• 제목/요약/키워드: Biological safety

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생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증 (Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products)

  • 김병철;김도근;홍성화;김연희;임종미;원윤정;김석환;홍지영;윤영민;김재옥
    • 약학회지
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    • 제55권4호
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    • pp.284-288
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    • 2011
  • The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.

생물자원의 관리와 정책 (An Introduction of Management and Policy of Biological Resources)

  • 조순로;설성수;박정민
    • 기술혁신학회지
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    • 제11권2호
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    • pp.219-240
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    • 2008
  • 본 연구는 새로운 국가자원인 생물자원에 대한 최근의 국제적인 이슈와 주요국의 정책의지 및 관리 체계 등을 살펴 본 것이다. 그렇지만 논의의 전개를 위해 생물자원과 관련된 이론적인 논의, 역사 등을 먼저 검토하였다. 생물자원과 관련된 최근의 이슈는 지적재산권, 보관과 배송의 안전과 관련된 국제규약의 강화, 생물자원의 생물학적 표준강화, 생물자원센터의 윤리문제 등으로 특징지어진다. 이러한 논의를 바탕으로 본고는 생물자원정책의 방향, 체계 및 내용을 간단히 권고하였다. 특히 범부처적 차원에서의 생물자원의 관리와 확보를 위한 종합 조정과 시스템 구축의 필요성을 강조하였다.

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국내 합성피혁제조업 근로자에 대한 디메틸포름아미드의 공기중 농도와 생물학적 노출지표간의 상관성 평가 (Assessment of correlation between markers of ambient monitoring and biological monitoring of dimethylformamide for workers in synthetic leather manufacturing factories in Korea)

  • 황양인;이미영;정윤경;김은아
    • 분석과학
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    • 제26권5호
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    • pp.315-325
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    • 2013
  • The possibility of acute hepatotoxicity caused by dimethylformamide (DMF) requires regular monitoring of the workers who are using DMF to prevent the occupational disease. The authors performed ambient and biological monitoring of workers involved in synthetic leather manufacturing processes using DMF to assess the correlation between the markers of ambient and biological monitoring of DMF. The authors monitored 142 workers occupationally exposed to DMF from 19 workshops in the synthetic leather and ink manufacturing industries located in northern region of Gyeonggi-do. The subjects answered questionnaire on work procedure and use of personal protective equipment to be classified by exposure type. DMF in air samples collected using personal air samplers, diffusive and active sampler, was analysed using gas chromatograph-flame ionization detector (GC-FID) with DB-FFAP column (length 30 m, i.d. 0.25 mm, film thickness 0.25 ${\mu}m$). Urinary N-methylformamide (NMF) was analysed using gas chromatograph-mass selective detector (GC-MSD) at selected ion monitoring (SIM) mode with DB-624 column (length 60 m, i.d. 0.25 mm, film thickness 1.40 ${\mu}m$). Geometric mean (GM) and geometric standard deviation (GSD) of the ambient DMF was $6.85{\pm}3.43$ ppm, and GM and GSD of urinary NMF was $42.3{\pm}2.7$ mg/L. The ratio of subjects with DMF level over 10 ppm was 44%, and those with urinary NMF over 15 mg/L was 87%. NMF in urine adjusted by DMF in air was $4.61{\pm}2.57$ mg/L/ppm and $9.50{\pm}2.41$ mg/L/ppm, respectively, with or without respirator. There was seasonal differences of NMF in urine adjusted by DMF in air, $7.63{\pm}2.74$ mg/L/ppm in summer and $4.53{\pm}2.29$ mg/L/ppm in winter. The urinary NMF concentration which corresponds to 10 ppm of ambient DMF was 52.7 mg/L (r=0.650, n=128). Considering the difference of the route of exposure which resulted from the compliance of wearing personal protective equipment, the estimated contribution of respiratory and dermal exposure route for DMF was 48.5% vs. 51.5%.

일부 납 제련업 종사 외국인 근로자의 납 노출 실태 (A pilot study on increased blood lead concentration of some foreign workers in lead refining industry)

  • 양정선;김태균;박인정;김민기;이선웅;허경화;강성규
    • 한국산업보건학회지
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    • 제18권3호
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    • pp.248-251
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    • 2008
  • During survey of blood lead concentration of workers who worked in lead refining industry, we found that some foreign workers showed increased blood lead level compared with that of domestic workers. The mean concentration of lead in blood for foreign workers (15%, 13 workers, mean age: 29) was 55.8 ug/dL which was over biological exposure index, while that of Korean workers (85%, 76 workers, mean age: 42) was 28.9 ug/dL. Some other biological markers of lead exposure such as ZPP and ${\delta}-ALA$ also showed elevated levels. Most of foreign workers stayed in dormitories near or in the factories that may cause to let them under the condition of 24 hours exposure of lead. The lack of safety manual on proper prevention of lead exposure in their own language for effective communication may be one of reasons of elevated blood lead concentration of foreign workers.

인듐 노출 근로자를 위한 생물학적 노출지표로써 혈청 Krebs von den lungen-6의 활용가능성 (Applicability of Serum Krebs von den lungen-6 as a Biological Exposure Index for Workers Exposed to Indium)

  • 원용림;이광용;이미영;김은아
    • 한국산업보건학회지
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    • 제23권2호
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    • pp.108-113
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    • 2013
  • Objectives: Although several cases of lung diseases caused by indium have been reported in Japan, the United States and China, South Korea, which is estimated to have been the world's largest consumer of indium, has not yet established a criteria for the diagnosis of lung diseases caused by indium exposure. In this study, we tried to determine the applicability of the Krebs von den lungen-6, which has been widely recognized for its use with interstitial lung disease in Japan, as a biological exposure index for indium. Methods: Methods: The analysis of indium in serum was conducted by inductively coupled plasma mass spectrometry and the analysis of KL-6 in serum was carried out using enzyme-linked immunosorbent assay kit. Results: The indium levels in serum were distributed from below the detection limit to a peak of $125.78{\mu}g/L$, and the values of the KL-6 were distributed from 104.5 U/mL to 2162.2 U/mL. The serum indium and KL-6 showed good correlation ($R^2$=0.389,pfortrend=0.000) and smoking did not affect the KL-6. Conclusions: The usefulness of KL-6 as a specific biomarker for interstitial lung disease has been recognized. In addition, it is expected that effective prevention of health problems can be achieved by determining the lung-damage progress at an early stage according to individual susceptibility.

In vivo micronucleus test of 4-butylaniline and N-butylaniline to classify a chemical's mutagenicity according to the globally harmonized system of classification and labelling of chemicals (GHS)

  • Kim, Soo-Jin;Shin, Seo-ho;Kim, Hyun-ock;Rim, Kyung-Taek
    • Journal of Applied Biological Chemistry
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    • 제62권4호
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    • pp.355-359
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    • 2019
  • In vivo micronucleus tests were performed to investigate the mutagenic potential of 4-butylaniline and N-butylaniline, which are used in dye intermediates and organic intermediates respectively. Groups of 5 male ICR mice were treated with vehicle or 4-butylaniline for 2 consecutive days by oral gavage at concentrations of 0 (control), 64, 160, 400, and 1000 mg/kg. Statistically significant and dose-dependent increases were found for micronuclei frequencies in male mice (p <0.05). These results suggest that 4-butylaniline can induce genetic effects in the micronuclei of male mouse bone marrow cells. Based on the positive results obtained in cytogenetic analyses of somatic cells in vivo, Globally Harmonized System of Classification and Labelling of Chemicals Category 2 was assigned. N-butylaniline was administered for 2 consecutive days by oral gavage to male ICR mice at dose of 0 (control), 64, 160, 400, and 800 mg/kg. N-butylaniline tested negative for micronuclei induction in mice, although N-butylaniline was associated with micronucleus induction at the highest dose. Based on the negative results obtained for cytogenetic analyses of somatic cells in vivo, "Not Classified" was assigned.

Comparison of the plant uptake factor of perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) from the three different concentrations of PFOA and PFOS in soil to spinach and Welsh onion

  • Lee, Deuk-Yeong;Choi, Geun-Hyoung;Rho, Jin-Ho;Lee, Hyo-Sup;Park, Sang-Won;Oh, Kyeong-Yeol;Kim, Jin-Hyo
    • Journal of Applied Biological Chemistry
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    • 제63권3호
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    • pp.243-248
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    • 2020
  • The long-chained perfluoroalkyl acids (PFAAs), perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), are a potential exposure risk in the environment, specifically for humans due to high levels of bioaccumulation, persistence, and toxicity. In the current study, the plant uptake factors (PUFs) of spinach and Welsh onion were investigated on the three different concentration levels of PFOA and PFOS in soil. Spinach and Welsh onion were divided into three residue groups, a control group and two levels of PFOA and PFOS. The PFAAs spiked soils were aged for six months and the extractable residue of PFOS in the aged soil was reduced to 30-59% of the initial spiked concentrations for PFOS, while PFOA showed almost the same initial spiked concentrations. The PUFs for PFOA and PFOS were 0.111-2.821 and 0.047-3.175 for spinach, and 0.203-0.738 and 0.035-0.181 for Welsh onion, respectively. The highest PUF values in both vegetable were displayed when the residual concentration of PFAAs were part-per-billion (ppb) or sub-ppb in soil.

생체시료 중 중금속 및 유기용제 대사물 분석의 실험실간 정도관리 프로그램 (Inter-laboratory Comparison for Analyses of Heavy Metals and Organic Solvent Metabolites in Biological Samples)

  • 양정선;이미영;박인정;강성규
    • 분석과학
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    • 제13권2호
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    • pp.258-267
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    • 2000
  • 1995년부터 실시해 온 산업보건 분야의 '유해물질 및 대사물 분석의 실험실간 정도관리 프로그램'(공식명: 특수건강진단기관 분석정도관리)의 5년간 실시 경과와 결과를 보고하고, 고찰을 통하여 우리나라 산업보건분야 실험실 서비스의 질관리를 위한 앞으로의 방향 등을 제시하고자 한다. 산업현장에서 많이 쓰이는 4가지 혈중 중금속과 5가지 유기용제 대사물에 대하여 연구원에서 제조된 표준시료를 분배하고 결과 분석값과 크로마토그람 등 관련 자료들을 분석하여 참가기관에 대한 분석능력 평가를 실시하였다. 연 2회 실시된 정도관리 결과는 인터넷 등을 통하여 고시하여 산업보건 관련 실험실들의 자율적인 질관리 서비스 경쟁을 유도하고, 관련 실험실 서비스의 사용자인 근로자, 사업주, 산업보건 관련자들의 알 권리를 충족시켜, 실험실의 분석데이타에 대한 객관적인 신뢰도를 확보하고 산업보건 서비스의 질 향상에 크게 기여하였다.

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