)의 마우스에 대한 급성독성 (Acute Toxicity of Yukmijihwang-tang in ICR Mice)

  • 전원경;이재훈;이지혜;김미연;마진열
    • 대한한의학방제학회지
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    • 제17권2호
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    • pp.65-72
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    • 2009
  • Objectives : Yukmijihwang-tang (YJT) is known as a tonifying formula for reinforcement of yin deficiency conditions. The present study was carried out to investigate the potential acute toxicity of YJT in ICR male and female mice. Methods : We investigated the acute toxicity about boiling water-extracted YJT. The test article was orally administered once by gavage to 20 male and 20 female mice at dose levels of 0 (control group), 1250, 2500 and 5000 mg/kg body weight. Mortalities, clinical findings, autopsy and body weight changes were monitored daily for the 14 days following the administration according to the Regulation of Korean Food and Drug Administration. Results : We observed survival rates, general toxicity, change of body weight, and autopsy. Single oral administration of YJT with different dosages, no animals died of the test drug. Autopsy of animal revealed no abnormal gross finding. Therefore, $LD_{50}$ value of YJT for ICR mice was more than 5000 mg/kg on oral route. Conclusions : These results suggest that no toxic dose level of YJT in mice is considered to be more than 5000 mg/kg. Consequently, it was concluded that YJT have no effect on acute toxicity and side effect in ICR mice.

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