• Title/Summary/Keyword: (주)GMP

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Effect of Ethanol Extracts of Cinnamon on the Proliferation and COX-2 Pathway in HT-29 Human Colon Cancer Cell Line (육계 에탄올 추출물이 HT-29 대장암 세포주의 성장 및 COX-2 기전에 미치는 영향)

  • Lee, Seung-Youn;Kim, Hee-Seok;Kim, Jeoung-Ok;Hwang, Sung-Wan;Hwang, Sung-Yeoun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.35 no.9
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    • pp.1115-1120
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    • 2006
  • The effect of cinnamon ethanol extract (CN) on HT-29 cancer cell line has been examined. CN inhibited the growth of HT-29 colon cancer cells in a concentration and time dependent manner but not the growth of CCD-112CoN normal colon cells. And CN markedly inhibited the production of $PGE_2$ and cGMP as well as the mRNA expression of COX-2. These data suggest that non toxic concentration of CN has a significant inhibition effect on the growth of HT-29 cells, probably through the inhibition of $PGE_2$ production via COX-2 inhibition, and may have value as a safe chemopreventive agent for colon cancer.

A Study on the Development and Effectiveness of ISO13485:2016 Education Programs for Domestic Medical Device Manufacturers (국내 의료기기 제조업체의 ISO13485:2016 교육 프로그램 개발 및 교육 효과 연구)

  • Lee, Seul-Bi;Kang, Giho;Jang, Wonseuk;Kwon, Byeong-Ju
    • Journal of Korean Society for Quality Management
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    • v.50 no.3
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    • pp.503-515
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    • 2022
  • Purpose: As ISO 13485 was revised in 2016, the domestic GMP (Good Manufacturing Practice) system was also revised and implemented in 2019. However, there are many problems in the domestic medical device industry because most of the small and medium-sized enterprises lack human and material resources. Accordingly, this study was conducted to provide education programs for domestic medical device companies to induce information provision and improve the company's quality management ability. Methods: First, analyze existing education. Second, based on the revised GMP system, a survey paper was produced to investigate difficulties and problems experienced by companies. Third, a two-week survey was conducted on domestic medical device manufacturers, and a total of 77 companies responded to this survey. Fourth, educational program development was conducted based on the results of the survey. Results and Conclusion: The developed education program consists of a total of five sessions. In this study, the educational program developed by grasping the needs of the company through a survey consists of a total of five sessions. The first session consisted of theoretical education and the second to fifth sessions of practical education. Through the education program developed in this study, it is expected to contribute to the overall development of medical device quality by establishing a domestic medical device manufacturing environment that secures the safety and performance of domestic medical device companies.

집중안전포커스 - 수준 높은 안전문화로 우수 의약품 생산 -한화제약(주)

  • Hyeon, Cheon-Il
    • The Safety technology
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    • no.165
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    • pp.15-17
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    • 2011
  • 한화제약(주)는 1976년 창립된 이래 계속해서 국민의 건강증진을 위해 힘써온 치료의약품개발 전문기업이다 한화제약(주)는 최근 제2의 도약기를 맞이하고 있다. 2005년에는 스피드경영을 위해 웹기반 통합정보시스템을 도입했고, 2008년에는 cGMP(미국우수의약품관리기준)공장을 준공해 신규시장 개척에도 힘을 기울였다. 특히 최근에는 R&D투자확대, 지역 대학 및 연구기관과의 산학협력 강화 글로벌 기업과의 연계를 통한 신약개발 등 다양한 활동으로 '글로벌 헬스케어 전문기업'을 향한 비상을 준비하고 있다. 한화제약(주)가 이렇게 성장할 수 있었던 데에는 직원들의 안전을 기치로 한 '한화가족' 경영마인드가 크게 작용했다는 것이 임직원들의 공통된 의견이다. '한화가족' 경영마인드를 바탕으로 한 다양한 안전활동을 펴고 있는 한화제약(주)를 찾아가 봤다.

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Microbiological Studies and Biochemical Changes in Fermenting Soybean Curd Residue during Fermentation (비지의 발효과정중 발효미생물 및 성분변화)

  • Lee, Moon-Sook;Kim, Kil-Hwan;Lee, Gui-Ju
    • Korean Journal of Food Science and Technology
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    • v.19 no.6
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    • pp.520-527
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    • 1987
  • This study was attempted to identify microorganisms in fermenting soybean curd residues (SCR). The changes in contents of free amino acids, nucleosides, reducing sugars, and oligosaccharides were also studied. The fermentation of SCR which was by change inoculation was carried out at $55^{\circ}C$ for 48 hrs. pH increased gradually during fermentation and isolated microorganisms were identified as Bacillus subtilis and Bacillus licheniformis. Moisture content decreased from 80.8% to 58.4% at 48 hrs of fermentation and other proximate composition did not show any changes during fermentation. The content of total free amino acids increased rapidly and the number and quantities of each amino acid analyzed also increased during the course of fermentation. Glutamic acid, phenylalaine, lysine and aspartic acid were rapidly liberated during fermentation. As to the changes of nucleotides, 5'-AMP little changed during the first 36 hrs but subsequently decreased to approximately 1/6 after 48 hrs of fermentation. On the other hand, 5'-IMP plus 5'-GMP did not show almost any change during the first 36 hrs but increased about 3.5 times at 48 hrs of fermentation. However, 5'-XMP was not detected. The reducing sugar level showed rapid and steady increase throughout the fermentation and that of stachyose plus raffinose decreased slightly. From these results, a possible way of utilization of fermented SCR was proposed as a substitute for soybean in meju preparation.

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Inhibitory Effect of Mixture of Ethanol Extracts in Agastachis Herba and Pueraria Radix on the Proliferation and $PGE_2$ Production of HT-29 Human Colon Cancer Cell Line (곽향과 갈근 복합제제의 대장암 세포주 HT-29 증식 저해효과 및 $PGE_2$ 생성 억제효과)

  • Lee, Seung-Youn;Kim, Hee-Seok;Kim, Jeoung-Ok;Hwang, Sung-Wan;Hwang, Sung-Yeoun
    • Korean Journal of Pharmacognosy
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    • v.37 no.4 s.147
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    • pp.283-289
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    • 2006
  • Ethanol extracts of the whole herb of Agastachis Herba (A) and of Pueraria Radix (P) alone and of their mixture (A+P) downregulated the cell growth, cyclooxygenase-2 (COX-2) expression, prostaglandin $E_2\;(PGE_2)$, and cGMP production. A, P, and A + P inhibited the cell growth of HT-29 colon cancer cells in a concentration- and time-dependent manner but not the growth of normal colon cell, CCD-112CoN. In addition, they markedly inhibited the productions of $PGE_2$ and cGMP as well as the mRNA expression of COX-2. These data suggest that non-toxic concentration of A, P, and A + P have a significant effect on the in vitro growth of HT-29 cells, specifically through the inhibition of the $PGE_2$ production via COX-2.

The Origin of Ribityl Side Chain of Riboflavin in Ashbya gossypii (Ashbua gossypii에서의 리보플라빈 측쇄의 기원)

  • 최원자;임정빈
    • Korean Journal of Microbiology
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    • v.23 no.3
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    • pp.167-171
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    • 1985
  • In order to investigate the origin of the ribityl froup of riboflavin and the involvement of GTP cyclohydrolase II in the riboflavin pathway, we studied the incorporation of $^{14}C-labeled$ guanosine using a well known riboflavin over producer, Ashbya gossypii.Cells were grown in a media containing $(U- ^{14}C)$ guanosine and the riboflavin and GMP were isolated and purifired by column chromatography. The isolated compounds, riboflavin and GMP were labeled in the ribityl and ribosyl side chain and the isoalloxazine and guannine moiety. By comparing the specific radioactivity of each compound we reached a conclusion that the ribose of guanosine is converted directly to the rivityl moiety of riboflavin. The results indicate that biosynthesis of the vitamin begins at the level of a guanosine compound and also suppory the involvement of GTP cyclohydrolase II in one of the early steps in the biosynthetic pathway.

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Studies on the Processing of Yeast Extract by Waste Brewery Yeast (맥주효모박을 이용한 효모추출물의 제조에 관한 연구)

  • 최형택;이성갑;손종연
    • The Korean Journal of Food And Nutrition
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    • v.14 no.2
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    • pp.161-166
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    • 2001
  • The optimum condition for production of yeast extract by autolysis and enzymatic method were studied with waste brewers\` yeast. The major components of brewer\`s yeast in proximate compositions were carbohydrate(46.0%) and protein(41.7%). There was a little appreciable difference in the promaximate composition of waste brewers\` and bakery yeast. The major minerals were identified as K, P, Mg and Ca, and their contents were about 1,659.7%, 1,197.4mg%, 210.4mg% and 105.6mg%, respectively. The major vitamins were identified as vitamin C and vitamin B group, and their contents were about 7.9IU/100g and 4.2IU/100g, respectively. The optimum yeast concentration in the reaction suspension was 10% (w/v) waste brewer\`s yeast slurry. The protein content in brewer\`s yeast extract was increased with addition of NaCl as plasmolyzers. However, the plasmolyzer effect of ethanol a little showed as the concentration increasd from 3% ∼7%. The 5\`-nucleotides(5\`-GMP and 5\`-IMP) content in brewer\`s yeast extract was increased with addition of glucanase. The total content of 5\`-nucleotides (5\`-GMP and 5\`-IMP) increased by 160% than those by the autolysis of waste brewer\`s and bakery yeast.

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안전현장 스케치 - (주)우성양행

  • Park, Byeong-Tak
    • The Safety technology
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    • no.204
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    • pp.26-28
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    • 2014
  • 충남 논산에 위치한 (주)우성양행은 동물용의약품 분야에서 탑티어에 속하는 기업이다. 모기업인 우성사료와는 축산업분야에서 동반자적 관계를 유지하면서 높은 성장도 이뤄냈다. 우성양행에서 생산관리를 총괄하는 나기선 상무이사는 "동물의약품 분야에서 매출액 기준 10위권인 우성양행은 첨가제, 의약품 쪽으로는 3위권이고, 팜세이프, 농장 소독 등 농장 청결제 분야에서는 선도를 달리고 있다"고 밝혔다. 단순히 시장점유율만 높은 것이 아니다. 철저한 제조과정 속에 6년 동안 단 한차례의 사고도 발생하지 않았고 농림축산검역본부의 GMP(동물용의약품 등 제조 검사시설 및 품질관리기준)를 준수하며 적합한 제품을 생산해 오고 있다. 동물의약품 제조분에서 시장점유율, 안전분야 모두 선두에 서 있는 우성양행이 어떠한 안전관리와 경영활동을 펼치고 있는 이야기를 들어봤다.

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Comparative Expression of the Aedes aegypti 5-Hydroxytryptamine7 Receptor in Drosophila Schneider2 and Chinese Hamster Ovary-K1 Cells (초파리 Schneider2 세포와 Chinese hamster ovary-K1 세포에서 Aedes aegypti 5-Hydroxytryptamine7 수용체의 발현비교)

  • 이대원
    • Korean journal of applied entomology
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    • v.43 no.2
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    • pp.155-162
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    • 2004
  • Serotonin receptor binds to serotonin (5-HT) and activates effector proteins such as adenylyl cyclase, phospholipase C, cyclic GMP phosphodiesterase or ion channel through G protein on the cell membrane, resulting in various physiological responses like diuresis, memory and development. To examine the comparative expression of the 5-HT$\_$7/ receptor of Aedes aegypti, the Aedes 5-HT$\_$7/ receptor gene was transfected into Drosophila Schneider2 (S2) cells and mammalian Chinese hamster ovary (CHO)-Kl cells. The expression of the Aedes 5-HT$\_$7/ receptor gene in selected cell lines, Tr-CHO and Tr-S2, was confirmed with reverse transcription-PCR, Western blot and immunocytochemistry. Compared with the induced intracellular cAMP level of Tr-S2 cell line to 5-HT, the induced cAMP in the Tr-CHO cell line was over 9 times higher and was dose-dependent. These results suggest that the functionality of Aedes 5-HT$\_$7/ receptor is much more effective in mammalian CHO-K 1 cells and that the Tr-CHO cell line expressing Aedes 5-HT$\_$7/ receptor can be used for synthetic agonist or antagonist candidate screening.

Effect of Complex Extract Including Cornus officinalis on the Cimetidine/Ethanol-induced Erectile Dysfunction Model in Rats (산수유를 포함한 복합추출물이 cimetidine으로 발기부전을 유도한 동물모델에서 성기능 개선 효과)

  • Jang, Ji Hun;Kim, Tae Muk;Sim, Mi Ok;Nho, Jong Hyun;Jung, Ho Kyung;Lee, Mu Jin;Lee, Ki Ho;An, Byeong Kwan;Cho, Hyun Woo
    • Korean Journal of Plant Resources
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    • v.31 no.2
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    • pp.109-116
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    • 2018
  • Erectile dysfunction (ED), also known as impotence, is the inability to attain and sustain an erection firm enough to have sexual intercourse. Frequent ED may be a symptom of health problems including heart disease, obesity, alcoholism, stress, smoking, and depression, that need treatment. This study aimed to effect of complex extract (CPL) including Cornus officinalis on sexual function factor in the erectile dysfunction rat model. The erectile dysfuction rat model was induced by cimetidine (500 mg/kg in 5% ethanol, oral injection 2 weeks). Rats were oral administered with different concentration of CPL in rat erectile dysfunction model. As a results, sexual function factors (NO, cGMP) significantly improved in CPL treated groups (CPL-300, 600, 900 mg/kg) compared to CON group. Serum testosterone was increased in a dose-dependent manner after CPL treatment. Furthermore, administrations of CPL restored lumen areas of the prostate in the erectile dysfunction rat model. These results indicated that CPL alleviated erectile dysfunction by increasing sexual function factor and testosterone in rat model. CPL could be used to natural treatement for erectile dysfunction. However, further study is required to identify active ingredient and its mechanism of erectile dysfunction.