• Title/Summary/Keyword: 의약품 안전 관리

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A Study on Introduction of e-Pedigree for eradicating Counterfeit Drugs in Pharmaceutical Industry (제약산업에서의 위조의약품 방지를 위한 전자계보(e-Pedigree) 도입에 관한 연구)

  • NamGung, Kwang;Choi, Yong-Jung
    • Proceedings of the Korean Society of Computer Information Conference
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    • 2012.01a
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    • pp.51-54
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    • 2012
  • 전 세계적으로 유통되고 있는 가짜의약품으로 인하여 제약사들은 판매수익과 기업브랜드 이미지에 큰 피해를 입고 있으며 가짜 의약품을 복용한 소비자들은 생명에 위협을 받고 있는 실정이다. 이러한 가짜의약품의 유통을 근절시키기 위하여 세계 각국에서는 의약품의 생산에서부터 소비자에게 판매될 때까지, 즉 의약품 유통과정을 추적하여 가시성있는 이력관리를 할 수 있도록 RFID 및 barcode 등 IT기반의 e-Pedigree(electronic pedigree)를 법제화시키고 있지만 구체적이고 실질적인 구축방법이 제시되지 못하고 있다. 따라서 본 연구는 국내 제약산업의 유통합리화와 소비자 안전성을 제고시키기 위하여 RFID 기반의e-Pedigree 적용방안을 제시하는데 그 목적이 있고 더 나아가 세계 각 국가의 e-Pedigree 구축을 위한 참조모델 개발에 일조하고자 한다.

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Development of Analytical Method for Kasugamycin in Agricultural Products using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 Kasugamycin 시험법 개발)

  • Lee, Han Sol;Do, Jung-Ah;Park, Ji-Su;Cho, Sung Min;Shin, Hye-Sun;Jang, Dong Eun;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.3
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    • pp.235-241
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    • 2019
  • An analytical method was developed for the determination of an antibiotic fungicide, kasugamycin, in agricultural products (hulled rice, potato, soybean, mandarin and green pepper) using liquid chromatographytandem mass spectrometry (LC-MS/MS). Samples were extracted with methanol adjusted to pH 13 using 1 N sodium hydroxide, and purified with a HLB (hydrophilic lipophilic balance) cartridge. Linearity of a matrix-matched calibration curve using seven concentration levels, from 0.001 to 0.1 mg/kg, was excellent with a correlation coefficient ($R^2$) of more than 0.9998. The limits of detection (LOD) and quantification (LOQ) of instrument were 0.0005 and $0.001{\mu}g/mL$, respectively, and the LOQ of analytical method calculated as 0.01 mg/kg. The average recoveries at three spiking levels (LOQ, $LOQ{\times}10$, $LOQ{\times}50$, n=5) were in the range of 71.2~95.4% with relative standard deviation of less than 12.1%. The developed method was simple and all optimized results was satisfied with the criteria ranges requested in the Codex guidelines and Food Safety Evaluation Department guidelines. The present study could be served as a reference for the establishment of maximum residue limits (MRL) of kasugamycin and be used as basic data for safety management relative to kasugamycin residues in imported and domestic agricultural products.

잔류예방과 수의사의 역할

  • 손성완
    • Journal of the korean veterinary medical association
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    • v.39 no.2
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    • pp.147-154
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    • 2003
  • 수의사는 동물질병의 예방과 치료뿐만 아니라 축산물의 위생관리 및 안전성확보에 관한 최고의 전문가이다. 또한 축주와 가장 긴밀한 관계를 유지하고 있으며 신뢰관계를 구축하고 있다. 따라서 축산현장에서 올바른 동물용 의약품의 사용과 사양관리에 관해 적극적으로 지도$\cdot$홍보하는 책임있는 수의사의 역할이 잔류예방과 안전한 축산물의 생산을 위한 관건이라 할 수 있다.

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Development and Validation of an Analytical Method for Fungicide Sedaxane Determination in Agricultural Products using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 살균제 Sedaxane의 잔류시험법 개발 및 검증)

  • Cho, Sung Min;Do, Jung-Ah;Park, Shin-Min;Lee, Han Sol;Park, Ji-Su;Shin, Hye-Sun;Jang, Dong Eun;Choi, Young-Nae;Jung, Yong-hyun;Lee, Kangbong
    • Journal of Food Hygiene and Safety
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    • v.34 no.1
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    • pp.30-39
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    • 2019
  • An analytical method was developed for the determination of sedaxane in agricultural products using liquid chromatograph-tandem mass spectrometry (LC-MS/MS). The samples were extracted with acetonitrile and partitioned with dichloromethane to remove the interference, and then purified by using silica SPE cartridges to clean up. The analytes were quantified and confirmed by using LC-MS/MS in positive ion mode using multiple reaction monitoring (MRM). The matrix-matched calibration curves were linear over the calibration ranges ($0.001-0.25{\mu}g/mL$) into a blank extract with $r^2$>0.99. For validation, recovery tests were carried out at three different concentration levels (LOQ, 10LOQ, and 50LOQ, n=5) with five replicates performed at each level. The recoveries were ranged between 74.5 to 100.8% with relative standard deviations (RSDs) of less than 12.1% for all analytes. All values were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL 40, 2003) and Food Safety Evaluation Department guidelines (2016). The proposed analytical method was accurate, effective and sensitive for sedaxane determination in agricultural commodities.

Analysis and management of new hazard chemicals in foods (식품 중 신종유해물질의 관리 및 분석)

  • Choi, Dongmi;Hu, Soojung;Suh, Junghyuck;Yoon, Taehyung;Kim, Eunju;Choi, Jangduck;Park, Sung-Kug;Lee, Kwangho
    • Analytical Science and Technology
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    • v.22 no.2
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    • pp.172-185
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    • 2009
  • To help understanding about hazard chemicals occurring newly in food, it has been reviewed characteristics, mechanism, food standards and analytical trend of the hazard chemicals occurring avoidably in food manufacturing process. The new hazard chemicals in food are classified by 4 regarding mechanism such as heat, fermentation, additives and unknowns. The new hazard chemicals by heat process are acrylamide, furan, HCAs and PAHs. By the fermentation, ethylcarbamate and biogenic amines are occurred. According to food additives, 3-MCPD, benzene and nitrosamines can be produced. And the last group is the illegal compounds including anti-impotence drug analogues and anti-obesity drug analogues. To analyze the new hazard chemicals in food, GC or LC with UVD, FLD or MSD are used mainly after sample pretreatment by LLE, SPE or headspace method.

포장과 법률-식품이력추적관리기준 등에 관한 규정 제정고시

  • Korea Packaging Association INC.
    • The monthly packaging world
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    • s.186
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    • pp.126-131
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    • 2008
  • 식품의약품안전청은 식품의 제조.가공 또는 판매단계 등에서 식품이력을 추적.관리하기 위하여 필요한 기록의 작성.보관.관리, 표시 및 계획서 등에 관한 기준 등을 규정하여 식품이력추적관리제도의 시행에 차질이 없도록 하고자 식품이력추적관리기준 등에 관한 규정을 제정 고시했다. 본고에서는 주요 내용에 대해 살펴보도록 한다.

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Proficiency test for analyzing illegal compounds in food (식품 중 부정유해물질의 분석 능력평가)

  • Chang, Moonik;Yoon, Taehyung;Hong, Mooki;Choi, Dongmi
    • Analytical Science and Technology
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    • v.20 no.1
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    • pp.78-83
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    • 2007
  • To perform proficiency test for determining anti-impotence drug-like compounds in food, interlaboratory test has been done. Targets were 6 such as sildenafil, tadalafil, vardenafil, homosildenafil, hydroxy-homosildenafil and pseudo-vardenafilI. Total 13 institutes were participated and all is in charging of food analysis. To do double blind test, the reference materials were made as 13 different ginseng drink samples and each sample had random 3 targets. By the official method for anti-impotence drug-like compounds in food code, sample was just diluted in water, extracted in organic solvents, determined by HPLC/UV and then confirmed by LC/MS. The analytical duration was 60 days after receiving sample. Ten out of 13 institutes were satisfied by evaluation of Z-score and RSZ according to the regulation for managing analytical quality assurance.