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의약품의 효능별 안전성·유효성 평가에 관한 조사연구(Ⅰ) : 항균제 Antiboiotics
박윤주,최기환,김동섭,박인숙,정면우,임화경,오우용,강주희,박찬웅,김주일 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
새로운 물질이 개발되어 신약으로 탄생하기까지 많은 시간과 노력, 예산이 필요하다. 최근, 우리 나라에서도, 신약캐발이 어릴고 힘든 분야이지만 새로운 신약개발을 총해 얻어지는 분가가치가 막대함을 인식, 연구에 박차를 가하 있는 실정이다. 본 연구는, 의약품 개발 선진국인 미국 FDA에서 발행하는 참고자료 중 항균제 임상편가에 대한 가이드라인 및 주요 임상적응증별 항균제 기발(지역사획회득성 폐렴, 원내감염성 계렴, 급성기관지염의 2차세균감염, 만성기지염의 급성세균성 악화, 연쇄구균에 의한 인두영 및 편도염 , 단순성 요로감염증, 복합성 요로감염증 및 신우신영, 급성 세균성 부비동옆, 항 바이러스제 개발시 전임상단계에서 고려사항, 항 바이러스제 허가와 된련 잉상적 고려사항, 카레타 괸련 혈류감염)에 있어서의 파이드라인 등의 자료를 소개함으로져, 향후 제약사의 항균제 신약개발 및 허가 신청된 의악품의 전임상차료 및 잉상시험자료의 검토 평가업무에 참고자료로 활용될 수 있을 것이다. Changing or unclear interpretations of clinical trial data needed to demonstrate the effectiveness and safety of antimicrobial drug products have a times led to confusion and frustration on the part of both applicants and division of these drug products reviewers. The FDA published guidance on desing clinical protocols, implementing, and analyzing data from clinical trials for antimicrobial drug products has been presented and additional companion guidances introduced specific issues to individual infections. This document provides applicants and reviewers with minimal information appropriate for the clinical development of routine antimicrobial drug products and identifies issues common to many antimicrobial drug applications. The agency can use the kind of information to determine whether the antimicrobial drug product under study is safe and effective in the treatment of the specific infection studied.
Woo, Sun-Wook,Hwang, Kwan-Ik,Chung, Myeon-Woo,Jin, Sun-Kyung,Bang, Syrie,Lee, Sung-Ho,Lee, Sung-Hee,Chung, Hye-Joo,Sohn, Dong-Hwan 대한약학회 2007 Archives of Pharmacal Research Vol.30 No.11
Hepatic stellate cells (HSCs) are activated by producing potentially injurious connective tissue components during hepatic fibrosis, thereby exerting a pivotal action in the development of liver fibrogenesis. The aim of this study was to investigate differences in gene expression patterns during the activation of HSCs using complementary cDNA microarrays. HSCs were isolated from normal rat livers and cultured for 0 (3 h), 3, 5 and 7 d. RNA was extracted from cultured cells at each point. The target RNA was hybridized to gene-specific sequence probes immobilized on chips. The hybridization signal was assessed using a confocal laser scanner Comparison of hybridization signals and patterns allows the identification of mRNAs that are expressed differentially. Statistical analysis was used to classify and cluster the genes according to their up- or downregulation. As a result, 33 upregulated early-stage and 36 upregulated late-stage gene candidates were identified. This time-based study revealed a number of newly discovered genes involved in fibrogenesis during the activation of HSCs.
( Myeon Woo Chung ),( Syrie Bang ),( Sun Kyung Jin ),( Sun Wook Woo ),( Yoon Jung Lee ),( Young Sik Kim ),( Jong Keuk Lee ),( Sung Ho Lee ),( Hye Joo Chung ),( Jae Sook Roh ) 한국응용약물학회 2007 Biomolecules & Therapeutics(구 응용약물학회지) Vol.15 No.3
Rapid advances in pharmacogenomic research have provided important information to improve drug selection, to maximize drug efficacy, and to minimize drug adverse reaction. The SNPs that are the most abundant type of genetic variants have been proven as valid biomarkers to give information on the prediction of pharmacokinetic/pharmacodynamic properties of drugs based on genotype. In order to elucidate a correlation between SNPs of calcium channel encoding gene and adverse reactions of calcium channel blockers, we investigated SNPs in CACNA1C gene known as a binding site of calcium channel blocker. 96 patients with hypertension who had taken or are taking an antihypertensive drug, 1,4-dihydropyridine (DHP) were included for analysis. These patients were composed of 47 patients with adverse drug reactions (ADR) such as edema from calcium channel blockers and 49 patients without ADR as a control group. The exons encoding the drug binding sites were amplified by PCR using specific primers, and SNPs were analyzed by direct sequencing. We found that there was no SNP in the exons encoding DHP binding site, but four novel SNPs in the exon-intron junction region. However, four novel SNPs were not associated with the ADR of calcium channel blockers. In conclusion, this study showed that ADR from calcium channel blockers may not be caused by SNPs of the binding sites of calcium channel blockers in CACNA1C gene.
(Myeon Woo Chung),(Sub Sunoo),(Seung Hwan Kim),(Hack Seang Kim) 한국응용약물학회 2001 Biomolecules & Therapeutics(구 응용약물학회지) Vol.9 No.2
The effects of Malloti Cortex Water Extract (MCWE), bergenin (isolated as an active component from MCWE), and acetylbergenin (synthesized from acetylation of bergenin) on the liver fibrosis induced by bile duct ligation (BDL) in rats. We studied hydroxyproline (HYP) as a marker of collagen accumulation in the liver, alanine aminotransferase (s-ALT), aspartate aminotransferase (s-AST), and alkaline phosphatase (s-ALP) as serum markers of liver cell damage induced by BDL. MCWE, bergenin, and acetylbergenin decreased towards normal the accumulated levels of HYP in the liver and the elevated serum levels of s-ALT, s-AST and s-ALP The results indicate that MCWE, bergenin, and acetylbergenin ameliorated the liver damage induced by BDL in rats.
Chung, Myeon-Woo,Bang, Sy-Rie,Jin, Sun-Kyung,Woo, Sun-Wook,Lee, Yoon-Jung,Kim, Young-Sik,Lee, Jong-Keuk,Lee, Sung-Ho,Roh, Jae-Sook,Chung, Hye-Joo The Korean Society of Applied Pharmacology 2007 Biomolecules & Therapeutics(구 응용약물학회지) Vol. No.
Rapid advances in pharmacogenomic research have provided important information to improve drug selection, to maximize drug efficacy, and to minimize drug adverse reaction. The SNPs that are the most abundant type of genetic variants have been proven as valid biomarkers to give information on the prediction of pharmacokinetic/pharmacodynamic properties of drugs based on genotype. In order to elucidate a correlation between SNPs of calcium channel encoding gene and adverse reactions of calcium channel blockers, we investigated SNPs in CACNA1C gene known as a binding site of calcium channel blocker. 96 patients with hypertension who had taken or are taking an antihypertensive drug, 1,4-dihydropyridine (DHP) were included for analysis. These patients were composed of 47 patients with adverse drug reactions (ADR) such as edema from calcium channel blockers and 49 patients without ADR as a control group. The exons encoding the drug binding sites were amplified by PCR using specific primers, and SNPs were analyzed by direct sequencing. We found that there was no SNP in the exons encoding DHP binding site, but four novel SNPs in the exon-intron junction region. However, four novel SNPs were not associated with the ADR of calcium channel blockers. In conclusion, this study showed that ADR from calcium channel blockers may not be caused by SNPs of the binding sites of calcium channel blockers in CACNA1C gene.
Sun Wook Woo,Kwan-Ik Hwang,Myeon-Woo Chung,Sun Kyung Jin,Syrie Bang,이성호,Sung Hee Lee,정혜주,손동환 대한약학회 2007 Archives of Pharmacal Research Vol.30 No.11
Hepatic stellate cells (HSCs) are activated by producing potentially injurious connective tissue components during hepatic fibrosis, thereby exerting a pivotal action in the development of liver fibrogenesis. The aim of this study was to investigate differences in gene expression patterns during the activation of HSCs using complementary cDNA microarrays. HSCs were isolated from normal rat livers and cultured for 0 (3 h), 3, 5 and 7 d. RNA was extracted from cultured cells at each point. The target RNA was hybridized to gene-specific sequence probes immobilized on chips. The hybridization signal was assessed using a confocal laser scanner. Comparison of hybridization signals and patterns allows the identification of mRNAs that are expressed differentially. Statistical analysis was used to classify and cluster the genes according to their up- or downregulation. As a result, 33 upregulated early-stage and 36 upregulated late-stage gene candidates were identified. This time-based study revealed a number of newly discovered genes involved in fibrogenesis during the activation of HSCs.
冠岳樹木圓地域內 荒廢山地土壤의 肥沃化를 통한 綠化促進에 關한 硏究(II)
禹保命,權台鎬,李宗學,金景河,李峻雨,麻鎬燮 서울大學校 農科大學 1986 서울대농학연구지 Vol.11 No.2
The shallow soil depth and severe rock exposures on the hillslopes in the Kwanak aboretum area which resulted from the heavy soil erosion have made very poor growth of forest vegetation. In order to establish the forest vegetation in this area, it is urgent to recover the fertility of soil and the productivity of existing trees. For this reason, fertilization experiment (using the briquet compound fertilizer) was conducted on summer and autumn season in 1983 with the 4 main native species (Pinus densiflora, Pinus rigida, Juniperus rigida, Rhododendron schlippenbachii) growing on these eroded hillslopes. Result in 1985 and 1986 of this experiment represented that the fertilization was effective toward both height and root-collar diameter growth of trees and spring fertilization was, relatively, more effective than autumn fertilization. It also represented that effects of fertilization to P. rigida were more than those to other species. Therefore, besides the engineering methods and afforestation measures for soil erosion control, rapid establishment of vegetation through conservation and recovery of existing trees by fertilization is available measures for the rehabilitation of rockily eroded hillslopes like Mt. Kwanak area.
Myeon Choe,Dae Jung Kim,Yun Hwan Kang,Kyoung Kon Kim,Tae Woo Kim,Jae Bong Park 대한지역사회영양학회 2017 Nutrition Research and Practice Vol.11 No.3
BACKGROUND/OBJECTIVES: Recent living condition improvements, changes in dietary habits, and reductions in physical activity are contributing to an increase in metabolic syndrome symptoms including diabetes and obesity. Through such societal developments, humankind is continuously exposed to metabolic diseases such as diabetes, and the number of the victims is increasing. This study investigated Cordyceps militaris water extract (CMW)-induced glucose uptake in HepG2 cells and the effect of CMW treatment on glucose metabolism. MATERIALS/METHODS: Colorimetric assay kits were used to determine the glucokinase (GK) and pyruvate dehydrogenase (PDH) activities, glucose uptake, and glycogen content. Either RT-PCR or western blot analysis was performed for quantitation of glucose transporter 2 (GLUT2), hepatocyte nuclear factor 1 alpha (HNF-1α), phosphatidylinositol 3-kinase (PI3k), protein kinase B (Akt), phosphorylated AMP-activated protein kinase (pAMPK), phosphoenolpyruvate carboxykinase, GK, PDH, and glycogen synthase kinase 3 beta (GSK-3β) expression levels. The α-glucosidase inhibitory activities of acarbose and CMW were evaluated by absorbance measurement. RESULTS: CMW induced glucose uptake in HepG2 cells by increasing GLUT2 through HNF-1α expression stimulation. Glucose in the cells increased the CMW-induced phosphorylation of AMPK. In turn, glycolysis was stimulated, and glyconeogenesis was inhibited. Furthermore, by studying the mechanism of action of PI3k, Akt, and GSK-3β, and measuring glycogen content, the study confirmed that the glucose was stored in the liver as glycogen. Finally, CMW resulted in a higher level of α-glucosidase inhibitory activity than that from acarbose. CONCLUSION: CMW induced the uptake of glucose into HepG2 cells, as well, it induced metabolism of the absorbed glucose. It is concluded that CMW is a candidate or potential use in diabetes prevention and treatment.