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랫드에서 인체 재조합 적혈구 조혈인자, rHuEPO의 13주 정맥투여 아만성독성에 관한 연구
김형식,곽승준,천선아,박현선,한하수,임소영,안미영,김원배,김병문,안병옥,홍성렬,이병무 성균관대학교 약학연구소 1998 成均藥硏論文集 Vol.10 No.1
A recombinant human erythropoietin (rHuEPO) was administered intravenously at dosage levels of 0, 100, 500, and 2500 IU/㎏/day for a period of 13 weeks. There were no observed clinical signs and deaths related to treatment in all groups tested. Decreases in body weight gain and food consumption were observed only in males of 2,500 IU/㎏ group after 2 weeks. In hematological parameters, erythrocyte content, hematocrit values and hemoglobin concentration were dose-dependently increased in rHuEPO treated groups. The ratio between kidney weight and whole body weight was significantly increased in females of 500 and 2,500 IU/㎏ groups. The spleen weight was also increased in both sexes of 500 and 2,500 IU/㎏ groups. However, the absolute weight change of other organs was not observed. In histopathological examinations, the renal tubular basophilia was observed only in males and females of 2,500 IU/㎏ groups. From these results, it is concluded that the no-observed adverse effect level(NOAEL) of rHuEPO is 100 IU/㎏ in rats in the present study.
곽승준,김형식,천선아,임소영,박현선,한하수,홍채영,안미영,이병무 성균관대학교 약학연구소 1998 成均藥硏論文集 Vol.10 No.1
The acute toxicity of DWP-311 was investigated in Sprague-Dawley rats. DWP-311 was subcutaneously administratered at dose levels of 595, 1,070, 1,930, 3,470, and 6,250 ㎎/㎏. In this study, we daily examined numbers of deaths, clinical signs, body weights, and pathological examinations for 7 days after administration of DWP-311. The results indicate that DWP-311 did not show any toxic effect in rats and the oral LD_50 value was over 6,250 ㎎/㎏ in Sprague-Dawley rats.
OECD 급성경구투여독성시험 지침의 국내 확립 및 검증
조영래 ( Young Rae Cho ),염영나 ( Young Na Yum ),한의식 ( Eui Sik Han ),곽승준 ( Seung Jun Kwack ),김형섭 ( Hyung Sub Kim ),강미선 ( Mi Sun Kang ),이진영 ( Jin Young Lee ),오재호 ( Jae Ho Oh ),임채형 ( Chae Hyung Lim ),김대성 ( Da 한국동물실험대체법학회 2008 동물실험대체법학회지 Vol.2 No.2
As the study about the non-animal tests came to be internationally active and the interest in the animal welfare gradually became increased, OECD TG (Test Guideline) 401 that has been used since 1987 was abolished in 2002. Because TG401 is acute oral toxicity method depending on survival and death of many animals, it was heavily criticized. Therefore, the three alternative methods were developed. OECD TG420 and TG423 determine the class of chemicals according to GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures) classification and OECD TG425 suggests the predicted LD50 of chemicals using AOT425 program. In this study, 10 chemicals were selected. The internationally admitted TG420, TG423 and TG425 were introduced and established through the method that these chemicals were orally administrated to SD female rats and then, the results were observed. Each chemical belonged to already known GHS class in the study using TG420 and TG423 and predicted LD50 was same or higher in the study using TG425 compared to already known LD50 value. In conclusion, the result of our study confirmed the decrease in the animal number and validated. The international harmonization of the non-animal tests will be pursued through this validation study.
Application of ECVAM proposal for in vitro target organ toxicity using liver and kidney cell Lines
( Mi Sun Kang ),( Jin Young Lee ),( Eui Sik Han ),( Seung Tae Chung ),( Young Rae Cho ),( Seung Jun Kwack ),( Hyung Sub Kim ),( Dong Sup Kim ),( Soon Young Han ) 한국동물실험대체법학회 2009 한국동물실험대체법학회 학술대회집 Vol.2009 No.1
Repeated dose toxicity testing in rodents is used to have information on potential target organs in terms of toxicity, and the NOAEL (no-observed-adverse-effect-level). ECVAM and ICCVAM have not validated any non-animal methods for assessing chronic toxicity endpoints or repreated exposure target organ toxicity because in vivo systems often poorly resemble in vitro cell culture systems. However, recently ECVAM recommended a proposed approach for the assessment of repeated dose toxicity in vitro. We applied ECVAM`s proposal to assess target organ toxicity using liver and kidney cell lines. In order to predict liver and kidney target organ toxicities, we used four kinds of kidney toxicants(HgCl2, CH3HgCl, CdCl2, cyclosporin A) and three kinds of liver toxicants(acetaminophen, CuCl2, PFOS) in human hepatoma(HepG2) cells, human renal tubular epithelial(HK-2) cells, human embryonic kidney(HEK293) cells and NIH 3T3 fibroblast. We performed cytotoxicity assays, mitochondria damage and calcium influx tests to predict target organ toxicity. Cell viability and cell proliferation were assessed by NRU assay and MTT assays, respectively. Mitochondria potential and cell calcium concentration([Ca2+]i) were estimated by a fluorescence microscopy using JC-1 dye and a fluorometer using Fluo-4/AM dye, respectively. The cytotoxicity of nephrotoxicants (HgCl2, CH3HgCl, CdCl2) from the result of NRU and MTT assay was higher in the kidney cells than in the liver cells. Also, the cytotoxicity of hepatotoxicants(acetaminophen, CuCl2, PFOS) was higher in the liver cells than in the kidney cells. Mitochondria potential and [Ca2+]i show compatability with cytotoxicity results in the kidney cells but not in the liver cells. The results demonstrated that nephrotoxicants can predict target organ toxicity by in vitro tests like NRU, MTT assay, mitochondria potential and [Ca2+]i. However, hepatotoxicants can predict target organ toxicity by cytotoxicity assays like NRU and MTT assays but not by mitochondria potential and [Ca2+]i.
랫드에서 인체 재조합 적혈구 조혈인자 , rHu-EPO 의 급성정맥독성시험
곽승준(Seung Jun Kwack),김형식(Hyung Sik Kim),임소영(So Young Lim),천선아(Sun Ah Chun),홍채영(Chae Young Hong),박현선(Hyun Sun Park),김원배(Won Bae Kim),김병문(Byoung Moon Kim),안병옥(Byoung Ok Ahn),이병무(Byung Mu Lee) 한국응용약물학회 1996 Biomolecules & Therapeutics(구 응용약물학회지) Vol.4 No.4
Acute intravenous toxicities of rHu-EPO (recombinant human erythropoietin) were investigated in Sprague-Dawley rats. Seven days after administration of rHu-EPO, we examined the clinical signs, mortalities, body weight and etc. No clinical signs and mortalities of toxicity were observed in animals. Also, a significant change of body weights was not observed. These results suggest that LD_(50) value was >25,000 unit/kg in Sprague-Dawley rats and the acute intravenous toxicities of rHu-EPO were not significant.
마우스에 대한 Aloewhite의 급성 경구 및 피하독성시험
김형식,곽승준,안미영,김규봉,이승기,천선아,임소영,박현선,홍채영,조태영,오선택,이병무 성균관대학교 약학연구소 1995 成均藥硏論文集 Vol.7 No.1
Abstract - Acute oral and subcutaneous toxicities of Aloewhite(30% aloesine) were carried out in ICR mice. In this study, we daily examined number of deaths, clinical signs, body weights, and pathological examinations for 14 days after single oral and subcutaneous administration of Aloewhite with different dose levels. Aloewhite did not show any remarkable toxic effect in mice. These results suggest that oral and subcutaneous LD50 values in mice were over 6.8g/kg and 10g/kg, respectively.
곽승준,김형식,천선아,임소영,박현선,한하수,홍채영,안미영,이병무,Kwack, Seung-Jun,Kim, Hyung-Sik,Chun, Sun-Ah,Lim, So-Young,Park, Hyun-Sun,Han, Ha-Su,Hong, Chae-Young,Ahn, Mi-Young,Lee, Byung-Mu 한국독성학회 1998 Toxicological Research Vol.14 No.3
The acute toxicity of DWP-311 was investigated in Sprague-Dawley rats. DWP-311 was subcutaneously administratered at dose levels of 595, 1,070, 1,930, 3,470, and 6,250mg/kg. In this study, we daily examined numbers of deaths, clinical signs, body weights, and pathological examinations for 7 days after administration of DWP-311. The results indicate that DWP-311 did not show any toxic effect in rats and the oral $LD_{50}$ value was over 6,250mg/kg in Sprague-Dawley rats.