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Evaluation of Puretone Threshold Using Periodic Health Examination Data on Noise-exposed Workers in Korea (소음 특수건강진단 자료를 이용한 순음청력검사 평가)

  • Kim, Yang-Ho;Choi, Jung-Keun;Park, Jung-Sun;Moon, Young-Han;Kim, Kyoo-Sang
    • Journal of Preventive Medicine and Public Health
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    • v.32 no.1
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    • pp.30-39
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    • 1999
  • Objectives. This study was carried out to evaluate hearing impairment judgement and to investigate the differences in various diagnostic criteria for noise-induced hearing loss (NIHL) among workers who required for close observation (C). Methods. Out of 731,029 workers who had taken the specific periodic health examination in 1994, we used the audiometric data on 37,999 workers (C) eliminating the employees who had previous otologic problems. Many investigators have being using different criteria for the evaluation of hearing impairment. In this study, we used the criteria of early (1989-1994), current, compensation for NIHL in Korea, 2-, 3-, 4-divided classification and hearing loss at 4,000 Hz and compared the evaluation results. Results. The prevalences of C and workers who had occupational disease $(D_1)$ diagnosed for NIHL were 11.1 % and 0.44 %. There were significant difference in the prevalences of C and $D_1$, depending on different province of Korea. Pure tone averages (PTAs) were not appropriately applied in their evaluation 97% of workers whom we studied on were below the level of mild hearing loss judged by ISO standard. However, there were wide variations in the prevalence rate of mild hearing loss by diagnostic criteria. Thus, there were different judgements in determining the degree of NIHL depending on which diagnostic criteria were utilized. PTAs were found 20.54 (Rt) and 20.74 (Lt) when the method of 3-divided classification was applied for audiometric data. The degree of hearing impairment of the left ear was more severe than that of right ear. The prevalence of normal hearing threshold below 20 dB was 75.4% and the range of difference in both ear was below 10 dB. Right sided hearing threshold levels were 21.08 dB (500 Hz), 18.44 dB (1,000 Hz), 22.09 (2,000 Hz) and 52.36 dB (4,000 Hz). There was typical high frequency loss (C5-dip at 4,000 Hz) above 30 - 40 dB in normal hearing level. The increasing trend in hearing threshold level was gradually decreased by the increase of PTAs. The difference between PTAs and threshold at 4,000 Hz was about 10 dB. Conclusions. We could found that PTAs in the previous examination were not appropriately evaluated. This study revealed that they did not use unique criteria for managing the workers of NIHL. For the prevention of NIHL, it was found that the quality control on diagnosis and comprehensive management program were required, especially for those of hearing loss (C).

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Oestrogenic Activity of Parabens In Vitro Estrogen Assays (에틸, 프로필, 이소프로필, 부틸, 이소부틸 파라벤의 In Vitro 검색시험 연구에서의 내분비독성)

  • Lee Sung-Hoon;Kim Sun-Jung;Park Jung-Ran;Jo Eun-Hye;Ahn Nam-Shik;Park Joon-Suk;Hwang Jae-Woong;Jung Ji-Youn;Lee Yong-Soon;Kang Kyung-Sun
    • Journal of Food Hygiene and Safety
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    • v.21 no.2
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    • pp.100-106
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    • 2006
  • The use of underarm and body care cosmetics with oestrogenic chemical excipients (particularly the parabens) and the hypothesized association with breast cancer incidence, particularly in women. It is noted that the type of cosmetic product is irrelevant (e.g. antiperspirant/deodorant versus body lotion, moisturizers or sprays versus creams) and attention must focus on issues of actual exposure to chemicals through continued dermal application of body care products and the endocrine/hormonal activity and toxicity of the chemicals in the formulations. To evaluate the estrogenic activities of parabens such as ethylparaben, butylparaben, propylparaben, isobutylparaben and isopropylparaben, we used recombinant yeasts containing the human estrogen receptor [Saccharomyces cerevisiae ER+LYS 8127], human breast cancer MCF-7 cell lines and human estrogen receptor ${\alpha}\;and\;{\beta}$. In E-screen assays, isopropylparaben is the most estrogenic paraben, and in ER competition assay, isobutylparaben is the most estrogenic paraben. We evaluated isopropylparaben was most active in the recombinant yeast assay, followed by propylparaben, ethylparaben, isobutylparaben and butylparaben. Results from this study demonstrate that parabens are observed in human endocrine system. Therefore, we have shown that the parabens is induced the estrogenic activities similar to $17{\beta}$-estradiol and Bisphenol-A.

In vitro Antioxidant, Anti-allergic and Anti-inflammatory Effects of Ethanol Extracts from Korean Sweet Potato Leaves and Stalks (한국산 고구마잎과 고구마줄기 에탄올 추출물의 in vitro 항산화, 항알레르기 및 항염증효과)

  • Kwak, Chung Shil;Lee, Kun Jong;Chang, Jin Hee;Park, June Hee;Cho, Ji Hyun;Park, Ji Ho;Kim, Kyung Me;Lee, Mee Sook
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.42 no.3
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    • pp.369-377
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    • 2013
  • In order to increase the utilization of sweet potato leaves and stalks as much as roots, it is necessary to study their beneficial potential. In this study, the antioxidant, antiallergic and anti-inflammatory effects of sweet potato leaves and stalks were evaluated by measuring total polyphenol and flavonoid contents, DPPH radical scavenging effects, the reducing power and inhibition effects on xanthine oxidase (XO), 5-lipoxygenase (LOX), and cyclo-oxygenase (COX)-2 activities. Blanched sweet potato leaves (SL), raw whole purple stalks (ST) and peeled stalks (PST) were freeze-dried and extracted with 95% ethanol. Total polyphenol content was highest in SL (11.03 mg/g), followed by ST (0.87 mg/g), and PST (0.37 mg/g). Total flavonoid content was highest for SL (9.01 mg/g), followed by ST (0.50 mg/g) and PST (0.25 mg/g). The $IC_{50}$ for DPPH radical scavenging effects was highest for SL ($43.6{\mu}g/mL$), followed by ST ($308.4{\mu}g/mL$) and PST ($1,631.3{\mu}g/mL$). The reducing power was highest for SL ($59.72{\mu}g$ ascorbic acid eq./mL), followed by ST ($12.56{\mu}g$ ascorbic acid eq./mL) and PST ($2.18{\mu}g$ ascorbic acid eq./mL) with $1,000{\mu}g/mL$ of ethanol extract. The inhibition rate on XO activity was highest for SL (13.06%), followed by ST (5.05%) and PST (0.0%) at $250{\mu}g/mL$ extract treatment. The inhibition rate on COX-2 activity was highest for SL (55.34%), followed by ST (2.18%) and PST (0.0%) at $250{\mu}g/mL$ extract treatment. The inhibition rate on 5-LOX activity was highest for SL (91.16%), followed by ST (33.38%) and PST (14.93%) at $50{\mu}g/mL$ treatment. Taken together, sweet potato leaves showed high antioxidative, anti-allergic and anti-inflammatory activities, especially with very strong inhibition effects on 5-LOX activity. These beneficial effects of sweet potato leaves might be mainly caused by the high content of polyphenols and flavonoids.

The Comparison of Quantitative Indices by Changing an Angle of LAO View in Multi-Gated Cardiac Blood Pool Scan (게이트 심장 혈액풀 스캔에서 좌전사위상 각도의 변화에 따른 정량적 지표 비교)

  • Yoon, Soon-Sang;Nam, Ki-Pyo;Ryu, Jae-Kwang;Kim, Seong-Hwan
    • The Korean Journal of Nuclear Medicine Technology
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    • v.16 no.1
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    • pp.57-61
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    • 2012
  • Purpose: The multi-gated cardiac blood pool scan is to evaluate the function of left ventricle (LV) and usefully observe a value of ejection fraction (EF) for a patient who is receiving chemotherapy. To calculate LVEF, we should adjust an angle of left anterior oblique (LAO) view to separate both ventricles. And by overlapped ventricles, it is possible to affect LVEF. The purpose of this study is to investigate and compare quantitative indices by changing an angle of LAO view. Materials and methods: We analyzed the 49 patients who were examined by multi-gated cardiac blood pool scan in department of nuclear medicine at Asan Medical Center from June to September 2011. Firstly, we acquired "Best septal" view. And then, we got images by addition and subtraction of angle for LAO view to anterior and lateral. We compared three LAO views for 20 people by 5 degrees and 39 people by 10 degrees. And we analyzed quantitative indices, EF, end diastole and end systole counts, by automated and manual region of interest (ROI) modes. Results: Firstly, we analyzed quantitative indices by automated ROI mode. In case of 5 degrees, the averages of EF are $61.0{\pm}7.5$, $62.1{\pm}7.1$, $60.9{\pm}6.7%$ ($p$=0.841) in LAO, LAO $-5^{\circ}$ and LAO $+5^{\circ}$ respectively. And there is no difference in end diastole and end systole counts ($p$<0.05). In case of 10 degrees, the averages of EF are $62.4{\pm}9.5$, $62.3{\pm}10.8$, $61.6{\pm}.9.3%$ ($p$=0.938) in LAO, LAO $-10^{\circ}$ and LAO $+10^{\circ}$ respectively. And there is no difference in end diastole and end systole counts ($p$<0.05). Secondly, we analyzed quantitative indices by manual ROI mode. In case of 5 degrees, the averages of EF are $62.8{\pm}7.1$, $63.6{\pm}7.5$, $62.7{\pm}7.3%$ ($p$=0.903) in LAO, LAO $-5^{\circ}$ and LAO $+5^{\circ}$ respectively. And there is no difference in end diastole and end systole counts ($p$<0.05). In case of 10 degrees, the averages of EF are $65.5{\pm}9.0$, $66.3{\pm}8.7$, $63.5{\pm}.9.3%$ (p=0.473) in LAO, LAO $-10^{\circ}$ and LAO $+10^{\circ}$ respectively. And there is no difference in end diastole and end systole counts ($p$<0.05). Conclusion: When an image is nearly "Best septal" view, the difference of LAO angle would not affect to change LVEF. Although there was no difference in quantitative analysis, deviations could happen when to interpret wall motion qualitatively by reading physicians.

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The Changes of Brain Injury Markers(S100-$\beta$, Neuron-Specific enolase) After Retrograde Cerebral Perfusion Under Total Circulatory Arrest in Pigs (돼지에서 역행성 뇌관류 시행 후 혈청 및 소변의 뇌손상 관련지표(S100-$\beta$, Neuron-specific enolase)의 변화)

  • 김상윤;김만호;김경환
    • Journal of Chest Surgery
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    • v.35 no.12
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    • pp.847-853
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    • 2002
  • We previously published the data that proved the safety of retrograde cerebral perfusion for 120 minutes. At this time, we planned to check the neuron-specific enolase and S100-$\beta$ in serum and urine to assess the possibility of early detection of cerebral injury. Material and Method: We used pigs(Landrace species) weighing 35 kg and performed RCP for 120 minutes. After the weaning of cardiopulmonary bypass, we observed the pigs for another 120 minutes. Systemic arterial pressure, central venous pressure, and serum and urine levels of neuron-specific enolose (NSE) and S100$\beta$ protein were checked. Central venous pressure during RCP was maintained in the range of 20 to 25 mmHg. Result: Serum levels of NSE(ng/$m\ell$) were 0.67$\pm$0.18(induction of anesthesia), 0.53$\pm$0.47(soon after CPB), 0.44$\pm$0.27(20min alter CPB), 0.24$\pm$0.09(RCP 20min), 0.37$\pm$0.35(RCP 40min), 0.33$\pm$0.21 (RCP 60min), 0.37$\pm$0.22(RCP 80min), 0.41$\pm$0.23(RCP 100 min), 0.48$\pm$0.26(RCP 120min), 0.42$\pm$0.29(30min after rewarming), 0.35 $\pm$0.32(60min after rewarming, 0.42$\pm$0.37(CPBoff 30min), 0.47$\pm$0.34(CPBOff 60min), 0.47$\pm$0.28(CPBOff 90min), and 0.57$\pm$0.29(CPBOff 120min). There was no statistically significant difference in levels between before and after RCP(ANOVA, p>0.05). Urine levels of NSE also showed no statistically significant difference in levels between before and after RCP. There was no correlation between urine and serum levels of NSE(Pearson correlation, p>0.05). Serum levels of S100$\beta$ protein(ng/$m\ell$) during the same time frames were 0.14$\pm$0.08, 0.15$\pm$0.07, 0.22$\pm$0.15, 0.23$\pm$0.07, 0.28$\pm$0.10, 0.40$\pm$0.05, 0.47$\pm$0.03, 0.49$\pm$0.12, 0.43$\pm$0.11, 0.46$\pm$0.15, 0.62$\pm$0.17, 0.77$\pm$0.21, 0.78$\pm$0.23, 0.77$\pm$0.23, and 0.82$\pm$0.33. There was statistically significant difference in levels between before and after RCP(ANOVA, p<0.05). Urine levels of NSE also showed statistically significant difference in levels between before and after RCP(ANOVA, p<0.05). There was significant correlation between urine and serum levels of NSE(Pearson correlation, p<0.05). Conclusion: The author observed the increase in serum and urine levels of S100$\beta$ after 120 minutes of RCP. Significant correlation between serum and urine levels was observed. The results were considered to be the fundamental data that could correlate this study with human-based study.

Influence of Age on The Adenosine Deaminase Activity in Patients with Exudative Pleural Effusion (연령의 증가가 삼출성 흉수 Adenosine Deaminase 활성도에 미치는 영향)

  • Yeon, Kyu-Min;Kim, Chong-Ju;Kim, Jeong-Soo;Kim, Chi-Hoon
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.5
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    • pp.530-541
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    • 2002
  • Background : Pleural fluid adenosine deaminase (ADA) activity can be helpful in a differntial diagnosis of an exudative pleural effusion because it is increased in a tuberculous pleural effusion. The ADA activity is determined mainly by the lymphocyte function. Age-associated immune decline is characterized by a decrease in T-lymphocyte function. For that reason, the pleural fluid ADA level would be lower in older patients with exudative pleural effusion. This study focused on the influence of age on the pleural fluid ADA activity in patients with exudative pleural effusion. Methods : A total of 81 patients with exudative pleural effusion were enrolled in this study. In all patients, the pleural fluid ADA activity was measured using an automated kinetic method. Results : The mean age of the patients was $52.7{\pm}21.2$ years. In all patients with exudative pleural effusion, the pleural fluid ADA activity revealed a significant difference between young patients (under 65 years of age) and old patients (p<0.05), and showed a negative correlation with age (r=-0.325, p<0.05). In the 60 patients with a tuberculous pleural effusion, the pleural fluid ADA activity revealed a significant difference between the young and older patients : $103.5{\pm}36.9$ IU/L in young patients Vs. $72.2{\pm}31.6$ IU/L in old patients (p<0.05), and showed a negative correlation with age (r=-0.384, p<0.05). In the 21 patients with non-tuberculous exudative pleural effusion, the pleural fluid ADA activity of the young patients and old patients was similar : $23.7{\pm}15.3$ IU/L in young patients Vs. $16.1{\pm}10.2$ IU/L in old patients (p>0.05), and did not show any correlation with age (r=-0.263, p>0.05). The diagnostic cutoff value of pleural fluid ADA activity for tuberculous pleural effusion was lower in the older patients (25.9 IU/L) than in the younger patients (49.1 IU/L) or all patients (38.4 IU/L) with exudative pleural effusion. Conclusion : Tuberculous pleural effusion is an important possibility to consider in older patients with a clinical suspicion of a tuberculous pleural effusion, although no marked increase in the pleural fluid ADA activity is usually detected. For a diagnosis of a tuberculous pleural effusion in old patients, the cutoff for the pleural fluid ADA activity should be set lower.

Effect of Repetitive Transcranial Magnetic Stimulation in Drug Resistant Depressed Patients (치료 저항성 우울증 환자에서 반복적 경두개 자기자극후 국소뇌혈류 변화)

  • Chung, Yong-An;Yoo, Ie-Ryung;Kang, Bong-Joo;Chae, Jeong-Ho;Lee, Hye-Won;Moon, Hyun-Jin;Kim, Sung-Hoon;Sohn, Hyung-Sun;Chung, Soo-Kyo
    • Nuclear Medicine and Molecular Imaging
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    • v.41 no.1
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    • pp.9-15
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    • 2007
  • Purpose: Repetitive transcranial magnetic stimulation (rTMS) has recently been clinically applied in the treatment of drug resistant depressed patients. There are mixed findings about the efficacy of rTMS on depression. Furthermore, the influence of rTMS on the physiology of the brain is not clear. We prospectively evaluated changes of regional cerebral blood flow (rCBF) between pre- and post-rTMS treatment in patients with drug resistant depression. Materials and Methods: Twelve patients with drug-resistant depression (7 male, 5 female; age range: $19{\sim}52$ years; mean age: $29.3{\pm}9.3$ years) were given rTMS on right prefrontal lobe with low frequency (1 Hz) and on left prefrontal lobe with high frequency (20 Hz), with 20-minute-duration each day for 3 weeks. Tc-99m ECD brain perfusion SPECT was obtained before and after rTMS treatment. The changes of cerebral perfusion were analyzed using statistical parametric mapping (SPM; t=3.14, uncorrected p<0.01, voxel=100). Results: Following areas showed significant increase in rCBF after 3 weeks rTMS treatment: the cingulate gyrus, fusiform gyrus of right temporal lobe, precuneus, and left lateral globus pallidus. Significant decrement was noted in: the precental and middle frontal gyrus of right frontal lobe, and fusiform gyrus of left occipital lobe. Conclusion: Low-frequency rTMS on the right prefrontal cortex and high-frequency rTMS on the left prefrontal cortex for 3 weeks as an add-on regimen have increased and decreased rCBF in the specific brain regions in drug-resistant depressed patients. Further analyses correlating clinical characteristics and treatment paradigm with functional imaging data may be helpful in clarifying the pathophysiology of drug-resistant depressed patients.

Antioxidative Activity, Component Analysis, and Anti-elastase Effect of Aspalathus linearis Extract (루이보스 추출물의 항산화 활성, 성분 분석 및 엘라스테이즈 저해 효과)

  • Park, Soo-Nam;Yang, Hee-Jung;Won, Bo-Ryoung;Lim, Young-Jin;Yoon, Sun-Kyeong;Ji, Dong-Hwan;Choi, Jee-Yeon;Han, Seung-Joo;Lee, Chung-Woo
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.33 no.4
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    • pp.251-262
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    • 2007
  • In this study, the antioxidative effects, inhibitory effects on elastase, and components of Aspalathus linearis extracts were investigated. The free radical (1,1-diphenyl-2-picrylhydrazyl, DPPH) scavenging activities ($FSC_{50}$) of extract/fractions of Aspalathus linearis were in the order: 50 % ethanol extract ($11.50\;{\mu}g/mL$) < deglycosylated flavonoid aglycone fraction ($8.47\;{\mu}g/mL$) < ethylacetate fraction ($4.76\;{\mu}g/mL$). Reactive oxygen species (ROS) scavenging activities ($OSC_{50}$) of some Aspalathus linearis extracts on ROS generated in $Fe^{3+}-EDTA/H_2O_2$ system were investigated using the luminol-dependent chemiluminescence assay. The order of ROS scavenging activities were ethylacetate fraction ($OSC_{50},\;4.58\;{\mu}g/mL$) < deglycosylated flavonoid aglycone fraction ($2.20\;{\mu}g/mL$) < 50 % ethanol extract ($1.09\;{\mu}g/mL$). 50 % Ethanol extract showed the most prominent scavenging activity. The protective effects of extract/fractions of Aspalathus linearis on the rose-bengal sensitized photohemolysis of human erythrocytes were investigated. The Aspalathus linearis extracts suppressed photohemolysis in a concentration dependent manner, particularly 50 % ethanol extract exhibited the most prominent celluar protective effect (${\tau}_{50}$, 272.00 min at $50\;{\mu}g/mL$). Aglycone fractions obtained from the deglycosylation reaction of ethylacetate fraction among the Aspalathus linearis extracts, showed 3 bands in TLC and 3 peaks in HPLC experiments (360 nm). Three components were identified as luteolin (composition ratio, 18.24 %), quercetin (58.79), and kaempferol (22.97). TLC chromatogram of ethylacetate fraction of Aspalathus linearis extract revealed 7 bands and HPLC chromatogram showed 9 peaks, which were identified as isoorientin (composition ratio, 14.71 %), orientin (28.84 %), vitexin (5.63 %), rutin and isovitexin (12.73 %), hyperoside (9.24 %), isoquercitrin (5.40 %), luteolin (1.48 %), quercetin (17.61 %) and kaempferol (4.59 %) in the order of elution time. The inhibitory effect of aglycone fraction on elastase ($IC_{50},\;9.08\;{\mu}g/mL$) was very high. These results indicate that extract/fractions of Aspalathus linearis can function as antioxidants in biological systems, particularly skin exposed to UV radiation by scavenging $^1O_2$ and other ROS, and protect cellular membranes against ROS. And component analysis of Aspalathus linearis extract and inhibitory activity on elastase of the aglycone fraction could be applicable to new functional cosmetics for smoothing wrinkles.

An Analysis of the Specialist's Preference for the Model of Park-Based Mixed-Use Districts in Securing Urban Parks and Green Spaces Via Private Development (민간개발 주도형 도시공원.녹지 확보를 위한 공원복합용도지구 모형에 대한 전문가 선호도 분석)

  • Lee, Jeung-Eun;Cho, Se-Hwan
    • Journal of the Korean Institute of Landscape Architecture
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    • v.39 no.6
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    • pp.1-11
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    • 2011
  • The research was aimed to verify the feasibility of the model of Park-Based Mixed-Use Districts(PBMUD) around urban large park to secure private-based urban parks through the revision of the urban zoning system. The PBMUD is a type of urban zoning district in which park-oriented land use is mixed with the urban land uses of residents, advertising, business, culture, education and research. The PBMUD, delineated from and based on a new paradigm of landscape urbanism, is a new urban strategy to secure urban parks and to cultivate urban regeneration around parks and green spaces to enhance the quality of the urban landscape and to ameliorate urban environmental disasters like climate change. This study performed a questionnaire survey and analysis after a review of literature related to PBMUD. The study looked for specialists in the fields of urban planning and landscape architecture such as officials, researchers and engineers to respond to the questionnaire, which asked about degree of preference. The conclusions of this study were as follows. Firstly, specialists prefer the PBMUD at 79.3% for to 20.7% against ratio, indicating the feasibility of the model of PBMUD. The second, the most preferable reasons for the model, were the possibility of securing park space around urban parks and green spaces that assures access to park and communication with each area. The third, the main reason for non-preference for the model, was a lack of understanding of PBMUD added to the problems of unprofitable laws and regulations related to urban planning and development. These proposed a revision of the related laws and regulations such as the laws for planning and use of national land, laws for architecture etc. The fourth, the most preferred type of PBMUD, was cultural use mixed with park use in every kind of mix of land use. The degree of preference was lower in the order of use of commercial, residential, business, and education(research) when mixed with park use. The number of mixed-use amenities with in the park was found to be an indicator determining preference. The greater the number, the lower was preference frequencies, especially when related to research and business use. The fifth, the preference frequencies of the more than 70% among the respondents to the mixed-use ratio between park use and the others, was in a ratio of 60% park use and 40% other urban use. These research results will help to launch new future research subjects on the revision of zoning regulations in the laws for the planning and uses of national land and architectural law as well as criteria and indicators of subdivision planning as related to a PBMUD model.

Development and Research into Functional Foods from Hydrolyzed Whey Protein Powder with Sialic Acid as Its Index Component - I. Repeated 90-day Oral Administration Toxicity Test using Rats Administered Hydrolyzed Whey Protein Powder containing Normal Concentration of Sialic Acid (7%) with Enzyme Separation Method - (Sialic Acid를 지표성분으로 하는 유청가수분해단백분말의 기능성식품 개발연구 - I. 효소분리로 7% Siailc Acid가 표준적으로 함유된 유청가수분해단백분말(7%)의 랫드를 이용한 90일 반복경구투여 독성시험 평가 연구 -)

  • Noh, Hye-Ji;Cho, Hyang-Hyun;Kim, Hee-Kyong
    • Journal of Dairy Science and Biotechnology
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    • v.34 no.2
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    • pp.99-116
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    • 2016
  • We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.