• Title/Summary/Keyword: 식품 안전성 평가

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NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY (소아청소년정신과영역의 새로운 항우울제)

  • Lee, Soo-Jung
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.12-25
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    • 2003
  • Objectives:As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods:Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results:1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion:Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

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Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea - (국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 -)

  • Park, Onnuri;Jang, Kyoung won;Ha, Dong mun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.3
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    • pp.137-146
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    • 2020
  • Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

A Study on Development of Guideline on Writing Technical Document for Electrical Medical Devices : Bone Absorptiometric X-ray System (엑스선골밀도측정기의 기술문서 작성을 위한 가이드라인 개발 연구)

  • Lee, Seung-Youl;Kim, Jae-Ryang;Kim, Eun-Rim;Lee, Jun-ho;Lee, Chang-Hyung;Park, Chang Won
    • Journal of radiological science and technology
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    • v.39 no.2
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    • pp.263-271
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    • 2016
  • The market size of the bone absorptiometric X-ray system and the number of its approval by Ministry of Food and Drug Safety (MFDS) has annually increased, with a trend of increasing aging population and osteoporosis patients. For approval of manufactured or imported medical devices in Republic of Korea, it is required to submit its technical document. Therefore, it is need to develop the technical document guideline for the bone absorptiometric X-ray system for manufacturers, importers and reviewers. First of all, the technical documents which were already approved were examined and analyzed through MFDS approval administration system. Second, safety and performance test standards and methods that match international standards were drawn after conducting survey of the market status and the technology development trend for it, with examination and analysis of applicable domestic and overseas standards. Third, by operating industry-research-government cooperation, the guideline draft on writing technical document for the bone absorptiometric X-ray system was discussed, collecting their opinion. As a result, it is suitable to international and domestic condition, includes test evaluation methods and offer various information with appropriate examples to civil petitioner, when they write the technical documents.

Trend Analysis of Hazard Substances in/on Agricultural Products Reported by Press (언론에 보도된 농산물 중 유해물질 동향 분석)

  • Lee, Je-Bong;Moon, Byeng-Chul;Jin, Yong-Duk;Kwon, Hye-Young;Im, Geon-Jae;Hong, Moo-Ki;Kang, Kyu-Young
    • The Korean Journal of Pesticide Science
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    • v.15 no.4
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    • pp.434-440
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    • 2011
  • In order to establish the guidance of management and safe use hazard substance, trend analysis of hazard substance in/on agricultural products reported by press for 5 years (2005-2009) was performed. Data for the analysis collected from the articles about hazard substances from web portals, newspapers and so on. The mostly detected harmful factors in/on agricultural products were pesticides residue and heavy metals by the reports by press for last 5 years. The number of detected pesticides was slightly increased from 14 to 34 through the passage of time but the number of cases reported by press was not increased. On the other hand, the number of accidents and reports related to heavy metals were highly increased from 3 to 13 and 42 to 112, respectively. 65 pesticides including chlorpyrifos were detected in domestic agricultural products for the 5 years. Frequently detected pesticides were chlorpyrifos, endosulfan, carbendazim, azoxystrobin, and procymidone. Pesticide residues were repeatedly detected on green vegetables such as a green perilla leaf, a lettuce, a leek, and spinach among crops.

Monitoring and Risk Assessment of Lead and Cadmium in Various Agricultural Products Collected from the Korean Market

  • Chang, Eun Jung;Park, Sung Hee;Lee, Kyung Jin;Choe, Jee su;Kim, Mee hye
    • Journal of Food Hygiene and Safety
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    • v.33 no.4
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    • pp.240-247
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    • 2018
  • This study was carried out to determine the levels of lead and cadmium as found in nine agricultural products (n = 578) sold in Korea, and to estimate the risk to human health that is summarily associated with their intake. The concentrations of Pb and Cd were measured using an ICP-MS after microwave digestion in this study. The average contents of Pb and Cd were measured as 0.014 and 0.017 mg/kg for barley, 0.006 and 0.005 mg/kg for mung bean, 0.008 and 0.007 mg/kg for kidney bean, 0.010 and 0.004 mg/kg for green bean, 0.008 and 0.001 mg/kg for pineapple, 0.016 and 0.002 mg/kg for apricot, 0.015 and 0.002 mg/kg for Japanese apricot, 0.021 and 0.002 mg/kg for plum and 0.019 and 0.003 mg/kg for jujube, respectively. The levels of Pb and Cd in the study samples were less than the maximum residual levels established by the European Union (EU), CODEX, and the Korea Food Code. As we have seen, the daily dietary exposures of Pb and Cd from these agricultural products for the general population were noted as 0.067% of PTWI ($25{\mu}g/kg$ b.w./week) and 0.28% of PTMI ($25{\mu}g/kg$ b.w./month), respectively. In line with the study conclusions, these results suggest that the current dietary intakes of Pb and Cd from these agricultural products in Korea have no appreciable risk effects on health for humans as noted in this experiment.

Validation of a Rapid Quantitative Method for the Residues of Nitrofuran Metabolites in Loach by Accelerated Solvent Extraction and HPLC Triple Quadrupole Mass Spectrometry

  • Ryu, Eun Chae;Han, Yun-jeong;Park, Seong-soo;Lim, Chul-joo;Choi, Sunok;Park, Se Chang
    • Journal of Food Hygiene and Safety
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    • v.31 no.2
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    • pp.85-93
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    • 2016
  • A rapid method using HPLC-MS/MS has been developed for quantitative determination of the metabolites of nitrofurans, namely 3-amino-2-oxazolidone (AOZ), 5-morpholinomethyl-3-amino-2-oxazolidinone (AMOZ), 1-ammino-hydantoin (AHD) and semicarbazide (SEM) in loach. The extraction procedure was founded on simultaneous acidic hydrolysis and derivatization using 2-nitrobenzaldehyde (2-NBA) for 1 hour at $50^{\circ}C$, followed by purification with liquid-liquid extraction. Recovery was evaluated by spiking standards into blank samples at three levels (0.5, 1.0 and $2.0{\mu}g/kg$), and the mean recovery was 75.1-108.1%. Precision values expressed as the relative standard deviation (%RSD) were ${\leq}8.7%$ and ${\leq}8.5%$ for intra-day and inter-day precision, respectively. Linearity was studied in the range of $0.2-20{\mu}g/Kg$ for NBAOZ, $0.8-20{\mu}g/Kg$ for NBAMOZ, $0.2-20{\mu}g/Kg$ for NBAHD, and $0.1-20{\mu}g/Kg$ for NBSEM, and the obtained coefficient correlations (r) were ${\geq}0.99$ for all compounds. Limits of detection (LODs) for the derivatized nitrofuran metabolites were established at $0.06{\mu}g/Kg$ for NBAOZ, $0.24{\mu}g/Kg$ for NBAMOZ, $0.06{\mu}g/Kg$ for NBAHD, and $0.03{\mu}g/Kg$ for NBSEM. Limits of quantification (LOQs) were established at $0.2{\mu}g/Kg$ for NBAOZ, $0.8{\mu}g/Kg$ for NBAMOZ, $0.2{\mu}g/Kg$ for NBAHD, and $0.1{\mu}g/Kg$ for NBSEM. This simplified rapid method for reducing the derivatization and hydrolysis times can be applied to the determination of nitro-furan residues in loach.

Antimicrobial Activity of Korean Herbal Complex Extract and Clay Mineral Mixture against Escherichia coli O157:H7 (한약재 복합추출물과 점토 광물질 혼합제의 Escherichio coli O157:H7에 대한 항균효과)

  • Lee, Yeon-Ok;Jung, Won-Chul;Cha, Chun-Nam;Kim, Gon-Sup;Lee, Yeo-Eun;Kim, Suk;Lee, Hu-Jang
    • Journal of Food Hygiene and Safety
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    • v.25 no.1
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    • pp.1-5
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    • 2010
  • The present study was evaluated the antibacterial effect of the combination of Coptidis rhizoma, Lonicerae Flos, and Paeonia japonica (1:1:1) extracts (CLP1000). Also, the effectiveness of CLP1000, dioctahedral smectite (DHS), and the combination of CLP1000 and DHS (CLPS1000) against E. coli O157:H7 infection was studied using ICR female mice. During the incubation period, the dose of 10% and 20% CLP1000 were inhibited the growth of E. coli O157:H7 by 30% and 47%, respectively. For 7 days after single challenge with E. coli O157:H7, forty female ICR mice were divided into four experimental groups which were orally administered with saline, 10% CLP1000, 10% DHS, and 10% CLPS1000, respectively. On the 3rd day, the number of E. coli O157:H7 in mouse feces was significantly decreased by administration of CLP1000 (p < 0.05), DHS (p < 0.05) and CLPS1000 (p < 0.001). On the 7th day, CLP1000 (p < 0.05) and CLPS1000 p < 0.001) administration significantly decreased the number of E. coli O157:H7. According to the results of the present study, administration of CLPS1000 to mice can reduce the severity of E. coli O157:H7 infection. Also, it is suggested that CLPS100 represents a good candidate for the treatment of enteric infections in domestic animals.

Antimicrobial Activity of Natural Product Made by Opuntia ficus-indica var. saboten Against Salmonella spp. and Escherichia coli O157:H7 (백련초 (Opuntia ficus-indica var., saboten)의 Salmonella와 Escherichia coli O157 : H7에 대한 항균효과)

  • Kim, So-Hyun;Kwon, Nam-Hoon;Kim, J.Y.;Lim, J.Y.;Bae, W.K.;Kim, J.M.;Noh, K.M.;Hur, J.;Jung, W.K.;Park, K.T.;Lee, J.E.;Ra, J.C.;Park, Yong-Ho
    • Journal of Food Hygiene and Safety
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    • v.17 no.2
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    • pp.71-78
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    • 2002
  • With the incidence of antibiotic resistant bacteria there is increasing interest in natural products such as herb extract and probiotics to control antibiotic resistant bacteria. This study was focused on the determination of antimicrobial activity of Opuntia ficus-indica var. saboten against Salmonella enetrica serovar Enteritidis (S. enterifidis), S. enterica serovar Typhimurium (S. Typhimurium) DT 104 and Escherichia coli 0157:H7. Though bactericidal effect of 0. ficus-indica var. saboten was not observed, it had significant inhibitory activity against Salmonella spp. and E. coli O157:H7 on the Moulter Hinton agar containing its solution dissolved in deionized water. To investigate the antimicrobial activity in vivo, mice were challenged with 5. Typhimurium DT104 (3.7$\times$108 cfu/mouse) after pre-feeding 0. ficus-indica var. saboten solution. The fecal shedding of S. Typhimurium DT104 was more dramatically decreased and not detectable in feces and intestines 3 days after challenge in mice fed with 0. ficus-indica var. saboten. Antibody responses of the intestinal IgA were also significantly increased in mice fed with 0. ficus-indica var. saboten. These findings suggest that Opuntia ficus-indica var. saboten decreased the shedding of S. Typhimurium DT104 in vitro and also in the gastrointestinal tract in mice. In addition, administration of the product might enhance the mucosal immune response against S. Typhimurium DT 104. In conclusion, Opuntia ficus-indica var. saboten might be useful to control antibiotic resistant bacteria in vivo and in vitro.

Assessment of Demand and Use of Fresh-Cut Produce in School Foodservice and Restaurant Industries (학교급식 및 외식업체에서의 신선편이 농산물 사용실태 및 요구도 평가)

  • Sun, Shih-Hui;Kim, Ju-Hee;Kim, Su-Jin;Park, Hye-Young;Kim, Gi-Chang;Kim, Haeng-Ran;Yoon, Ki-Sun
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.39 no.6
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    • pp.909-919
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    • 2010
  • The purpose of this study was to investigate the demand and use of fresh-cut produce in school foodservice and restaurant industries. The subjects of this survey study were 200 school nutritionists and 70 cooks or managers in the restaurant industry nationwide. The data were collected by means of self-administered or e-mail questionnaires. Data analysis was completed using the SPSS window (ver. 12.0) program including frequency, $\chi^2$-test and t-test. Survey questions assessed the general characteristic of respondents, and the supply, use, and demand of fresh-cut produce in school foodservice and restaurant industries. Over 74% of the subjects have used fresh-cut produce. Most of the school foodservice (84.0%) kept fresh-cut produce for one day, while restaurant industry (28.3%) kept them up to three days. The nutritionists of school foodservice and managers of restaurant industry considered origin and date of production as the most important factor, respectively, when fresh-cut produce were being used. Fresh-cut root vegetable, such as potato and carrot was used mostly. The main reason not to use the fresh cut produce was due to the distrust of the fresh-cut produce safety in school foodservice and cost in restaurant industry. The main problem in fresh-cut produce use was the need of rewashing (29.9%) in school foodservice and irregular size (39.0%) in restaurant industry. These results indicate that the quality standard and size specification must be prepared with production guideline of safe fresh-cut produce.

A Study on the Sanitary Management Procedures of University and Industry Foodservice Operations in Pusan (부산지역 대학 및 사업체 급식소의 위생관리 수행 수준에 관한 연구)

  • 김소희;이용우
    • Journal of Food Hygiene and Safety
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    • v.16 no.1
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    • pp.1-10
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    • 2001
  • The levels of sanitary management procedures in university and industry foodservices, in pusan, were investigated. The questionnaires were administed to ninety three dietitians who managed university (n=21) and industry (n=72) foodservices and then the data were statistically analyzed. When sanitary management procedures were evaluated by 5 scales method of Likers, total mean scores of time-temperature management in the process of meal production, personal hygiene, equipments and facilities hygiene in university and industry foodseryice operations were 3.48, 3.76 and 3.27, repectively. In time-temperature management, the scores for storage, purchasing and receiving, pre-preparation, cooking, assembly and service, and hot or cold holding were 3.77, 3.74, 3.55, 3.54, 3.28, 3.05, respectively, in descending order. The management levels for personal hygiene, equipments and facilities hygiene of foodservices had biger serving scale (over 901) were significnatly higher than those of lower sclaled foodservices(below 900). The scores of foodservices managed by higher aged dietitian(over 31 years) were significantly higher than those of foodservices conducted by lower aged group(below 25 years) in the management procedures of time-temperature, personal hygiene, equipments and facilities hygiene(p<0.05). The dietitian group had the regular sanitary education showed significantly higher scores than irregularly educated group in the management of time-temperature and personal hygiene.

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