• Title/Summary/Keyword: UV detection

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Bioequivalence of Traline Tablet to Zoloft® Tablet (Sertraline HCI 50 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.41 no.5
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    • pp.317-322
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    • 2011
  • Sertraline HCl, (1S-cis)-4-(3, 4-dichloro-phenyl)-1, 2, 3, 4-tetrahydro-N-methyl-l-naphthalenamine hydrochloride, is a potent and selective serotonin reuptake inhibitor which is used in the treatment of depression and obsessivecompulsive disorders. The purpose of the present study was to evaluate the bioequivalence of two sertraline HCl tablets, Traline tablet (Myungin Pharm. Co. Ltd.) and Zoloft$^{(R)}$ tablet (Pfizer Inc.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of sertraline from the two sertraline HCl formulations was tested using KP VIII Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $23.50{\pm}1.74$ years in age and $64.09{\pm}7.10\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 50 mg as sertraline HCl was orally administered, blood samples were taken at predetermined time intervals and the concentrations of sertraline in serum were determined using an online columnswitching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Zoloft$^{(R)}$ tablet, were 0.04, 3.26 and -1.29% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Traline tablet was bioequivalent to Zoloft$^{(R)}$ tablet.

Bioequivalence of Hana Loxoprofen Sodium Tablet to Dongwha Loxonin® Tablet (Loxoprofen Sodium 60 mg)

  • Kang, Hyun-Ah;Cho, Hea-Young;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.41 no.2
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    • pp.117-123
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    • 2011
  • Loxoprofen sodium, a 2-phenylpropionate non-steroidal anti-inflammatory drug (NSAID), has marked analgesic and antipyretic activities and relatively weak gastrointestinal ulcerogenicity. The purpose of the present study was to evaluate the bioequivalence of two loxoprofen sodium tablets, Hana loxoprofen sodium tablet (Hana Pharm. Co., Ltd.) and Dongwha Loxonin$^{(R)}$ tablet (Dongwha Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of loxoprofen from the two loxoprofen sodium formulations was tested using KP IX Apparatus II method with various dissolution media. Twenty four healthy Korean male volunteers, $22.83{\pm}1.862$ years in age and $69.92{\pm}9.14$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ crossover study was employed. After a single tablet containing 60 mg as loxoprofen sodium was orally administered, blood samples were taken at predetermined time intervals and the concentrations of loxoprofen in serum were determined using a online column-switching HPLC method with UV/Vis detection. The dissolution profiles of two formulations were similar in all tested dissolution media. The pharmacokinetic parameters such as $AUC^t$, $C_{max}$ and $T_{max}$ were calculated, and computer programs (Equiv Test and K-BE Test 2002) were utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and un-transformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Dongwha Loxonin$^{(R)}$ tablet, were 2.03, 2.99 and -9.49% for $AUC_t$, $C_{max}$, and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., log0.9831~log1.0535 and log0.9455~log1.1386 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Hana loxoprofen sodium tablet was bioequivalent to Dongwha Loxonin$^{(R)}$ tablet.

Downregulation of $\textrm{NF}_{-{\kappa}}\textrm{B}$ activation in human keratinocytes by melanogenic inhibitors

  • Ahn, Kwang-Seok;Lee, Jinseon;Kim, Yeong-Shik
    • Proceedings of the SCSK Conference
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    • 2003.09a
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    • pp.780-803
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    • 2003
  • Exposure of skin cells, particularly keratinocytes to various nuclear factor-kappaB ($\textrm{NF}_{-{\kappa}}\textrm{B}$) activators [e.g. tumor necrosis factor-$\alpha$, interleukin-1, lipopolysaccharides, and ultraviolet light] leads to phosphorylation and degradation of the inhibitory protein, $\textrm{I}_{{\kappa}}\textrm{B}$. Liberated $\textrm{NF}_{-{\kappa}}\textrm{B}$ is translocated into the nucleus where it can change or alter expression of target genes, resulting in the secretion of extracellular signaling molecules including melanotrophic factors affecting melanocyte. In order to demonstrate the possible role of $\textrm{NF}_{-{\kappa}}\textrm{B}$ activation on the synthesis of melanotrophic factors from the keratinocytes, the activities of $\textrm{NF}_{-{\kappa}}\textrm{B}$ induced by melanogenic inhibitors (MIs) were determined in human HaCaT keratinocytes transfected with $\textrm{pNF}_{-{\kappa}}\textrm{B}$-SEAP-NPT plasmid. Transfectant cells released the secretory alkaline phosphatase (SEAP) as a transcription reporter in response to the $\textrm{NF}_{-{\kappa}}\textrm{B}$ activity and contain the neomycin phosphotransferase (NPT) gene for the dominant selection marker for geneticin resistance. MIs such as niacinamide, kojic acid, hydroquinone, resorcinol, arbutin, and glycolic acid were preincubated with transfectant HaCaT cells for 3 h and then ultraviolet B (UVB) was irradiated. $\textrm{NF}_{-{\kappa}}\textrm{B}$ activation was measured with the SEAP reporter gene assay using a fluorescence detection method. Of the Mis tested, kojic acid ($IC_{50}$/ = 60 $\mu$M) was found to be the most potent inhibitor of UVB-upregulating $\textrm{NF}_{-{\kappa}}\textrm{B}$ activation in transfectant HaCaT cells, which is followed by niacinamide ($IC_{50}$/= 540 $\mu$M). Pretreatment of the transfectant HaCaT cells with the Mis, especially kojic acid and niacinamide, effectively lowered $\textrm{NF}_{-{\kappa}}\textrm{B}$ binding measured by electrophoretic mobility shift assay. Furthermore, these two inhibitors remarkably reduced the secretion level of IL-6, one of melanotrophic factors, triggered by UV-radiation of the HaCaT cells. These observations suggest that Mis working at the in vivo level might act partially through the modulation of the synthesis of melanotrophic factors in keratinocyte.

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Effects of ${\gamma}$-Ray Irradiation on the Color of Pearl Nucleus (감마선 (Co-60) 조사에 의한 진주 핵의 영향)

  • Kim, Hea-Yeon;Min, Bong-Ki;Jeong, Woo-Geon
    • The Korean Journal of Malacology
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    • v.27 no.3
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    • pp.247-252
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    • 2011
  • The effect of ${\gamma}$-ray irradiation on the color of nucleus and cultured pearls was investigated. After ($^{60}Co$) ${\gamma}$-ray irradiation on the pearl nucleus, its color was altered from brownish to blackish brown or gray depending on irradiation dose. It was clearly found that the all samples are composed of aragonite. ESR spectra were based on the measurement of the paramagnetic species $CO_2$-radicals by the interaction with the ${\gamma}$-ray irradiation in $Mn^{2+}$ containing $CaCO_3$. In this study, we investigated optimal detection method of ${\gamma}$-ray irradiation to establish destructive or non-destructive test for pearl nucleus.

Assessment for the Comparability between Korean Ministry of Environment Standard and ISO Standard for the Determination of Heavy Metals in Soil (토양 중금속 함량 측정에 대한 토양오염공정시험기준과 국제표준간의 적합성 평가)

  • Shin, Gun-Hwan;Lee, Goon-Teak;Lee, Won-Seok;Kim, Ji-In;Kim, Bo-Kyong;Park, Hyun-Jeong
    • Journal of Soil and Groundwater Environment
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    • v.17 no.3
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    • pp.1-9
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    • 2012
  • According to the agreement on WTO/TBT, we are under the situation to adopt international standard (ISO standard) as a national standard if it exists. However, in case of environmental area, it is a domestic legal obligation to use Korean environmental standard method(KESM) for analyzing various contaminants. Therefore it is necessary to assess the comparability between KEM and ISO standard prior to apply ISO standard to soil conservation law in Korea. The main purpose of this study is to assess the comparability of both methods for analyzing heavy metals in soil. We looked over various aspects like pre-treatment, calibration curve range, detection wavelength, soil organic matter content and so on. Apparently, the procedure of both methods is almost same. However in details, both methods are different in stationary time before aqua-regia extraction using reflux system, calibration curve range for Cu, Pb, Ni and measuring wavelength for Pb. According to the results of comparison test, the results were significantly different when the different calibration range was used. In case that all the extracts independent of methods were reanalyzed with the same calibration range of each method, both methods showed statistically same results. Other conditions like different stationary time, measuring wavelength of AAS and soil organic matter content did not have any influence on the analytical result. Therefore, we suggest to extend the calibration curve range to 0~8 mg/L which is used in KS I ISO standard(Korean standard related with environment which is translation version of ISO standard without any technical change). In case of $Cr^{6+}$, the results showed no significant differences between two methods even though the pretreatment, instrumentation and other analysis conditions were different. In addition to UV/Visble spectrometry of KESM for soil contamination, we suggest to adopt ion chromatography of ISO 15192(US EPA method 7199) for analyzing $Cr^{6+}$ with the consideration of laboratory work efficiency.

Establishment of content criteria of marker compounds through the monitoring of Achyranthis Radix collected from Korea and China (한국 및 중국 지역에서 수집된 우슬의 모니터링을 통한 지표성분의 함량기준 설정)

  • Kim, Dae-Hyun;Kim, Sang-Hyuk;Jang, Yu-Seon;Shin, Min-Chul;Chu, Van Men;Lee, Young-Keun;Woo, Mi-Hee;Kang, Jong-Seong
    • Analytical Science and Technology
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    • v.25 no.4
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    • pp.250-256
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    • 2012
  • Two marker compounds of Achyranthis Radix, ecdysterone and inokosterone, were analyzed by HPLC on an ODS column ($250{\times}4.6$ mm, 5 ${\mu}m$) with a mobile phase of 15% acetonitrile containing 0.08% formic acid at a flow rate of 1.0 mL/min and a detection wavelength of UV 254 nm. The method was validated by ICH guideline and applied to the monitoring of marker compounds in 93 samples of Achyranthis Radix collected at various areas in Korea and China. The new content criteria of ecdysterone and inokosterone, established using linear regression method were 0.033% and 0.020%, respectively. When the new content criteria were applied to the quality control test of commercial Achyranthis Radix, 95.4% of total samples including 100% of Korean and 92.6% of Chinese samples were passed the test. Application of new content criteria could protect the Korean products and decrease the distribution of Chinese products with lower quality.

Residual Pesticides in Dried Agricultural Products Collected from Gyeonggi Province (경기도내 유통 건조농산물의 잔류농약 실태)

  • Lee, Myung-Jin;Kim, Myung-Gil;Jeong, Hong-Rae;Yun, Hee-Jeong;Kim, Nan-Young;Kim, Han-Taek;Kim, Chol-Young;Lee, Woon-Hyung;Yoon, Mi-Hye
    • The Korean Journal of Pesticide Science
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    • v.15 no.3
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    • pp.238-245
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    • 2011
  • This study was carried out to examine residual pesticides in dried agricultural products collected from Gyeonggi province in 2010. A total of 102 samples was collected and analyzed for 206 pesticides by multiresidue method using GC-${\mu}ECD$, GC-NPD, GC/TOF/MSD, HPLC-UVD, HPLC-FLD and HPLC/MS/MS. The detection rate of residual pesticides was 23.5% (24 of 102 samples) and the agricultural products exceeding their MRLs (Maximum Residue Limits) were 1 sample of pepper leaves. Additionally, the frequently detected pesticide were chlorothalonil, fenvalerate, chlorpyrifos, endosulfan, bifenthrin, cypermethrin, hexaconazole and iprodione. The pesticide types detected in the dried agricultural products showed in the descending order of organophosphorus (22%), pyrethroid (22%), organochloride (17%), dicarboxymide (11%), carboxymide (6%), carbamate (6%), triazole (5%) and the others (11%).

Residues of sulfadimethoxine in blood and liver of cultured olive flounder Paralichthys olivaceus by oral administration (Sulfadimethoxine의 경구 투여에 따른 넙치, Paralichthys olivaceus 혈액 및 간에서의 잔류량 변화)

  • Jun, Sung-Hee;Kim, Jin-Woo;Seo, Jung-Soo;Jee, Bo-Young;Park, Myoung-Ae
    • Journal of fish pathology
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    • v.25 no.2
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    • pp.95-101
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    • 2012
  • The residue levels of sulfadimethoxine (SDM) was studied after oral administration to cultured olive flounder, Paralichthys olivaceus at $20{\pm}1.0^{\circ}C$. The concentrations of SDM in the plasma and liver were determined by HPLC-UV detector after a single dosage of 400 mg/kg body weight. The average recoveries of SDM in spiked samples between 2~50 ppm were 92.24~93.62% for plasma and 88.34~91.90% for liver. Limit of detection for SDM was 0.05 ppm by using this method. Samples were taken at 1 h, 6 h, 12 h, 24 h, 48 h, 72 h, 168 h, 240 h, 336 h and 480 h post-dose. The peak plasma and liver concentrations of SDM, which attained at 1 h post-dose, was $402.64{\pm}59.66{\mu}g/ml$ and $238.18{\pm}54{\mu}g/g$, respectively. Thereafter, it's elimination from both tissues was considerably faster following process of time. Their concentrations of SDM were not measurable at 480 h post-dose. Based on this results, dosage and withdrawal times for SDM could be used when it is prescribed with SDM in olive flounder.

Optimization of Manufacturing Condition for Fried Garlic Flake and the Physicochemical Properties (튀긴 마늘 flake 제조조건의 최적화 및 이화학적 특성)

  • Kim, Kyeong-Yee;Lee, Eun-Kyung
    • Korean journal of food and cookery science
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    • v.28 no.6
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    • pp.805-811
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    • 2012
  • This study was carried out in order to optimize the manufacturing condition of fried garlic flakes as well as to investigate the physicochemical properties of the flakes. Fried garlic flake samples were prepared as follows: garlic was sliced by a thickness of 1.5 mm, 2.0 mm, 2.5 mm, which were measured by a thickness gage. The samples were fried in vegetable oil under different temperatures of $140{\sim}150^{\circ}C$, $160{\sim}170^{\circ}C$ and $180{\sim}185^{\circ}C$. The compression strength depending on the height (h) was measured in order to find the thickness effect by the rheometer (force control: 50 N, h: 3.25 mm). Moreover, the sample with 1.5 mm thickness showed crisp phenomena of the split compared with the crush shape of the 2.0 mm and 2.5 mm thick samples. The result of strength for time dependence showed a sample with a thickness of 1.5 mm, which was measured 5~9 times more than the 2.0 mm and 2.5 mm thick samples. We thought the reason that the 1.5 mm sample had less response power equivalent to compression force than the other samples. Alliin has been found to affect the immune responses in the blood, it is a derivative of the amino acid cysteine and is also quite heat stable. The LC system with a UV detection at 210 nm consists of a separation on a Zorbax TMS column and isocratic elution with water and ACN as a mobile phase. The alliin contents of raw and fried garlic flake under $140{\sim}150^{\circ}C$, $160{\sim}170^{\circ}C$ and $180{\sim}185^{\circ}C$ were 18.10 mg/mL, 14.0 mg/mL, 11.6 mg/mL and 11.1 mg/mL, respectively. The decrement of alliin content under different temperature was a small quantity hence, we confirmed that the increasing manufacturing temperature was not affected by the alliin content. Examining for the particle structure of fried garlic flakes by a polarization microscope, the color of the sample treated at $160{\sim}170^{\circ}C$ was pure yellow. Furder, the fiber shaped particle, which has an effect on the tough texture, almost did not appear compared to the different temperature conditions. Finally, the sensory test for the preference of fried garlic flake under different conditions was carried out and the scores for various sensory characteristics were surveyed. According to the physicochemical measurements and sensory evaluation, we confirmed that the optimum manufacturing condition of fried garlic flake was 1.5 mm thick at a temperature of $160{\sim}170^{\circ}C$.

Isolation and quantitative analysis of metabolites from Scrophularia buergeriana and their hepatoprotective effects against HepG2 Cells (현삼 (Scrophularia buergeriana)에서 분리한 화합물의 함량분석 및 간세포 보호 효과)

  • Na, Hyeon Seon;Oh, Seon Min;Shin, Woo Cheol;Bo, Jeon Hwang;Kim, Hyoung-Geun;Yoon, Dahye;Yang, Seung Hwan;Lee, Young-Seob;Kim, Geum-Soog;Baek, Nam-In;Lee, Moon-Soon;Lee, Dae Young
    • Journal of Applied Biological Chemistry
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    • v.62 no.4
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    • pp.399-406
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    • 2019
  • The roots of Scrophularia buergeriana were extracted with 80% aqueous Methanol and the concentrates were partitioned into EtOAc, n-BuOH, and H2O fractions. The repeated silica gel or octadecyl SiO2column, and medium pressure liquid chromatographies for the n-BuOH fraction led to isolation of phenylethanoid glycosides and iridoid glycosides. The chemical structures of these compounds were determined as harpagoside (1), angoroside C (2), aucubin (3) and acetoside (4) based on spectroscopic analyses including nuclear magnetic resonance and MS. A simple and efficient HPLC with UV detection method for the simultaneous determination of the four compounds (1-4) has been developed and applied to their content determination in the S. buergeriana. The roots were extracted by 80% methanol, and the contents of 1, 2, 3, and 4 were determined to 11.5, 7.6, 41.2, and 4.8 mg/g, respectively. Additionally, angoroside C (2) and acetoside (4) exhibited hepatoprotective effect against ethanol-induced hepatotoxicity in HepG2 cell line.