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Bioequivalence of Yutanal® Capsule to Harnal® Capsule (Tamsulosin HCl 0.2 mg) (하루날® 캡슐(염산 탐스로신, 0.2 mg)에 대한 유타날® 캡슐의 생물학적동등성)

  • Im, Ho-Taek;Cho, Sung-Hee;Lee, Heon-Woo;Park, Wan-Su;Kim, Young-Kwan;Rew, Jae-Hwan;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.35 no.4
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    • pp.309-315
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    • 2005
  • The purpose of the present study was to evaluate the bioequivalence of tamsulosin HCl capsule, $Harnal^{\circledR}$(Jeil Korea Ltd.) and $Yutanal^{\circledR}$(Kukje Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.29{\pm}2.14$ year in age and $72.08{\pm}7.83$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 0.2 mg of tamsulosin HCl were orally administered, blood was taken at predetermined time intervals and concentrations of tamsulosin in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $T_{max}$ and $C_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 (e.g., $log0.93{\sim}log1.11$ and $log0.80{\sim}log0.94$ for $AUC_t$, and $C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KFDA for bioequivalence indicating that $Yutanal^{\circledR}$ capsule is bioequivalent to $Harnal^{\circledR}$ capsule.

Bioequivalence of Glycomin Tablet to Glucophage Tablet (Metformin HCl 500 mg) (굴루코파지 정(염산메트폴민 500 mg)에 대한 그리코민 정의 생물학적 동등성)

  • Cho, Hea-Young;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.32 no.3
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    • pp.223-229
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    • 2002
  • Metformin is an oral antihyperglycemic agent used in the therapy of noninsulin-dependent diabetes mellitus and does not cause hypoglycemia at the therapeutic dose. Its mechanism of action may involve an increased binding of insulin to its receptors and glucose uptake at the post-receptor level. The purpose of the present study was to evaluate the bioequivalence of two metformin tablets, Glucophage (Daewoong Pharmaceutical Co., Ltd.) and Glycomin (Ilsung Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The metformin release from the two metformin tablets in vitro was tested using KP VII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $23.75{\pm}1.96$ years in age and $68.77{\pm}10.41\;kg$ in body weight, were divided into two groups with a randomized $2{\times}2$ cross-over study. After one tablet containing 500 mg as metformin was orally administered, blood was taken at predetermined time intervals and the concentrations of metformin in serum were determined using HPLC with UV detector. Besides, the dissolution profiles of two metformin tablets were very similar at 떠1 dissolution media. The pharmacokinetic parameters such as $AVC_t,\;C_{max}\;and\;T_{max}$ were calculated. The ANOVA test was performed for the statistical analysis of the logarithmically transformed $AVC_t\;and\;C_{max}$, untransformed $T_{max}$. The results showed that the differences in $AVC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the Glucophage were 0.09%, 6.09% and -8.22%, respectively. There were no sequence effects between two tablets in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.94){\sim}log(1.09)\;and \;log(1.01){\sim}log(1.15)$\;for\;AVC_t\;and\;C_{max},\;respectively)$, indicating that Glycomin tablet is bioequivalent to Glucophage tablet.

Bioequivalence of Flucona Capsule to Diflucan Capsule (Fluconazole 50 mg) (디푸루칸 캅셀(플루코나졸 50 mg)에 대한 플루코나 캅셀의 생물학적 동등성)

  • Cho, Hea-Young;Kang, Hyun-Ah;Lee, Suk;Oh, In-Joon;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.33 no.2
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    • pp.135-140
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    • 2003
  • Fluconazole is an orally active bis-triazole antifungal agent, which is used in the treatment of superficial and systemic candidiasis and in the treatment of cryptococcal infections in patients with the acquired immuno deficiency syndrome (AIDS). The purpose of the present study was to evaluate the bioequivalence of two fluconazole capsules, Diflucan (Pfizer Pharmaceuticals Korea Inc.) and Flucona (Korean Drug Pharmaceuticals Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The fluconazole release from the two fluconazole capsules in vitro was tested using KP VII Apparatus II method at 0.1 M hydrochloride dissolution media. Twenty normal male volunteers, $23.60{\pm}1.88$ years in age and $63.57{\pm}6.17\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three capsules containing 50 mg as fluconazole was orally administered, blood was taken at predetermined time intervals and the concentrations of fluconazole in serum were determined using HPLC method with UV detector. The dissolution profiles of two fluconazole capsules were very similar at 0.1 M hydrochloride dissolution media. Besides, 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 $AUC_t$ and $C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Diflucan were 4.96%, 5.65% and -13.76%, respectively. There were no sequence effects between two capsules in these parameter. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(1.01){\sim}log(1.08)\;and\;log(1.00){\sim}log(1.12)\;for\;AUC_t\;and\;C_{max},\;respectively)$, indicating that Flucona capsule is bioequivalent to Diflucan capsule.

Comparison of Effects of Different Activation Treatments on Development of Rabbit Embryos Reconstituted with Fetal Fibroblast

  • Lee, H.J.;Yoo, J.G.;Cho, S.R.;Lee, S.L.;Chong, J.R.;Yeo, H.J.;Hwang, J.M.;Park, J.S.;Yea, E.H.;Rho, G.J.;Choe, S.Y.
    • Proceedings of the KSAR Conference
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    • 2001.03a
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    • pp.22-22
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    • 2001
  • To produce reconstituted rabbit embryos with fetal fibroblasts, the present study was evaluated the efficiencies of the different fusion and activation conditions as assessments of subsequent development and chromosome in the embryos. New Zealand White rabbits were used throughout the study. Fetal fibroblasts collected from 22-d of fetuses were cultured in DMEM + 10% FBS in 5% $CO_2$ in air. The culture was maintained for 10 passages. In every passage half of cell suspension were kept In frozen. From rabbits treated with FSH in 30% PVP solution and hCG, oocytes were surgically collected from oviducts at 14 h post-hCG injection and stripped off their cumulus cells by re-pipetting in a 300 IU hyaluronidase solution. Oocytes with an extruded first polar body and dense cytoplasm were enucleated by micromanipulation in Ham's F-10 medium+7.5 g/$m\ell$ cytochalasin B. Euncleation was confirmed under a fluorescence microscope after staining with 5 g/$m\ell$ bisbenzimide for 2 min. Each enucleated oocyte was injected with a fetal fibroblast into a perivitelline space. Reconstructed eggs were compared fusion rates either at 2.0 ㎸/cm or 1.6 ㎸/cm(60 sec, double pulses). After fusion, all eggs were activated with the combination of 5 M ionomycin (5 min) and 10 g/$m\ell$ cycloheximide (CHX, 3h), and cultured in CRlaa medium and transferred into TCM199+10% FBS on day 3. Although there was not significantly differ in fusion rate between treatments (60%, 2.0 ㎸/cm vs. 79.4%, 1.6 ㎸/cm), none of them in the eggs fused with 2.0 ㎸/cm developed to blastocyst. In comparison of development and chromosome status between different activation treatments (Group 1; 5 M ionomycin/10 g/$m\ell$ CHX, Group 2; 5 M ionomycin/5 g/$m\ell$ CHX + 2 mM DMAP after fusion with 1.6 ㎸/cm), there were not differ in cleavage and development rates (67.3% and 28.9% in Group 1; 67% and 33% in Group 2). All out of 8 embryos evaluated in Group 1 appeared a normal diploid chromosome sets and mean number of cells (Mean SEM) on day 4.5 of culture was 141.5 23.15 (n=8). It can be concluded that the use of cycloheximide has not happened in chromosome abnormalities, and fetal fibroblasts can be used for cloning in rabbit.

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Resumption of Ovarian Cyclicity after Superovulation Treatment to Donor Cow in Holstein Donor Cows (젖소 공란우 과배란 처리 후 난소주기 재개에 관한 연구)

  • Son, Jun-Kyu;Baek, Kwang-Soo;Yoon, Ho-Beak;Lim, Hyun-Joo;Kwon, Eung-Gi;Cho, Sang-Rae;Jung, Yeon-Sub;Kim, Sun-Kyu;Choe, Changyong
    • Reproductive and Developmental Biology
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    • v.37 no.1
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    • pp.35-40
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    • 2013
  • The objective of this study was to investigate the effects of abnormal ovarian cycles after superovulation treatment of Holstein Donor Cows. CIDRs were inserted into the vaginas of twenty two head of Holstein cows, regardless of estrous cycle. Superovulation was induced using folliclar stimulating hormone (FSH). For artificial insemination, donor cows were injected with $PGF_2{\alpha}$ and estrus was checked about 48 hours after the injection. Then they were treated with 4 straws of semen 3 times, with 12-hour intervals. Embryos were collected by a non-surgical method 7 days after the first artificial insemination. The cows were considered to have resumed ovarian cyclicity on the day of ovulation if followed by regular ovarian cycles. Seventy two point seven percentage of the cows(16/22) had normal resumption of ovarian cyclicity(resumption within 40 days after superovulation), and 27.3%(6/22) had delayed resumption(resumption did not occur until>40 days after superovulation). Delayed resumption Type II(first ovulation did not occur until ${\geq}40$ days after superovulation, i.e. delayed first ovulation 13.6%) were the most common types of delayed resumptions. The mean numbers of total ova from < 10 and $10{\leq}$ of corpora lutea(CL) was $7.8{\pm}1.8$ and $12.7{\pm}2.7$, respectively. The number of transferable embryos differed between < 10 and $10{\leq}$ CL was $5.4{\pm}1.3$ and $8.1{\pm}3.4$, respectively. Four point five percentage of the cows(1/22) did not resumption their ovarian cyclicity until 60 days after superovulation treatment. Diverse researches on the superovulation treatment method that is suitable for high-producing Holstein donor cows would contribute to preventing ovarian cyclicity disorder, as well as to the early multiplication of cows with superior genes by increasing the utilization value of donor cows.

Neural Substrates of Picture Encoding: An fMRI Study (그림의 부호화 과정과 신경기제 : fMRI 연구)

  • 강은주;김희정;김성일;나동규;이경민;나덕렬;이정모
    • Korean Journal of Cognitive Science
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    • v.13 no.1
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    • pp.23-40
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    • 2002
  • This study is to examine brain regions that are involved in picture encoding in normal adults using fMRI methods. In Scan 1, the picture encoding was studied during a semantic categorization task in comparison with word. In Scan 2 task type effects were studied both during a picture naming task and during a semantic categorization task with pictures. Subjects were asked to make decision either by pressing a mouse button (Scan 1) or by responding subvocally (naming or saying yes/no) (Scan 2). Regardless of stimulus type, left prefrontal, bilateral occipital, and parietal activations were observed during semantic processing in comparison with fixation baseline. Processing of word stimulus relative to picture resulted in activations in prefrontal and parieto-temporal regions in the left side while that of picture stimulus relative to word resultd in activations in bilateral extrastriatal visual cortices and parahippocampal regions. In spite of the same task demands, stimulus-specific information processings were involved and mediated by different neural substrates; the word encoding was associated with more semantic/lexical processings than pictures and the picture processing associated with more perceptual and novelty related information processings than word. Activations of dorsal part of inferior prefrontal region, i.e., Broca's areas were found both during the picture naming and during the semantic tasks subvocally performed Especially, during the picture naming task, greater occipital activations were found bilaterally relative to the semantic categorization task. indicating a possibility that greater and higher visual processing was involved in retrieving the name referred by picture stimuli.

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The Dietary Intake, Plasma Lipid Peroxidation and Vitamin C in NIDDM Patients (당뇨병 환자에 있어 식이섭취량, 혈장 지질과산화 및 Vitamin C의 농도)

  • 서혜연;하애화;조정순
    • Journal of Nutrition and Health
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    • v.34 no.8
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    • pp.912-919
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    • 2001
  • The increased oxidative stress may play an important role on the pathogenesis of diabetes and diabetic complications, and the blood level of vitamin C and lipid peroxidation in NIDDM patients may be used as an indicator for oxidative stress. However there is only scanty evidence on the blood level of vitamin C in NIDDM patients with or without diabetic complications. The study population consisted of 90 NIDDM patients(diabetes without complication, 48, and diabetes with complications, 42) and 41 normal subjects. The 42 diabetic complications were divided into 3 groups : 15 diabetic nephropathy, 18 diabetic neuropathy, 9 diabetic retinopathy. The anthropometric data and blood biochemical data were studied. The dietary intake was determined by 24 hour recall methods and food frequency questionnaire. The plasma concentrations of MDA and vitamin C were determined by fluorophotometer and HPLC respectively. 1) In blood lipoprotein study, diabetes with complication had higher level of TG than diabetes without complications, while no significant differences in total cholesterol, HDL, and LDL were shown. Diabetic neuropathy had the highest TG level among diabetic complication groups. 2) The intakes of vitamin B complexes(vitamin B$_2$, vitamin B$_{6}$, not vitamin B$_1$) and antioxidant vitamins(vitamin A and vitamin E, not vitamin C) and certain minerals such as iron and calcium in diabetes were not sufficient but the intakes of energy, protein, niacin, and phosphorus in diabetes were sufficient. The dietary intakes between diabetes with-and without complications were not significantly different. Among diabetic complications, the diabetic retinopathy had the lowest intake of vitamin B$_2$ and B$_{6}$(p < 0.05). the diabetic neuropathy or nephropathy consumed extremely low amount of vitamin A. 3) The MDA concentrations of NIDDM was significantly higher than that in controls(p < 0. 05) while no significant difference in the MDA concentration between with and without complications was shown. Although there were no statistical differences, the diabetic nephropathy and diabetic neuropathy showed the higher concentration of MDA than the diabetes without complications or diabetic retinopathy. 4) The plasma concentration of vitamin C in controls was higher than that in diabetes(p < 0.05) while the plasma vitamin C in diabetes with and without complications were similar. In diabetic complications, no differences in plasma vitamin C concentration of three groups were shown. This study showed that the oxidative stress in NIDDM patients was highly increased and the vitamin C reserve was significantly depleted, as compared with normals, although their intakes of vitamin C met korean RDA, which means that diabetes need more vitamin C intake to decrease oxidative stress in NIDDM patients.nts.

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Peanut sprouts extract (Arachis hypogaea L.) has anti-obesity effects by controlling the protein expressions of $PPAR{\gamma}$ and adiponectin of adipose tissue in rats fed high-fat diet

  • Kang, Nam E;Ha, Ae Wha;Woo, Hye Won;Kim, Woo Kyoung
    • Nutrition Research and Practice
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    • v.8 no.2
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    • pp.158-164
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    • 2014
  • BACKGROUD/OBEJECTIVES: This study aims to find out the effects of peanut sprout extracts on weight controls and protein expressions of transcription factors related to adipocyte differentiation and adipocytokine in rats under high-fat diets. MATERIALS/METHODS: Four week-old Sparague-Dawley (SD) were assigned to 4 groups; normal-fat (NF) diets (7% fat diet), high-fat (HF) diets (20% fat diet), high fat diets with low peanut sprout extract (HF + PSEL) diet (20% fat and 0.025% peanut sprout extract), and high fat diets with high peanut sprout extract (HF + PSEH) diet (20% fat and 0.05% peanut sprout extract). Body weight changes, lipid profiles in adipose tissue, and the mRNA protein expressions, such as peroxisome proliferator-activated receptor ${\gamma}$ ($PPAR{\gamma}$), CCAAT element binding protein ${\alpha}$ (C/EBP ${\alpha}$), leptin, and adiponectin, were determined. RESULTS: After 9 weeks of feeding, the HF + PSEH group had significantly less weight gains than the HF group (P < 0.05). However, the total dietary intakes or food efficiency ratios among groups were not significantly different. The weight of epididymal fat in HF + PSEH group, $3.61{\pm}0.5g$, or HF + PSEL group, $3.80{\pm}0.7g$, was significantly lower than the HF group, $4.39{\pm}0.4g$, (P < 0.05). Total lipids and total cholesterol in adipose tissue were significantly decreased in HF + PSEH group compared to those in the HF group, respectively (P < 0.05). PSEH supplementation caused AST and ALT levels to decrease when it compared to HF group, but it was not statistically significant. The protein expression of $PPAR{\gamma}$ in HF + PSEH group was significantly lower than the HF group (P < 0.05). Comparing with the HF group, the protein expression of adiponectin in HF + PSEH group was significantly increased (P < 0.05). The protein expressions of C/EBP ${\alpha}$ and leptin in HF + PSEH group were lower than the HF group, but it was not statistical significant. CONCLUSIONS: In conclusion, peanut sprout extract has anti-obesity effect by lowering the expressions of $PPAR{\gamma}$ which regulates the expression of adiponectin.

Raising Visual Experience of Soccer Video for Mobile Viewers (이동형 단말기 사용자를 위한 축구경기 비디오의 시청경험 향상 방법)

  • Ahn, Il-Koo;Ko, Jae-Seung;Kim, Won-Jun;Kim, Chang-Ick
    • Journal of KIISE:Computing Practices and Letters
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    • v.13 no.3
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    • pp.165-178
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    • 2007
  • The recent progress in multimedia signal processing and transmission technologies has contributed to the extensive use of multimedia devices to watch sports games with small LCD panel. However, the most of video sequences are captured for normal viewing on standard TV or HDTV, for cost reasons, merely resized and delivered without additional editing. This may give the small-display-viewers uncomfortable experiences in understanding what is happening in a scene. For instance, in a soccer video sequence taken by a long-shot camera techniques, the tiny objects (e.g., soccer ball and players) may not be clearly viewed on the small LCD panel. Moreover, it is also difficult to recognize the contents of the scorebox which contains the elapsed time and scores. This renuires intelligent display technique to provide small-display-viewers with better experience. To this end, one of the key technologies is to determine region of interest (ROI) and display the magnified ROI on the screen, where ROI is a part of the scene that viewers pay more attention to than other regions. Examples include a region surrounding a ball in long-shot and a scorebox located in the comer of each frame. In this paper, we propose a scheme for raising viewing experiences of multimedia mobile device users. Instead of taking generic approaches utilizing visually salient features for extraction of ROI in a scene, we take domain-specific approach to exploit unique attributes of the soccer video. The proposed scheme consists of two modules: ROI determination and scorebox extraction. The experimental results show that the proposed scheme offers useful tools for intelligent video display on multimedia mobile devices.

Flow and smoke behavior of a longitudinal ventilation tunnel with various velocities using computational fluid dynamics (팬의 운전조건에 따른 종류식환기터널 내의 연기거동에 관한 전산유체역학연구)

  • Lee, J.H.;Kwon, Y.J.;Kim, D.E.
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.16 no.1
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    • pp.105-115
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    • 2014
  • A numerical analysis on the smoke behavior and evacuee safety has been performed with computational fluid dynamics. The purpose of this study is to build computational processes for an evacuation and prevention of a fire disaster of a 3 km-length tunnel in Korea. To save computational cost, 1.5 km of the tunnel that can include a few cross-passing tunnels is considered. We are going to assess the fire safety in a road tunnel according to the smoke level, which consists of the smoke density and the height from the floor. The smoke density is obtained in detail from three-dimensional unsteady CFD analysis. To obtain proper temperature distributions on the tunnel wall, one-dimensional conduction equation is considered instead of an adiabatic wall boundary or a constant heat flux. The tunnel considered in this study equips the cross passing tunnels for evacuees every 250 m. The distance is critical in both safety and economy. The more cross passing tunnels, the more safe but the more expensive. Three different jet fan operations can be considered in this study; under- and over-critical velocities for normal traffic condition and 0-velocoty operation for the traffic congestion. The SE (smoke environment) level maps show a smoke environment and an evacuating behavior every moment.