• Journal of Pharmaceutical Investigation
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• 제40권2호
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• pp.109-115
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• 2010

The purpose of the present study was to evaluate the bioequivalence of two choline alphoscerate soft capsules, Gliatilin soft capsule (Daewoong Pharmaceuticals Co., Ltd.) and Cholicerin soft capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Serum concentrations of choline after oral administration of choline alphoscerate were determined using a validated LC/MS/MS method. This method showed linear response over the concentration range of 0.5-20 ${\mu}g$/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 100 ${\mu}L$ of serum was 0.5 ${\mu}g$/mL which was sensitive enough for pharmacokinetic studies. Thirty six healthy male Korean volunteers received each medicine at the choline alphoscerate dose of 1200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Blood samples were taken at predetermined time intervals up to 8 hr. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 8 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters, indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Cholicerin/Gliatilin were log0.9998-log1.1172 and log0.9938-1.0944, respectively. These values were within the acceptable bioequivalence intervals of log0.80-log1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Cholicerin soft capsule and Gliatilin soft capsule are bioequivalent.

• Journal of Pharmaceutical Investigation
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• 제40권2호
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• pp.117-123
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• 2010

Ibudilast, 3-isobutyryl-2-isopropyrazolo[1,5-a]pyridine, is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). It preferentially inhibits PDE 3A, PDE4, PDE10 and PDE11 as well as a number of the other PDE families, albeit to a lesser extent. Ibudilast is used clinically to treat bronchial asthma and cerebrovascular disorders. Thes e clinical uses are based on the ability of ibudilast to inhibit platelet aggregation, improve cerebral blood flow and attenuate allergic reactions. The purpose of the present study was to evaluate the bioequivalence of two ibudilast capsules, Ketas capsule (Handok Pharmaceuticals Co., Ltd.) and Pinatos capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of ibudilast from the two ibudilast formulations was tested using KP Apparatus method with various dissolution media. Twenty six healthy male subjects, 23.31${\pm}$1.09 years in age and 70.45${\pm}$8.51 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 10 mg as ibudilast was orally administered, blood samples were taken at predetermined time intervals and the concentrations of ibudilast in serum were determined using HPLC/UV detector. 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 untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, Ketas, were 6.99%, -2.48% and 9.93% 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 0.8791~log 1.1861 and log 0.8347~log 1.1199 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Pinatos capsule was bioequivalent to Ketas capsule.

• Journal of Korean Home Economics Education Association
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• 제25권4호
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• pp.13-27
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• 2013

The purpose of the study was to analyze the levels of knowledge and behaviors of green dietary life and the factors affecting them, and to examine the educational content need for green dietary life. The data were collected from 246 middle school students in Daegu and Gyeongbuk region through a self-administered questionnaire. Data were analyzed by SPSS Windows V.21.0. The levels of knowledge and behaviors of green dietary life were not generally high. Percentage of correct answers of health category was higher than that of environment category in the knowledge of green dietary life. On the other hand, in the mean of the behaviors of green dietary life, health, environment, and consideration was higher in order. According to the result of multiple regression analysis for knowledge of green dietary life, grade was significant. In addition, monthly allowance (60,000~90,000 won), socioeconomic status (medium), and knowledge of green dietary life were the significant factors affecting behaviors of green dietary life. In the educational content need, the mean of weight maintenance was the highest, followed by separate garbage collection, prevention of environmental pollution, healthy foods, and traditional foods. On the basis of these results, education to increase knowledge of green dietary life is needed to revitalize behaviors of green dietary life.

• Journal of Dental Rehabilitation and Applied Science
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• 제29권3호
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• pp.308-316
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• 2013

The purpose of this study is to investigate the production method of posterior bridges pontic ridge lap type which prevents the infection in bridge pontic base and is able to cleanse itself, in the process of producing final prothesis that maintains healthy mucous membrane of oral cavity and interproximal papilla, minimizing diastema, is aesthetic and has no effect on pronunciation. New technology is applied to make optimal pontic base which prevent inflammation and clean itself and its products were clinically evaluated in 10 places of dental clinics in busan and gyeongnam. The making of posterior 3 unit bridge pontic base, it was presented as the new technology of forming ridge lab type and to carry out clinical validation, existing conventional method and the new technology were compared. Pontic base made with the existing conventional method cause infection and other periodontal disease by 96% but the pontic base made with the new technology cause infection and other periodontal disease by 3%. Remains of food cause infection and other periodontal disease 100% by the existing conventional method and 91% by the new technology, showing a distinct difference. However, after a gargle, the new technology had low 13%. Additionally, the pontic base made with the existing conventional method showed 71% of chance, the new technology method showed 8% of chance in terms of self-cleansing.

• Korean Journal of Environment and Ecology
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• 제30권2호
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• pp.261-270
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• 2016

The concept of Eco-welfare emerged in the process of discovering the relationship between a healthy ecosystem and human wellbeing. The objective of this study is to offer basic data for eco-welfare policy realization by conceptualizing the 'National Park Eco-welfare' since national parks are appropriate places for eco-welfare to be optimally implemented. A pre-workshop and two rounds of Delphi surveys were conducted to determine the concept of the 'National Park Eco-welfare ' and the main elements to be included in ecosystem service. Through this study, the concept of 'National Park Eco-welfare' was defined as efforts to conserve the biodiversity and sustainability of the ecosystem and create harmony between 'National Park Ecosystem Welfare' and 'National Park Human Welfare'. To establish the direction of the National Park Eco-welfare policy, we identified the main elements of ecosystem services which are appropriate for the National Park. These are comprised of 3 elements (food, fresh water and genetic resources) from supply service, all elements from regulating service and supporting/habitat service and 4 elements (aesthetic information, recreation-based ecotourism, healing, and knowledge systems with educational values) from culture service. In this study, the concept of National Park Eco-welfare was established, and its policy objectives and scope were suggested. However, further studies are necessary to develop action plans areand thereby realize the policy.

• Journal of Life Science
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• 제18권3호
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• pp.304-310
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• 2008

Heat shock protein 70 (HSP70) is known as molecular chaperone, the fundamental protein participating in various processes, from nascent protein synthesis to protection of proteins during abiotic stresses and developmental programs. However, their biological functions in plants are not yet well known. Here, NtHSP70-1 (AY372069), HSP70 of Nicotiana tabacum induced by heat stress was investigated. To analyze the protective role of NtHSP70-1, transgenic tobacco plants, which constitutively overexpressed NtHSP70-1 as well as contained either the vector alone or having NtHSP70-1 in the antisense orientation, were constructed. The altered NtHSP70-1 levels in plants were confirmed by western blotting and transgenic sense lines exhibited tolerance to heat stress. Seedlings with the constitutively expressed NtHSP70-1 grew as green or healthy plants after heat stress. In contrast, transgenic vector or antisense lines exhibited yellowing of leaves or some delay in growth, which finally led to death. Evaluation of chlorophyll contents of heat-shocked transgenic tobacco seedlings indicated that NtHSP70-1 contributes to thermotolerance by preventing chlorophyll synthesis in plants.

• Journal of Life Science
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• 제18권3호
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• pp.395-402
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• 2008

Level of microbial contamination was examined in four fish farms of Jeju east coast for sanitary indication of bacterial contamination such as heterotrophic bacteria, Escherichia coli O157:H7, Salmonella spp., Vibrio parahaemolyticus, Staphylococcus aureus, Bacillus cereus and total coliforms. The samples were collected and investigated from June to October in 2007. Bacterial species of S. aureus, B. cereus and Salmonella spp. were frequently detected from the seawater of above fish farms. Salmonella spp., S. aureus, B. cereus were detected in the range of $0{\sim}4.3{\times}l0^3,\;0{\sim}2.7{\times}l0^4,\;0{\sim}7.6{\times}l0^3$ CFU/ml, respectively, from the fish feed used in all four selected farms. Additionally, Salmonella spp., S. aureus, B. cereus were detected in oliver flounder (Paralichthys olivaceus) of these farms, however total coliforms and E. coli O157:H7 were not detected during our experimental period. For the production of microbiologically safe and healthy oliver flounder, proper quality control of feed, sanitation programs, and continuous monitoring of microorganism are essential practices, which required to include in the farm management system.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.209-214
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• 2004

A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• 제34권3호
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• pp.215-222
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• 2004

The purpose of the present study was designed to evaluate the bioequivalence of two oxiracetam tablets, Neuromed tablet (Korea Drug Co., reference drug) and Neuracetam tablet (Sam Jin Pharmaceutical Co., test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Release of oxiracetam from the tablet 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-four healthy volunteers, $23.7\;{\pm}\;2.4$ year in age and $68.9\;{\pm}\;6.2$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 800 mg of oxiracetam, blood samples were taken at predetermined time intervals and concentrations of oxiracetam in plasma were determined using HPLC-MS-MS. The dissolution profiles of two formulations were very similar at all dissolution media. In addition, 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 $C_{max}$ untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug were 0.42%, 0.45% and -12.58% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log0.94{\sim}log1.06$ and $log0.90{\sim}log1.07$ for $AUC_t$, and $C_{max}$, respectively), indicating that Neuracetam tablet is bioequivalent to Neuromed tablet. The major pharmacokinetic parameters, $AUC_t$, and $C_{max}$ met the criteria set by KFDA for bioequivalence indicating that Neuracetam tablet is bioequivalent to Neuromed tablet.

• Journal of Pharmaceutical Investigation
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• 제38권6호
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• pp.421-427
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• 2008

The purpose of the present study was to evaluate the bioequivalence of two etodolac capsules, Kuhnillodin capsule (Kuhnil. Co., Ltd., Seoul, Korea) as reference drug and Etodin capsule (Myungmun Pharm. Co., Ltd., Seoul, Korea) as test drug, according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-three healthy male Korean volunteers received one capsule at the dose of 200 mg etodolac in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of etodolac were monitored by a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) for over a period of 24 hr after the administration. $AUC_{0-24\;hr}$ was calculated by the linear trapezoidal rule method. $C_{max}$ and $T_{max}$ were compiled from the plasma concentration-time data. Analysis of variance (ANOVA) was carried out using logarithmically transformed $AUC_{0-24\;hr}$ and $C_{max}$. The 90% confidence intervals of the $AUC_{0-24\;hr}$ ratio and the $C_{max}$ ratio for Etodin/Kuhnillodin were $\log\;0.97{\sim}\log\;1.08$ and $\log\;0.89{\sim}\log\;1.19$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$. Thus, our study demonstrated that Etodin was bioeqiovalent to Kuhnillodin preparation when the rate and extent of absorption between two preparations were compared.