• Korean Journal of Clinical Pharmacy
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• v.9 no.1
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• pp.49-54
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• 1999

This study was carried out to compare the bioavailability of Hanmi clarithromycin (250 mg/tablet) with that of $Klaricid^{(R)}$ The bioavailability was examined on 20 volunteers who received a single dose (500 mg) of each drug in the fasting state in a randomized balanced 2-way crossover design. After dosing, blood samples were collected for a period of 12 hours. Plasma samples were analyzed for clarithromycin and roxithromycin(internal standard) by HPLC/Coulometric BCD. The pharmaco-kinetic parameters ($AUC_{0-l2hr}$, Cmax, Tmax, $AUC_{inf}$, Ka, Kel, $t_{1/2}$, Vd/F and Cl/F) were calculated from the plasma clarithromycin concentration-time data of each volunteer. The computer program 'WinNonlin' was used for compartmental analysis. One compartment model with first-order input, from order output with lag time, weighting factor $l/y^2$ was chosen as the appropriate pharmacokinetic model. The major pharmacokinetic parameters ($AUC_{0-l2hr},\;AUC_{inf}$, Cmax and Tmax) of Hanmi clarithromycin were $10.7\pm0.5\;{\mu}g{\cdot}hr{\cdot}ml^{-1},\;12.7\pm0.7\;{\mu}g{\cdot}hr{\cdot}ml^{-1},\;1.7\pm0.1\;{\mu}g/ml\;and\;2.0\pm0.2\;hr$, respectively, and those of $Klaricid^{(R)}\;were\;9.8\pm0.5\;{\mu}g{\cdot}hr{\cdot}ml^{-1},\;11.7\pm0.6\;{\mu}g{\cdot}hr{\cdot}ml^{-1},\;1.6\pm0.1\;{\mu}g/ml\;and\;2.1\pm0.1\;hr$, respectively. The differences in mean values of $AUC_{0-l2hr},\;AUC_{inf}$ and Cmax between two products were $9.88\%,\;8.94%\;and\;6.59\%$, respectively. The least significant differences at $\alpha=0.05$ for $AUC_{0-l2hr},\;AUC_{inf}$ and Cmax were $16.08\%,\;17.81\%\;and\;18.94\%$, respectively. Though the plasma clarithromycin concentrations of Hanmi clarithromycin were higher than those of $Klaricid^{(R)}$ at all observed times, the bioavailability of Hanmi clarithromycin appeared to be bioequivalent with that of $Klaricid^{(R)}$. The Ka, Kel, $t_{1/2}$, Vd/F and Cl/F of the Hanmi clarithromycin were $2.69\pm0.53\;hr^{-1},\;0.18\pm0.01 hr^{-1},\;3.9\;hr,\;248.8\pm11.4\;L\;and\;43.7\pm2.6\;L/hr$, respectively, and those of $Klaricid^{(R)} were 2.19\pm0.51\;hr^{-1},\;0.18\pm0.02\;hr^{-1},\;3.7\;hr,\;266.7\pm22.4\;L\;and\;45.3\pm2.8L/hr$, respectively. There were no statistically significant differences between two drugs in all pharmacokinetic parameters.

• Journal of Korean Medicine for Obesity Research
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• v.13 no.1
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• pp.1-9
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• 2013

Objectives: This study was performed to analyze the recent trend of the studies about obesity in medicine and to provide background for futher studies. Methods: All of the article were selected in "The Korean Journal of Obesity". Search were conducted through "http://kosso.or.kr" with the search word "obesity". Collected articles were classified into clinical study, experimental study, literary study, case report. Results: One hundred eighty four studies were included and analyzed in terms of study design, subject, intervention, period, obesity index and so on. The numbers of clinical studies, literary studies, experimental studies, case reports were respectively 143 (77.7%), 26 (14.1%), 2 (1.1%) and 7 (3.8%). In clinical studies, observational studies were 112 (78.3%) and intervention studies were 31 (21.7%). And most of sample sizes were more than 100 and less than 499. Body mass index, waist circumstance, body fat percent were major criteria of clinical study. Most of the subjects on obesity were about relation with another disease or experimental results and diagnosis. According to classification by the kinds of intervention, diet, exercise, drug, behavior were respectively 22, 18, 8, and 8. More than fourty percent of intervention studies were studied for 12 weeks. Conclusions: To improve the quality of Korean Medicine study for obesity, we need to recruiting big sample size and activate randomized clinical trial.

• Korean Journal of Psychosomatic Medicine
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• v.26 no.2
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• pp.112-118
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• 2018

Objectives : Delirium is one of the most common mental illnesses that can affect cognitive function. Melatonin has been shown to be effective in the treatment of insomnia, and recent studies have shown a protective effect to prevent delirium. This study was conducted to investigate the efficacy of melatonin in delirium patients. Methods : All patients were referred to psychiatric department for insomnia and symptoms of delirium, and were diagnosed delirium by the DSM-5 diagnostic criteria. We compared base line severity of delirium with K-DRS-R-98-R (Korean version of Delirium Rating Scale revised 98) and after taking 2mg of melatonin, retrospectively. The side effects were also identified by referring to the medical records. Results : A total 21 patients had taken melatonin for insomnia and delirious symptoms. The K-DRS-R-98 scores were decreased from $15.24{\pm}2.64$ before treatment to $6.57{\pm}5.42$ after treatment. And CGI-S scores were also decreased from $4.14{\pm}0.48$ before treatment to $2.81{\pm}0.93$ after treatment (p<0.05). Conclusions : This study illustrates the possibility of melatonin as an effective treatment option for delirious symptoms such as disorientation, motor agitation, lability of affect and hallucinations as well as insomnia, with less concerns of drug side effect. Further study with a larger sample and prospective design will be required to confirm these results.

• The Journal of Korean Medicine
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• v.40 no.1
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• pp.124-152
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• 2019

Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer" by analyzing the existing guidelines and clinical trials. Methods: The development committee searched guidelines for herbal medicinal products for colorectal cancer that have already been developed. Then, clinical trials for colorectal cancer using herbal medicine were searched. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the regulations and guidelines of the Ministry of Food and Drug Safety in order to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicinal products were searched on the national institution homepage. In addition, 12 articles were searched using a combination of the following search terms: 'colorectal neoplasms', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional', 'medicine, East Asian medicine', 'medicine, Kampo', etc. Results: The characteristics of participants were various, such as people with medical histories of surgeries or recurrent cancers or who complained of chemotherapy-induced side effects. The types of interventions were also various and included decoctions, powders, intravenous fluids, intraperitoneal injections and gargles. Comparators used included placebos and conventional treatments. The outcome measurements used in the studies were quality of life, symptom score, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for colorectal cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Colorectal Cancer".

• Journal of Korean Medicine for Obesity Research
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• v.20 no.2
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• pp.138-148
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• 2020

Objectives: The aim of this study is to evaluate the effects of Bangpungtongseong-san (Fangfengtongsheng-san, BTS) and Daesiho-tang (Dachaihu-tang, DST) on weight loss and improvement in lipid metabolism and glucose metabolism. Furthermore, we intend to develop a prediction model for drug effects through the analysis of the single nucleotide polymorphism (SNP), gut-microbiota, and the expression of immune-related biomarkers. Methods: This study is a single-center, randomized, double-blind, parallel-design clinical trial. One hundred twenty-eight participants will be assigned to the BTS group (n=64) and DST group (n=64). Both groups will be administered 4 g medication three times a day for up to 2 weeks. The primary outcomes is weight loss. The secondary outcomes include bioelectrical impedance analysis, waist circumstance, body mass index, total cholesterol, high-density lipoprotein, triglyceride, insulin resistance. The exploratory outcomes include 3-day dietary recall, food frequency questionnaire, quality of life questionnaire, gut microbiota analysis, immune biomarkers analysis, and SNP analysis. Assessment will be made at baseline and at week 4, 8, and 12. Conclusions: This protocol will be implemented by approval of the Institutional Review Board of Dongguk University. The results of this trial will provide a systematic evidence for the treatment of obesity and enable more precise herbal medicine prescriptions.

• Design & Manufacturing
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• v.15 no.2
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• pp.11-16
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• 2021

Recently, three-dimensional (3D) cell culture systems, which are superior to conventional two-dimensional (2D) vascular systems that mimic the in vivo environment, are being actively studied to reproduce drug responses and cell differentiation in organisms. Conventional two-dimensional cell culture methods (scaffold-based and non-scaffold-based) have a limited cell growth rate because the culture cannot supply the culture medium as consistently as microvessels. To solve this problem, we would like to propose a 3D culture system with an environment similar to living cells by continuously supplying the culture medium to the bottom of the 3D cell support. The 3D culture system is a structure in which microvascular structures are combined under a scaffold (agar, collagen, etc.) where cells can settle and grow. First, we have manufactured molds for the formation of four types of microvessel-mimicking chips: width / height ①100 ㎛ / 100 ㎛, ②100 ㎛ / 50 ㎛, ③ 150 ㎛ / 100 ㎛, and ④ 200 ㎛ / 100 ㎛. By injection molding, four types of microfluidic chips were made with GPPS (general purpose polystyrene), and a 100㎛-thick PDMS (polydimethylsiloxane) film was attached to the top of each microfluidic chip. As a result of observing the flow of the culture medium in the microchannel, it was confirmed that when the aspect ratio (height/width) of the microchannel is 1.5 or more, the fluid flows from the inlet to the outlet without a backflow phenomenon. In addition, the culture efficiency experiments of colorectal cancer cells (SW490) were performed in a 3D culture system in which PDMS films with different pore diameters (1/25/45 ㎛) were combined on a microfluidic chip. As a result, it was found that the cell growth rate increased up to 1.3 times and the cell death rate decreased by 71% as a result of the 3D culture system having a hole membrane with a diameter of 10 ㎛ or more compared to the conventional commercial. Based on the results of this study, it is possible to expand and build various 3D cell culture systems that can maximize cell culture efficiency by cell type by adjusting the shape of the microchannel, the size of the film hole, and the flow rate of the inlet.

• Journal of Food Hygiene and Safety
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• v.35 no.6
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• pp.607-617
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• 2020

Human bio-monitoring (HBM) data is a very important resource for tracking total exposure and concentrations of a parent chemical or its metabolites in human biomarkers. However, until now, it was difficult to execute the integration of different types of HBM data due to incompatibility problems caused by gaps in study design, chemical description and coding system between different sources in Korea. In this study, we presented a standardized code system and HBM knowledge model (KM) based on relational database modeling methodology. For this purpose, we used 11 raw datasets collected from the Ministry of Food and Drug Safety (MFDS) between 2006 and 2018. We then constructed the HBM database (DB) using a total of 205,491 concentration-related data points for 18,870 participants and 86 chemicals. In addition, we developed a summary report-type statistical analysis program to verify the inputted HBM datasets. This study will contribute to promoting the sustainable creation and versatile utilization of big-data for HBM results at the MFDS.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.47 no.2
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• pp.179-184
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• 2021

Stratum corneum known as a skin barrier, which maintains water in skin, is the outer layer of the skin. Natural moisturizing factors (NMF) are one of the constituents in stratum corneum and amino acids are the highest components among NMF. In this study, we designed stearic acid-based solid lipid nanoparticles (SLNs) for improved skin penetration of serine (Ser). Ser-capsulated SLN was manufactured by double-melting emulsification method. The mean particle size and zeta potential of SLNs were 256.30 ~ 416.93 nm and -17.60 ~ -35.27 mV, respectively. The higher the degree of hydrophobicity or hydrophilicity of emulsifiers, the smaller the particle size and the higher the stability and capsulation rate. In addition, skin penetration was conducted using SkinEthic^TM RHE which is one of the reconstructed human epidermis models. The results of Ser penetration demonstrated that all SLNs enhanced than serine solution. The amount of enhanced Ser penetration from SLNs were approximately 4.1 ~ 6.2 times higher than that from Ser solution. Therefore, Ser-loaded SLN might be a promising drug delivery system for moisturizing formulation in cosmeceutical.

• Journal of the Korean Society of Radiology
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• v.16 no.2
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• pp.169-175
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• 2022

In this study, envisioned a laboratory equipped with virus blocking equipment for chest X-ray examinations of respiratory or droplet-transmitted virus-infected patients, and the material with the least deterioration in X-ray output and image quality among the proven blocking materials that block viruses in the design process. and experimented to find the thickness. As a result, when 1 cm of acrylic was applied, the X-ray output was reduced by only about 3.27 % compared to the absence of the barrier material, the SNR was 40.7 and CNR was 30.9, which was the best. The SSIM index result was analyzed as 0.891, which was analyzed to be implemented as the most similar image compared to the original image. The barrier material applied in the research method was objective in that it used a product approved by the Ministry of Food and Drug Safety. the results of this study are expected to provide useful information when installing X-ray examination facilities for the diagnosis and treatment of respiratory-related virus-infected patients in the future.

• Journal of Korean Home Economics Education Association
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• v.34 no.2
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• pp.153-166
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• 2022

The purpose of this study is to develop and evaluate a dietary education program to improve the caring ability and multicultural acceptance of middle school students. Based on the instructional system design of ADDIE model, the dietary education program was developed to contain five sessions including four theoretical lectures and one lab session. Visual thinking technique was used to train students to express their thoughts and emotion by writing and drawing. The dietary education program was conducted for four weeks (from November 19 to December 14, 2018) at a middle school located in Seoul on a total of 69 middle school students, out of which 34 were assigned to an experimental group and 35 were assigned to a control group. Separate paired t-test were conducted for the experimental group and the control group, respectively, to determine the changes in caring ability and multicultural acceptance scores before and after the dietary education. There were significant increases in caring ability (dietary-, emotional-, behavioral- and cognitive caring) and multicultural acceptance (diversity, relationship and universality) scores among the experimental group after the dietary program. However, no differences were observed among the control group. The results indicate that the dietary education program can be an effective tool to improve caring ability and multicultural acceptance of middle school students.