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랫드에서 인체 재조합 적혈구 조혈인자, rHuEPO의 13주 정맥투여 아만성독성에 관한 연구
김형식,곽승준,천선아,박현선,한하수,임소영,안미영,김원배,안병옥,홍성렬,이병무,Kim, Hyung-Sik,Kwack, Seung-Jun,Chun, Sun-Ah,Park, Hyun-Sun,Han, 한하수,Lim, So-Young,Ahn, Mi-Young,Kim, Won-Bae,Ahn, Byoung-Ok,Hong, Sung-Youl,Lee, Byung-Mu 한국독성학회 1998 Toxicological Research Vol.14 No.3
A recombinant human erythropoietin (rHuEPO) was administered intravenously at dosage levels of 0, 100, 500, and 2500IU/kg/day for a period of 3 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 2,5000IU/kg 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 2,500IU/kg groups. The spleen weight was also increased in both sexes of 500 and 2,500IU/kg 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 2,500IU/kg groups. From these results, it is concluded that the no-observed adverse effect level (NOAEL) of rHuEPO is 100 IU/kg in rats in the present study.
김형식,곽승준,천선아,한하수,박현선,안미영,배기환,이병무 성균관대학교 약학연구소 1998 成均藥硏論文集 Vol.10 No.1
The subacute oral toxicity study of DWP-311 was carried out in Sprague-Dawley rats of both sexes. We daily examined clinical signs, body weights, hematological and biochemical parameters, and histopathological examinations for 30 days after administration of DWP-311 with different dose levels (0, 0.04, 0.2, and 1.0 g/㎏). There were no clinical signs and pathological changes compared with control group except slight decreases in spontaneous motor activities and locomotions at high dose group of DWP-311. Body weights were not significantly changed in animals treated with DWP-311. In histopathological examinations, there were 2 cases of pneumonia in control group for one male and one female, but it was not directly related to DWP-311. These results indicate that subacute oral toxicities of DWP-311 were low and the no-observed adverse effect level(NOAEL) was considered to be 1.0 g/㎏ in rats.
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.
김형식,곽승준,천선아,한하수,박현선,안미영,배기환,이병무 충남대학교 약학대학 의약품개발연구소 1998 藥學論文集 Vol.14 No.-
The subacute oral toxicity study of DWP-311 was carried out in Sprague-Dawley rats of both sexes. We daily examined clinical signs, body weights, hematological and biochemical parameters, and histopathological examinations for 30 days after administration of DWP-311 with different dose levels (0, 0.04, 0.2, and 1.0 g/㎏). There were no clinical signs and pathological changes compared with control group except slight decreases in spontaneous motor activities and locomotions at high dose group of DWP-311. Body weights were not significantly changed in animals treated with DWP-311. In histopathological examinations, there were 2 cases of pneumonia in control group for one male and one female, but it was not directly related to DWP-311. There results indicate that subacute oral toxicities of DWP-311 were low and the no-observed adverse effect level (NOAEL) was considered to be 1.0 g㎏ in rats.
비글개에서 인체 재조합 적혈구 조혈인자, rHuEPO의 아만성 정맥독성에 관한 연구
조명행,성하정,김형식,곽승준,천선아,한하수,임소영,안미영,김원배,김병문,안병옥,홍성렬,이병무 성균관대학교 약학연구소 1998 成均藥硏論文集 Vol.10 No.1
The subchronic toxicity study of rHuEPO, a newly developed recombinant erythropoietin, was investigated for 13 weeks in Beagle dogs intravenously treated with doses of 100,500 and 2,500 IU/㎏/day. There were no significant changes in body weight, food intake, physical and opthalmic examination, urine analysis, etc. Any toxic response was not observed except for enlarged spleen and extramedullary hematopoiesis. These results indicate that the no-observed adverse effect level (NOAEL) of rHuEPO is 100 IU/㎏ in Beagle dogs.
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.
곽승준,김형식,천선아,임소영,박현선,홍채영,한하수,최병천,이병무 한국독성학회 1996 Toxicological Research Vol.12 No.2
Acute toxic effects of the Woo Whang Chung Shim Won suspension and pills were studied with the doses of 60, 74, 90, and 110 ml/kg in mice. In this study, we daily examined number of deaths, clinical signs, body weights, and pathological findings for 7 days after administration of Woo Whang Chung Shim Won. All mice given the highest dose (110ml/kg) died at 24 hour after administration of Sam-Sung Woo Whang Chung Shim Won suspension (Byunbang, SS-BS and Wonbang, SS-WS), one male and two female mice given 90 ml/kg dose of SS-BS died, and a few mice given middle dose (74 ml/kg) of SS-WS died. In control group (110 ml/kg) treated with vehicle (SS-BS and SS-WS), three out of 5 males and two out of 5 females mice died during the study. However, in animals treated with Kwang-Dong Woo Whang Chung Shim Won suspension (KD-S) and pill (KD-P), deaths were not observed. In the clinical signs, increase of drooling and decrease of spontaneous motor activities were observed in the highest dose group (110 ml/kg). No significant dose-related change in body weight was observed. The results suggest that the toxic effect of SS-BS and SS-WS may be atttributed to the solution for the Woo Whang Chung Shim Won suspension.
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.
김형식(Hyung Sik Kim),곽승준(Seung Jun Kwack),천선아(Sun Ah Chun),한하수(Ha Su Han),박현선(Hyun Sun Park),안미영(Mi Young Ahn),배기환(Ki Hwan Bae),이병무(Byung Mu Lee) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.3
The subacute oral toxicity study of DWP-311 was carried out in Sprague-Dawley rats of both sexes. We daily examined clinical signs, body weights, hematological and biochemical parameters, and histopathological examinations for 30 days after administration of DWP-311 with different dose levels (0, 0.04, 0.2, and 1.0 g/kg). There were no clinical signs and pathological changes compared with control group except slight decreases in spontaneous motor activities and locomotions at high dose group of DWP-311. Body weights were not significantly changed in animals treated with DWP-311. In histopathological examinations, there were 2 cases of pneumonia in control group for one male and one female, but it was not directly related to DWP-311. These results indicate that subacute oral toxicities of DWP-311 were low and the no-observed adverse effect level (NOAEL) was considered to be 1.0 g/kg in rats.