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Bioequivalence of Rebamide Tablet to Mucosta Tablet (Rebamipide 100 mg) (무코스타 정(레바미피드 100 mg)에 대한 레바미드 정의 생물학적 동등성)

  • Cho, Hea-Young;Jeong, Hyun-Cheol;Oh, In-Joon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.31 no.4
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    • pp.281-287
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    • 2001
  • Rebamipide is a novel anti-gastric ulcer agent that has been reported to increase the synthesis of mucus, to increase the mucosal concentration of prostaglandin, and to promote rapid ulcer healing. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{TM}$ (Otsuka Korea Pharmaceutical Co., Ltd.) and $Rebamide^{TM}$ (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The rebamipide release from the two rebamipide tablets in vitro was tested using KP VII Apparatus II method at pH 6.8 dissolution media. Twenty normal male volunteers, $24.20{\pm}2.26$ years in age and $66.19{\pm}9.41\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 100 mg of rebamipide was orally administered, blood was taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two rebamipide tablets were very similar at pH 6.8 dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$, $C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t$, $C_{max}\;and\;T_{max}$ between two tablets based on the $Mucosta^{TM}$ were -2.57%, 5.77% and -1.47%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 12.62% and 17.63% for $AUC_t,\;and\;C_{max}$, respectively). The powers $(1-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t\;and\;C_{max}$ were above 99.00% and 88.56%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-9.96{\sim}4.82$ and $-4.54{\sim}16.09$ for $AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that $Rebamide^{TM}$ tablet is bioequivalent to $Mucosta^{TM}$ tablet.

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Bioequivalence of Cardil Tablet to Cardura Tablet (Doxazosin 2 mg) (카두라 정(독사조신 2 mg)에 대한 카르딜 정의 생물학적 동등성)

  • Cho, Hea-Young;Kim, Soo-Jin;Shim, Young-Sun;Lim, Dong-Koo;Oh, In-Joon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.30 no.1
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    • pp.61-65
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    • 2000
  • Doxazosin, a postsynaptic selective ${\alpha}1-adrenoceptor$ antagonist, is a potent antihypertensive agent which reduces peripheral resistance and blood pressure by vasodilatation of peripheral vessels. It is also used in the treatment of urinary obstruction by benign prostatic hypertrophy. The purpose of the present study was to evaluate the bioequivalence of two doxazosin tablets, $Cardura^{TM}$ (Pfizer Korea Ltd.) and $Cardil^{TM};$ (Kyungdong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers, $24.19{\pm}2.48$ years in age and $62.41{\pm}6.66$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of doxazosin was orally administered, blood was taken at predetermined time intervals and the concentrations of doxazosin in serum were determined with an HPLC method using spectrofluorometric detector. Pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets were -1.54%, -1.51 % and 3.42%, respectively, when calculated against the $Cardura^{TM}$ tablet. The powers $(1-{\beta})$ for $AUC_t,\;C_{max}\;and\;T_{max}$ were all more than 99.00%. Minimum detectable differences $(\Delta)$ at ${\alpha}=0.05\;and\;1-{\beta}=0.8$ were all less than 20% (e.g., 12.73%, 12.84% and 13.01% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The 90% confidence intervals were all within :${\pm}20%$ (e.g., $-8.97{\sim}5.90,\;-9.01{\sim}6.00\;and\;-4.16{\sim}11.05\;for\;AUC_t,\;C_{max}\;and\;T_{max},\;respectively)$. All of the above para- meters met the criteria of KFDA for bioequivalence, indicating that $Cardil^{TM}$ tablet is bioequivalent to $Cardura^{TM}$ tablet.

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Paleomagnetic Study of the Daedong Group in the Choongnam Coal Field (충남탄전에 분포하는 대동층군에 대한 고지자기학적 연구)

  • Min, Kyung Duck;Um, Jeong-Gi;Kim, Dong Wook;Choi, Yong Hoon;Lee, Youn Soo;Nishimura, Susumu
    • Economic and Environmental Geology
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    • v.25 no.1
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    • pp.87-96
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    • 1992
  • Paleomagnetic study on the sedimentary rocks in the Choongnam Coal Field has been carried out to determine the direction of declination and inclination of NRM and position of paleomagnetic pole, and to investigate the geotectonism and geomagnetic stratigraphy of the sedimentary rocks in the Daedong Group. As a result of paleomagnetic study, the study area can be divided tectonically into two blocks by Baegunsa fault, namely northwestern and southeastern blocks. Site mean declination and inclination of Baegunsa and Seoungjuri Formations in the northwestern block are $23.2^{\circ}$ and $54.9^{\circ}$, respectively. Those of Amisan, Jogyeri, Baegunsa and Seoungjuri Formations in the southeastern block show normal direction with declination and inclination of $-22.1^{\circ}$ and $11.2^{\circ}$, and reversed direction with those of $158.5^{\circ}$ and $-12.6^{\circ}$, respectively. Average paleomagnetic pole position in the northwestern block is located at $212.9^{\circ}E$ and $71.1^{\circ}N$, and that in the southeastern block at $345.7^{\circ}E$ and $53.3^{\circ}N$. This difference suggests relative rotation of about $45^{\circ}$ between two blocks. The paleolatitude of Daedong Group at the time of sedimentation is $5.6^{\circ}N$ much lower than present latitude of $37.7^{\circ}N$. Compared with worldwide Mesozoic paleomagnetic polarity stratigraphy, Amisan Formation is correlated with the lower boundary of Nuanetsi reversal zone in Graham interval, and Baegunsa and Seoungjuri Formations are correlated with just upper part of the upper boundary of Nuanetsi reversal zone, and their geologic ages are Late Triassic to Early Jurassic. The position of paleomagnetic pole acquired from Daedong Group in the study area is different from those in other places. This may be attributed to the different tectonic movement by Daebo Orogeny occurred after the deposition of Daedong Group.

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The Evidence for Pepsin-Catalyzed Transpeptidation (펩신촉매에 의한 Transpeptide의 생성)

  • 조용권
    • Journal of Life Science
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    • v.8 no.4
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    • pp.410-415
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    • 1998
  • Procine pepsin hydrolysis of hexapeptide L-S-pNF-Nle-A-OMe in the presence of dipeptide L-L generates a new peak on HPLC analysis of reaction mixtures that is not seen when enzyme is incubated with either peptide alone. The peaks can be detected spectroscopically at either 214 or 254 nm, the latter consistent with a new peptide containing the p-nitro-F residue. The data suggest acyl transpeptidation between E(L-S-pNF) and L-L to form L-S-pNF-L-L. Consistent with this inference are (1) the ability of L-L-NH$_{2}$ and inability of Boc-L-L to undergo a similar transpeptidation reaction, and (2) the data from electrospray mass spectrum. This synthesis requires that Nle-A-L-OMe be released before L-S-pNF, an order opposite to that proposed on the basis of product inhibition kinetics. Consistent with this inference are reciprocal solvent isotope effects ; normal isotope effects of 1.736$\pm$0.121 on the formation of Nle-A-L-OMe and 2.281$\pm$0.184 in the formation of L-S-pNF, coupled to an inverse isotope effects of 0.576$\pm$0.045 on the formation of L-S-pNF-L-L. Because transpeptidation precedes faster in D$_{2}$O, the isotopically-sensitive step must occur after release of Nle-A-L-OMe. Isotopically-enhanced transpeptidation is consistent with the Uni-Bi iso memchanism postulated on the basis of an isotope effects on Vmax but not on Vmax/Km$^{1)}$ and confirmed by isotope effects on the onset of inhibition by pepstatin$^{2)}$.

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Advancement and Application of Somatic Cell Nuclear Transfer Technique in Dog

  • Oh, H.J.;Hong, S.G.;Park, J.E.;Kim, M.J.;Gomez, M.N.;Kim, M.K.;Kang, J.T.;Kim, J.E.;Jang, G.;Lee, B.C.
    • Proceedings of the Korean Society of Developmental Biology Conference
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    • 2009.02a
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    • pp.49-57
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    • 2009
  • The cloning of canids was succeeded in 2005, several years after the birth of Dolly the sheep and also after the cloning of numerous other laboratory and farm animal species. The delay of successful somatic cell nuclear transfer (SCNT)was due to the unique reproductive characteristics of the female dogin comparison to other domestic mammals, such as ovulation of immature canine oocyte and a requirement of 25 days for the completion of meiosis within the oviduct (Holst & Phemister, 1971). When the technology for the recovery of in vivo matured oocyte was established, the application of cloning also became possible and cloned dog offspring were obtained. This report summarizes the progress of technical procedures that are required for cloning canids and the application of this technique. The first cloned dog, Snuppy, was achieved using an in vivo-matured oocyte which was enucleated and transferred with an adult skin cell of male Afghan hound. After establishment of a criterion of well-matured oocyte for the improvement of SCNT efficiency, we obtained three cloned female Afghan hound and a toy poodle cloned from 14 year-old aged Poodle using SCNT through this factor. To date, cloned dogs appeared to be normal and those that have reached puberty have been confirmed to be fertile. Through application of canine SCNT technique, first, we demonstrated that SNCT is useful for conserving the breed of endangered animal from extinction through cloning of endangered gray wolves using inter-species SCNT and keeping the pure pedigree through the cloning of Sapsaree, a Korean natural monument. Secondly, we showed possibility of human disease model cloned dog and transgenic cloned dog production through cloning of red fluorescent protein expressing dog. Finally, SCNT can be used for the propagation of valuable genotypes for making elite seed stock and pet dog. In summary, dog cloning is a reproducible technique that offers the opportunity to preserve valuable genetics and a potential step towards the production of gene targeted transgenic cloned dogs for the study of human diseases.

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Corrosion-Resisting Performance Evaluation of Concrete Mixed with Fly-Ash (플라이애시 혼합 콘크리트의 철근 부식 저항성능 평가)

  • Park, Sang-Soon
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.21 no.1
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    • pp.117-125
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    • 2017
  • The role of fly ash in concrete become impotent with finding the characteristics of fly ash in which it is used as cement replacement material. In this paper, corrosion test results obtained by two test methods such as the long-term exposure corrosion test and the accelerated corrosion test method, were compared to investigated the corrosion resistance between fly ash concrete and normal concrete. Corrosion initiation time was measured in two types of concrete, i.e., one mixed with fly ash(FA) and the other without admixture(OPC). The accelerated corrosion test was carried out by four case, i.e., two samples is a cyclic drying-wetting method combined without carbonation(case 1) and combined with carbonation(case 2), and the other two samples is a artificial seawater ponding test method combined without carbonation(case 3) and combined with carbonation(case 4). Whether corrosion occurs, it was measures using half-cell potential method. The ponding test combined without carbonation was most effective in accelerating corrosion time of steel bars. The results indicated that the corrosion of rebar embedded in concrete occurred according to the order of OPC, FA. The delay relative ratio of corrosion obtained by corrosion initiation time between FA and OPC is 1.04 to 1.27. Consequently, fly ash concrete as the age increases its corrosion resistance was improved compared with OPC concrete.

The Acclerated Life Test of Hard Disk In The Environment of PACS (PACS 환경에서 하드디스크의 가속 수명시험)

  • Cho, Euy-Hyun;Park, Jeong-Kyu;Chae, Jong-Gyu
    • Journal of Digital Contents Society
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    • v.16 no.1
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    • pp.63-70
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    • 2015
  • In this paper, we estimate the life cycle from acceleration life test about the hard disk of disk array of image storage of PACS. Webuil distribution was selected by the Anderson-Darling goodness-of-fit test with data of down time at $50^{\circ}C$ and $60^{\circ}C$. The equality test of shape parameter and scale parameter was conducted, so that the probability distribution estimated from data of down time at $50^{\circ}C$ and $60^{\circ}C$ was not statistically significant. The shape parameter was 1.0409, The characteristic life was 24603.5 hours at normal user condition($30^{\circ}C$) by the analysis of weibull-arrhenius modeling which included the acceleration factor of temperature, and The activation energy was 0.5011 eV through arrhenius modeling. The failure analysis of the failure samples of acceleration test and the samples of market return was conducted, so that the share percentage of failure mode was detail difference but the rank of share percentage was almost same. This study suggest the test procedure of acceleration test of hard disk drive in PACS using environment, and help the life estimation at manufacture and use.

Feasibility Study of Improved Train Control System Using On-board Controller for Intelligent Control of Trackside Facilities (선로변 시설물의 지능적 제어를 위한 차상중심 열차제어시스템 시뮬레이션 기반 성능 평가)

  • Baek, Jong-Hyen;Jo, Hyun-Jeong;Chae, Eun-Kyung;Choi, Hyun-Young;Kim, Yong-Gyu
    • Journal of the Korean Society for Railway
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    • v.16 no.6
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    • pp.528-533
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    • 2013
  • To improve the efficiency and safety of railway systems, the train control system has considerably evolved from the ground-equipment-based control system (e.g. track circuit, interlocking system, etc.) into the on-board-equipment-based control system. In addition, this train control system enables the rolling stock to intelligently control the trackside facilities by introducing information and communication technologies (ICT). Accordingly, since the ICT-based train control system simplifies the railway system (i.e. the heavy ground-equipment can be removed), an efficient and cost-effective railway system can be realized. In this paper, we perform a feasibility test of the ICT-based train control system using a simulation. To this end, we implement a test-bed consisting of prototype machines of on-board/ground equipment and introduce an integrated operation scenario for the train control. The simulation results satisfy all the requirements of train operation according to the scenario and show the effectiveness of the proposed train control system.

Korean Red Ginseng improves atopic dermatitis-like skin lesions by suppressing expression of proinflammatory cytokines and chemokines in vivo and in vitro

  • Kee, Ji-Ye;Jeon, Yong-Deok;Kim, Dae-Seung;Han, Yo-Han;Park, Jinbong;Youn, Dong-Hyun;Kim, Su-Jin;Ahn, Kwang Seok;Um, Jae-Young;Hong, Seung-Heon
    • Journal of Ginseng Research
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    • v.41 no.2
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    • pp.134-143
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    • 2017
  • Background: The prevalence of allergic inflammatory diseases such as atopic dermatitis (AD), asthma, and allergic rhinitis worldwide has increased and complete recovery is difficult. Korean Red Ginseng, which is the heat-processed root of Panax ginseng Meyer, is widely and frequently used as a traditional medicine in East Asia. In this study, we investigated whether Korean Red Ginseng water extract (RGE) regulates the expression of proinflammatory cytokines and chemokines via the mitogen-activated protein kinases (MAPKs)/nuclear factor kappa B ($NF-{\kappa}B$) pathway in allergic inflammation. Methods: Compound 48/80-induced anaphylactic shock and 1-fluoro-2,4-dinitrobenzene (DNFB)-induced AD-like skin lesion mice models were used to investigate the antiallergic effects of RGE. Human keratinocytes (HaCaT cells) and human mast cells (HMC-1) were also used to clarify the effects of RGE on the expression of proinflammatory cytokines and chemokines. Results: Anaphylactic shock and DNFB-induced AD-like skin lesions were attenuated by RGE administration through reduction of serum immunoglobulin E (IgE) and interleukin (IL)-6 levels in mouse models. RGE also reduced the production of proinflammatory cytokines including $IL-1{\beta}$, IL-6, and IL-8, and expression of chemokines such as IL-8, thymus and activation-regulated chemokine (TARC), and macrophage-derived chemokine (MDC) in HaCaT cells. Additionally, RGE decreased the release of tumor necrosis $factor-{\alpha}$ ($TNF-{\alpha}$), $IL-1{\beta}$, IL-6, and IL-8 as well as expressions of chemokines including macro-phage inflammatory protein $(MIP)-1{\alpha}$, $MIP-1{\beta}$, regulated on activation, normal T cell expressed and secreted (RANTES), monocyte chemoattractant protein (MCP)-1, and IL-8 in HMC-1 cells. Furthermore, our data demonstrated that these inhibitory effects occurred through blockage of the MAPK and $NF-{\kappa}B$ pathway. Conclusion: RGE may be a useful therapeutic agent for the treatment of allergic inflammatory diseases such as AD-like dermatitis.

Effects of Cnidium of ficinale(CO) extracts through administrated by means of oral and herbal acupuncture method at GB2l acupoint on focal ischemic brain injury induced by MCAO in rats (천궁(川芎)의 구강투여(口腔投與) 및 약침시술(藥鍼施術)이 흰쥐 MCAO로 유발된 국소뇌허혈(局所腦虛血)에 대(對)한 콜린성 신경보호효과(神經保護效果) 연구(硏究))

  • Kim, Kyung-Sun;Youn, Dae-Hwan;Hong, Seok;Na, Chang-Su
    • Korean Journal of Acupuncture
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    • v.22 no.3
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    • pp.137-156
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    • 2005
  • Objectives : Cnidium officinale(CO) has been used for medication for stroke in the Oriental Medicine. So this study was planned to investigate the effects of CO on the focal ischemia-induced by Middle Cerebral Artery Occlusion(MCAO) in rats Materials and methods : The focal ischemia was induced by MCAO. CO extracts through oral administration and herbal acupuncture at GB2l was carried out during 3 weeks after focal ischemia-induced. Eight-arm radial maze was used for the behavioral task. For the neuroprotective effect of CO, we investigated AchE, ChAT, and NGF-expression by immnohistochemical method. Results : The error rate in the eight-arm radial maze task was significantly decreased in normal group compared to control group on 1-6days, OA-CO1(CO oral administration, 0.8g/kg) group on 1-6days, OA-CO2(CO oral administration, 1.6g/kg) group on 1-3,5,6days, HA-CO1(CO herbal acupuncture, 0.016g/kg) group on 2,3,6days, HA-CO2(CO herbal acupuncture, 0.008g/kg) group on 1-3,5,6days. The rate of correct choice was significantly increased in OA-CO1, HA-CO2. The density of neurons in the hippocampal CA1 was the most increased in OA-CO1, HA-CO1, HA-CO2. The density of ChAT in the hippocampal CA1 was increased in OA-CO1, HA-CO2. The density of ChAT in the hippocampal CA1 was significantly increased in OA-CO1, HA-CO2. The density of NGE in the hippocampal CAI was significantly increased in OA-CO1, OA-CO2, HA-CO2. Conclusions : These results suggest that CO oral administration with 0.8g/kg and CO herbal acupuncture with 0.008g/kg might be used as a regulator of cell death of cholinergic system induced by stroke.

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