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Bioequivalence Evaluation of Fleroxacin Tablets in healthy Korean (플레록사신정의 생물학적 동등성 평가)

  • Lee, Myong-Jae;Sun, Yih Hsiu;Sohn, Uy-Dong
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.2
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    • pp.132-136
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    • 2008
  • 생물학적동등성시험기준에 따라 플레록사신정 (Fleroxacin, 100 mg) 을 시험약으로 하고 메가로신정 100 mg을 대조약으로 하여 $2{\times}2$ 교차 시험법에 따라 건강한 성인 지원자 24명에게 3정 (fleroxacine, 300 mg/정) 씩을 경구투여한 후, 각 피험자들의 혈중 약물농도 데이터로부터 구한 혈중농도-시간곡선하면적 (AUCtmax.) 과 최고혈중농도 (Cmax) 등의 생체이용률 파라미터에 대해 통계학적으로 고찰하여 두 제제간의 생물학적동등성을 평가하였다. 혈중 약물농도는 HPLC/UV 검출기로 분석하다. 플레록사신정의 대조약과 시험약에 대한 동등성 여부를 종합적으로 판단하여 보면 생물학적동등성시험의 판단 기준인 2항목 (AUCt, Cmax) 에 대하여 두 가지 비교항목 중 AUCt 값의 경우 대조약은 $44.26{\pm}7.12{\mu}g{\cdot}hr/mL$, 시험약은 $4.11{\pm}1.63{\mu}g/mL$이며 두 약물의 로그변환한 평균치 차의 90% 신뢰구간은 log 0.9570 에서 log 1.0565 이다. Cmax 값의 경우 대조약은 $45.16{\pm}10.04{\mu}g{\cdot}hr/mL$, 시험약은 $3.78{\pm}1.01{\mu}g/mL$ 이며, 대조약과 시험약의 로그변환한 평균치 차의 90% 신뢰구간이 log 0.8369에서 log 1.0626 로서, AUCt 와 Cmax 두 항목 모두 log 0.8에서 log 1.25 이내이어야 한다는 생물학적동등성시험 기준을 충족시켰다. 이러한 결과들로부터, 시험약 플레록사신정 (Fleroxacin, 100mg)은 대조약인 메가로신정 100 mg 대하여 생물학적동등성의 판단 기준인 두 항목 AUCt와 Cmax에 있어서 생물학적으로 동등함을 알 수 있었다.

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Comparison of Seasonal Nitrogen Removal by Free-Water Surface Wetlands Planted with Iris pseudacorus L. (노랑꽃창포 자유수면습지의 계절에 따른 질소제거 비교)

  • Yang, Hongmo
    • Journal of the Korean Society of Environmental Restoration Technology
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    • v.14 no.1
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    • pp.121-132
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    • 2011
  • Removal rates of $NO_3$-N and TN in the free-water surface wetland system during winter; December, January, February and March, spring and fall; April, May, October and November, and summer; Jun, July, August and September were investigated. The system was established on floodplain in the downstream reach of the Gwangju Stream in 2008. It measures 50 meters in length and 5.5 meters in width. Iris pseudacorus L. grown in pots for about two years were planted in the system. The water stream was funneled in by gravity and its effluent was discharged back in. Volumes and water quality of inflow and outflow were analyzed from December 2008 to November 2010. The inflow was averaged approximately 350 $m^3/day$ and hydraulic residence time was about 3 hours. Average influent and effluent $NO_3$-N concentration was 3.75 and 3.35 mg/L, respectively and $NO_3$-N retention was amounted to 10.6%. Influent and effluent TN concentration were averaged 4.93 and 4.30 mg/L, respectively and TN abatement reached to 12.9%. One-way ANOVA statistics claimed that the average removal rates of $NO_3$-N and TN during winter, spring and fall, and summer were not always the same (p<0.001). The t-Tests of three pairs among $NO_3$-N removal rates of winter, spring and fall, and summer illustrated that the removal rates of winter ($5.04{\pm}1.94$), spring and fall ($10.53{\pm}2.24$), and summer ($18.61{\pm}2.26$) were significantly different each others (p<0.001). Among TN removal rates, the three pairs of t-Tests of three seasons showed that the removal rates of winter ($5.21{\pm}2.51$), spring and fall ($11.71{\pm}3.12$), and summer ($21.53{\pm}4.86$) were significantly different from each others (p<0.001).

Isolation and Identification of Bacteria Removing Sulfur Compound Odor (황 화합물계 악취 제거 미생물의 분리 및 동정)

  • 김진수;유용규;이상섭
    • Korean Journal of Microbiology
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    • v.40 no.2
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    • pp.127-132
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    • 2004
  • We isolated 50 strains from sludge of wastewater treatment aeration tank using selective medium for Thio-bacillus sp. by membrane filtration method. They were identified as Thiobacillus neapolitanus (7), T. tepidarius (4), T. dientrificans (5), T. versutus (23), T. intermedius (2) and T. perometabolis (9). We selected Thiobacillus versutus strain KT51, which had the highest removal efficiency (100%) of hydrogen sulfide and the highest removal efficiency (85%) of dimethyl sulfide for 30 min in screen test. Also Thiobacillus versutus strain KT81 had the highest removal efficiency (26%) of dimethyl disulfide for 30 min in screen test. In applification of lab-scale reactor (closed-biological treatment) using Thiobacillus versutus strain KT51, results were 99.8% (<0.02 ppm) removal efficiency of hydrogen sulfide for 15 min.

Determination of Bumetanide in Human Plasma by a Validated HPLC Method and Its Application to Single-dose Pharmacokinetics (사람 혈장 중 부메타니드의 HPLC 분석법 검증 및 단일 용량 투여에 의한 약물동태 연구)

  • Park, Hae-Young;Gwak, Hye-Sun;Chun, In-Koo
    • Journal of Pharmaceutical Investigation
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    • v.35 no.1
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    • pp.51-55
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    • 2005
  • A high-performance liquid chromatographic method was employed for the determination of bumetanide in human plasma. After addition of internal standard (IS, naproxen) and acidification of the plasma with 1 M hydrochloric acid, the drug and IS were extracted into dichloromethane. The organic phase was back-extracted into 1 M sodium bicarbonate solution and 50 ${\mu}l$ of the aqueous phase was injected onto a reversed-phase C18 column with a mobile phase consisting of methanol: water: glacial acetic acid = 65 : 35 : 1. The samples were detected utilizing a fluorescence detector (excitation wavelength 235 nm, emission wavelength 405 nm). The method was specific and validated with a lower limit of 5 ng/mL. Intra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification. The applicability of the method was demonstrated by analysis of plasma after oral administration of a single 2 mg dose to 24 healthy subjects. From the plasma bumetanide concentration vs. time curves, the mean AUC was $246.5{\pm}73.8\;ng{\cdot}hr/mL$ and $C_{max}$ of $132.1{\pm}40.9$ ng/mL reached 1.2 hr after administration. The mean biological half-life of burnet ani de was $1.1{\pm}0.2$hr. Based on the results, this simple and validated assay method could readily be used in any pharmacokinetic or bioequivalence studies using humans.

Interactions between Hyaluronic Acid, Lysozyme, Peroxidase, and Glucose Oxidase in Enzymatic Activities at Low pH

  • Kim, Bum-Soo;Kim, Yoon-Young;Chang, Ji-Youn;Kho, Hong-Seop
    • Journal of Oral Medicine and Pain
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    • v.39 no.4
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    • pp.127-132
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    • 2014
  • Purpose: Many substances in saliva or oral health care products interact with each other. The aim of this study was to investigate interactions between hyaluronic acid (HA), lysozyme, peroxidase, and glucose oxidase (GO) in enzymatic activities at low pH levels. Methods: HA (0.5 mg/mL), hen egg-white lysozyme (HEWL, $30{\mu}g/mL$), bovine lactoperoxidase (bLPO, $25{\mu}g/mL$), and GO ($50{\mu}g/mL$) were used. The influences of HA, bLPO, and GO on HEWL activity were determined by measuring the turbidity of a Micrococcus lysodeikticus suspension. The influences of HA and HEWL on bLPO activity were determined by the NbsSCN assay, measuring the rate of oxidation of 5-thio-2-nitrobenzoic acid (Nbs) to 5,5'-dithiobis(2-nitrobenzoic acid) $(Nbs)_2$. The influences of HA and HEWL on GO activity were determined by measuring oxidized o-dianisidine production. All experiments were performed at pH 4, 5, and 6. Results: HA and GO did not affect the enzymatic activity of HEWL at pH 4, 5, and 6. bLPO enhanced the enzymatic activity of HEWL at pH 5 (p<0.05) and pH 6 (p<0.05) significantly. The enzymatic activity of bLPO was not affected by HA and HEWL at pH 4, 5, and 6. HA and HEWL did not affect the enzymatic activity of the GO at pH 4, 5, and 6. Conclusions: Peroxidase enhances lysozyme activity at low pH, otherwise there were no significant interactions in enzymatic activities between HA, lysozyme, peroxidase, and GO at low pH levels.

Isolation and Characterization of Lectin in Soybean(Glycine max L.) (대두(Glycine max L.)의 렉틴 분리 및 특성)

  • 박원목;이용세;박상호;김성환;윤경은
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.34 no.2
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    • pp.120-126
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    • 1989
  • This experiment was carried out to investigate the lectin of soybean (Glycine max L.) seed. Purification was done by 50-80% ammonium sulfate precipitation, CM-cellulose and Sephadex G-100 column. The purity was ascertained by electrophoresis. The molecular weight of purified lectin was estimated as 132,000. It was composed of three subunits which molecular weight was 45,000. The lectin was identified as glycoprotein by Schiff's reagent staining and Dubois method. The lectin agglutinated erythrocytes of rabbit and human. The amounts of the lectin to agglutinate human erythrocytes differed among the blood types: The blood type A required the least amount, the next was B, O, and AB in order. The agglutination was specifically inhibited by 5${\mu}$g/ml of N -acetyl.-D-galactoseamine and 200${\mu}$g/ml of D-galactose. Other tested sugars could not inhibit the agglutination of the erythrocytes by the lectin.

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Solubilization of Rock Phosphates by Alginate Immobilized Cells of Pantoea agglomerans (Alginate에 고정화된 Pantoea agglomerans에 의한 인광석 가용화)

  • Ryu, Jeoung-Hyun;Madhaiyan, Munusamy;Seshadri, Sundaram;Sa, Tong-Min
    • Korean Journal of Soil Science and Fertilizer
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    • v.38 no.4
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    • pp.188-193
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    • 2005
  • Pantoea agglomerans immobilized in alginate solubilized four different rock phosphates efficiently under in vitro conditions. The solubilization pattern differed according to the rock phosphate source, where maximum solubilization of Morocco and Tunisia rock phosphates (215.6 and $186.1mg\;P\;L^{-1}$) on 6 days, Israel rock phosphate ($60.98mg\;P\;L^{-1}$) and tricalcium phosphate ($132.3mg\;P\;L^{-1}$) on 10 days and China rock phosphate ($48.8mg\;P\;L^{-1}$) on 12 days after inoculation was observed. The shelf life of the immobilized bacteria immobilized beads stored in two different temperatures was studied for six months. Beads stored at both room temperature as well as cold storage ($4^{\circ}C$) were found equally good in supporting the bacterial population as well as phosphate solubilizing activity. P. agglomerans immobilized in alginate might be exploited for large scale biosolubilization of rock phosphates intended for fertilizer use.

AlLTPs from Allium species represent a novel class of lipid transfer proteins that are localized in endomembrane compartments

  • Yi, Seung-In;Park, Mee-Yeon;Kim, Ju-Kon;Choi, Yang Do
    • Plant Biotechnology Reports
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    • v.3 no.3
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    • pp.213-223
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    • 2009
  • Lipid transfer proteins (LTPs) are widely distributed in the plant kingdom, but their functions remain elusive. The proteins AlLTP2-4 were isolated from three related Allium plants: garlic (A. sativum L.), Welsh onion (A. fistulosum L.), and Nanking shallot (A. ascalonicum L.). These novel proteins comprise a new class of LTPs associated with the Ace-AMP1 from onion (A. cepa L.). The AlLTP genes encode proteins harboring 132 common amino acids and also share a high level of sequence identity. Protein characteristics and phylogenetic analysis suggest that LTPs could be classified into five distinct groups. The AlLTPs were clustered into the most distantly related plant LTP subfamily and appeared to be restricted to the Allium species. In particular, the number of amino acids existing between the fourth and fifth Cys residue was suggested as a conserved motif facilitating the categorization of all the LTP-related proteins in the family. Unlike other LTPs, AlLTPs harboring both the putative C-terminal propeptide and N-terminal signal peptide were predicted to be localized to cytoplasmic vacuoles. When a chimeric GFP protein fused with both N-terminal and C-terminal AlLTP2 signal peptides was expressed in rice cells, the fluorescence signal was detected in the endomembrane compartments, thereby confirming that AlLTPs are an unprecedented intracellular type of LTP. Collectively, our present data demonstrate that AlLTPs are a novel type of LTP associated with the Allium species.

Effectiveness and Safety of Tranexamic Acid in Spinal Deformity Surgery

  • Choi, Ho Yong;Hyun, Seung-Jae;Kim, Ki-Jeong;Jahng, Tae-Ahn;Kim, Hyun-Jib
    • Journal of Korean Neurosurgical Society
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    • v.60 no.1
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    • pp.75-81
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    • 2017
  • Objective : Spinal deformity surgery has the potential risk of massive blood loss. To reduce surgical bleeding, the use of tranexamic acid (TXA) became popular in spinal surgery, recently. The purpose of this study was to determine the effectiveness of intra-operative TXA use to reduce surgical bleeding and transfusion requirements in spinal deformity surgery. Methods : A total of 132 consecutive patients undergoing multi-level posterior spinal segmental instrumented fusion (${\geq}5$ levels) were analyzed retrospectively. Primary outcome measures included intraoperative estimated blood loss (EBL), transfusion amount and rate of transfusion. Secondary outcome measures included postoperative transfusion amount, rate of transfusion, and complications associated with TXA or allogeneic blood transfusions. Results : The number of patients was 89 in TXA group and 43 in non-TXA group. There were no significant differences in demographic or surgical traits between the groups except hypertension. The EBL was significantly lower in TXA group than non-TXA group (841 vs. 1336 mL, p=0.002). TXA group also showed less intra-operative and postoperative transfusion requirements (544 vs. 812 mL, p=0.012; 193 vs. 359 mL, p=0.034). Based on multiple regression analysis, TXA use could reduce surgical bleeding by 371 mL (37 % of mean EBL). Complication rate was not different between the groups. Conclusion : TXA use can effectively reduce the amount of intra-operative bleeding and transfusion requirements in spinal deformity surgery. Future randomized controlled study could confirm the routine use of TXA in major spinal surgery.

Effect of therapeutic radioiodine activity on ablation response in differentiated thyroid cancer patients with cut-off serum thyroglobulin levels after 2 weeks of thyroid hormone withdrawal: a retrospective study

  • Ji Young Lee;Hee-Sung Song;Young Hwan Kim
    • Journal of Medicine and Life Science
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    • v.19 no.3
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    • pp.95-102
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    • 2022
  • This retrospective study aimed to investigate whether there was a difference in the success rate of removal of residual thyroid tissue in patients with the same cutoff serum thyroglobulin (Tg) value-measured 2 weeks after thyroid hormone withdrawal (THW)-for different radioactive iodine (RAI) activities. We identified 132 patients with papillary thyroid cancer who were treated with total thyroidectomy and RAI therapy to evaluate the efficacy of three radioactivities of I-131: 1,110, 3,700, and 5,550 MBq. Serum Tg testing was performed 1 week before RAI treatment and 2 weeks after THW (pre-Tg); the cutoff pre-Tg level was below 10 ng/mL. Stimulated Tg levels were measured on the day of I-131 administration (off-Tg). After 6 months of treatment, we compared the groups for complete ablation, defined as no uptake on a diagnostic I-131 scan, stimulated Tg level of <1.0 ng/mL, and Tg antibody level of <100 ng/mL. Ninety-five patients (72.0%) achieved complete ablation, with 57.1% (8/14), 78.2% (68/87), and 61.3% (19/31) in the 1,110 MBq, 3,700 MBq, and 5,550 MBq groups, respectively. There was no significant difference in the complete ablation rates between the three groups. In the multivariate analysis, the off-Tg level was a significant predictor of complete ablation. RAI therapy with low radioactivity (1,110 MBq) seemed sufficient for ablation in patients with papillary thyroid cancer with a pre-Tg level below 10 ng/mL. The off-Tg level is a promising and useful predictor of complete ablation after initial RAI therapy.