• Title/Summary/Keyword: Ministry of Food and Drug Safety in Korea

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Detection of CTX-M Type ESBL Producing Salmonella in Retail Meat in Korea

  • Kim, Yong Hoon;Joo, In Sun;Kim, Yoon Jeong;Oh, Mi Hyun;Cho, Joon Il;Han, Min Kyong;Kim, Soon Han;Moon, Tae Wha;Park, Kun Sang
    • Journal of Food Hygiene and Safety
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    • v.29 no.1
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    • pp.47-52
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    • 2014
  • This study was performed to evaluate antimicrobial resistance of food-borne pathogens isolated from retail meat in Korea. A total of 157 samples of beef, pork, and chicken were collected and analyzed for E. coli, Salmonella, Campylobacter. Resistances to tetracycline were declined in accord with reduced usage of tetracycline in live stock production. E. coli stains from chicken meat had higher multi-drug resistance ratio than strains from other meat. One extended spectrum beta lactamase (ESBL) producing E. coli and two ESBL producing Salmonella were identified in this study. ESBL producing Salmonella strains were confirmed to carry CTX-M-1 type genes.

Dependence Potential of Tramadol: Behavioral Pharmacology in Rodents

  • Cha, Hye Jin;Song, Min Ji;Lee, Kwang-Wook;Kim, Eun Jung;Kim, Young-Hoon;Lee, Yunje;Seong, Won-Keun;Hong, Sa-Ik;Jang, Choon-Gon;Yoo, Han Sang;Jeong, Ho-Sang
    • Biomolecules & Therapeutics
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    • v.22 no.6
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    • pp.558-562
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    • 2014
  • Tramadol is an opioid analgesic agent that has been the subject of a series of case reports suggesting potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive in Korea. In this study, we examined the dependence potential and abuse liability of tramadol as well as its effect on the dopaminergic and serotonergic systems in rodents. In animal behavioral tests, tramadol did not show any positive effects on the experimental animals in climbing, jumping, and head twitch tests. However, in the conditioned place preference and self-administration tests, the experimental animals showed significant positive responses. Taken together, tramadol affected the neurological systems related to abuse liability and has the potential to lead psychological dependence.

Genetic Analysis of Medicinal Plants in Adenophorae Radix Using DNA Barcode (DNA바코드를 활용한 사삼(沙蔘)의 종 감별)

  • Kim, Minkyeoung;Lee, Wookyu;Kim, Jaelim;Lee, Kiho;Choi, Yoorae;Kim, Jonghwan;Kang, Ilhyun;Kang, Juhye
    • Proceedings of the Plant Resources Society of Korea Conference
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    • 2019.10a
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    • pp.97-97
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    • 2019
  • 사삼(沙蔘, Adenophorae Radix)은 "대한민국약전외한약(생약)규격집(KHP)"에 잔대 Adenophora triphylla var. japonica Hara 또는 사삼(당잔대, A. stricta Miq.)의 뿌리로 수재되어 있으나, 형태학적으로 유사한 제니(모시대, A. remotiflorus Miquel), 층층잔대(윤엽사삼, A. tetraphylla (Thunb.) Fisch), 더덕 Codonopsis lanceolata (Sieb. et Zucc.)과 오 혼용 우려가 있어 이들을 구별하기 위한 종 감별법이 필요하다. 본 연구에서는 '사삼'과 오 혼용 우려가 있는 종들을 구별할 수 있는 유전자 마커 개발을 위하여 DNA 바코드로 활용되고 있는 유전자 부위를 분석하여 ITS (25%), atpB-rbcL (15%), atpF-atpH (14%), rpl16 (13%), trnL-F (10%), matK (9%), rpoC1 (7%)에서 변이율(percent of variable sites)을 확인하였다. 또한, 분석한 유전자 부위 중 종간 차이를 확인하기 용이한 matK 구간을 활용해 기원종인 잔대, 당잔대와 형태적으로 유사하여 오 혼용될 우려가 있는 층층잔대, 모시대 및 더덕을 감별 할 수 있는 유전자 마커를 개발하였다. 본 연구를 통해 얻어진 염기서열과 분자 마커는 '사삼'의 품질관리에 유용하게 활용 가능할 것으로 사료된다.

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Total Diet Studies as a Tool for Ensuring Food Safety

  • Lee, Joon-Goo;Kim, Sheen-Hee;Kim, Hae-Jung;Yoon, Hae-Jung
    • Toxicological Research
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    • v.31 no.3
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    • pp.221-226
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    • 2015
  • With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety.

Phototoxicity Evaluation of Pharmaceutical Substances with a Reactive Oxygen Species Assay Using Ultraviolet A

  • Lee, Yong Sun;Yi, Jung-Sun;Lim, Hye Rim;Kim, Tae Sung;Ahn, Il Young;Ko, Kyungyuk;Kim, JooHwan;Park, Hye-Kyung;Sohn, Soo Jung;Lee, Jong Kwon
    • Toxicological Research
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    • v.33 no.1
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    • pp.43-48
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    • 2017
  • With ultraviolet and visible light exposure, some pharmaceutical substances applied systemically or topically may cause phototoxic skin irritation. The major factor in phototoxicity is the generation of reactive oxygen species (ROS) such as singlet oxygen and superoxide anion that cause oxidative damage to DNA, lipids and proteins. Thus, measuring the generation of ROS can predict the phototoxic potential of a given substance indirectly. For this reason, a standard ROS assay (ROS assay) was developed and validated and provides an alternative method for phototoxicity evaluation. However, negative substances are over-predicted by the assay. Except for ultraviolet A (UVA), other UV ranges are not a major factor in causing phototoxicity and may lead to incorrect labeling of some non-phototoxic substances as being phototoxic in the ROS assay when using a solar simulator. A UVA stimulator is also widely used to evaluate phototoxicity in various test substances. Consequently, we identified the applicability of a UVA simulator to the ROS assay for photoreactivity. In this study, we tested 60 pharmaceutical substances including 50 phototoxins and 10 non-phototoxins to predict their phototoxic potential via the ROS assay with a UVA simulator. Following the ROS protocol, all test substances were dissolved in dimethyl sulfoxide or sodium phosphate buffer. The final concentration of the test solutions in the reaction mixture was 20 to $200{\mu}M$. The exposure was with $2.0{\sim}2.2mW/cm^2$ irradiance and optimization for a relevant dose of UVA was performed. The generation of ROS was compared before and after UVA exposure and was measured by a microplate spectrophotometer. Sensitivity and specificity values were 85.7% and 100.0% respectively, and the accuracy was 88.1%. From this analysis, the ROS assay with a UVA simulator is suitable for testing the photoreactivity and estimating the phototoxic potential of various test pharmaceutical substances.

A Collaborative Study to Establish the Second Korean National Reference Standard for Snake Venom

  • Han, Kiwon;Jung, Kikyung;Oh, Hokyung;Song, Hojin;Park, Sangmi;Kim, Ji-Hye;Min, Garam;Lee, Byung-Hwa;Nam, Hyun-sik;Kim, Yang Jin;Ato, Manabu;Jeong, Jayoung;Ahn, Chiyoung
    • Toxicological Research
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    • v.34 no.3
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    • pp.191-197
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    • 2018
  • In 2015, a candidate for the second national reference standard (NRS) of Gloydius snake venom was produced to replace the first NRS of Gloydius snake venom. In the present study, the potencies of the candidate were determined by a collaborative study, and the qualification of the candidate was estimated. The potencies of the candidate were determined by measuring the murine lethal titers and lapine hemorrhagic titers of venom against the regional working reference standard (RWRS) for antivenom using the methods described in the previous report for the first NRS of Gloydius snake venom. Three Korean facilities contributed data from a total of 30 independent assays. Subsequently, two foreign national control research laboratories contributed to this collaborative study. The results were calculated using the Reed-Muench method for lethality and determined using a mixed-effects model for hemorrhage. The general common potencies of the lethal and hemorrhagic titers were obtained from the results of the 30 tests performed at three Korean facilities. The results are expressed in micrograms for 1 test dose (TD) with a 95% confidence interval as follows: a lethal titer of $90.13{\mu}g/TD$ (95% confidence interval = $87.39{\sim}92.86{\mu}g$) and a hemorrhagic titer of $10.80{\mu}g/TD$ (95% confidence interval = $10.46{\sim}11.14{\mu}g$). In addition, the candidate preparation showed good quality evaluation according to the results of the quality estimation of the candidate and is judged to be suitable to serve as the Korean NRS for snake venom. In conclusion, the second NRS of Gloydius snake venom was established in this study and will be used for national quality control, including a national lot release test of Korean antivenom products.

Multiclass Method for the Determination of Anthelmintic and Antiprotozoal Drugs in Livestock Products by Ultra-High-Performance Liquid Chromatography-Tandem Mass Spectrometry

  • Hyunjin Park;Eunjung Kim;Tae Ho Lee;Sihyun Park;Jang-Duck Choi;Guiim Moon
    • Food Science of Animal Resources
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    • v.43 no.5
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    • pp.914-937
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    • 2023
  • The objective of this study was to establish a multi-residue quantitative method for the analysis of anthelmintic and antiprotozoal drugs in various livestock products (beef, pork, and chicken) using ultra-high-performance liquid chromatography-tandem mass spectrometry. Each compound performed validation at three different levels i.e., 0.5, 1, and 2× the maximum residue limit according to the CODEX guidelines (CAC/GL 71-2009). This study was conducted according to the modified quick, easy, cheap, effective, rugged, and safe procedure. The matrix-matched calibrations gave correlation coefficients >0.98, and the obtained recoveries were in the range of 60.2%-119.9%, with coefficients of variation ≤32.0%. Furthermore, the detection and quantification limits of the method were in the ranges of 0.03-3.2 and 0.1-9.7 ㎍/kg, respectively. Moreover, a survey of residual anthelmintic and antiprotozoal drugs was also carried out in 30 samples of beef, pork, and chicken collected in Korea. Toltrazuril sulfone was detected in all three samples. Thus, our results indicated that the developed method is suitable for determining the anthelmintic and antiprotozoal drug contents in livestock products.

Measurement of CYP450 Enzymes Activity of Bosentan in HepaRG Cell (HepaRG 세포를 이용한 Bosentan 약물의 CYP450 효소활성 측정)

  • Han, Kyoung-Moon;Jung, Jung-A;Sin, Ji-Soon;Cha, Hye-Jin;Bae, Young-Ji;Kim, Hyun-Uk;Kim, Young-Hoon;Seong, Won-Keun;Kang, Hoil
    • YAKHAK HOEJI
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    • v.58 no.4
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    • pp.255-261
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    • 2014
  • Poly-pharmacy has been on the rise because of aging of population and chronic disease. Most of drug metabolism happens in the liver by CYP isozymes and the metabolism by CYP450 enzymes. The Cytochrome P450 (CYP) is a superfamily of enzymes that catalyzes the oxidations of many endogenous and exogenous compounds. Primary human Hepatocytes (HH) are considered as the gold standard model for In vitro drug interaction studies. However, there are several limitations (cost, limited life span) for using HH cells. HepaRG cells are being used as a possible alternative. HepaRG cells were cultured in William E medium containing the positive control inducers (1A2: 10, 25, 50 ${\mu}M$ omeprazole, 2C9 and 2C19: 10 ${\mu}M$ rifampin, 3A4: 10, 25, 50 ${\mu}M$ rifampin) at $37^{\circ}C$, 5 % $CO_2$ in a humidified atmosphere. This study was to evaluate the induction of CYP isozymes (1A2, 2C9, 2C19 and 3A4) using LC-MS/MS. We evaluated the potential induction ability of Bosentan, as a drug of pulmonary artery hypertension, in HepaRG cells. For reference, dose of the Bosentan is determined to the basis of the $C_{max}$ (835 mg/ml) value. The enzyme activity demonstrated that CYP2C9 and 3A4 were induced up to 20 times by Bosentan. Like as In vivo, the enzyme activity of CYP2C9 and CYP3A4 is significantly induced in a dose-dependent by Bosentan.

Discrimination of biological and artificial nicotine in e-liquid

  • Hyoung-Joon Park;Heesung Moon;Min Kyoung Lee;Min Soo Kim;Seok Heo;Chang-Yong Yoon;Sunyoung Baek
    • Analytical Science and Technology
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    • v.36 no.1
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    • pp.22-31
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    • 2023
  • As the use of e-liquid cigarettes is rapidly increasing worldwide, it multiplies the potential risk undisclosed to the health of non- and smokers. To reduce the hazard, each country has its own set of regulations for controlling e-liquids. In Korea, the narrow definition of tobacco makes it difficult and have been steadily occurring tax evasion exploiting the difference in natural and artificial nicotine. Therefore, it is very important to distinguish source of nicotine for their regulation. To find biochemical discriminant markers, this study established analysis methods based on high-performance liquid chromatography coupled with diode array detector (HPLC-DAD) and high-performance liquid chromatography coupled with triple Quadrupole mass spectrometry (HPLC-MS/MS) for nicotine enantiomers and tobacco alkaloids targeted using the difference in pathways of nicotine biosynthesis and chemical synthesis. The method was validated by experimenting linearity (R2 > 0.999), recovery (80.99-108.41 %), accuracy (94.11-109.73 %) and precision (0.04-8.27 %). Then, the results for discrimination of the nicotine obtained from analysis of 65 commercial e-liquid products available in Korean market was evaluated. The method successfully applied to the e-liquids and one sample labelled 'synthetic nicotine' for tax exemption was found to contain a natural nicotine product. This method can be used to determine whether an e-liquid product uses natural or artificial nicotine and monitor non-taxable e-liquid products. The method is more scientific than the existing one, which relies only on field evidence.

Study for Residue Analysis of Pinoxaden in Agricultural Commodities

  • Kim, Ji Young;Yoon, Eun Kyung;Kim, Jong Soo;Seong, Nu Ri;Yun, Sang Soon;Jung, Yong Hyun;Oh, Jae Ho;Kim, Hyochin
    • Korean Journal of Environmental Agriculture
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    • v.38 no.4
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    • pp.321-331
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    • 2019
  • BACKGROUND: Pinoxaden is the phenylpyrazoline herbicide developed by Syngenta Crop Protection, Inc. and marketed on 2006. The maximum residue levels for wheat and barley were set by import tolerance. Thus, Ministry of Food and Drug Safety (MFDS) official analytical method determining Pinoxaden residue was necessary in various food matrixes. Satisfaction of international guideline of CODEX (Codex Alimentarius Commission CAC/GL 40) and National Institute of Food and Drug Safety Evaluation-MFDS (2017) are additional pre-requirements for analytical method. In this study, liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was investigated to analyze residue of Pinoxaden (M4), which is defined as pesticide residue in Korea, in foods. METHODS AND RESULTS: Pinoxaden (M4) was extracted followed by acid digestion (2hr reflux with 1N HCl) and pH adjusting (pH 4-5 with 3% ammonium solution). To remove oil, additional clean-up step with hexane saturated with acetonitrile was required to high oil contained sample before purification. HLB cartridge and nylon syringe filter were used for purification. Then, samples were analyzed by LC-MS/MS using reserve phase column C18. Five agricultural group representative commodities (mandarin, potato, soybean, hulled rice, and red pepper) were used to verify the method in this study. The liner matrix-matched calibration curves were confirmed with coefficient of determination (r2) > 0.99 at calibration range 0.002-0.2 mg/kg. The limits of detection and quantitation were 0.004 and 0.01 mg/kg, respectively, which were suitable to apply Positive List System (PLS). Mean average accuracies of pinoxaden (M4) were shown to be 74.0-105.7%. The precision of pinoxaden and its metabolites were also shown less than 14.5% for all five samples. CONCLUSION: The method investigated in this study was suitable to CODEX (CAC/GL 40) and National Institute of Food and Drug Safety Evaluation-MFDS (2017) guideline for residue analysis. Thus, this method can be useful for determining the residue in various food matrixes in routine analysis.