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Bioequivalence of Kuhnil GabapentinTM Capsule 300 mg to NeurontinTM Capsule 300 mg (Gabapentin 300 mg) (뉴론틴 캡슐 300밀리그람(가바펜틴 300 mg)에 대한 건일가바펜틴 캡슐 300밀리그람의 생물학적동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Park, Eun-Ja;Oh, Se-Won;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.35 no.3
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    • pp.193-199
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    • 2005
  • Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, 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 using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% 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 log 0.8 to log 1.25 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.

Quantitative Analysis of Trace Metals in Lithium Molten Salt by ICP-AES (ICP-AES를 이용한 리튬 용융염내의 미량 금속성분원소 정량에 관한 연구)

  • Kim, Do-Yang;Pyo, Hyung-Yeal;Park, Yong-Joon;Park, Yang-Soon;Kim, Won-Ho
    • Analytical Science and Technology
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    • v.13 no.3
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    • pp.309-314
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    • 2000
  • The quantitative analysis of various trace metals including fission products in lithium molten salts has been performed using a inductively coupled plasma atomic emission spectrometer (ICP-AES). The spectral interferences of lithium content, 500, 1,000 and 2,000 mg/L, in the sample solution were investigated using an optimum wavelength for the respective metal species. As a result, the line intensities for Y, Nd, Sr, and La had no influences from the lithium content up to 2,000 mg/L, while Mo, Ba, Ru, Pd, Rh, Zr and Ce showed spectral interferences of 10% to 50%. The group separation of metals from lithium in the molten salts solution was carried out by adding ammonia water into the solution. The recovery of Ru, Y, Rh, Zr, Nd, Ce, La and Eu was found to be over 90%, while Mo, Ba, Pd, and Sr provided low recovery percentages.

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Desalinated underground seawater of Jeju Island (Korea) improves lipid metabolism in mice fed diets containing high fat and increases antioxidant potential in t-BHP treated HepG2 cells

  • Noh, Jung-Ran;Gang, Gil-Tae;Kim, Yong-Hoon;Yang, Keum-Jin;Lee, Chul-Ho;Na, O-Su;Kim, Gi-Ju;Oh, Won-Keun;Lee, Young-Don
    • Nutrition Research and Practice
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    • v.4 no.1
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    • pp.3-10
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    • 2010
  • This study was performed to investigate the effect of desalinated underground seawater (named as 'magma seawater', MSW) of Jeju Island in Korea on lipid metabolism and antioxidant activity. MSW was collected from underground of Han-Dong in Jeju Island, and freely given to high fat diet (HFD)-fed C57BL/6 mice for 10 weeks. Although there were no significant differences in the body weight changes and plasma lipid levels, hepatic triglyceride levels were significantly lower in the MSW group than in the normal tap water (TW)-drunken control group. Furthermore, the activity of fatty acid synthase (FAS) was significantly decreased and carnitine palmitoyltransferase (CPT) activity was increased in MSW group compared to TW group. Similarly, real-time PCR analysis revealed that mRNA expressions of lipogenic genes were lowered in MSW groups compared to the control group. In a morphometric observation on the liver tissue, accumulation of fats was remarkably reduced in MSW group. Meanwhile, in vitro assay, tree radical scavenging activity measured by using diphenylpicrylhydrazyl (DPPH) was increased in MSW group. The 2'-7'-dichlorofluorescein diacetate (DCF-DA) staining followed with fluorescent microscopy showed a low intensity of fluorescence in MSW-treated HepG2 cells, compared to TW-treated HepG2 cells, which indicated that the production of reactive oxygen species by tert-butyl hydroperoxide (t-BHP) in HepG2 cells was decreased by MSW treatment. The antioxidant effect of MSW on t-BHP-induced oxidative stress in HepG2 cells was supported by the increased activities of intracellular antioxidant enzymes such as catalase and glutathione reductase. From these results, we speculate that MSW has an inhibitory effect on lipogenesis in liver and might play a protective role against cell damage by t-BHP-induced oxidative stress.

Adhesion Behavior of Chondrocyte and Osteoblast on Surface-Modified Biodegradable PLLA Films and Scaffolds (표면개질된 생분해성 PLLA 필름 및 지지체의 연골세포와 조골세포 점착거동)

  • Choi, Ji-Yeon;Jung, Hyun-Jung;Park, Bang-Ju;Joung, Yoon-Ki;Park, Kwi-Deok;Han, Dong-Keun
    • Polymer(Korea)
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    • v.36 no.3
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    • pp.357-363
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    • 2012
  • Surface-modified poly(L-lactic acid) (PLLA) films and scaffolds were treated with plasma discharge in oxygen gas and subsequently subjected to $in$ $situ$ grafting of acrylic acid (AA) in order to increase the cell compatibility. The surface of AA-grafted PLLA was converted to hydroxyapatite (HA)-deposited PLLA in stimulated body fluid (SBF). After the samples were immersed in phosphate-buffered saline (PBS), fetal bovine serum (FBS), normal saline, or cell medium, the water contact angles were significantly reduced on the surface of HA-deposited PLLA. Chondrocyte and osteoblast showed a higher attachment and cell proliferation on HA-deposited surfaces and in particular, it was confirmed that chondrocyte was considerably influenced by HA. However, osteoblast showed better cell proliferation on the surfaces immersed in FBS, cell medium or HA-deposited surface. In addition, the cell proliferation in 3D scaffolds was much higher than that on film type, irrespective of chondrocyte and osteoblast. Therefore, such surface-modified PLLAs are expected to be useful as organic-inorganic hybrid scaffolds in the regeneration of cartilage and bone.

Anti-Allergic Activities of Ultra-fine Powder from Persimmon (감 초미세 분말의 추출물을 이용한 항산화 및 항아토피 활성)

  • Heo, Jin-Chul;Lee, Kang-Yol;Lee, Beom-Goo;Choi, So-Young;Lee, Sook-Hee;Lee, Sang-Han
    • Food Science and Preservation
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    • v.17 no.1
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    • pp.145-150
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    • 2010
  • Ultra-fine powder (FA) extracts from persimmon were investigated as potential food materials in industrial processes because such extracts have various useful biological activities. We examined the antioxidant and anti-allergic activity of FA extracts using the 1,1-diphenyl-2-picrylhydrazyl (DPPH) and ferric reducing activity of plasma (FRAP) models, and by measuring interleukin 4 (IL-4) expression in spleen cells and in an atopy animal model. FA extracts were prepared using solvents including distilled water and 50% (v/v) acetone. The results showed that FA extracts had potent DPPH and FRAP activities, decreased IL-4 expression in spleen cells, and inhibited ear thickness and inflammation in a mouse animal model. The data indicate that a FA extract could be used as an antioxidant and/or anti-inflammation agent, and in industrial food preparation processes.

Measurement of Mechanical Properties of Thin Film Materials for Flexible Displays (플렉서블 디스플레이용 박막 소재 물성 평가)

  • Oh, Seung Jin;Ma, Boo Soo;Kim, Hyeong Jun;Yang, Chanhee;Kim, Taek-Soo
    • Journal of the Microelectronics and Packaging Society
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    • v.27 no.3
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    • pp.77-81
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    • 2020
  • Commercialization of flexible OLED displays, such as rollable and foldable displays, has attracted tremendous interest in next-generation display markets. However, during bending deformation, cracking and delamination of thin films in the flexible display panels are the critical bottleneck for the commercialization. Therefore, measuring mechanical properties of the fragile thin films in the flexible display panels is essential to prevent mechanical failures of the devices. In this study, tensile properties of the metal and ceramic nano-thin films were quantitatively measured by using a direct tensile testing method on the water surface. Elastic modulus, tensile strength, and elongation of the sputtered Mo, MoTi thin films, and PECVD deposited SiNx thin films were successfully measured. As a result, the tensile properties were varied depending on the deposition conditions and the film thickness. The measured tensile property values can be applied to stress analysis modeling for mechanically robust flexible displays.

Stress Responses of Olive Flounder (Paralichthys olivaceus) to Salinity Changes (염분변화에 따른 넙치(Paralichthys olivaceus)의 스트레스 반응)

  • Park, Hyung-Jun;Min, Byung-Hwa
    • Korean Journal of Ichthyology
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    • v.30 no.1
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    • pp.1-8
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    • 2018
  • We tried to determine the optimum salinity for a cultured of olive flounder (Paralichthys olivaceus) by investigating after exposing the fish at different salinity (10, 15, 20 and 25 psu) for 24 and 48 hours compared with control group (fish before transfer to experimental tank). As a control groups, we compared an analyzed with other experimental groups using olive flounder in natural sea water. Hematological parameters including hematocrit (Ht) and hemoglobin (Hb), cortisol and glucose, aspartate aminotransferase (AST) and alanine aminotransferase (ALT), $NH_3$, osmolality, total protein (TP), $Na^+$, $K^+$ and $Cl^-$ mostly exhibited significant changes at 10 and 15 psu groups compared with control groups for 24 and 48 hours exposed. Plasma SOD (superoxide dismutase) and CAT (catalase) activity also increased with experimental groups (10 and 15 psu) compared to the control groups. The expression of HSP70 mRNA was also higher at low-salinity (10 and 15 psu) than at control group. In particular, after 24 hours exposed, it expression to 15 psu groups showed a significant difference compared to the control group. However, after 48 hours exposed, it expression was higher in the 10 psu groups than the control. It is assumed that the changes in the hematological responses and hormone, homeostasis and metabolism were resulted in to protect fish body from stress. Based on these results, we are expected that it will be used as basic data for the culture of olive flounder prepared for low salinity.

WETTABILITY AND DRUG DELIVERY OF FUNCTIONALLY GRADED NANO-MICRO POROUS TITANIUM SURFACE

  • Yun, Kwi-Dug;Vang, Mong-Sook;Yang, Hong-So;Park, Sang-Won;Park, Ha-Ok;Lim, Hyun-Pil
    • The Journal of Korean Academy of Prosthodontics
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    • v.46 no.3
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    • pp.307-319
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    • 2008
  • STATEMENT OF PROBLEM: It is known that an anodic oxidation technique, one of the methods for the implant surface treatment, remarkably increased surface area, enhanced wettability and accelerated the initial bone healing. Purpose: This study was performed to evaluate the wettability of anodized titanium surface which has a nanotubular structure, to assess osseointegration after the placement of implant with nano-size tubes on tibia of rats and to analyze quantitatively transferable rhBMP-2 on each surface. MATERIAL AND METHOD: Four different kinds of surface-treated titanium discs (polished (machined surface) group, micro (blasting surface) group, nano (anodizedmachined surface) group, and nano-micro (anodized-blasting surface) group) were fabricated (n=10). Three different media were chosen to measure the surface contact angles; distilled water, plasma and rhBMP-2 solution. After a single drop (0.025 $m{\ell}$) of solution, the picture was taken with the image camera, and contact angle was measured by using image analysis system. For the test of osseointegration, 2 kinds of anodized surface (anodized-machined surface, anodized-blasting surface) implants having 2.0 mm in diameter and 5.0 mm in length inserted into the tibia of Wistar rats. After 3 weeks, tibia were harvested and the specimens were stained with hematoxylin and eosin for histological analysis. To test the possibility of drug delivery, after soaking sample groups in the concentration of 250 ng/$m{\ell}$l of rhBMP-2 for 48 hours, the excess solution of rhBMP-2 were removed. After that, they were lyophilized for 24 hours, and then the rhBMP-2 on the surface of titanium was resolved for 72 hours in PBS. All the extracted solution was analyzed by ELISA. One-way analysis of variance (ANOVA) was performed on the data. RESULTS: The wettability is improved by anodic oxidation. The best wettability was shown on the nano-micro group, and it was followed by nano group, micro group, and polished group. In the histological findings, all implants showed good healing and the new bone formation were observed along the implant surface. After 3 days, nano-micro group delivered the most amount of rhBMP-2, followed by nano group, micro group, and polished group. CONCLUSION: It indicated that anodic oxidation on blasting surface produce functionally graded nano-micro porous structure and enhance hydrophilicity of the surface and osseointegration. The findings suggest that the nano-micro porous structure could be a useful carrier of osteogenic molecules like rhBMP-2.

Bond Strength of Wafer Stack Including Inorganic and Organic Thin Films (무기 및 유기 박막을 포함하는 웨이퍼 적층 구조의 본딩 결합력)

  • Kwon, Yongchai;Seok, Jongwon
    • Korean Chemical Engineering Research
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    • v.46 no.3
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    • pp.619-625
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    • 2008
  • The effects of thermal cycling on residual stresses in both inorganic passivation/insulating layer that is deposited by plasma enhanced chemical vapor deposition (PECVD) and organic thin film that is used as a bonding adhesive are evaluated by 4 point bending method and wafer curvature method. $SiO_2/SiN_x$ and BCB (Benzocyclobutene) are used as inorganic and organic layers, respectively. A model about the effect of thermal cycling on residual stress and bond strength (Strain energy release rate), $G_c$, at the interface between inorganic thin film and organic adhesive is developed. In thermal cycling experiments conducted between $25^{\circ}C$ and either $350^{\circ}C$ or $400^{\circ}C$, $G_c$ at the interface between BCB and PECVD $ SiN_x $ decreases after the first cycle. This trend in $G_c$ agreed well with the prediction based on our model that the increase in residual tensile stress within the $SiN_x$ layer after thermal cycling leads to the decrease in $G_c$. This result is compared with that obtained for the interface between BCB and PECVD $SiO_2$, where the relaxation in residual compressive stress within the $SiO_2$ induces an increase in $G_c$. These opposite trends in $G_cs$ of the structures including either PECVD $ SiN_x $ or PECVD $SiO_2$ are caused by reactions in the hydrogen-bonded chemical structure of the PECVD layers, followed by desorption of water.

Protective Effect of Myeongganbo Extract on Acetaminophen-Induced Liver Injury (명간보(明肝補) 추출물의 Acetaminophen 유도 간 손상에 대한 보호효과)

  • Kim, Hong-Jun;Mok, Ji-Ye;Park, Kwang-Hyun;Jeon, In-Hwa;Kim, Hyeon-Soo;Hwang, Sung-Yeoun;Jang, Seon-Il
    • The Korea Journal of Herbology
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    • v.27 no.2
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    • pp.85-91
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    • 2012
  • Objective : Myeongganbo (MGB) composited with Hovenia Semen, Puerariae Radix and Dioscoreae Rhizoma is the prescription for protection of liver function. The purpose of this study was to investigate the effects of MGB extract against acetaminophen (APAP)-induced liver injury in mice. Methods : MGB extract was prepared by extracting with hot distilled water. The extract was freeze-dried following filtration through vacuum distillation system. Mice fasted for overnight were orally administrated with or without MGB extract of different doses (25-200 mg/kg/day). After 30 min, APAP was orally applied with a single dose (400 mg/kg). The levels of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were measured in plasmas of mice. Glutathione (GSH), glutathione peroxidase GSH-px), cyclooxygenase-2 (COX-2) activity and tumor necrosis factor-${\alpha}$ (TNF-${\alpha}$) level were investigated in liver homogenates. Liver sections were stained with haematoxylin & eosin, anti-TNF-${\alpha}$ and anti-mouse COX-2 antibodies. Results : APAP treatment remarkably increased AST and ALT activities in plasma but inhibited GSH and GSH-px levels in liver homogenates. Also, liver injury was significantly accelerated by APAP treatment. Furthermore, APAP remarkably elevated COX-2 activity and TNF-${\alpha}$ levels in liver homogenates. However, administration of MGB extract was able to counteract these effects. Histological studies provided supportive evidence for biochemical and molecular analysis Conclusions : These results suggest that MGB extract has potent hepatoprotective effect against APAP-induced liver injury, these properties may contribute to liver disease care.