• Title/Summary/Keyword: Drug safety data

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Mainstream smoke level of harmful substances in korean domestic cigarette brands

  • Choi, Hyun Doc;Song, Seok Ho;Cho, Hoonsik;Kim, Hyung Kyung;Lee, Jin-Hee;Yoon, Soon-Byung;Heo, Seok;Park, Hyoung-Joon
    • Analytical Science and Technology
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    • v.31 no.1
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    • pp.14-22
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    • 2018
  • After signing the WHO FCTC in 2003, South Korea ratified the FCTC in 2005. This study was conducted to provide data on toxic constituents that can be used as useful information for the level of exposure to Korean smokers. Emissions data from five brands of cigarettes were tested under the ISO and "Canadian Intense (HCI)" smoking regimes, respectively. We conducted an analysis of 25 compounds containing nicotine, tar, carbonyls, phenolics, volatile organic compounds (VOCs), and semi-VOC cigarette smoke. Tar and nicotine showed levels of 4.3 to 5.8 mg/cig and 0.4 to 0.5 mg/cig, respectively, which are within the range of tolerance presented in ISO 8243. In the case of carbonyls, formaldehyde was detected within a range of 8.2 to $14.3{\mu}g/cig$, and acetaldehyde was present within a range of 224.7 to $327.2{\mu}g/cig$ under the ISO smoke regime. Crotonaldehyde was not detected under the ISO regime, and all of the carbonyls showed values 2.3 to 4.5 times higher under the HCI regime than those under the ISO regime. Catechol, which showed a level of 47.0 to $80.5{\mu}g/cig$ under the ISO regime and 117.5 to $184.7{\mu}g/cig$ under the HCI regime, was the highest constituent among the phenols. The amount of isoprene was 91.7 to $158.3{\mu}g/cig$ under the ISO regime and 221.0 to 377.0 under the HCI regime. To summarize, most of the constituents showed a tendency to be detected at levels 2 to 4 times higher under the HCI regime than under the ISO regime. Above all, these results represent the first analysis in Korea from an independent institute of tobacco companies under accreditation of ISO 17025.

Analysis of Major Foodborne Pathogens in Various Foods in Korea

  • Kim, Mi-Gyeong;Oh, Mi-Hwa;Lee, Gun-Young;Hwang, In-Gyun;Kwak, Hyo-Sun;Kang, Yun-Sook;Koh, Young-Ho;Jun, Hong-Ki;Kwon, Ki-Sung
    • Food Science and Biotechnology
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    • v.17 no.3
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    • pp.483-488
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    • 2008
  • Foodborne pathogenic bacteria in various food samples in Korea were monitored and the obtained data was statistically analyzed. A total of 1,240 food samples including 280 sashimi, 244 processed frozen products, 258 kimbab (cooked rice wrapped with seaweed), 337 soybean pastes were obtained from 7 cities including Seoul in Korea. Microorganisms tested were Bacillus cereus, Salmonella spp., Staphylococcus aureus, Escherichia coli, E. coli O157:H7, Vibrio parahaemolyticus, Yersinia enterocolitica, Listeria monocytogenes, Campylobacter jejuni, and Clostridium perfringens. The contaminated microorganisms in food samples were comprised of 10.55% B. cereus, 2.7% S. aureus, 2.0% V. parahaemolyticus, 0.8% C. perfringens, 0.2% Y. enterocolitica, and 0.1% of L. monocytogenes, respectively. Salmonella spp., C. jejuni, and E. coli O157:H7 were not detected in any of the food samples. Particularly, B. cereus that harbors the enterotoxin gene was detected in various foods and regions in Korea, therefore it should be a given special consideration not to allow the hazardous level of contamination.

A Comparative Analysis of Elderly Intoxication Patient between Urban and Rural Area for the Safety Management and Emergency Care (농촌과 도시지역 노인약물중독환자의 응급처치와 약물중독안전관리에 대한 연구)

  • Rhim, Jae-Dong;Cho, Byung-Jun;Seoung, Youl-Hun;Kim, Seon-Rye
    • Journal of the Korea Safety Management & Science
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    • v.12 no.1
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    • pp.19-25
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    • 2010
  • To investigate acute drug intoxication trends in the elderly visited Emergency Medical Centers, Data was collected from the records of poisoning patients visited Five different Hospitals from January 1. 2007 to December 31. 2007. The analysis was conducted by using 135 cases of 624 cases. When considering only the elderly and making comparisons between the urban areas and the rural areas the following data was produced. In regard to patients with acute drug intoxication, the main substance of choice was pesticides. Cases of acute drug intoxication are definitely higher for those categorized as the rural elderly (75.0%) when compared with those categorized as the urban elderly (44.1%). The male to female ratio, those living together as a family, past suicide attempts, mental state and sobriety condition when they came, monthly distribution etc. between the two groups did not demonstrate a difference between them. In regard to reasons given for acute drug intoxication, suicide was the highest at 60.7% of the cases. When comparing accidental reasons for poisoning, the urban elderly, at 34.2% of their cases, were higher than in the rural elderly, at 23.7%. After first aid was administered, the admission rate was higher for the rural elderly (47.4%) than for the urban elderly (33.9%). This shows that the rural elderly have a more severe acute drug intoxication poisoning problem than the urban elderly do.

Adverse Drug Reaction Surveillance System in Korea (우리나라 약물유해반응 감시체계)

  • Choi, Nam-Kyong;Park, Byung-Joo
    • Journal of Preventive Medicine and Public Health
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    • v.40 no.4
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    • pp.278-284
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    • 2007
  • Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.

Effects of Mercuric Chloride on Gene Expression in NRK-52E Cells

  • Ahn, Joon-Ik;Baik, Si-Yeon;Ko, Moon-Jeong;Shin, Hee-Jung;Chung, Hye-Joo;Jeong, Ho-Sang
    • Genomics & Informatics
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    • v.8 no.1
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    • pp.50-57
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    • 2010
  • Mercuric chloride, a model nephrotoxicant was used to elucidate time- and dose- dependent global gene expression changes associated with proximal tubular toxicity. Rat kidney cell lines NRK-52E cells were exposed for 2, 6 and 12 hours and with 3 different doses of mercuric chloride. Cell viability assay showed that mercuric chloride had toxic effects on NRK-52E cells causing 20% cell death (IC20) at $40{\mu}M$ concentration. We set this IC20 as high dose concentration and 1/5 and 1/25 concentration of LC20 were used as mid and low concentration, respectively. Analyses of microarray data revealed that 738 genes were differentially expressed (more than two-fold change and p<0.05) by low concentration of mercuric chloride at least one time point in NRK-52E cells. 317 and 2,499 genes were differentially expressed at mid and high concentration of mercuric chloride, respectively. These deregulated genes showed a primary involvement with protein trafficking (CAV2, CANX, CORO1B), detoxification (GSTs) and immunity and defense (HMOX1, NQO1). Several of these genes were previously reported to be up-regulated in proximal tubule cells treated with nephrotoxicants and might be aid in promoting the predictive biomarkers for nephrotoxicity.

Prevalence and Genetic Characterization of mcr-1-Positive Escherichia coli Isolated from Retail Meats in South Korea

  • Kim, Seokhwan;Kim, Hansol;Kang, Hai-Seong;Kim, Yonghoon;Kim, Migyeong;Kwak, Hyosun;Ryu, Sangryeol
    • Journal of Microbiology and Biotechnology
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    • v.30 no.12
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    • pp.1862-1869
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    • 2020
  • The spread of plasmid-mediated colistin resistance has posed a serious threat to public health owing to its effects on the emergence of pandrug-resistant bacteria. In this study, we investigated the prevalence and characteristics of mcr-1-positive Escherichia coli isolated from retail meat samples in Korea. In total, 1,205 E. coli strains were isolated from 3,234 retail meat samples in Korea. All E. coli strains were subjected to antimicrobial susceptibility testing and were examined for the presence of mcr-1 gene. All mcr-1-positive E. coli (n = 10, 0.8%) from retail meat were subjected to pulse-field gel electrophoresis (PFGE) and whole-genome sequencing (WGS). The transferability of mcr-1 gene was determined by conjugation assays. The mcr-1-positive strains exhibited diverse clonal types. Our mcr-1 genes were located in plasmids belonged to the IncI2 (n = 1) and IncX4 (n = 8) types, which were reported to be prevalent in Asia and worldwide, respectively. Most mcr-1 genes from mcr-1-positive strains (9/10) were transferable to the recipient strain and the transfer frequencies ranged from 2.4 × 10-3 to 9.8 × 10-6. Our data suggest that the specific types of plasmid may play an important role in spreading plasmid-mediated colistin resistance in Korea. Furthermore, our findings suggest that the retail meat may be an important tool for disseminating plasmid-mediated colistin resistance.

Development of Analytical Method for Ergot Alkaloids in Foods Using Liquid Chromatoraphy-Tandem Mass Spectrometry (LC-MS/MS를 이용한 식품 중 맥각 알칼로이드 시험법 개발)

  • Chun, So Young;Chong, Euna;Lee, Bomnae;Kwon, Jin-Wook;Park, Hye Young;Kim, Sheenhee;Gang, Giljin
    • Journal of Food Hygiene and Safety
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    • v.34 no.2
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    • pp.158-169
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    • 2019
  • Ergot alkaloids are mycotoxin produced by fungi of the Claviceps genus, mainly by Claviceps purpurea in EU. Recently obtained informations indicates necessity for control the ergot in imported grains. Recent occurrence data of ergot alkaloids from EU countries indicate the necessities of management and control these toxins from the imported grains like rye, wheat, oat etc. The aim of this study is to optimize the liquid chromatography-tandem mass spectrometry method for determination of ergot alkaloids (ergometrine, ergosine, ergotamine, ergocornine, ergocryptine, ergocristine and their epimers (-inines) from grain and grain-based food. The test method was optimized by extracting the sample with acetonitrile containing 2 mM ammonium carbonate, purification with Mycosep cartridge, and instrumental analysis by LC-MS/MS using Syncronis C18 column. The standard calibration curves showed linearity with correlation coefficents; $R^2$ >0.99. Mean recoveries ranged from 72.0 to 111.3% at three different fortified levels (20, 50, and $100{\mu}g/kg$). The correlation coefficient expressed as precision was within the range of 1.9-12.9%. The limit or quantifications (LOQ) ranged from 0.012 to $0.058{\mu}g/kg$. The developed analytical method met the criteria of AOAC Int. and CAC validation parameters like accuracy and sensitivity. As a result, it was confirmed that the test method developed in this study is suitable for the simultaneous analysis of six species of ergot alkaloid from grains and grain products.

Suggestion of Herbal Medicine-Induced Liver Injury Investigation Forms for Improving the Research Quality of Herbal Safety (간손상 관련 한약 안전성 연구의 개선을 위한 한약인성 간손상 조사표 제안)

  • Yun, Young-Ju;Shin, Byung-Cheul;Shin, Woo-Jin;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.30 no.1
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    • pp.181-190
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    • 2009
  • It is important to establish the safety of herbal medicine because of its frequent and widespread use in Korea. Several studies on the safety of herbal medicine have been performed and there have been rare serious adverse drug reactions from those reports in Korea. However, the results are not strongly supported because of not adopting appropriate enough research methodology as to make the safety issue clear. For improving the quality of the safety research on herbal medicine. including investigations of drug induced liver injury (DILl). the aim of this study was to suggest herbal medicine-induced liver injury investigation forms for performing reasonable safety research. After a systematic review of the preceding studies regarding herbal safety in Korea was performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as a following step. one a basic investigation form for herbal safety research and the other an advanced investigation form for suspected DILl cases, Those forms include the essential informations and data needed to make an appropriate assessment of whether DILl occurred during or after the use of herbal medicine. Guidelines for using those forms and other recommendations were also suggested. More rigorous studies are required for answering the safety issue of herbal medicine as well as the efficacy issue. We hope for wide use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.

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Determination of Risk Ranking of Combination of Potentially Hazardous Foods and Foodborne Pathogens Using a Risk Ranger (Risk Ranger를 활용한 잠재적 위해식품과 미생물 조합에 대한 위해순위 결정)

  • Min, Kyung-Jin;Hwang, In-Gyun;Lee, Soon-Ho;Cho, Joon-Il;Yoon, Ki-Sun
    • Journal of Food Hygiene and Safety
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    • v.26 no.2
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    • pp.91-99
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    • 2011
  • Risk ranking must be determined for various hazards/food combinations to conduct microbial risk management effectively. Risk Ranger is a simple, easy-to-use calculation tool developed in Microsoft Excel and designed to rank the risk (low, medium, and high) for semi-quantitative microbial risk assessment. The user is required to answer 11 questions in Risk Ranger related to 1) severity of the hazard, 2) likelihood of a disease-causing dose of the hazard being present in the meal, and 3) the probability of exposure to the hazard in a defined time. This study determined the risk ranking for twenty three combinations of foodborne pathogens/potentially hazardous foods (PHFs) using a Risk Ranger. In this study, pathogenic E. coli in fresh cut produce salad was scored as 79, which was the highest rank among the 23 combinations of the foodborne pathogens and PHFs. On the other hand, zero risk was obtained with V parahaemolyticus in sushi, Salmonella in meat products and E. coli O157:H7 in hamburger patties. Although Risk Ranger is very simple method to rate the risk of foodborne pathogens and PHFs combination, the accuracy of result was mainly affected by the availability and accuracy of data in the literature. According to the result of literature review, the data are needed for contamination rate of raw materials, consumption amount/frequency of PHFs, and the effect of processing on pathogen. Risk ranking must be continuously revalidated with new data.

Evaluation of Toxicological Data on Food Additives and Guideline for ADI establishment - Polydimethylsiloxane as emulsifier - (식품첨가물의 독성자료 고찰과 ADI 평가지침 - 소포제 Polydimethylsiloxane를 사례로 -)

  • Choi, Chan-Woong;Jeong, Ji-Yoon;Park, Hyoung-Su;Moon, Jin-Hyun;Lee, Kwang-Ho;Lee, Hyo-Min
    • Journal of Food Hygiene and Safety
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    • v.24 no.4
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    • pp.352-356
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    • 2009
  • The purpose of this study was to introduce the toxicological study review to evaluate the safety of PDMS on the 69th JECFA meeting. Polydimethylsiloxane is a polymer and its ADI was established at 23rd JECFA meeting in 1979. The ADI was maintained although the specification was expanded at its 26th, 29 th, 37 th meetings. Recently, it was reported that PDMS with low molecular weight and viscosity has high absorption rate and different toxicity, so it was submitted at 69th meeting. Toxicological studies of PDMS were submitted from the sponsor and additional information is collected from a document searching. The toxicological studies were reviewed in accordance with the 'Guidelines for the preparation of toxicological working papers for the Joint FAO/WHO Expert Committee on Food Additives'. In the available acute, sub-chronic and chronic toxicity studies on PDMS, dose-related increases in incidence and severity of ocular lesions(corneal crystal, inflammation of the corneal epithelium etc.) were consistently observed after oral dosing. It seems to be a local irritant effect, but the mechanism by which the ocular lesions arose is unclear, although the lack of absorption of PDMS indicates that it is unlikely to be a direct systemic effect. Consequently, the relevance of the ocular lesions for food use of PDMS could not be determined. The ADI of PDMS was re-established from 0-1.5 mg/kg bw/day to 0-0.8 mg/kg bw/day by applying additional safety factor 2 based on its ocular toxicity. The result of 0-0.8 mg/kg bw/day is a temporary ADI until further data are provided to 2010.