• Journal of Pharmaceutical Investigation
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• v.37 no.6
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• pp.397-402
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• 2007

To evaluate the bioequivalence of two venlafaxine formulations, a standard 2-way randomized cross-over study was conducted in twenty-four healthy male Korean volunteers. A single oral dose of 75 mg of test formulation Venfaxine $OR^{(R)}$ (tablet) or reference formulation Efexor $XR^{(R)}$ (capsule) was administered with one-week washout period. Plasma concentrations of venlafaxine were assayed for over a period of 72 hours with a well validated method using liquid chromatography coupled to tandem mass spectrometry (LC-MS-MS). The $mean{\pm}S.D$. of maximum concentration $(C_{max})$ and elimination half-life $(t_{1/2})$ were $64.7{\pm}28.5$ ng/mL, $9.2{\pm}3.0$ h, and $67.2{\pm}30.2$ ng/mL, $9.9{\pm}3.5$ h for test and reference formulations, respectively. Time to reach maximum concentration $(T_{max})$ expressed in median value (range), for the test and the reference, were 10 h (6-14) and 8h (4-12), respectively. Similarly, area under the plasma concentration-time curve, from time zero to last sampling time $(AUC_t)$ and from time zero to time infinity $(AUC_{inf})$, for test and reference formulations were $1185{\pm}755$, $1326{\pm}896$ and $1124{\pm}737$, $1185{\pm}755$ $ng{\cdot}h/mL$, respectively. The parametric 90% confidence intervals on the mean of the differences between the two formulations (test-reference) of the log transformed values of $AUC_t$, and $C_{max}$ were 0.9630 to 1.1383 and 0.8650 to 1.0446, respectively. The overall results indicate that the two formulations are bioequivalent and can be prescribe interchangeably.

• Journal of Pharmaceutical Investigation
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• v.38 no.2
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• pp.135-142
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• 2008

The present study describes the evaluation of the bioequivalence of two atorvastatin tablets, Lipitor $Tablet^{(R)}$ (Pfizer, reference drug) and Atorva $Tablet^{(R)}$ (Yuhan, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Forty-nine healthy male Korean volunteers received each medicine at the atorvastatin dose of 40 mg in a $2{\times}2$ crossover study with a two weeks washout interval. After drug administration, serial blood samples were collected at a specific time interval from 0-48 hours. The plasma atorvastatin concentrations were monitored by an high performance liquid chromatography -tandem mass spectrometer (LC-MS/MS) employing electrospray ionization technique and operating in multiple reaction monitoring (MRM) and positive ion mode. The total chromatographic run time was 4.5 min and calibration curves were linear over the concentration range of 0.1-100 ng/mL for atorvastatin. The method was validated for selectivity, sensitivity, linearity, accuracy and precision. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 48hr) was calculated by the linear log trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were complied trom 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 crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Atorva $Tablet^{(R)}$ / Lipitor $Tablet^{(R)}$ were ${\log}\;0.9413{\sim}{\log}\;1.0179$ and ${\log}\;0.831{\sim}{\log}\;1.0569$, respectively. These values were within the acceptable bioequivalence intervals of ${\log}\;0.8{\sim}{\log}\;1.25$. Based on these statistical considerations, it was concluded that the test drug, Atorva $Tablet^{(R)}$ was bioequivalent to the reference drug, Lipitor $Tablet^{(R)}$.

• Journal of Biosystems Engineering
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• v.34 no.2
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• pp.127-132
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• 2009

In the working population, muscle fatigue and musculoskeletal discomfort are common, which, in the case of insufficient recovery may lead to musculoskeletal pain. Workers suffering from musculoskeletal pains need to be rehabilitated for recovery. Isokinetic testing has been used in physical strengthening, rehabilitation and post-operative orthopedic surgery. Frequency analysis of electromyography (EMG) signals using the mean frequency (MNF) has been widely used to characterize muscle fatigue. During isokinetic contractions, EMG signals present strong nonstationarities. Hilbert-Haung transform (HHT) and autoregressive (AR) model have been known more suitable than Fourier or wavelet transform for nonstationary signals. Moreover, several analyses have been performed within each active phase during isokinetic contractions. Thus, the aims of this study were i) to determine which one was better suitable for the analysis of MNF between HHT and AR model during repetitive maximum isokinetic extensions and ii) to investigate whether the analysis could be repeated for sequential fixed epoch lengths. Seven healthy volunteers (five males and two females) performed isokinetic knee extensions at $60^{\circ}/s$ and $240^{\circ}/s$ until 50% of the maximum peak torque was reached. Surface EMG signals were recorded from the rectus femoris of the right thigh. An algorithm detecting the onset and offset of EMG signals was applied to extract each active phase of the muscle. Following the results, slopes from the least-square error linear regression of MNF values showed that muscle fatigue of all subjects occurred. The AR model is better suited than HHT for estimating MNF from nonstationary EMG signals during isokinetic knee extensions. Moreover, the linear regression can be extracted from MNF values calculated by sequential fixed epoch lengths (p> 0.0I).

• The Korean Journal of Physiology and Pharmacology
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• v.16 no.3
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• pp.175-180
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• 2012

Yoga has been known to have stimulatory or inhibitory effects on the metabolic parameters and to be uncomplicated therapy for obesity. The purpose of the present study was to test the effect of an 8-week of yoga-asana training on body composition, lipid profile, and insulin resistance (IR) in obese adolescent boys. Twenty volunteers with body mass index (BMI) greater than the 95th percentile were randomly assigned to yoga (age $14.7{\pm}0.5$ years, n=10) and control groups (age $14.6{\pm}1.0$ years, n=10). The yoga group performed exercises three times per week at 40~60% of heart-rate reserve (HRR) for 8 weeks. IR was determined with the homeostasis model assessment of insulin resistance (HOMA-IR). After yoga training, body weight, BMI, fat mass (FM), and body fat % (BF %) were significantly decreased, and fat-free mass and basal metabolic rate were significantly increased than baseline values. FM and BF % were significantly improved in the yoga group compared with the control group (p<0.05). Total cholesterol (TC) was significantly decreased in the yoga group (p<0.01). HDL-cholesterol was decreased in both groups (p<0.05). No significant changes were observed between or within groups for triglycerides, LDL-cholesterol, glucose, insulin, and HOMA-IR. Our findings show that an 8-week of yoga training improves body composition and TC levels in obese adolescent boys, suggesting that yoga training may be effective in controlling some metabolic syndrome factors in obese adolescent boys.

• Korean Journal of Oriental Medicine
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• v.15 no.3
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• pp.83-91
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• 2009

$\beta$-glucan is a fiber-type complex sugar (polysaccharide) derived from the cell wall of baker's yeast, oat and barley fiber, and many medicinal mushrooms, such as maitake. The primary uses of $\beta$-glucan are to enhance the immune system, to lower blood cholesterol levels and to treat tumor. $\beta$-glucan has no systemic toxicity in mice, therefore it needed clinical trail to prove efficacy and safety for human. The subjects total 56 healty volunteers were divided into two groups including taken $\beta$-glucan tablet group and placebo group. Subjects were taken two tablets per oral for 4 weeks. They had agreed to take part in this experiment, and didn't take any other clinical trail products. After 4 weeks blood of subjects were checked. The check list are TNF-$\alpha$, INF-$\gamma$, IL-2, IL-4, total WBC, differential WBC, RBC, hemoglobin, platelet, MCV, MCH, MCHC, HCT, Na, K, Ca, Cl, AST, ALT, ALP, $\gamma$-GTP, total protein, triglyceride, total cholesterol, total bilirubin, albumin, uric acid, creatinine, BUN, pH, protein, glucose, ketone body, blood, bilirubin. We evaluated efficacy by cytokines that compare before and after taking. Collected data were analyzed as two sample t-test, chi-square test and ANOVA using SAS V.9.1.This study results are that in TNF-$\alpha$ of $1^{st}$ efficacy measurement item, all of two groups figure were increased significantly compare to before figure. In IL4 of $2^{nd}$ efficacy measurement item, experimental group figure were decreased significantly but placebo group figure were increased. The conclusions show that based on the above results, $\beta$-glucan has favorable effect to enhance immune system, especially IL4 results showed that it has effect to improve the allergic immune system.

• Journal of Korean Ophthalmic Optics Society
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• v.16 no.3
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• pp.255-264
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• 2011

Purpose: To study the effect of hyaluronic acid(HA), which was widely used in artificial tears, multi-purpose solution(MPS), cosmetics, and drug acting on the musculo-skeletal system, in wettability and comfort of contact lens, we compared HA including lens(+HA) with HA excluding lens(-HA) by clinical evaluation. Methods: During four weeks, the selected 28 university student volunteers who did not have any eye disease wore +HA contact lens on their right eyes, and -HA contact lens on their left eyes, and then compared right eyes to left eyes as control. After prescribing by spherical equivalent calculation, over-refraction by auto-refractometer, and contact lens wearing for two weeks and four weeks, tear evaluation, the anterior of eyes examination, fitting convenience evaluation, surface wetting test, surveys were checked up. Results: Compared with the control group (-HA contact lens), +HA contact lens provided better wetting properties. The amount of released tear in -HA contact lens group became less in four weeks than before, but that in +HA contact lens group showed no significant difference from the initial one. In terms of the redness in eye, there was no significant difference between +HA and -HA contact lens groups. Fitting of +HA contact lens on eye was much easier than the control, -HA contact lens. From the results of survey, comfort, wettability, ease of cleaning, and dryness of eye in +HA contact lens group were generally better than those of -HA group, but redness and contact lens handling showed little difference. Conclusions: The addition of HA in soft contact lens(+HA) may enhance the wettability of lens during lens wearing, resulted in the better comfortable wearing of lens eventually.

• Journal of Physiology & Pathology in Korean Medicine
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• v.20 no.5
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• pp.1254-1260
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• 2006

The purpose of this study was to the Pre-Post submaximal exercise for analyze the Blood Lactate, LDH(Lactate Dehydrogenase) and Glucose in the runners. The subjects were 12 volunteers 6 sprinters and 6 distance runners who agreed to intention of this study. Subjects peformed until possible all-out trials. Blood samples were taken from a Ante cubital vein Pre-Post exercise and every rest 5min during the all-out trial. The results obtained were summarized as follow; 1) Blood Lactate of Pre-Post exercise in treadmill test showed no significant difference between sprinters and distance runners, but showed significant in sprinters and distance respectively. 2) Serum LDH of Pre-Post exercise in treadmill test showed no significant difference between sprinters and distance runners, and that showed no significant in sprinters and distance respectively. 3) Blood Glucose of Pre-Post exercise in treadmill test showed no significant difference between sprinters and distance runners, and showed no significant in distance, but showed significant in sprinters. These data indicate first that the value of 4mmol/${\ell}$, commonly referred to as OBLA(Onset of Blood Lactate),may often underestimate the upper limit of tolerance to lactate during a maximal endurance peformance test until all-out. second, our date suggested that the sprinters exercise decreases serum LDH activities and the distance increases serum LDH activities. therefore serum LDH concentration changed following a different exercise. Third. for the concentration of the glucose in blood the sprinters was show to be higher. However it needs more studies to find out the relationship between this result and the fitness factor. therefor, since the runners has an intermittent characteristic which includes a frequent momentary change, it needs the fitness training that being consisted of various training. in the training method, it needs the training process which is from the whole fitness to specific fitness to improve general physical ability.

• Journal of Oriental Neuropsychiatry
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• v.19 no.1
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• pp.107-124
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• 2008

We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t test(in group) and Student t test(between two groups) were used to verify the result. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

• Korean Journal of Acupuncture
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• v.26 no.2
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• pp.15-25
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• 2009

Objective: This paper aimed to understand influences on EEG conducting acupuncture stimulation, by comparing the changes in the acupoints on the body before and after normal people are treated with acupuncture at PC9 and TE3, which are referred to as Wood points(木穴), and PC5 and TE1, which are referred to as the Metal points(金穴) among the five shu points of Yin pericardium Meridian and Yang Triple Energizer Meridian. Methods: The study was performed on 30 healthy female volunteers in their 20's. EEG was measured for 5 minutes before acupuncture stimulation was conducted on PC9, TE3, PC5 and TE1. During 20 minutes of acupuncture treatment, the same items were continuously measured to find out whether there were any changes in them, and they were measured for 5 minutes after removing the acupuncture needles in order to implement a comparative analysis. Results: Comparision of EEG data before and after the treatment at PC9 shows no significant differences in all wave. Compared with the pre-acupuncture period at TE3, $\delta-\theta$ wave decreased significantly (P<0.05) during the acupuncture stimulation periods. Compared with the pre-acupuncture period at PC5, $\delta-\theta$ wave and high $\alpha$ wave increased significantly (P<0.05) during the acupuncture stimulation periods. And Mid $\beta$ wave and high $\beta$ wave decreased significantly (P<0.05) during the acupuncture periods and the post acupuncture periods. Compared with the Pre-acupuncture period at TE1, $\delta-\theta$ wave, $\theta$ wave and high $\alpha$ wave increased significantly (P<0.05) during the acupuncture stimulation periods. And Low $\beta$ wave decreased significantly (P<0.05) during the acupuncture periods. Conclusion: When acupuncture stimulation was performed on PC9 and TE3, referred to as the "Wood points", brain waves were stabled, while when acupuncture was performed on PC5 and TE1, called the "Metal points", a brain was waked. From the findings of this study, we hypothesize that the wood properties, from which growing starts in all things, are related with fast waves of EEG, and the metal properties, which stabilize and converge in all things, are related with slow waves of EEG.

• Journal of Life Science
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• v.17 no.12
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• pp.1744-1753
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• 2007

The purpose of this study was to provide obese middle school girls with walking and behavior modification program(WBMP) by investigating effects of the exercise on their body composition(BC), physical fitness(PF) and metabolic syndrome(MS). Analysis result of the difference between before and after the exercise(paired and independent t-test) was acquired by measuring BC, PF and MS for 12 weeks(60min/day, three a week). 24 Volunteers were 14 years over ${\geq}223.64kg/m^2$ and 15 years over ${\geq}24.00kg/m^2$. In the body composition, waist circumference(WC), body fat mass(BFM), %fat, arm muscle circumference(AMC), total body water(TBW), physical score(PS) were significant difference between the exercise group(EG) and the control group(CG), also including all factors in PF. The components of metabolic syndrome were significant difference between EG and CG, but HDL-C, systolic & diastolic blood pressure were no difference. The metabolic syndrome factors by separate of waist girth were no difference between EG and CG, but BMI, diastolic blood pressure were significant difference. The prevalence of metabolic syndrome was 4 of 24(16.7%) before intervention, but it dropped from 2 to 1 after intervention in WBMP. The components of metabolic syndrome was distributed a big WC>low HDL-C>high TG>hypertension. The changes of AMC, We, PS, BW, 50m run and BFM effect the factors on BMI(35%), WHR(waist-hip ratio, 69%), HDL-C(42%), fasting blood glucose(65%), HOMA-IR index(34%) and systolic blood pressure(39%) respectively. There were significantly increased in breakfast frequency, walking steps, and meal eating period, but decreased in snacks and eating out in exercise group.