• Title/Summary/Keyword: KFDA

검색결과 710건 처리시간 0.033초

Population Pharmacokinetics of Loxoprofen

  • Yun, J.H.;Cho, H.Y.;Kim, S.J.;Ahn, M.R.;Park, S.O.;Chung, H.J.;Yang, J.S.;Lee, Y.B.
    • 대한약학회:학술대회논문집
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    • 대한약학회 2001년도 Proceedings of the Pharmaceutical Society of Korea
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    • pp.109.2-110
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    • 2001
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EVALUATION OF CELL PROLIFERATION IN EAR AND LYMPH NODE USING BRDU IMMUNOHISTOCHEMISTRY FOR MOUSE EAR SWELLING TEST

  • Lee, Jong-Kwon;Park, Jae-Hyun;Kim, Hyung-Soo;Jung, Seung-Tae
    • 한국독성학회:학술대회논문집
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    • 한국독성학회 2002년도 Current Trends in Toxicological Sciences
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    • pp.97-97
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    • 2002
  • A mouse ear swelling test (MEST) has been developed as an alternative to guinea pig models for contact sensitization potential. However, the MEST relies on a quantitative measurement of ear swelling as an endpoint by micrometer. In this study, we aimed to investigate the cell proliferation in ear and lymph node using Bromodeoxyuridine (BrdU) immunohistochemistry as a possible reliable marker for MEST.(omitted)

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재조합 사람성장호르몬(소마트로핀)의 KFDA 표준품(KS 98/674) 설정 연구 (Collaborative Study for the Establishment of KFDA Reference Standard for Somatropin (KS 98/674))

  • 신원;정지원;진재호;;손여원
    • 약학회지
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    • 제45권2호
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    • pp.227-236
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    • 2001
  • The complexity and variability of both the biologicals and the bioassays used to test them led to the use of the reference standard- a sample of the product of defined purity and potency, against which all preparations of that product must be calibrated. In order to prepare and establish KFDA reference standard for recombinant human growth hormone (somatropin), somatropin substance was filled in ampoules in National Institute for Biological Standards and Control (NIBSC). The candidate KFDA reference standard for somatropin (designated as 98/674) was evaluated to determine the suitability of serving as a KFDA reference standard for somatropin by the collaborative study, in which 10 laboratories participated. Physicochemical analysis and in vivo bioassay were performed by direct comparison with the international somatropin standard 88/624. 98/674 was identified as somatropin by SDS-PAGE, IEF, peptide mapping, and HPLC. Determination of somatropin content by SE-HPLC yielded a mean estimate of 2.01 mg somatropin per ampoule. Data from the study also yielded mean values of 0.39 $\pm$ 0.26% for high molecular weight impurities by SE-HPLC and mean values of 2.13 $\pm$ 1.29% for somatropin related proteins by RP-HPLC. Estimates of relative potency by weight gain bioassay in the hypophysectomised rats showed that relative potency of KS 98/674 was 1.07 aganist IS 88/624. Based on the results of the collaborative study, the candidate reference standard for somatropin is suitable to serve as a KFDA reference standard for somatropin.

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다장기 중기발암성 시험법을 이용한 셀렌염의 대장암 억제효과에 대한 연구 (The Chemopreventive Effect of Sodium Selenite on Colon Carcinogenesis in Medium-Term Multi-Organ Bioassay)

  • 한범석;홍충만;신동환;이국경;안병우;장동덕
    • 한국수의병리학회지
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    • 제5권1호
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    • pp.23-28
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    • 2001
  • This study was conducted to assess the chemopreventive effects of sodium selenite in the rat medium-term multi-organ bioassay using a DMBDD model (DEN+MNU+BBN+DMH+DHPN). Seventy five,6-week-old, male SD rats were divided into 3 groups. The animals in group 1 received DEN(diethylnitrosamine,100 mg/kg bw, single i.p., in saline), MNU (N-methyl-nitrosourea,20 mg/kg bw, i.p.,4 times for 2 weeks), BBN (N-butyl-N-(4-hydroxybutyl) nitrosamine, 0.2% in drinking water for 2 weeks), DMH (1,2-dimethylhydrazine, 40 mg/kg bw, s.c., in saline.4 times (or 2 weeds), and DHPN (N-bis(2-hydroxy-pro-pal)nitrosamine,0.1% in drinking water for 2 weeks), then were placed on sodium selenite (4 ppm in drinking water) for 22 weeks from weeks 4 to 26. The animals in group 2 were given DMBDD alone. The animals in group 3 were given sodium selenite alone. Animals were sacrificed at week 12 for ACF quantitative analysis and at week 26 for tumor induction. The body weights in the group 1 were significantly decreased compared with those of group 2. The tumor multiplicities of large intestine in the group 1 were significantly decreased compared with those of group 2 (P<0.05). These results indicate that sodium selenite may have a potential as chemopreventive agents of colon carcinogenesis.

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HPLC-FLD 및 LC-MS/MS에 의한 식품 중 총아플라톡신 오염실태 조사 (A Survey of Total Aflatoxins in Food Using High Performance Liquid Chromatography-Fluorescence Detector (HPLC-FLD) and Liquid Chromatography Tandem Mass Spectrometry(LC-MS/MS))

  • 장미란;이창희;조성혜;박준식;권은영;이은진;김소희;김대병
    • 한국식품과학회지
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    • 제39권5호
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    • pp.488-493
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    • 2007
  • 국내유통중인 곡류, 견과류 및 그 가공품 총 25품목, 393건의 시료에 대해 immunoaffinity column 정제방법을 이용하여 총아플라톡신 오염실태를 조사하였으며, 그 결과 곡류 및 곡류가공품 6건, 견과류 및 견과류 가공품 37건에서 아플라톡신 오염이 확인되었으며 오염수준은 아플라톡신 $B_1$으로서 $0.04-2.65{\mu}g/kg$, 총아플라톡신으로서 $0.04-5.51{\mu}g/kg$ 범위로 나타났다. Immunoaffinity column 정제를 거쳐 HPLC-FLD로 분석한 결과 아플라톡신이 검출된 시료에 대해서 LC-MS/MS로 확인하였으며, 그 결과 모두 아플라톡신으로 확인되었다. 본 연구결과에서 나타난 곡류 및 견과류에 대한 아플라톡신 검출빈도 및 오염수준은 국내, 외 연구 결과와 유사하거나 비교적 낮게 나타났으며 국내 아플라톡신 기준 및 미국, CODEX에서 설정된 기준규격 이하로 검출되었다.

Effects of Long-Term Vitamin E and Butylated Hydroxytoluene Supplemented Diets on Murine Intestinal and Hepatic Antioxidant Enzyme Activities

  • Jang, I.S.;Chae, K.R.;Kang, T.S.;Kim, Y.K.;Kim, C.K.;Hwang, J.H.;Hwang, D.Y.;Choi, C.B.;Jung, K.K.;Cho, J.S.
    • Asian-Australasian Journal of Animal Sciences
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    • 제12권6호
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    • pp.932-938
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    • 1999
  • The present study was designed to determine long-term feeding effects of vitamin E and BHT (butylated hydroxytoluene) on serum biochemical profiles, organ weight, and intestinal and hepatic antioxidant enzymes including superoxide dismutase (SOD), glutathione peroxidase (GSH-PX), and glutathione-S-transferase (GST) in ICR mice. Four wk old ICR mice (n=8 per group) were fed the diets supplemented with vitamin E (I ; 0.03% and II ; 0.3%) and BHT (I ; 0.05% and II ; 0.5%) for 12 months. Feeding the diets containing vitamin E and BHT had no effects on growth and serum biochemical profiles. However, feeding the diets supplemented with 0.5% BHT for 12 months significantly increased liver weight of the mice. In the small intestine, there were no effects of vitamin E or BHT on SOD and GSH-PX activities in the mucosa. However, the activity of intestinal GST of the mice that received 0.5% BHT was almost twice as high as that of control mice. In the liver, the activity of SOD was not affected by feeding antioxidants for 12 months, whereas GSH-PX activity was significantly increased in mice that received the diets containing BHT (0.05%, 0.5%) and vitamin E (0.03%, 0.3%). In addition, supplementation of 0.5% BHT markedly enhanced hepatic GST activity compared with other groups. Enhanced activity of GSH-PX in response to feeding vitamin E or BHT might aid hepatic enzymes to eliminate active oxygen in organs from mice. However, we could not exclude the possibility of increased lipid peroxidation by high dosage of BHT supplementation. More detailed study is necessary for assessment of preventive or toxicological effects of high dosage of BHT supplementation.

HPLC-FLD 및 LC-MS/MS에 의한 두류 중 제랄레논 오염실태 조사 (A Survey of Zearalenone in Beans Using High Performance Liquid Chromatography-Fluorescence Detector (HPLC-FLD) and Ultra Performance Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS))

  • 장미란;이창희;이효정;김지연;손상혁;신춘식;김소희;김대병
    • 한국식품과학회지
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    • 제40권3호
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    • pp.354-359
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    • 2008
  • 국내유통 중인 대두, 붉은콩, 검은콩 녹두 등 6품목의 두류 총 127건을 immunoaffinity column 정제방법 및 HPLC-FLD을 이용하여 제랄레논에 대한 오염실태를 조사하였다. 상관계수($R^2$) 0.999 이상으로 양호한 직선성을 보였고 검출한계 및 정량한계는 각각 2.0 ${\mu}g/kg$, 6.0 ${\mu}g/kg$, 회수율 82.2-98.4%로 나타났다. RSD가 0.82-6.40%로 양호한 재현성을 나타내었다. 모니터링 결과, 대두(백태) 27건 중 1건(3.7%)에서 37.62 ${\mu}g/kg$ 검출되었고 붉은콩(팥) 27건 중 12건 검출되어 44.4%의 검출율을 보였고 그 오염수준은 8.01-38.98 ${\mu}g/kg$이었다. 나머지 시료 검정콩 16건, 녹두 24건, 서리태(속청) 19건, 서목태(약콩) 14건에서는 모두 검출되지 않았다. 따라서 총 시료 127건 중 13건 검출되어 10.2%의 검출율을 보였고 그 오염수준은 8.01-38.98 ${\mu}g/kg$이었다, 검출시료 13건을 LCMS/MS로 확인한 결과 모두 제랄레논임이 확인되었다. 본 연구결과에서 나타난 두류의 검출빈도 및 오염수준은 유럽연합에서 설정된 기준규격 이하의 수준이었으나 곰팡이독소의 생성의 특이성을 고려한다면 지속적이고 광범위하게 오염실태 조사가 되어야 한다고 판단된다.