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금은화(Flos lonicerae) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험
한충택,장호송,강상철,길기현,공광한,김도형,안태환,배진숙,고현규,한명규,김학수,허현숙,박은미,송시환,김갑호,박찬구,이현걸,Han, Zhong-Ze,Zhang, Hu-Song,Kang, Sang-Chul,Gil, Ki-Hyun,Kong, Kwang-Han,Kim, Do-Hyung,Ahn, Tae-Hwan,Bae, Jin-Sook,Go, Hyeon-Kyu,Ha 대한수의학회 2008 大韓獸醫學會誌 Vol.48 No.4
This study was performed to evaluate repeated-dose oral toxicities of Flos lonicerae extract in Fischer 344/n rats. Flos lonicerae was administered orally to rats at dose levels of 0, 37, 111, 333, 1,000 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Flos lonicerae extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program and The Standards of Toxicity Study for Medicinal Products. In the present study, there were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Flos lonicerae extract. These results suggest that the oral no observed adverse-effect level of the test item, Flos lonicerae extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.
Sprague-Dawley 랫드를 이용한 발생독성시험의 기초자료연구
김종춘(Jong-Choon Kim),이상준(Sang-Joon Lee),배진숙(Jin-Sook Bae),박종일(Jong-Il Park),김용범(Yong-Beom Kim),정문구(Moon-Koo Chung) 한국독성학회 2001 Toxicological Research Vol.17 No.2
The background control data were compiled from rat developmental toxicity studies conducted at Toxicology Research Center, KR1CT during the 1993-1999 period. These data were assembled in order to provide background information for the maternal and fetal data collected in 13 developmental toxicity studies using Sprague-Dawley rats. A total of 325 mated females were used in these studies during the seven-year period and overall pregnancy rate of these females was 93.8%. The present background control data included body weights, food consumption, hematological values, and organ weights of pregnant caesarean section data, and fetal examination data. These data can be used not only as a historical database for the meaningful interpretation of data from reproductive and developmental toxicity studies, but also as a contribution to biological characterization of Sprague-Dawley rats.
백굴채(Chelidonium majus) 추출물의 Fischer 344/N 랫드를 이용한 90일간 반복 경구투여 독성시험
김도형,장호송,김광호,강상철,김학수,길기현,공광한,안태환,배진숙,고현규,김갑호,박찬구,이현걸,송시환,한충택,Kim, Do-Hyung,Zhang, Hu-Song,Kim, Kwang-Ho,Kang, Sang-Chul,Kim, Hak-Soo,Gil, Ki-Hyun,Kong, Kwang-Han,Ahn, Tae-Hwan,Bae, Jin-Sook,Go, Hyeon-K 대한수의학회 2009 大韓獸醫學會誌 Vol.49 No.1
This study was performed to evaluate repeated-dose oral toxicities of Chelidonium majus extract in Fischer 344/N rats. Chelidonium majus extract was administered orally to rats at dose levels of 0, 25, 74, 222, 666 and 2,000 mg/kg/day. Each group consisted of 10 rats of each gender. The Chelidonium majus extract was given once a day, 5 times a week, for 90 day repeatedly. This study was conducted in accordance with the Protocol of Korea National Toxicology Program (issued by National Institute of Toxicological Research) and The Standards of Toxicity Study for Medicinal Products (issued by Korea Food and Drug Administration). In the present study, There were no toxicologically significant changes in mortality, clinical signs, body weight gains, ophthalmoscopy, urine analysis, hematology, serum biochemistry, necropsy findings, organ weights, histopathology, estrus cycle and sperm examination of all animals treated with Chelidonium majus extract. These results suggest that the oral no observed adverse-effect level of the test item, Chelidonium majus extract, in rats is higher than 2,000 mg/kg/day in both genders. The target organs were not established.
Sprague-Dawley계 흰쥐를 이용한 HT042의 14일 반복 경구투여 독성연구
송정빈 ( Jungbin Song ),이동헌 ( Donghun Lee ),김영식 ( Young-sik Kim ),이승경 ( Seunggyeong Lee ),배진숙 ( Jin-sook Bae ),김호철 ( Hocheol Kim ) 대한본초학회 2017 大韓本草學會誌 Vol.32 No.1
Objectives : HT042 is a combination of three herbal extracts from the roots of Astragalus membranaceus , the stems of Eleutherococcus senticosus and the roots of Phlomis umbrosa, which has been demonstrated to increase longitudinal bone growth rate. The aim of this study was to assess the safety of HT042 after repeated oral administration. Methods : A 14-day repeated oral dose toxicity study was conducted using male and female Sprague-Dawley rats. HT042 was administered orally at repeated doses of 500, 1,000 and 2,000 ㎎/㎏/day for 14 days. Clinical signs and mortality were observed daily, whereas body weight and food consumption were recorded weekly throughout the experiment. At the end of the study, blood was taken from the posterior vena cava for hematology and serum biochemistry. All organs of the body surface, subcutis, head, thoracic cavity, and abdominal cavity were observed grossly. Then, the internal organs were removed and weighed. Results : No death occurred and no significant changes in clinical sign, body weight, food consumption and serum biochemistry parameters were observed in male and female rats over the study period. Although there were some alterations in hematologic and necropsy findings, and organ weights, these changes were not considered toxicologically significant. Conclusions : These results suggest that the 14-day repeated administration of HT042 does not produce any significant oral toxicity at doses of up to 2,000 ㎎/㎏/day in male and female rats under the present experimental conditions.
1,4-Dichlorobutane의 랫드 2주 반복경구투여독성시험
김종규 ( Jong Kyu Kim ),이인철 ( In Chul Lee ),김성환 ( Sung Hwan Kim ),백형선 ( Hyung Seon Baek ),배진숙 ( Jin Sook Bae ),송시환 ( Si Whan Song ),김종춘 ( Jong Choon Kim ),정용현 ( Yong Hyun Chung ) 한국산업위생학회 2013 한국산업보건학회지 Vol.23 No.1
OObbjjeeccttiivveess:: The present study investigated the potential subacute toxicity of 1,4-dichlorobutane (1,4-DCB) by a 2-week repeated oral dose in male Sprague-Dawley rats. MMaatteerriiaallss aanndd MMeetthhooddss:: The test chemical was administered once daily by gavage to male rats at dose levels of 0, 74, 222, 667, and 2000 mg/kg/day for 2 weeks. All rats were sacrificed at the end of treatment period. During the test period, clinical signs, mortality, body weights, food and water consumption, urinalysis, hematology, serum biochemistry, gross findings, and organ weights were examined. RReessuullttss:: At 2000 mg/kg/day, treatment-related clinical signs, as evidenced by hypothermia, decreased locomotor activity, piloerection, lying on side, and prone position were observed. All the rats were found dead on test day 2. At 667 mg/kg/day, polyuria, suppressed body weight gain, food consumption, and spleen and thymus weights, and increased adrenal gland and liver weights were observed.Hematological and serum biochemical investigations revealed increases in the alanine aminotransferase, alkaline phosphataseand total bilirubinand decreases in the serum Na+ level, white blood cell count and lymphocyte ratio. There were no treatment-related adverse effects in the 74 and 222 mg/kg/day groups. CCoonncclluussiioonnss:: In the present experimental conditions, target organs were determined to be spleen, thymus,and liver. The no-observed-adverse-effect level was considered to be 222 mg/kg/day in male rats.
새로운 관절염 CONP01의 생식독성연구: 랫드 배·태자 발생시험
이정숙(June-Suk Lee),홍동호(Dong Ho Hong),김광호(Kwang-Ho Kim),장호송(Hu-Song Zhang),길기현(Gi Hyun Gil),한명규(Myong Kyu Han),양현주(Hyun Ju Yang),배진숙(Jin-Sook Bae),김남두(Nam Du Kim),송시환(Si Whan Song) 한국독성학회 2005 Toxicological Research Vol.21 No.1
A developmental study of CONP01, a new antiarthritic agent, was conducted in Sprague- Dawley rats. Dosage of CONP01 0, 111, 333, and 1000 mg/kg/day were administered to dams orally from day 6 to day 16 of gestation. Two-third of dams per group were subjected to caesarean section on day day 20 of pregnancy for examination of their fetuses, and the remaining one-third of dams per group were allowed to deliver naturally for postnatal examination of their offspring. There was no change in the dams body weights, food consumptions, specific clinical sings and gross findings. There was significant decrease only in the absolute and relative weights of right ovary in 111 mg/kg treatment group, when compared with the vehicle control, whereas other organ weights were not changed. Moreover, no increase in the frequencies of external, visceral and skeletal malformation of fetuses were observed in the treated groups. These results suggest that the oral NOAEL (no observed adverse effect level) of CONP01 may be over 1,000 mg/kg in dams and fetuses of rats.
흥동호(Dong Ho Hong),장호송(Hu-Song Zhang),김광호(Kwang-Ho Kim),길기현(Gi Hyun Gil),김재민(Jae Min Kim),한명규(Myong Kyu Han),배진숙(Jin-Sook Bae),김남두(Nam Du Kim),이현걸(Hyun Kul Lee),이정숙(Jung Suk Lee),이선경(Sun Kyung Lee),박찬구 한국독성학회 2004 Toxicological Research Vol.20 No.4
This study was performed to evaluate repeated-dose toxicities of CONP01 in Sprague-Dawley rats. CONP01, a new antiarthritic agent was administered orally to rats at dose levels of 0, 125, 500 and 2,000 mg/kg/day for 4 weeks. In present study, there were no dose response changes in mortality, clinical signs, body weight changes, food and water consumption, ophthalmoscopy, organ weights, urine analysis, hematological findings, and biochemical examination of all animals treated with CONP01. Gross and histopathological findings revealed no evidence of specific toxicity related to CONP01. These result suggest that no observed adverse effect level (NOAEL) of CONP01 may be over 2,000 mg/kg in rats.