• Title/Summary/Keyword: Healthy Volunteers

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Cloning and Characterization of a Bile Salt Hydrolase from Enterococcus faecalis Strain Isolated from Healthy Elderly Volunteers (사람 분변에서 분리한 Enterococcusfaecalis가 생성하는 BileSaltHydrolase의 특징)

  • Eom, Seok-Jin;Kim, Geun-Bae
    • Journal of Dairy Science and Biotechnology
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    • v.29 no.1
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    • pp.49-54
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    • 2011
  • Bile salt hydrolase (BSH, EC 3.5.1.24) activity, which cleaves amide bond between carboxyl group (bile acid) and amino group (glycine or taurine), is commonly detected in gut-associated species of human and animal. During the screening of BSH active strains from the fecal samples of elderly human volunteers, strain CU30-2 was isolated on the basis of the highly active BSH producing activity. A bsh gene of the isolate was cloned into the pET22b expression vector and overexpressed in Escherichia coli BL21 (DE3) Gold by induction with 1mM IPTG. The overexpressed BSH enzyme with 6x His-tag was purified with apparent homogeneity using a $Ni^+$-NTA agarose column and characterized. The BSH enzyme of E. faecalis CU30-2 exhibited approximately 50 times higher activity against glycol-conjugated bile salts than tauro-conjugated bile salts having the highest activity against glycocholic acid. Considering the prevalence of E. faecalis strains in the human GI tract and glycol-conjugates dominated bile acid composition of human bile, further study is needed to investigate the impact of the BSH activity exerted by E. faecalis strains to the host as well as to the BSH producing strains.

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Bioequivalence of Sinil Atenolol Tablets to Tenormin Tablets (Atenolol 50 mg) (테놀민 정(아테놀올 50 mg)에 대한 신일아테놀올 정의 생물학적 동등성)

  • Gwak, Hye-Sun;Kang, Sung-Ha;Chun, In-Koo
    • Journal of Pharmaceutical Investigation
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    • v.33 no.1
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    • pp.51-53
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    • 2003
  • This study was conducted to compare the bioavailability of a generic product of Sinil Atenolol Tablets (Sinil Pharmaceutical Co., Ltd., Korea) with the innovator product, $Tenormin^{\circledR}$ Tablets in 20 healthy Korean volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way crossover design. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs time curves, the following parameters were compared: area under the plasma concentration-time curve (AUC), peak plasma concentration $(C_{max})$, time to reach peak plasma concentration $(T_{max})$, and terminal first order elimination half-life $(t_{1/2})$. No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed AUC and $C_{max}$ values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and $C_{max}$ values of Sinil Atenolol Tablets over those of $Tenormin^{\circledR}$ Tablets were calculated to be between 0.99 and 1.07, and 1.04 and 1.16, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean $t_{1/2}$ values of $Tenormin^{\circledR}$ Tablets and Sinil Atenolol Tablets were 5.9 and 6.0 hour, respectively. Based on these results, it was concluded that Sinil Atenolol Tablets were comparable to $Tenormin^{\circledR}$ Tablets in both the rate and extent of absorption, indicating that Sinil Atenolol Tablets were bioequivalent to the reference product, $Tenormin^{\circledR}$ Tablets

Analysis of Brain Activation due to Mouth Shape during Grip Movement (잡기동작 수행 시 입모양에 따른 뇌활성화 분석)

  • Shim, Je-Myung;Kim, Hwan-Hee;Kim, Chung-Sun
    • Journal of the Korean Society of Physical Medicine
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    • v.5 no.3
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    • pp.467-476
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    • 2010
  • Purpose : This study was performed to understand the relationship between hand and mouth shapes using functional magnetic resonance imaging(fMRI). Methods : Two healthy volunteers without any previous history of physical or neurological illness were recruited. fMRI was done that volunteers was 6 repeated of natural mouth, close mouth and open mouth while power grip and pinch grip movement. Results : Cerebral cortex activation was not well observed for the natural mouth during the power grip exercise. For the closed mouth, the temporal lobe, Broca's area, the prefrontal area related to thinking and judgment, the supplementary motor area, the auditory area and Wernicke's area were activated. For the open mouth, cortical activation was also observed in the temporal lobe, Wernicke's area, the prefrontal area related to thinking and the orbital frontal area related to visual sense. During the pinch grip exercise, cortical activation was observed for the natural mouth in the primary sensory area, Wernicke's area, the primary and supplementary motor area, and the prefrontal area. For the closed mouth, cortical activation was observed in the temporal lobe, Wernicke's area, the prefrontal area related to thinking, the secondary visual area, the primary sensory area and the supplementary motor area. In the case of the open mouth, cortical activation was observed in a few parts in the temporal lobe as well as Wernicke's area, the prefrontal area related to thinking, and other areas related to visual sense such as the primary visual area, the secondary visual area and the visual association area. Conclusion : Brain was more activation for close mouth and open mouth more than natural mouth movement.

Clinical Studies of Sweet Bee Venom to The Effect of Abdominal Fat Accumulation (Sweet BV가 복부비만에 미치는 영향)

  • Lim, Chung-San;Park, Won-Pil;Jang, Seong-Bong;Choi, Young-Chon;Kim, Kwan-Soo;Kwon, Ki-Rok;Lee, Hee-Choon
    • Journal of Pharmacopuncture
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    • v.11 no.2
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    • pp.33-40
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    • 2008
  • Objective The purpose of this study was to investigate the effects of Sweet Bee Venom to the abdominal fat accumulation clinically. Methods The 20 healthy women volunteers who showed the notice of this study by the home page of Sangji University were treated with Sweet Bee Venom(SBV) during twenty times. To investigate the effects of Sweet Bee Venom of the abdominal fat accumulation, abdominal CT, LFT, Thermography, BMI, Inbody 3.0 etc. were performed during clinical trials. And statistical analysis was carried out the data of 10 volunteers who performed all the schedule of this study. Results Following results were obtained from the clinical studies Sweet Bee Venom showed the effect of decreased the body weight, thickness of abdominal skin and fat layer, BMI, and increased abdominal heat, but they are not showed statistical significant. Conclusions These results suggest that treatment Sweet Bee Venom on the abdomen was effective to decrease fat tissue but for the treatment of obesity was performed with right diet program and exercise.

Bioavailability of Tripotassium Dicitrato Bismuthate by ICP-MS in Human Volunteers (ICP-MS를 사용한 구연산비스마스칼륨 (Tripotassium dicitrato bismuthate)의 생체이용률 측정)

  • Kwon, Oh-Seung;Kwon, Jee-Young;Yoon, Ae-Rin;Park, Kyung-Soo
    • Journal of Pharmaceutical Investigation
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    • v.37 no.2
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    • pp.79-84
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    • 2007
  • This study was aimed to establish analytical method of Bi to develop a guideline of the bioequivalence test of tripotassium dicitrato bismuthate (TDB). For this purpose, a simple, specific and sensitive inductively coupled plasma-mass spectrometry (ICP/MS) method were developed and validated in human plasma. Various concentrations of bismuth standard solution (0-25ng/mL) were prepared with distilled water and human blank plasma. To 10mL of the volumetric flasks, 2mL of blank plasma was added with 8ml of distilled water. Bi standard solution was added to prepare the calibration samples and injected into ICP-MS. The plasma samples obtained from volunteers given 3 tablets of bismuth (total 900mg as TDB) were analyzed as described above. As a result, the coefficients of variation were <20% in quantitation limit (0.2 ng/mL) and <15% at the rest of concentrations. The stability test by repeated freezing-thawing cycles showed that the samples were stable only for 24hr. The stability tested for samples with a short-term period of storage at room temperature and pre-treatment prior to the analysis showed very stable over 24hr. In 8 healthy Korean subjects received Denol tablets at the dose of 900mg bismuth, AUC, $C_{max},\;T_{max}$ and half-life $(t_{1/2})$ were determined to be $198.33{\pm}173.78 ng{\cdot}hr/mL,\;64.48{\pm}27.06 ng/mL,\;0.52{\pm}0.21 hr,\;and\;5.15{\pm}2.67 hr$, respectively, from the plasma bismuth concentration-time curves. In conclusion, the method was suitable for the determination of bismuth in human plasma samples and could be applied to bioequivalence test of bismuth tablet.

Effects of Imagery Tennis Training on Cerebral Activity

  • Jung, Seokwon;Choi, Min-sun;Kim, Min-uk;An, Hye-jin;Shin, Min-gyeong;Kwon, Oh-Young
    • Korean Journal of Clinical Laboratory Science
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    • v.47 no.1
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    • pp.46-50
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    • 2015
  • The previous studies showed that the visual imagery activated the occipital and posterior inferior temporal area of the brain, and the damage to the occipital cortex impaired the visual mental imagery. We studied current-source distribution of electroencephalography (EEG) to observe neuronal activity during imagery tennis playing. Eleven healthy volunteers were enrolled. All volunteers were right-handed males and novices for tennis playing. The mean age of them was 24.9 years. The EEGs were recorded on the scalp electrodes located according to the International 10~20 System. The number of electrodes was 25 channels including subtemporal electrodes. The EEG recording session was 13 min including 5 segments: resting-I, scenery-slide show, resting-II, watching tennis-game video, and imagery-tennis playing. The recoding durations were 3, 2, 3, 2, and 3 min respectively. Five 'artifact free 3-sec segments' were selected in each segment of 'imagery-tennis playing' and 'resting-II'. We did the frequency domain analysis with the EEG segments using a distributed model of current-source analysis. The statistical-nonparametric maps (SnPMs) were obtained between the segments of 'imagery-tennis playing' and the segments of 'resting-II' (p<0.01). The significant change of current-source density was observed only in alpha-2 frequency band (10~12 Hz). The current-sourcedensity was increased in the hippocampus, parahippocampus, and occipital fusiform gyrus in the right cerebral hemisphere (p<0.01). Imaginary-tennis playing may activate the hippocampal-occipital alpha networks of nondominant hemisphere.

Pharmacokinetic Evaluation of Flurbiprofen Sustained Release Capsule (플루르비프로펜 서방캅셀의 약물속도론적 평가)

  • Park, Kyoung-Ho;Lee, Min-Hwa;Yang, Min-Yeol;Lee, Chong-Won
    • Journal of Pharmaceutical Investigation
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    • v.23 no.3
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    • pp.179-186
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    • 1993
  • In vitro dissolution test and pharmacokinetic study in human volunteers were conducted to evaluate the pharmacokinetic characteristics of 150 mg furbiprofen sustained-release capsule (FPSR-150). As a reference product, 50 mg flurbiprofen conventional-release capsule (FPCR-50) was used. Dissolution tests of two products were run using the paddle method in 450 : 540 (v/v %) mixture of simulated gastric and intestinal fluids (K.P. VI) by adjusting medium pH according to time. FPCR-50 was dissolved very rapidly, and it took about 1.5 hr for FPCR-50 to be dissolved over 90%, whereas 15 hr for FPSR-150. Also, in pharmacokinetic study, ten healthy male volunteers were administered one capsule of FPSR-150 or two capsules of FPCR-50 (FPCR-l00) with randomized two period cross-over study. Significant differences between FPCR-l00 and FPSR-150 were found in mean times to reach peak concentration, mean resident times and mean terminal phase halflives, while not in AUC/Dose (Student's t-test). In ANOVA for AUC/Dose to compare the bioavailabilities of two FP products, there was no significant difference. From the comparison of the simulated steady-state plasma concentration-time curves following multiple medications of FPCR-50 (3 capsules a day, dosing interval=8 hrs) and FPSR-150 (1 capsule a day) based on the above results obtained from single doses of two FP products, it was noted that the medication of FPSR-150 is more useful in clinical application rather than FPCR-50.

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Comparative Serum Proteomic Analysis of Serum Diagnosis Proteins of Colorectal Cancer Based on Magnetic Bead Separation and MALDI-TOF Mass Spectrometry

  • Deng, Bao-Guo;Yao, Jin-Hua;Liu, Qing-Yin;Feng, Xian-Jun;Liu, Dong;Zhao, Li;Tu, Bin;Yang, Fan
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.10
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    • pp.6069-6075
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    • 2013
  • Background: At present, the diagnosis of colorectal cancer (CRC) requires a colorectal biopsy which is an invasive procedure. We undertook this pilot study to develop an alternative method and potential new biomarkers for diagnosis, and validated a set of well-integrated tools called ClinProt to investigate the serum peptidome in CRC patients. Methods: Fasting blood samples from 67 patients diagnosed with CRC by histological diagnosis, 55 patients diagnosed with colorectal adenoma by biopsy, and 65 healthy volunteers were collected. Division was into a model construction group and an external validation group randomly. The present work focused on serum proteomic analysis of model construction group by ClinProt Kit combined with mass spectrometry. This approach allowed construction of a peptide pattern able to differentiate the studied populations. An external validation group was used to verify the diagnostic capability of the peptidome pattern blindly. An immunoassay method was used to determine serum CEA of CRC and controls. Results: The results showed 59 differential peptide peaks in CRC, colorectal adenoma and health volunteers. A genetic algorithm was used to set up the classification models. Four of the identified peaks at m/z 797, 810, 4078 and 5343 were used to construct peptidome patterns, achieving an accuracy of 100% (> CEA, P<0.05). Furthermore, the peptidome patterns could differentiate the validation group with high accuracy close to 100%. Conclusions: Our results showed that proteomic analysis of serum with MALDI-TOF MS is a fast and reproducible approach, which may provide a novel approach to screening for CRC.

Effects of Oriental Medicine Music Therapy for Mental Stress on Short-term Analysis of Heart Rate Variability (한방음악치료가 정신적 스트레스를 가한 정상 성인의 심박변이도에 미치는 영향)

  • Kim, Jin-Yi;Kim, Soo-Jung;Seo, Joo-Hee;Ryu, Chun-Gil;Yoon, In-Ae;Park, Eun-Young;Sung, Woo-Yong
    • Journal of Oriental Neuropsychiatry
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    • v.22 no.1
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    • pp.1-12
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    • 2011
  • Objectives : This study was conducted to assess effects of oriental medicine music therapy on heart rate variability(HRV) in normal subjects under mental stress. Methods : 34 healthy volunteers(control group:17, experimental group:17) participate in this study. The volunteers were randomly allocated into two groups. After 10-minutes rest period and instrumentation, both groups performed a mental stress test for 12-minutes. HRV was recorded before and after the mental stress. And then the experimental group applied oriental medicine music therapy for 10-minutes. In the control group, they rested for 10-minutes. And HRV was recorded. Results : After giving mental stress stimulation to both groups, LF and LF/HF ratio were significantly increased and HF, mean HRV were decreased. In experimental group, LF, LF/HF ratio were significantly decreased and HF, SDNN were significantly increased after applying oriental medicine music therapy. In control group, LF was significantly decreased. And LF/HF ratio was decreased and HF, SDNN were increased, but it was not significant. Conclusions : This results show that oriental medicine music therapy could be relatively useful to decrease sympathetic activity and prevent the alteration of autonomic nervous system due to mental stress.

Changes of HRV according to Emotional Stimulus in Sasang Constitutional Groups (정서유발 자극에 따른 사상인(四象人)의 심박변이도 변화 연구)

  • Lee, Gyung-Ro;Shin, Dong-Yun;Kim, Young-Won;Yi, Ja-Hyeong;Song, Jung-Mo;Kim, Lak-Hyung
    • Journal of Oriental Neuropsychiatry
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    • v.18 no.2
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    • pp.25-34
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    • 2007
  • Objective : This study was done to investigate the differences of HRV(Heart Rate Variability) change as the response to the emotional stimulus in each Sasang constitutions. Method : We investigated 44 healthy volunteers consisted of 10 Soyangin, 14 Soeumin and 20 Taeumin. After diagnosing the Sasang constitution by specialist of Sasang medicine, we measured the baseline emotional state(100 sec) before the stimulus, the changing emotional state(100 sec) while fearful film was being played. And we rechecked the emotional state(100 sec) while taking a rest. At last, volunteers checked the questionnaire for emotional response. We analysed ECG data with HRV-time domain and frequency domain analysis. Results : (1) There were no significant difference in Mean-RR , SDNN between each groups. (2) LF of Taeumin group significantly increased by the emotional stimulation compared with other groups. (3) There was no significant difference in TP, HF, normalized LF, normalized HF, but the variation of each period in Taeumin group was bigger than those of other groups. (4) Soeumin group reported that they felt significant disgust-emotion in the questionnaire compared with other groups. Conclusion : Taeumin group showed significant emotional changes on HRV by fear stimulus film.

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