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Bioequivalence Assessment of Acephyll® Capsule to Surfolase® Capsule (Acebrophylline HCl 100 mg) by Liquid Chromatography Tandem Mass Spectrometry

  • Nam, Kyung-Don;Seo, Ji-Hyung;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.41 no.5
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    • pp.309-315
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    • 2011
  • A sensitive and specific liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/MS) was developed for the analysis of ambroxol (active moiety of acebrophylline). After acetonitrile precipitation of proteins from plasma samples, ambroxol and the domperidone (internal standard, IS) were eluted on a C18 column. The isocratic mobile phase was consisted of 10 mM ammonium acetate and methanol (10 : 90, v/v), with flow rate at 0.2 mL/min. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z 379.2${\rightarrow}$264.0 and the m/z 426.2${\rightarrow}$175.1 transitions for ambroxol and the IS, respectively. Twenty four healthy Korean male subjects received two capsules (100 mg ${\times}$ 2) of either the test or the reference formulation of acebrophylline HCl in a 2 ${\times}$ 2 crossover study, this was followed by a 1week washout period between either formulation. $AUC_{0-t}$ (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were acceptable range of log 0.8 to log 1.25 (e.g., log 0.8964 - log 0.9910 for $AUC_{0-t}$ log 0.8690 - log 1.0750 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of Korea Food and Drug Administration for bioequivalence indicating that Acephyll$^{(R)}$ capsule (test) is bioequivalent to Surfolase$^{(R)}$ capsule (reference).

Peptide Nucleic Acid Probe-Based Analysis as a New Detection Method for Clarithromycin Resistance in Helicobacter pylori

  • Jung, Da Hyun;Kim, Jie-Hyun;Jeong, Su Jin;Park, Soon Young;Kang, Il-Mo;Lee, Kyoung Hwa;Song, Young Goo
    • Gut and Liver
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    • v.12 no.6
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    • pp.641-647
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    • 2018
  • Background/Aims: Helicobacter pylori eradication rates are decreasing because of increases in clarithromycin resistance. Thus, finding an easy and accurate method of detecting clarithromycin resistance is important. Methods: We evaluated 70 H. pylori isolates from Korean patients. Dual-labeled peptide nucleic acid (PNA) probes were designed to detect resistance associated with point mutations in 23S ribosomal ribonucleic acid gene domain V (A2142G, A2143G, and T2182C). Data were analyzed by probe-based fluorescence melting curve analysis based on probe-target dissociation temperatures and compared with Sanger sequencing. Results: Among 70 H. pylori isolates, 0, 16, and 58 isolates contained A2142G, A2143G, and T2182C mutations, respectively. PNA probe-based analysis exhibited 100.0% positive predictive values for A2142G and A2143G and a 98.3% positive predictive value for T2182C. PNA probe-based analysis results correlated with 98.6% of Sanger sequencing results (${\kappa}$-value=0.990; standard error, 0.010). Conclusions: H. pylori clarithromycin resistance can be easily and accurately assessed by dual-labeled PNA probe-based melting curve analysis if probes are used based on the appropriate resistance-related mutations. This method is fast, simple, accurate, and adaptable for clinical samples. It may help clinicians choose a precise eradication regimen.

Fracture Toughness Prediction of RPV Steels Using Crack Arrest Load of Load-Displacement Curve in Charpy V - Notch Impact Test (샤피 V - 노치 충격 하중-변위 곡선의 균열정지하중을 이용한 원자로압력용기강의 파괴인성 예측)

  • Park, Jeong-Yong;Kim, Ju-Hak;Lee, Yun-Gyu;Hong, Jun-Hwa
    • Korean Journal of Materials Research
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    • v.10 no.4
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    • pp.305-311
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    • 2000
  • Applicability of crack arrest load measured from the Charpy V-notch impact test has been investigated to predict the fracture toughness of nuclear reactor pressure vessel (RPV) steels (ASME SA508 Cl.3). The temperature dependence of the crack arrest load was well described by the type of exponential function characterized by an index temperature at which the crack arrest load is 2kN. The specific index temperature, which also well correlated with $T_{NDT}\;and\;T_{41J}$ is expected to be representative index temperature characterizing the crack arrest fracture toughness of RPV steels. Also, the crack arrest load correlated well with the stable crack length measured from the fracture surface. From the measurements of the crack arrest load and the stable crack length, the lower bound fracture toughness, $K_{Ia}$ of RPV steels could be predicted with sufficient accuracy.

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Internal Short-circuiting Estimation in Clearwell : Part A. Improving T10/T Using Intra Basin and Diffuser Wall by Applying ISEM to Field (정수지 내부 단락류 발생 평가 : Part A. 정수장 내부 단락류 분석을 통한 장폭비와 형태가 T10/T 값에 미치는 영향 연구)

  • Shin, Eunher;Lee, Seungjae;Kim, Sunghoon;Park, Heekyung
    • Journal of Korean Society of Water and Wastewater
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    • v.22 no.1
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    • pp.105-112
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    • 2008
  • Disinfection is a basic and effective microorganism inactivation method and historically contributed a decrease in waterborne diseases. To guarantee the disinfection ability, improving T in CT value is important. Many indexes are used to estimate the hydraulic efficiency, however, these are black-box analysis. Therefore it is need to develope new estimation method. In this study, internal short-circuiting estimation method (ISEM) is developed using CFD and we inquire into the factor which causes increase of $T_{10}/T$ value as LW ratio increases. And the effect of shape on the relation of LW ratio and $T_{10}/T$ is analyzed. As LW ratio increases, internal short-circuiting index (ISI) of influent and effluent zone is rapidly reduced and recirculation and dead zone are reduced in channel zone. Therefore, as the $T_{10}/T$ value converges maximum value, ISI curve is changed from "V" shape to "U" shape and hydraulic efficiency is improved especially in downstream portion of clearwell. The less the shape ratio(width/length of clearwell) is the less the $T_{10}/T$ value is at a same LW ratio because the portion of turning zone increases as shape ration decreases, therefore more boundary separation is generated.

Process Parameters on Quality Characteristics of Jacopever (Sebastes schlegeli Hilgendorf) under Treatment of Hydrostatic Pressure (고압처리 공정변수가 조피볼락의 초기 품질특성에 미치는 영향)

  • Kim, Min-Ji;Lee, Soo-Jeong;Kim, Chong-Tai
    • The Korean Journal of Food And Nutrition
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    • v.29 no.3
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    • pp.371-381
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    • 2016
  • The present study investigated the effects of processing parameters such as time (10, 20, 30, 40 min), pressure (25, 50, 75, 100 MPa), and the salinity of brine (0~10%(w/v)) on jacopever (Sebastes schlegeli Hilgendorf) in order to establish optimization of the three factors using a high hydrostatic pressure (HHP) machine. To do so, it analyzed the quality characteristics of volatile basic nitrogen (VBN), trimethylamine (TMA), total bacterial counts, dynamic viscoelasticities, and differential scanning calorimetry (DSC) properties. First, when the time increased to 40 mins, by 10 min intervals, the total bacterial counts in HHP groups under $25^{\circ}C$, 100 MPa, and 4%(w/v) brine were significantly decreased except for the first 10 min in comparison to the control group. In regards to DSC properties, the onset temperature ($T_O$) of the first endothermal curve was significantly reduced. Second, when the pressure level increased up to 100 MPa by 25 MPa increments, the total bacterial counts in the HHP samples significantly decreased for 20 min at 50 MPa or higher. As the pressure increased, G', G" and the slope of tan ${\delta}$ decreased (except for 50 MPa). Third, in regards to the salinities of brine, when the HHP processing was treated at 100 MPa, $25^{\circ}C$ for 20 min, the total bacterial counts of all the HHP groups significantly decreased in comparison to those of the control group. A significant difference was found in the enthalpy of the second endothermic curve in the 6~10%(w/v) (except 7%(w/v)) HHP groups. Therefore, the salinity of the immersion water under the HHP condition was appropriate when it was lower than 6%(w/v). The present study demonstrated that the optimum parameter condition according to/under the condition of the microbial inhibition and economic effects using an HHP would be the reaction time for 20 min, reaction pressure at 100 MPa, and the salinity of 4%(w/v) brine.

Effects of the Addition of Mn and $AB_5$ Type Alloy on the Electrochemical Characteristics of Ti-Cr-V BCC Type Alloys (BCC계 Ti-Cr-V 합금의 전기화학적 특성에 미치는 Mn 및 $AB_5$계 합금 첨가 효과)

  • Kim, J.Y.;You, J.H.;Park, C.N.;Park, C.J.;Choi, J.;Cho, S.W.
    • Journal of Hydrogen and New Energy
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    • v.18 no.1
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    • pp.52-59
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    • 2007
  • We investigated the effects of the addition of Mn and $AB_5$ type alloy on the electrochemical characteristics of Ti-Cr-V BCC type alloys as anode materials for Ni-MH battery. The activation behavior and discharge capacity of the BCC type alloys were significantly improved by ball-milling with the $LmNi_{4.1}Al_{0.25}Mn_{0.3}Co_{0.65}$ alloy, because the $AB_5$ type alloy acted as hydrogen path on the surface of the BCC type alloy. Among the Mn substituted alloys($Mn=0.03%{\sim}0.08%$), the $Ti_{0.32}Cr_{0.38}Mn_{0.05}V_{0.25}$ alloy ball-milled with $AB_5$ type alloy exhibited the greatest discharge capacity of $336\;mAh{\cdot}g^{-1}$. In addition, Mn substituted alloys exhibited the lower plateau pressure in P-C- T curve, the better hydrogen storage capacity and faster surface activation compared with the alloy without Mn.

Corrosion resistance assessment of nickel-titanium endodontic files with and without heat treatment

  • Tatiana Dias Costa;Elison da Fonseca e Silva;Paula Liparini Caetano ;Marcio Jose da Silva Campos ;Leandro Marques Resende ;Andre Guimaraes Machado;Antonio Marcio Resende do, Carmo
    • Restorative Dentistry and Endodontics
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    • v.46 no.1
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    • pp.6.1-6.10
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    • 2021
  • Objectives: The aim of this study was to evaluate the corrosion resistance of heat-treated (Reciproc and WaveOne) and non-heat-treated (ProTaper and Mtwo) superelastic nickel-titanium endodontic files when immersed in a 5.25% sodium hypochlorite solution. Materials and Methods: Anodic polarization curves were obtained with potential sweeps that began at the open circuit potential or corrosion potential (Ecorr). The pitting potential (Epit) was identified on the anodic polarization curve as the potential at which a sudden increase in current was observed. The micromorphology of the 28 tested files was analyzed before and after the electrochemical assay using scanning electron microscope (SEM). The data were analyzed using 1-way analysis of variance with the post hoc Bonferroni test (for Ecorr) and the Student t-test for independent samples (for Epit). Results: The mean Ecorr values were 0.506 V for ProTaper, 0.348 V for Mtwo, 0.542 V for Reciproc, and 0.321 V for WaveOne files. Only WaveOne and Protaper files exhibited pitting corrosion, with Epit values of 0.879 V and 0.904 V, respectively. On the SEM images of the ProTaper and WaveOne files, cavities suggestive of pitting corrosion were detected. Conclusions: Signs of corrosion were observed in both heat-treated and non-heat-treated files. Of the evaluated files, WaveOne (a heat-treated file) and ProTaper (a non-heat-treated file) exhibited the lowest corrosion resistance.

Soil Ionization Phenomena around a Hemispherical Electrode Stressed by Impulse Voltages (임펄스전압에 의한 반구형 전극계에서 토양의 이온화 현상)

  • Heo, Dae-min;Kim, Hoe-gu;Lee, Bok-hee
    • KEPCO Journal on Electric Power and Energy
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    • v.2 no.4
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    • pp.601-608
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    • 2016
  • The electrical characteristics of the soil where a ground electrode is buried vary with regions, seasons and environmental factors. Electrical discharge in the vicinity of the ground electrode will occur differently and significantly affect the performance of the grounding system. It is necessary to analyze discharge and ionization characteristics of soils when the grounding system is designed. The aims of this investigation are to understand correlation between the soil ionization and the transient ground impedance. This paper presents the experimental results on the soil ionization parameters and the transient ground resistance due to the soil ionization around a hemispherical ground electrode stressed by lightning impulse voltages.

Structural properties of $Zn:LiNbO_3/Mg:LiNbO_3$ single crystal thin films grown by LPE method (LPE법으로 성장시킨 $Zn:LiNbO_3/Mg:LiNbO_3$ 단결정 박막의 구조적 특성)

  • Lee, H.J.;Shin, T.I.;Lee, J.H.;Yoon, D.H.
    • Journal of the Korean Crystal Growth and Crystal Technology
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    • v.15 no.3
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    • pp.120-123
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    • 2005
  • The 5 mol% ZnO doped $LiNbO_3$ film and the 2 mol% MgO doped $LiNbO_3$ film were grown on the $LiNbO_3$ (001) substrate by liquid phase epitaxy (LPE) method with $Li_2CO_3-V_2O_5$ flux system. The crytsallinity and the lattice mismatch between $Zn:LiNbO_3$, film and $Mg:LiNbO_3$, film were analyzed by x-ray rocking curve (XRC). In addition, the ZnO and MgO distribution in the cross-section of the multilayer thin films was observed using electron probe micro analyzer (EPMA).

Dielectric Characteristics of N2 Gas under Impulse Voltage in a Quasi-Uniform Electric Field (준평등전계에서 임펄스전압에 대한 N2가스의 절연파괴특성)

  • Lee, Bok-Hee;Kim, Dong-Kyu;Li, Feng
    • Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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    • v.24 no.8
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    • pp.126-132
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    • 2010
  • This paper presents dielectric characteristics of $N_2$ gas under impulse voltages in a quasi-uniform electric field gap. The experiments were carried out at the test gap applied by the 1.2/50[${\mu}s$] lightning impulse voltage, 180/2500[${\mu}s$] switching impulse voltage, 500[ns]/1[MHz] very fast transient overvoltage(VFTO). The gap separation of sphere-to-plane electrodes was 14[mm] and the electric field utilization factor was about 71.2[%]. The gas pressure ranges from 0.2 to 0.6[MPa]. As a result, the electrical breakdowns are occurred by streamer discharge. Breakdown voltages are linearly increased with the gas pressure and the highest breakdown voltage is appeared under the VFTOs having fast rising time. Breakdown voltages under the positive impulse voltages were higher than those under the negative ones, and also the time to breakdown in the positive polarity is longer than that in the negative polarity.