• 대한한의학회지
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• 제36권4호
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• pp.35-41
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• 2015

Objectives: This study aimed to provide basic information for the trend of individual-authorization on functional food materials in Korea to side of Korean medicine. Methods: Approval of materials for individual-authorized functional food in Korea was analyzed from 2004 to August 2015 using database from Ministry of Food and Drug Safety (MFDS), regarding the kinds of function, materials and their functional level by year. Results: Korean functional food market has rapidly grown to 1.56 trillion Won in 2014, with about 10% of annual growth rate. In particular, the increase of individual-authorized functional food is worth of notices, in detail 313 kinds of functional materials covering 31 body functions have been approved by August 2015. 15.7% of individual-authorized functional foods have used the herbal materials. This quantitative and qualitative expansion of functional foods, especially of individual-authorized functional foods, will affect the herbal drug industry negatively. Conclusion: This study figured out the current pattern of material approval for individual-authorized functional food in Korea, which would be essential in development of strategies by Korean medicine community in order to overcome such conditions.

• 한국유기농업학회지
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• 제23권1호
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• pp.1-18
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• 2015

The purpose of this study is to examine the tendency of certified organic cosmetics market and the certification standards and regulations they are under, compare one of the most commonly used COSMOS-standard AISBL with the Korea Ministry of Food and Drug Safety (MFDS) organic cosmetic standard regulation. And then examining their differences and any potential issues is to present suggestions to be made as data for certification standard for natural & organic cosmetics in Korea regulation. This contents of study will be used as good research and development to promote the sustainable growth of the natural & organic cosmetic ingredients which have been grown by organic farmers certified. Also certified organic ingredients may help to growth the organic industry. I believe these are actual comparative for application to develop of natural and organic cosmetics in Korea as well the strengthening of the competitiveness of organic cosmetics certified in the world.

• 대한안전경영과학회지
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• 제8권2호
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• pp.71-80
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• 2006

There are many display panels in the flight cockpit and pilots get various flight information from those displays. The ergonomic layout of the displays must be determined based upon frequency of use and sequence of use. This study investigated the visual search patterns of the six display groups(one head-up-display: HUD, two multi function displays: MFDs, one engine group: EG, one flight display group: FD and others) in a fighting aircraft. Four expert pilots conducted Imaginary flight in the physical mock-up and the eye movements were collected using eye tracking system. Data of dwell time, frequency of use, and eye movement path were collected. Pilots spent most of time on HUD(55.2%), and others (21.6%), FD(14.2%), right MFD(4.7%), EG(3.2%), and left MFD(1.1%) in descending order. Similarly HUD(42.8%) and others(30.0%) were the most frequently visited displays. These data can be used in the layout of cockpit displays and the determination of optimal visual search pattern.

• 항공우주시스템공학회지
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• 제15권2호
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• pp.45-51
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• 2021

In this study, we aim to eliminate the flickering phenomenon in multi-function display (MFD) units during the flight of fixed-wing aircraft. To execute flight missions effectively, the video signals transmitted to MFDs must provide information accurately and seamlessly. Therefore, a method for addressing the flickering phenomenon-including cause analysis and failure diagnosis-is adopted; specifically, a wiring configuration with a direct connection between the video signal cables and with a short cable length is adopted. The proposed method is experimentally verified using a flight test.

• 한국환경보건학회지
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• 제43권4호
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• pp.257-266
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• 2017

Objectives: The hazardous metals content of medicinal herbs distributed in the Daegu area was investigated, and the place of origin and the content of herbicides and medicinal components were studied. Methods: An analysis of hazardous metals content (10 types) was carried out on 164 samples of 99 types of herbal medicines. Among the total samples, 45 were domestic and 119 were imported. Hg was analyzed by the amalgamation method. Other hazardous metals content (nine types) was digested using the microwave method and measured by inductively coupled plasma optical emission spectrometry (ICP-OES). Results: The mean values of the hazardous metals content in the herbal medicines were Pb 1.0833 mg/kg, As 0.0136 mg/kg, Cd 0.0840 mg/kg, Cr 3.7120 mg/kg, Cu 4.2666 mg/kg, Mn 40.080 mg/kg, Ni 1.4330 mg/kg, Sb 0.1053 mg/kg, Al 202.64 mg/kg and Hg 0.0062 mg/kg. Three of the samples violated the Ministry of Food and Drug Safety (MFDS) regulatory guidance on cadmium (less than 0.3 mg/kg). The measured values of heavy metals (Pb, As, Cd, Hg) showed levels below the recommended levels for herbal medicines in MFDS regulatory guidance. In the comparison of domestic samples with imported herbal medicines, it was found that one domestic and two imported samples surpassed the maximum residue limits for cadmium. The median values of the hazardous metals detected in the three medicinal parts of the root, leaf (branch), and flower (seed and fruit) were as follows. Cr, Ni, Sb and Al were highly detected in roots, Pb, Cd, Mn, Hg in leafs (branch), and As, Cu in flowers (seed and fruit). Conclusion: There were various kinds of hazardous metals which were detected at high levels according to the place of origin of the medicinal herb and the parts the plant. For hazardous metals for which no acceptance criteria have been established, safety standards should be further studied and managed to ensure the safety of herbal medicines.

• 대한방사선기술학회지:방사선기술과학
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• 제39권2호
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• pp.263-271
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• 2016

최근 인구 고령화에 따른 골다공증 환자의 증가 및 의료기기 시장의 성장으로 인해 엑스선골밀도측정기 시장이 커지고 있으며, 이에 따른 의료기기 허가 심사건수가 증가하고 있다. 의료기기 기술문서는 의료기기의 허가 심사 시 가장 기본이 되는 문서로 필수 제출 첨부자료 중 하나이다. 기술문서는 의료기기 관련 법령 및 고시에 그 근거를 두고 있으며, 의료기기 전반적인 항목을 기술해야하는 만큼 작성자의 전문성이 필요한 항목이다. 하지만 최근 부정확한 작성의 증가로 인한 심사자들의 업무부담이 증가되고 있어 민원 처리 효율이 저하되고 있다. 특히 엑스선골밀도측정기의 경우 식품의약품안전처 기준규격이 없어, 의료기기 제조/수입업체 등에서 시험항목을 설정하는 데 많은 어려움을 겪고 있다. 따라서 본 연구에서는 개선된 제도가 반영된, 엑스선골밀도측정기 기술문서 작성 가이드라인 개발을 위해 첫째, 개선된 제도 운영에 대한 조사, 품목별 의료기기의 제도 적용에 따른 문서 작성 방법 검토, 기 허가된 품목에 대한 허가 및 기술문서 검토를 완료하였다. 둘째, 품목별 시장현황 조사, 적용 가능한 국내 외 규격을 조사 분석하여 품목별 국제조화된 안전성 및 성능평가 시험기준 및 방법을 도출하였다. 마지막으로, 산 연 관 전문가협의체 논의를 거쳐 기술문서 작성 가이드라인(안)을 최종 도출하였다.

• 한국환경보건학회지
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• 제41권3호
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• pp.203-215
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• 2015

Objectives: This study was designed to evaluate the filtration efficiencies and pressure drops of five commercial cloth masks (4 plate type, 1 cup type) in comparison to the performance of a class 1 disposable respirator (reference respirator). A further objective was to evaluate the effects of the number of layers and wash treatment independently on filtration efficiencies and pressure drops. Methods: Polydisperse NaCl aerosols were generated in an aerosol chamber and their concentrations were measured by an optical particle counter (OPC) in the size range of $0.3{\sim}10{\mu}m$ (five channels). Results: The filtration efficiencies of the five cloth masks and the reference respirator were D: 9.5%, C: 18.5%, E: 23.6%, A: 28.5%, B: 29.7% and R: 91.1%, respectively, and the pressure drops through them were C, D: 0.8 Pa, E: 1.7 Pa, B: 6.4 Pa, A: 42.7 Pa and R: 19.3 Pa, respectively. The filtration efficiencies of the cloth masks and reference respirator were below the class 1 respirator criterion (${\geq}94.0%$) of the Ministry of Employment and Labor (MOEL) and Ministry of Food and Drug Safety (MFDS). The pressure drops satisfied the class 1 respirator criterion (${\leq}70Pa$) of MOEL and MFDS. When the cloth masks were folded into two and four layers, the filtration efficiencies of cloth masks A, B, C, D (plate type) increased 1.7-4.6 times, and 2.3-6.8 times, respectively, compared to the efficiencies of the same products in a single layer. Pressure drops increased as the number of layers was increased. The filtration efficiency of cloth mask E with a liner was 1.3 times higher than that of the same mask without a liner, and the pressure drop was lower in the no-liner configuration. After a single washing, the filtration efficiencies of all the cloth mask products decreased 1.04-4.0 times compared to those of the same products intact. For the cloth masks C and E, their filtration efficiencies were significantly decreased after washing (p<0.05). The pressure drops of all cloth masks were 1.2-2.0 times lower after washing. Conclusions: The filtration efficiencies of the five cloth masks were below 30% and did not improve greatly by increasing the number of layers. After a single washing, their performances decreased. Considering the above and other issues identified with cloth masks, such as poor fit and stretched fibers through use, people should not expect protection against particulate matters from the cloth masks on the market.

• 한국식품영양과학회지
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• 제43권2호
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• pp.293-299
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• 2014

글루코사민의 관절건강 기능성을 건강기능식품 재평가 기준에 맞추어 체계적 고찰을 실시하였다. 2012년 5월 기준 DB 검색을 통해 703건의 자료를 수집하여, 선정/제외 기준에 따라 선별한 결과 총 34건의 연구가 평가되었다. 34건 중 28건(4,225명)의 연구에서 통계적으로 유의한 개선 효과가 나타났으며(P<0.05), 일일 섭취량은 1.5~2 g으로 공전에서 제시되어 있는 섭취량 범위에 해당하였다. 글루코사민의 기능성 재평가 이후의 연구 결과는 16건이었고, 이 중 1,158명 대상 14건의 연구에서 유의한 관절건강 개선효과를 보였다(P<0.05). 연구대상자에 따른 분석 결과, 방사선 검사 기준에 따라 관절 연골의 손상 정도가 심한 대상자를 제외한 연구는 11건이었으며, 이 중 2,934명 대상 10건의 연구에서 글루코사민이 관절건강에 유의한 개선 효과를 보였다(P<0.05). 따라서 현시점에서 건강기능식품인 글루코사민의 관절건강 기능성은 인정될 것으로 판단되나 향후 연구 결과 추이를 지속적으로 지켜볼 필요가 있다.

• 한국식품위생안전성학회지
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• 제33권3호
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• pp.207-213
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• 2018

본 연구는 까마귀쪽나무열매추출물(LJF-HE)의 유전독성을 평가하고자 하였다. 유전독성연구는 OECD와 MFDS(Korea Ministry of Food and Drug Safety) 지침에 따라 복귀돌연변이시험, 염색체이상시험, 마우스 골수세포를 이용한 소핵시험을 실시하였다. 세균을 이용한 복귀돌연변이시험은 까마귀쪽나무열매추출물(LJF-HE) 처리군에서 S9 mix 존재유무에 상관없이 복귀돌연변이 콜로니 수는 음성 대조군과 비교하였을 때 증가 양상을 나타내지 않은 반면에 양성 대조물질에서 유발된 복귀돌연변이 콜로니 수는 대사활성계 미적용(S9-) 및 적용(S9+)의 모든 시험 균주에 대하여 음성(용매)대조 값의 2배를 넘어 증가한 것으로 나타났다. 염색체 이상 시험에서 까마귀쪽나무열매추출물(LJF-HE) 처리군에서 모든 세포주의 처리시간 및 S9 mix 존재유무에 상관없이 5%미만의 비정상적인 염색체이상을 나타내었으나, 음성대조군에 비해 유의적인 변화는 없었다. 소핵시험은 까마귀쪽나무열매추출물(LJF-HE) 처리군에서 음성 대조군과 비교하여 소핵을 가진 다염성 적혈구의 증가는 볼 수 없었으며 통계학적인 유의성도 나타나지 않았다. 상기의 결과를 종합하면 까마귀쪽나무열매추출물(LJF-HE)은 유전독성을 유발하지 않는 것으로 판단되어진다.

• KSBB Journal
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• 제29권1호
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• pp.58-66
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• 2014

Demand for in vitro pharmacological evaluation and toxicity test using human hepatocytes has been increasing. In USA and Europe, human hepatocytes obtained from donated whole liver unsuitable for transplantation were distributed to researchers and deposited in cell bank facility as cryopreserved vial. In Korea, however, incidence of transplantation- inappropriate whole liver has been quite low and the whole livers almost have so severe liver disease such as fatty or fibrotic liver that cannot meet the demand. In this study we aimed to isolate human hepatocytes from liver resection surgery-originated partial liver, and assure the isolated human hepatocytes and its cryopreserved hepatocytes to be qualified for the in vitro pharmacological evaluation and drug toxicity tests. We compared those with commercially available human hepatocyte, BD $GenTest^{TM}$ by cell morphology, hepatic gene expression, urea synthesis, albumin secretion, ammonia removal, and cytochrome P450 induction activities. Changes in hepatotoxic gene expression after cryopreservation are evaluated with a typical hepatotoxic drug, acetaminophen. Consequently, the fresh hepatocytes from the partial liver and its cryopreserved hepatocytes expressed their intrinsic hepatic functions well and showed equal hepatotoxicity gene expression trend regardless to cryopreservation. Therefore, liver resection surgery-originated partial liver can be used as a useful source of human hepatocytes for various pharmacological and hepatotoxicity test.