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Bioequivalence of Hanmi Fexofenadine Hydrochloride Tablet to Allegra Tablet(Fexofenadine Hydrochloride 180 mg) (알레그라정(염산펙소페나딘 180 mg)에 대한 한미염산펙소페나딘정의 생물학적 동등성)

  • Ko, In-Ja;Chi, Sang-Cheol
    • Journal of Pharmaceutical Investigation
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    • v.36 no.1
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    • pp.53-58
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    • 2006
  • Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 180 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Hanmi Fexofenadine Hydrochloride $Tablet^{\circledR}$ made by Hanmi Pharm. Co. and the reference product was Allegra $Tablet^{\circledR}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2\;{\time}\;2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were $log\;0.822{\sim}log \;1.142$ and $log\;0.848{\sim}log\;1.172$, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet is bioequivalent to Allegra Tablet.

Genotypic Variation in Leaf Water Status of Soybean

  • Jin, Yong-Moon;Lee, Hong-Suk;Lee, Suk-Ha;Kwon, Yong-Woong;Im, Jeong-Nam
    • KOREAN JOURNAL OF CROP SCIENCE
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    • v.44 no.1
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    • pp.55-58
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    • 1999
  • Plant water status during growth is directly and indirectly associated with seed yield. The objective of the present study was to determine the genotypic differences in leaf water characteristics at an early growth stage of soybean [Glycine max (L.) Merrill] plants through the pressure-bomb technique. Measurements of water potential as well as relative water content (RWC) were made at the third leaf from the fully-expanded top leaf of eight different soybean genotypes grown for 31 to 35 days after field emergence. On the basis of the modified exponential model, pressure-volume (PV) curves were fitted well ($R^2$=0.92** to 0.99** for the curvi-linear region and R=0.67** to 0.96** for the linear region), indicating that a segmented model using PROC NLIN of SAS could be used effectively to estimate the leaf water characteristics. The regression analysis for the pressure-volume (PV) curve revealed genotypic variation in the solute potential at saturation (Ψ$_{s,sat}$ :-10.7 to -14.8 bar), solute potential at incipient plasmolysis (Ψ$_{s,ip}$ : -14.3 to -18.3 bar), RWC at incipient plasmolysis (RW $C_{ip}$ : 83.3 to 91.7%), high integrated turgor pressure from saturation to plasmolysis ( $_1$$^{b}$ : 0.39 to 0.81), and maximum volumetric modulus of elasticity ($\varepsilon$$_{max}$ : 150 to 445 bar).).

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Methods for Pharmacodynamic Analysis and Proposed Protocols for Bioequivalence Study of Acarbose (Acarbose 제제의 약력학적 평가 및 생물학적동등성 시험법에 대한 연구)

  • Bae, Jung-Woo;Jang, Choon-Gon;Lee, Seok-Yong
    • YAKHAK HOEJI
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    • v.51 no.6
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    • pp.440-446
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    • 2007
  • Arcabose is a competitive inhibitor of the intestinal ${\alpha}$-glucosidases and reduces the postprandial digestion and absorption of carbohydrate and disaccharides. Due to its negligible oral absorption, measuring drug concentration in the plasma is impractical. Thus, the common pharmacokinetic study is not available to determine the bioequivalence of the generic acarbose preparations. The aim of this study is the establishment of pharmacodynamic assessment method for the bioequivalence test of the generic acarbose preparations. Placebo-controlled cross-over ($3{\times}3$) clinical study was conducted in 23 healthy volunteers. Volunteers received a single oral dose of placebo, reference drug ($Glucoby^{(R)}$ 100 mg, Lot # D043) or test drug ($Glucoby^{(R)}$ 100 mg, Lot # E005) just before breakfast, then blood samples for evaluation of serum glucose and insulin levels were taken during for 4 hours. $C_{max},\;AUC_{0-2},\;AUC_{0-4},\;{\Delta}C_{max},\;{\Delta}AUC_{0-2}\;and\;{\Delta}AUC_{0-4}$ of the postprandial plasma glucose level significantly decreased when a single dose of acarbose 100 mg preparations was administered. However, any significant difference was not detected between the groups taken the reference drug and the test drug. These results proposed that the pharmacodynamic protocols of this study is suitable to use for bioequivalence test of acarbose preparations. On the basis of the results of this study and the data of literature on this subject, the standard protocols of bioequivalence study of acarbose preparation are proposed.

LC-MS Determination and Bioavailability Study of Imidapril Hydrochloride after the Oral Administration of Imidapril Tablets in Human Volunteers

  • Yun Ji Hye;Myung Ja Hye;Kim Hye Jin;Lee Sibeum;Park Jong-Sei;Kim Won;Lee Eun-Hee;Moon Cheol Jin;Hwang Sung-Joo
    • Archives of Pharmacal Research
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    • v.28 no.4
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    • pp.463-468
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    • 2005
  • The purpose of the present study was to develop a standard protocol for imidapril hydrochloride bioequivalence testing. For this reason, a specific LC-MS method was developed and validated for the determination of imidapril in human plasma. A solid-phase extraction cartridge, $Sep-pak^{R}$ C18, was used to extract imidapril and ramipril (an internal standard) from deproteinized plasma. The compounds were separated using a XTerra $MS^{R}$?C18 column ($3.5 {\mu}m, 2.1\times150 mm$) and $acetonitrile-0.1\%$ formic acid (67:33, v/v) adjusted to pH 2.4 by 2 mmol/L ammonium formic acid, as mobile phase at 0.3 mL/min. Imidapril was detected as m/z 406 at a retention time of ca. 2.3 min, and ramipril as m/z 417 at ca. 3.6 min. The described method showed acceptable specificity, linearity from 0.5 to 100 ng/mL, precision (expressed as a relative standard deviation of less than $15\%$), accuracy, and stability. The plasma concentration-versus-time curves of eight healthy male volunteers administered a single dose of imidapril (10 mg), gave an $AUC_{12hr}$ of imidapril of $121.48\pm35.81 ng mL^{-1} h$, and $C_{max} and T_{max}$ values of $32.59\pm9.76 ng/mL and 1.75\pm0.27 h$. The developed method should be useful for the determination of imidapril in plasma with sufficient sensitivity and specificity in bioequivalence study.

Bioequivalence of Paroxetine Tablet to Seroxat Tablet (Paroxetine 20 mg) (세로자트정(파록세틴 20 mg)에 대한 삼천리파록세틴정의 생물학적동등성)

  • Ko, In-Ja;Chi, Sang-Cheol
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.499-504
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    • 2004
  • Paroxetine, a potent and selective serotonine reuptake inhibitor, has been used for the treatment of depression, obsessive-compulsive disorder, panic disorder and social phobia. The bioequivalence of two paroxetine preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Samchully Paroxetine $tablet^{\circledR}$ made by Samchully Pharm. Co. and the reference product was Seroxat $tablet^{\circledR}$ made by GlaxoSmithKline. Twenty healthy male subjects, $22.4{\pm}2.6$ years old and $63.8{\pm}4.2\;kg$, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 20 mg paroxetine was orally administered, blood was taken at predetermined time intervals and the concentration of paroxetine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were log 0.84-log 1.16 and log 0.85-log 1.14, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Samchully Paroxetine tablet is bioequivalent to Seroxat tablet.

Identification of a Proper Phytoavailable Arsenic Extraction Method Associated with Arsenic Concentration in Edible Part of three Crops in Soils Near Abandoned Mining Areas

  • Yoon, Jung-Hwan;Kim, Young-Nam;Lee, Dan-Bi;Kim, Kwon-Rae;Kim, Won-Il;Kim, Kye-Hoon
    • Korean Journal of Soil Science and Fertilizer
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    • v.50 no.6
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    • pp.497-508
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    • 2017
  • This study aimed to investigate correlations between concentrations of extractable Arsenic (As) with varying chemical solutions (0.1 M $Ca(NO_3)_2$, 0.1 M $(NH_4)2HPO_4$, 0.5 M EDTA, Mehlich 3, and 0.5 M $NaHCO_3$) and those of As in crops, and then to seek the most suitable soil extraction method for predicting the potential of As uptake in crops cultivated in soils contaminated with As. For a mesocosm experiment, pepper (Capsicum annuum L.), soybean (Glycine max L.), and rice (Oryza sativa L.) were cultivated for three months in pots containing soils taken from the arable areas near abandoned mines in Korea. Following the cultivation, soil pH and DOC significantly increased by treatments of lime and lime plus compost, respectively, while insignificant influences in changing total and all extractable As concentrations were found in all soils. Arsenic concentration in edible part of all crops considerably depended on the extractable As concentration in the soils, particularly with Mehlich 3. All extractable As concentrations in the soils of C. annuum and G. max were significantly correlated with As concentration in their edible parts. For O. sativa, the extractable concentrations of Mehlich 3 ($R^2$: 0.18 at p: 0.006) and EDTA ($R^2$: 0.11 at p: 0.036) showed only marked relationships with As concentration in the edible part. These results may indicate that the Mehlich 3 and EDTA are soil extractants to determine phytoavailable As in soil that provide better prediction for As transfer from soil to crop.

Bioluminescence capability and intensity in the dinoflagellate Alexandrium species

  • Park, Sang Ah;Jeong, Hae Jin;Ok, Jin Hee;Kang, Hee Chang;You, Ji Hyun;Eom, Se Hee;Yoo, Yeong Du;Lee, Moo Joon
    • ALGAE
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    • v.36 no.4
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    • pp.299-314
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    • 2021
  • Some species in the dinoflagellate genus Alexandrium are bioluminescent. Of the 33 formally described Alexandrium species, the bioluminescence capability of only nine species have been tested, and eight have been reported to be bioluminescent. The present study investigated the bioluminescence capability of seven Alexandrium species that had not been tested. Alexandrium mediterraneum, A. pohangense, and A. tamutum were bioluminescent, but A. andersonii, A. hiranoi, A. insuetum, and A. pseudogonyaulax were not. We also measured the bioluminescent intensity of A. affine, A. fraterculus, A. mediterraneum, A. ostenfeldii, A. pacificum, A. pohangense, A. tamarense, and A. tamutum. The mean 200-second-integrated bioluminescence intensity per cell ranged from 0.02 to 32.2 × 104 relative luminescence unit per cell (RLU cell-1), and the mean maximum bioluminescence intensity per cell per second (BLMax) ranged from 0.01 to 10.3 × 104 RLU cell-1 s-1. BLMax was significantly correlated with the maximum growth rates of Alexandrium species, except for A. tamarense. A phylogenetic tree based on large subunit ribosomal DNA (LSU rDNA) showed that the bioluminescent species A. affine, A. catenella, A. fraterculus, A. mediterraneum, A. pacificum, and A. tamarense formed a large clade. However, the toxicity or mixotrophic capability of these species was split. Thus, their bioluminescence capability in this clade was more consistent than their toxicity or mixotrophic capability. Phylogenetic trees based on LSU rDNA and the luciferase gene of Alexandrium were consistent except for A. pohangense. The results of the present study can provide a basis for understanding the interspecific diversity in bioluminescence of Alexandrium.

Object Detection Based on Deep Learning Model for Two Stage Tracking with Pest Behavior Patterns in Soybean (Glycine max (L.) Merr.)

  • Yu-Hyeon Park;Junyong Song;Sang-Gyu Kim ;Tae-Hwan Jun
    • Proceedings of the Korean Society of Crop Science Conference
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    • 2022.10a
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    • pp.89-89
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    • 2022
  • Soybean (Glycine max (L.) Merr.) is a representative food resource. To preserve the integrity of soybean, it is necessary to protect soybean yield and seed quality from threats of various pests and diseases. Riptortus pedestris is a well-known insect pest that causes the greatest loss of soybean yield in South Korea. This pest not only directly reduces yields but also causes disorders and diseases in plant growth. Unfortunately, no resistant soybean resources have been reported. Therefore, it is necessary to identify the distribution and movement of Riptortus pedestris at an early stage to reduce the damage caused by insect pests. Conventionally, the human eye has performed the diagnosis of agronomic traits related to pest outbreaks. However, due to human vision's subjectivity and impermanence, it is time-consuming, requires the assistance of specialists, and is labor-intensive. Therefore, the responses and behavior patterns of Riptortus pedestris to the scent of mixture R were visualized with a 3D model through the perspective of artificial intelligence. The movement patterns of Riptortus pedestris was analyzed by using time-series image data. In addition, classification was performed through visual analysis based on a deep learning model. In the object tracking, implemented using the YOLO series model, the path of the movement of pests shows a negative reaction to a mixture Rina video scene. As a result of 3D modeling using the x, y, and z-axis of the tracked objects, 80% of the subjects showed behavioral patterns consistent with the treatment of mixture R. In addition, these studies are being conducted in the soybean field and it will be possible to preserve the yield of soybeans through the application of a pest control platform to the early stage of soybeans.

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Nodulation Experiment by Cross-Inoculation of Nitrogen-Fixing Bacteria Isolated from Root Nodules of Several Leguminous Plants

  • Ahyeon Cho;Alpana Joshi;Hor-Gil Hur;Ji-Hoon Lee
    • Journal of Microbiology and Biotechnology
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    • v.34 no.3
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    • pp.570-579
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    • 2024
  • Root-nodule nitrogen-fixing bacteria are known for being specific to particular legumes. This study isolated the endophytic root-nodule bacteria from the nodules of legumes and examined them to determine whether they could be used to promote the formation of nodules in other legumes. Forty-six isolates were collected from five leguminous plants and screened for housekeeping (16S rRNA), nitrogen fixation (nifH), and nodulation (nodC) genes. Based on the 16S rRNA gene sequencing and phylogenetic analysis, the bacterial isolates WC15, WC16, WC24, and GM5 were identified as Rhizobium, Sphingomonas, Methylobacterium, and Bradyrhizobium, respectively. The four isolates were found to have the nifH gene, and the study confirmed that one isolate (GM5) had both the nifH and nodC genes. The Salkowski method was used to measure the isolated bacteria for their capacity to produce phytohormone indole acetic acid (IAA). Additional experiments were performed to examine the effect of the isolated bacteria on root morphology and nodulation. Among the four tested isolates, both WC24 and GM5 induced nodulation in Glycine max. The gene expression studies revealed that GM5 had a higher expression of the nifH gene. The existence and expression of the nitrogen-fixing genes implied that the tested strain had the ability to fix the atmospheric nitrogen. These findings demonstrated that a nitrogen-fixing bacterium, Methylobacterium (WC24), isolated from a Trifolium repens, induced the formation of root nodules in non-host leguminous plants (Glycine max). This suggested the potential application of these rhizobia as biofertilizer. Further studies are required to verify the N2-fixing efficiency of the isolates.

The Effect of 12-week exercise type on body composition, ABI, and PWV in middle-aged women (12주간 운동 형태가 중년여성의 신체조성, ABI 및 PWV에 미치는 영향)

  • Soon-Gi Baek
    • Journal of Industrial Convergence
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    • v.22 no.9
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    • pp.63-68
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    • 2024
  • In this study, This study is to explain the effects of body composition and blood vessel stiffness in middle-aged women according to exercise types. 16 middle-aged women were randomly assigned to group A (40~60% of 1RM) in the resistance exercise group and 8 in group B (VO2max 60~70%) in the aerobic exercise group, 3 times a week (monthly) for 12 weeks., Wednesday, Friday) As a result of comparison and analysis to determine the effect of 40 to 60 minutes of exercise per day on body composition, ABI, and PWV, the main effect of period on R-PWV, LPWV on vascular stiffness during aerobic exercise A significant difference (p<.05) was found. Based on the results of this study, it will be meaningful to study various angles of inflammatory factors and vascular endothelial growth factors according to exercise shape and to increase the number of follow-up cases, and it is expected to be used as basic data for improving blood vessel-related indicators of middle-aged women.