• Korean Journal of Clinical Pharmacy
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• v.8 no.2
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• pp.101-106
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• 1998

A bioequivalence study of the Kerola tablets (Dongkwang Pharmaceutical Co., Korea) to the Tarasyn tablets (Roche Co., Korea), formulations of ketorolac trometamine(KTR), was conducted. Sixteen healthy Korean male subjects received each formulation at the dose of 10 mg as KTR in a $2\times2$ crossover study. There was a 1-week washout period between the dose. Plasma concentrations of KTR were monitored by an HPLC method for over a period of 12 hr after each administration. AUC (area under the plasma concentration-time curve) was calculated by the linear trapezoidal method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}\;and\;T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than $20\%$ (i.e., 2.31, 8.19 and $0\%$ for AUC, $C_{max}\;and\;T_{max}$, respectively). Minimum detectable differences $(\%)\;at\;\alpha=0.1\;and\;1-\beta=0.8$ were all less than $20\%$ difference in these parameters between the formulations were all over 0.8. The $90\%$ confidence intervals for these parameters were also within $20\%$. These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 1998-86). Therefore, these results indicate that the 2 formulations of KTR are bioequivalent and, thus, may be prescribed interchangeably.

• Korean Journal of Clinical Pharmacy
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• v.29 no.4
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• pp.231-237
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• 2019

Objective: The aim of this study was to analyze the status of split tablet prescription in South Korea. Methods: We conducted this analysis using 2016 National Patient Sample data from the Health Insurance Review and Assessment Service. We computed split tablet prescription rates by sex and age and determined which medicine and medical specialties had the highest split tablet prescribing rates. Results: The proportion of prescriptions that included split tablets was 15.6% (n=6,687,35). The proportion of prescriptions that included split tablets was higher for females (56.7%) than for males (43.3%), while that of prescriptions including split tablets versus total prescriptions for each sex was higher for males (16.4%) than for females (14.9%) (p<0.001). In the age group under 19 years, the proportion of prescriptions including split tablets (53.7%) was more than half of the total. The highest tablet splitting rate was found to be 89.9% for formoterol fumarate (40 ㎍), and pseudoephedrine hydrochloride (60 mg) had the highest number of prescriptions. Pediatrics (65.6%) was the medical field with the highest rate of split tablet prescription. Conclusion: Split tablets were most prescribed to pediatric patients. To minimize the use of split tablets, it is necessary to develop lower dose tablets and establish a policy that promotes prescription of these lower-dose tablets.

• The Korea Journal of Herbology
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• v.28 no.2
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• pp.61-65
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• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• Proceedings of the Korean Society of Medical Physics Conference
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• 2004.11a
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• pp.75-77
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• 2004

Stereotactic radiosurgery(SRS) is a technique to deliver a high dose to a particular target region and a low dose to the critical organ using only one or a few irradiations while the patient is fixed with a stereotactic frame. The optimized plan is decided by repetitive work to combine the beam parameters and identify prescribed doses level in a tumor, which is usually called a trial and error method. This requires a great deal of time, effort, and experience. Therefore, we developed the automatic arrangement of multi-isocenter within irregularly shaped tumor. At the arbitrary targets, which is this method based on the voxel unit of the space, well satisfies the dose conformity and dose homogeneity to the targets relative to the RTOG radiosurgery plan guidelines

• The Journal of the Korea Contents Association
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• v.15 no.8
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• pp.416-423
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• 2015

The study was conducted targeting 25 patients who underwent the respiratory gated radiation therapy in the abdominal region at Radiation Oncology of a University Hospital from December 2013 to June 2014 and types of cancer included liver(64%), CBD(8%), gastric(8%), GB(8%), pancreas(8%), SMA(4%). The means of ITV and PTV volume are 471.44 cm3 and 425.48 cm3, showing an increase in volume. Normal tissue volume was also found to have increased due to the increase of the section selected from PTV section to ITV section. Right kidney showed a significant increase in differences between increase in normal tissue volume, increase in target volume and increase in therapy irradiation area and difference between the means of dose applied to normal tissue. There was no significant difference in the mean dose applied to normal tissue according to the respiratory average. Both kidneys showed a significant difference in the difference between mean doses of target moving and normal tissue. In this study, both therapy methods through PTV section and ITV section volume setting were appropriate for protection doses of normal tissue and distributed over 95% of the prescribed dose and therefore, it is considered to be okay to be optionally used depending on the patient's therapeutic purpose. But in order to minimize the unexpected side effect, the plan of PTV section and ITV section should be established and used by evaluating normal tissue protection dose.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.6
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• pp.1034-1041
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• 2010

The oriental medicine Jangwonhwan, which is a boiled extract of 12 medicinal herbs/mushroom, has been prescribed for patients with cognitive dysfunction and it is originally from the Korean medical text, DonguiBogam(amnesia chapter). Recently, a modified recipe of Jangwonhwan (LMK02-Jangwonhwan) consisting of seven medicinal plants/mushroom, was shown to reduce ${\beta}$-amyloid deposition in the brain of Tg-APPswe/PS1dE9 mouse model of Alzheimer disease. The toxicity of LMK02 was investigated in SD rats by oral repeated adminstration for 4 weeks and we tried to determine test does for 13 weeks repeated study. Quality control of tablet form of LMK02 was established by estimating indicative components, Ginsenoside Rg3 of Red Ginseng and Decursin of Angelicagigas Nakai. The toxicity of LMK02 was investigated in 6 weeks old specific pathogen free (SPF) Sprageu-Dawley rats by oral administration. Each test group were consist of 5 male and 5 female and they received doses of 500, 1,000 and 2,000 mg/kg/day of test substance for 4 weeks. The clinical signs, death rate, body weight, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemistry, organ weight and pathological changes were examined and compared with those of control group. Urinalysis : We observed increase of PRO(p<0.01), SG(p<0.01) in female rats of 1,000 mg/kg/day and 2,000 mg/kg/day(p<0.01). Also, we observed increase of pH and KET in female rats of 1,000 mg/kg/day(p<0.05) and of 2,000 mg/kg/day(p<0.01). WBC in female rats in 1,000 mg/kg/day and 2,000 mg/kg/day were on increase. Hematological test : We observed increase of MCV in male rats of 250 mg/kg/day. (p<0.05) Serum biochemistry test : We found increase of CHO in female rats of 2,000 mg/kg/day(p<0.05). During the experimental period, there were no animals dead or moribund. There were no treatment related changes of general symptom, food and water consumption, organ weight and autopsy According to the results of 4-week repeated dose range finding study, the highest dose was established as 1000 mg/kg for 13-week repeated dose toxicity study and we determined to put 2 more groups by common ratio two.

• Radiation Oncology Journal
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• v.38 no.1
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• pp.68-76
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• 2020

Purpose: The present study was conducted to compare dosimetric parameters for the heart and left lung between free breathing (FB) and deep inspiration breath hold (DIBH) and determine the most important potential factors associated with increasing the lung dose for left-sided breast radiotherapy using image analysis with 3D Slicer software. Materials and Methods: Computed tomography-simulation scans in FB and DIBH were obtained from 17 patients with left-sided breast cancer. After contouring, three-dimensional conformal plans were generated for them. The prescribed dose was 50 Gy to the clinical target volume. In addition to the dosimetric parameters, the irradiated volumes and both displacement magnitudes and vectors for the heart and left lung were assessed using 3D Slicer software. Results: The average of the heart mean dose (D_mean) decreased from 5.97 to 3.83 Gy and V₂₅ from 7.60% to 3.29% using DIBH (p < 0.001). Furthermore, the average of D_mean for the left lung was changed from 8.67 to 8.95 Gy (p = 0.389) and V₂₀ from 14.84% to 15.44% (p = 0.387). Both of the absolute and relative irradiated heart volumes decreased from 42.12 to 15.82 mL and 8.16% to 3.17%, respectively (p < 0.001); however, these parameters for the left lung increased from 124.32 to 223.27 mL (p < 0.001) and 13.33% to 13.99% (p = 0.350). In addition, the average of heart and left lung displacement magnitudes were calculated at 7.32 and 20.91 mm, respectively. Conclusion: The DIBH is an effective technique in the reduction of the heart dose for tangentially treated left sided-breast cancer patients, without a detrimental effect on the left lung.

• Radiation Oncology Journal
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• v.28 no.2
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• pp.99-105
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• 2010

Purpose: To compare radiation dose of the brain and lens among various conventional whole brain radiotherapy (WBRT) techniques. Materials and Methods: Treatment plans for WBRT were generated with planning computed tomography scans of 11 patients. A traditional plan with an isocenter located at the field center and a parallel anterior margin at the lateral bony canthus was generated (P1). Blocks were automatically generated with a 1 cm margin on the brain (5 mm for the lens). Subsequently, the isocenter was moved to the lateral bony canthus (P2), and the blocks were replaced into the multileaf collimator (MLC) with a 5 mm leaf width in the craniocaudal direction (P3). For each patient plan, 30 Gy was prescribed at the isocenter of P1. Dose volume histogram (DVH) parameters of the brain and lens were compared by way of a paired t-test. Results: Mean values of $D_{max}$ and $V_{105}$ of the brain in P1 were 111.9% and 23.6%, respectively. In P2 and P3, $D_{max}$ and $V_{105}$ of the brain were significantly reduced to 107.2% and 4.5~4.6%, respectively (p<0.001). The mean value of $D_{mean}$ of the lens was 3.1 Gy in P1 and 2.4~2.9 Gy in P2 and P3 (p<0.001). Conclusion: WBRT treatment plans with an isocenter located at the lateral bony canthus have dosimetric advantages for both the brain and lens without any complex method changes.

• Journal of Life Science
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• v.29 no.6
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• pp.735-739
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• 2019

The dried rhizomes and roots of Gentiana scabra (GS) have been frequently prescribed as a traditional folk medicine in East Asia (including China, Japan, and Korea) for the treatment of various pathophy-siological conditions, such as inflammatory skin diseases, anorexia, indigestion, gastric infections, and diabetes mellitus. In the present study, the effects of aqueous (GS-W) and ethanolic (GS-E) extracts of GS on gastrointestinal (GI) motor function were investigated by measuring the in vivo gastric emptying rate (GER) and the intestinal transit rate (ITR) in mice. The GER was significantly increased by GS-W at a dose of 1 g/kg. The ITR was significantly increased by GS-W (at doses of 0.1 and 1 g/kg) or GS-E (at a dose of 1 g/kg) in a dose-dependent manner. Furthermore, the ITR value of GS-W (at a dose of 1 g/kg) appeared to be higher than that of cisapride, which was the most prominent prokinetic agent in the 1900s but was removed from the market in 2000 due to its fatal side effects. The above results suggest that GS-W might be a potential prokinetic agent to replace cisapride.

• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.985-991
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• 2023

A tissue-equivalent phantom is necessary for quality control of hyperthermia therapy. However, since there is no phantom for this purpose, phantoms made from agar are being used in various studies. The tissue-equivalent properties of the agar phantom were confirmed by comparison with the tissue-equivalent material bolus in this study. CT images of the agar phantom and bolus were acquired, and tissue equivalent characteristics were analyzed with image analysis and dose calculation using a computerized radiation therapy planning system. The average pixel value was 96.960±10.999 in bolus, 108.559±8.233 in 3% agar phantom, and 111.844±8.651 in 4% agar phantom. Using the SSD technique, 100 cGy was prescribed at a depth of 1.5 cm and 6 MV X -ray was set to irradiated to 10x10 cm2, and the absorbed dose according to depth was calculated from the central axis of the beam. The intraclass correlation coefficient of dose distribution of bolus, 3% agar phantom, and 4% agar phantom was 0.979 (p<.001, 95%CI .957-.991). The density (g/cm3) at the point where the absorbed dose was calculated was 0.990±0.020 at the bolus, 1.018±0.020 at the 3% agar phantom, and 1.035±0.024 at the 4% agar phantom. In this study, the internal density distribution and uniformity of the agar phantom were confirmed to be appropriate as a tissue equivalent material by analysis of CT images and a computerized radiation therapy planning system.