• 한국산업보건학회지
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• 제34권1호
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• pp.48-56
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• 2024

Objectives: The coronavirus pandemic that began in 2019(COVID-19) has been one of the worst pandemics of the 21st century. Masks have been used to prevent COVID-19, but there are currently no standards for the long-term use of masks in the Republic of Korea. This study was conducted to assess the microbiological safety of KF94(Korea Filter 94) disposable face masks according to wearing duration by evaluating the bacterial filtration efficiencies of masks worn by research participants. Methods: A commercially available KF94 mask certified by the Ministry of Food and Drug Safety(MFDS) in the Republic of Korea was selected as the test mask. The research participants(n = 15) wore masks for the durations of one, three, and seven days. Participants also reported several parameters, including wearing time, makeup frequency, and storage. Bacterial filtration efficiencies of the worn masks were measured by a mask bioaerosol filtration tester. Staphylococcus aureus(S. aureus) was used as the test bacteria and quantitatively measured through the cultivation method. Then, bacterial filtration efficiency was calculated using the formula suggested by the MFDS. Results: All worn masks showed over 99.98% of mean bacterial filtration efficiency for S. aureus. There were no significant differences among bacterial filtration efficiencies of face masks according to wearing duration. There was also no significant difference among bacterial filtration efficiencies among participants. There was no correlation between the results of bacterial filtration efficiencies and reported parameters from participants. Conclusions: In the absence of significant external damage to the mask, the bacterial filtration efficiency of the mask can be maintained even after seven days of wearing. This result suggests that KF94 masks certified by the MFDS can be used repeatedly for about a week without loss of bacterial filtration efficiency.

• 월간포장계
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• 통권347호
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• pp.98-103
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• 2022

식품의약품안전처(처장 김강립)가 2020년 식·의약품 통계자료를 바탕으로 발간한 '2021년 식품의약품통계연보'를 분석한 결과를 발표했다. 이 연보는 식·의약 안전정책의 주요성과와 식품, 의약품, 화장품, 의약외품, 의료기기, 위생용품 등 관련 산업의 현황을 쉽게 파악할 수 있도록 식·의약 분야 통계를 종합하여 식약처가 매년 발간하는 자료집으로, 식품의약품통계연보의 자세한 내용은 식약처 누리집(www.mfds.go.kr → 통계 → 통계간행물)에서 확인 가능하다. 다음에 분석 결과의 상세한 내용을 살펴보도록 한다.

• 한국임상약학회지
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• 제25권2호
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• pp.120-129
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• 2015

Objectives: Drug utilization review program in Korea has provided 'drug combinations to avoid (DCA)' alerts to physicians and pharmacists to prevent potential adverse drug events or inappropriate drug use. Seven hundred and six DCA pairs have been announced officially by the Ministry of Food and Drug Safety (MFDS) by March, 2015. Some DCA pairs could be grouped based on the drug interaction mechanism and its consequences. This study aimed to investigate the drug-drug interaction (DDI) pairs, which may be potential DCAs, generated by the drug class-drug class interaction method. Methods: Eleven additive/synergistic and one antagonistic drug class-drug class interaction groups were identified. By combining drugs of two interacting drug class groups, numerous DDI pairs were made. The status and severity of DDI pairs were examined using Lexicomp and Micromedex. Also, the DCA listing rate was calculated. Results: Among 258 DDI pairs generated by the drug class-drug class interaction method, only 142 pairs were identified as official DCA pairs by the MFDS. One hundred and four pairs were identified as potential DCA pairs to be listed. QT prolonging agents-QT prolonging agents, triptans-ergot alkaloids, tricyclic antidepressants-monoamine oxidase inhibitors, and dopamine agonists-dopamine antagonists were identified as drug class-drug class interaction groups which have less than 50 % DCA listing rate. Conclusion: To improve the clinicians' adaptability to DCA alerts, the list of DCA pairs needs to be continuously updated.

• 한국환경보건학회지
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• 제46권1호
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• pp.78-87
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• 2020

Objectives: To identify the degree of physical burden, a determination was undertaken of dust collection efficiency, inhalation pressure, and CO₂ concentration related to health masks certified by the Ministry of Food and Drug Safety (MFDS). Methods: Twenty health masks were purchased on the market. Dust collection efficiency and inhalation pressure were determined in the same manner as in MFDS certification testing, respectively using TSI Model 8130 (TSI, U.S.) and ART Plus (Korea). CO₂ concentrations for 20 subjects using a CO₂ analyzer (G100, G150, Geotechnical Instrument Ltd., UK) were measured with a similar method as a total inward leakage test. In addition to CO₂ levels, dead space volumes in the masks was determined for predicting concentrations of CO₂ in inhalation air. Results: Most of the dust collection efficiencies found for the 20 masks were far higher than the standard. Four KF94s met KF99 and four KF80s even met KF94. Most inhalation pressures were also much lower than the standard, with many almost one-half of the standard. The mean and standard deviation of CO₂ concentration in the mask were 2.9±0.44%. Considering dead volume, the prediction for CO₂ concentration in the inhalation air was 4,395±1,266 ppm. Conclusions: For healthy men and women, the dust collection efficiency and inhalation pressure of health masks were not at a level that would affect their health. Although CO₂ levels in the inhalation air were predicted not to affect health, research on the physiological effects of health masks on Koreans is needed for more precise research.

• 한국환경보건학회지
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• 제41권1호
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• pp.30-39
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• 2015

Objectives: This study was conducted to determine the heavy metal contents in commercial herbal medicines in Korea. Methods: Monitoring of lead, arsenic, cadmium and mercury was carried out on 116 samples of eleven types of herbal medicines. Among the total samples, 71 samples were domestic and 45 were imported. The samples were digested using the microwave method. The heavy metal contents were measured by inductively coupled plasma atomic emission spectrometry (ICP-AES) and a mercury analyzer. ICP-AES was used to analyze lead, arsenic cadmium. Mercury was analyzed by the amalgamation method. Results: The mean values of the heavy metal contents in the herbal medicines were Pb 0.64mg/kg, As 0.26mg/kg, Cd 0.07mg/kg and Hg 0.004mg/kg. Of the total samples, one violated the MFDS (Ministry of Food and Drug Safety) regulatory guidance on heavy metals in herbal medicines. Lead was detected at more than 5mg/kg in one sample. The measured values of arsenic, cadmium and mercury in the herbal medicines showed levels lower than 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 sample surpassed the maximum residue limits for lead. Conclusion: These results will be used to establish the regulation and control of heavy metal contents in herbal medicines. In addition, continuous monitoring is needed to ensure confidence in and the safety of these herbal medicines.

• 보건교육건강증진학회지
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• 제31권2호
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• pp.65-78
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• 2014

Objectives: The aim of this study is to evaluate promotional Internet health information on health functional foods with regard to labeling information, website structure, and overall quality. Methods : The websites of 15 producers of three health functional foods (Red ginseng, vitamin, aloe) were selected. Ministry of Food and Drug Safety (MFDS) required labeling information was used to evaluate the integrity of basic information, and the structural properties of the websites were investigated. Moreover, DISCERN instrument was used to evaluate reliability and quality of information. Results : 1) Among MFDS required labeling information, seven items, including 'sell by date', and 'possible side effects' were not fully specified, and only 6.7% of Internet advertisements provided 'possible side effects'. 2) Each of 92.9% of these websites offered 'Introducation to websites and producers', and 'customer service', whereas only 64.3% and 42.9% of these websites offered 'FAQ about website utilization' and 'multilingual support', respectively. 3) The evaluation using DISCERN instrument showed the scores of $2.03{\pm}0.24$ in reliability, $1.87{\pm}0.28$ in quality, and $2.10{\pm}0.55$ in overall quality. Conclusions : Current promotional Internet health information on health functional foods has various weaknesses in terms of reliability and quality that need to be improved.

• 대한본초학회지
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• 제36권4호
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• pp.41-50
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• 2021

Objectives : This study is to check the quality of Moschus products in Korean markets using a chromatographic analysis. Methods : We collected musk products, two genuine products from Russia (A, B), two authentic products from Hong Kong (C) and Korea (D), the Ministry of Food and Drug Safety (MFDS) standard (E), and two fire ants products (E, F). Results : For identification, TLC analysis of 60% ethanol extracts of each product showed that A, B, C, and E have the suitable patterns before color development at 365 nm UV light for the MFDS regulation in Korea. A clear red spot was observed from the E at R_f 0.6 with 365 nm UV light after color development, but this spot was not found in A and B. For the purity test, a distinct violet spot with R_f 0.87 was observed from the A and B in TLC analysis of methanol extracts of each product at white light, however, this spot was not matched with the impurities of E and F. In HPLC-UV pattern analysis, a similar peak pattern was shown in A, B and E, and similar peaks were observed C, although the similarity was weaker than that of A, B, and E. The F and G showed different peak patterns compared with the peak patterns of other samples. Conclusions : Hence, it is considered that the test methods need flexibility in application for identification and purity test depending on the type of sample.

• 한국환경보건학회지
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• 제47권3호
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• pp.292-301
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• 2021

Objectives: Wearing medical masks has been recommended since the declaration of coronavirus disease-19 (COVID-19) as a pandemic disease. Certified medical masks are evaluated according to filtration efficiency and facial inhalation resistance. However, some people use non-certified common masks. This study aimed to evaluate various non-certified commercial masks based on the certification criteria for medical masks. Methods: Twenty mask products (three anti-droplet, three disposable dental, eight fashion, three cotton, and three children's masks) were selected. For performance evaluation, filtration efficiency and facial inhalation resistance tests were conducted. The evaluation method followed the certification method for KF-certified masks of the Ministry of Food and Drug Safety (MFDS) and the N95 respirator of the National Institute for Occupational Safety and Health (NIOSH). Results: None of the 20 masks met the KF94 certification standard set by the MFDS. Four and three masks respectively met the KF80 certification standard and the N95 standard of NIOSH. Filtration efficiency was significantly higher in three-layer masks than in single layer masks. Pleated-type masks had higher filtration efficiency than cone-type masks. There was no correlation between the structure of masks and facial inhalation resistance. Conclusion: While no masks complied with the KF94 certification standard, a few masks met the KF80 and the N95 certification standards of NIOSH. Although some people wear non-certified commercial masks, protection from aerosols is not guaranteed by such masks. Evaluation of the protection efficiency of non-certified mask against microbiological infection is needed for the prevention of infectious disease.

• 대한본초학회지
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• 제37권5호
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• pp.9-16
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• 2022

Objectives : The purpose of this study is to report that applying the genetic discrimination method to Pinelliae Tuber is suitable as a countermeasure for the limitations of morphological identification announced publicly in the Ministry of Food and Drug Safety(MFDS). Methods : Randomly selected fifty samples in Pinelliae Tuber imported from China were used for morphological and genetic identification. The morphological identification was applied method announced publicly by the MFDS. The traits of morphological identification were classified as Pinellia ternata, P. tripartita, Pinellia pedatisecta, and Typhonium flagelliforme, according to the formation of tuberous root and tuber morphology. The genetic identifications were conducted by Sequence Characterized Amplified Region(SCAR) marker and DNA barcoding analysis for cross-validation, respectively. SCAR marker was verified according to the presence or absence of amplicon through PCR amplification using species-specific primers. DNA barcoding analysis used sequence information of the matK region. Results : As a result of the morphological identification, 27 out of 50 samples were identified as original species 'P. ternata' of genuine 'Pinelliae Tuber', and 23 were identified as adulterant species 'P. pedatisecta'. Unlike this, the genetic identification was identified as the original species 'P. ternata' in all 50 samples in the SCAR marker and matK regional sequence analysis. Conclusions : Pinelliae Tuber of morphological mutant that can not be classified by morphological identification is imported from China. The SCAR marker would be used as accurate and efficient assays for species identification of the morphological mutant.

• 한국식품저장유통학회지
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• 제30권1호
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• pp.28-41
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• 2023

Non-aflatoxigenic Aspergillus oryzae and aflatoxigenic A. flavus cannot be clearly identified by partial sequencing of the internal transcribed spacer (ITS) and 18S ribosomal ribonucleic acid (18S rRNA) regions. This study aimed to compare the accuracy among three aflatoxin detection methods using ultra-performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), and an enzyme-linked immunosorbent assay (ELISA) kit and to select the non-aflatoxigenic Aspergillus sp. isolated from soybean paste. All analytical methods were suitable according to the international standards of Codex Alimentarius FAO-WHO (CODEX) or the Ministry of Food and Drug Safety (MFDS). UPLC exhibited the best of limit of detection (LOD) and limit of quantification (LOQ). Based on UPLC, HPLC, and the ELISA kit assay, the P5 and P7 strains isolated from soybean paste had 1,663.49, 1,468.12, and >20 ㎍/kg and 1,470.08, 1,056.73, and >20 ㎍/kg, respectively, detected and re-identified as A. flavus. In contrast, the P3 and P4 strains (A. oryzae), which were detected below the MFDS standards in all assays, were confirmed as non-aflatoxigenic fungi. Among the methods evaluated for quantitative analysis of aflatoxin, UPLC and HPLC are superior in terms of accuracy, and the ELISA kit rapidly detects low concentrations of aflatoxin. Furthermore, this study demonstrates that any Aspergillus sp. isolated for use as a fermentation starter should be analyzed for potential aflatoxin production using UPLC and HPLC for accurate quantitative analysis or ELISA for the rapid detection of low-level concentrations of aflatoxin.