• 제목/요약/키워드: Drug safety data

검색결과 373건 처리시간 0.033초

Establishment of Acceptable Daily Intakes (ADIs) and Risk Assessment for Ephedrine, Menichlopholan, Anacolin, and Etisazole Hydrochloride

  • Min Ji Kim;Ji Young Kim;Jang Duck Choi;Guiim Moon
    • 한국환경농학회지
    • /
    • 제41권4호
    • /
    • pp.261-275
    • /
    • 2022
  • BACKGROUND: Prior to implementing a positive list system (PLS), there is a need to establish acceptable daily intake (ADI) and maximum residue limit (MRL) for veterinary drugs that have been approved a few decades ago in South Korea. On top of that, chronic dietary exposure assessment of veterinary drug residues should be performed to determine whether the use of these veterinary drugs would cause health concerns or not. METHODS AND RESULTS: To establish the ADI, the relevant toxicological data were collected from evaluation reports issued by international organizations. A slightly modified global estimate of chronic dietary exposure (GECDE) model was employed in the exposure assessment owing to the limited residual data. Therefore, only the ADI of ephedrine was established due to insufficient data for the other veterinary drugs. Thus, instead of ADI, the threshold of toxicological concern (TTC) value was used for the other drugs. Lastly, the hazard index (HI) was calculated, except for etizazole hydrochloride, due to the potential of mutagenicity. CONCLUSION(S): The HI values of ephedrine, menichlopholan, and anacolin were found to be as high as 6.4%, suggesting that chronic dietary exposure to the residues from these uses was unlikely to be a public health concern. Further research for exposure assessment of veterinary drug residues should be performed using up-todate Korean national health and nutrition examination survey (KNHANES) food consumption data. In addition, all relevant available data sources should be utilized for identifying the potentials of toxicity.

QuEChERS법을 활용한 농산물 중 제초제 Tolpyralate의 최적 분석법 선발 및 검증 (Application and Validation of an Optimal Analytical Method using QuEChERS for the determination of Tolpyralate in Agricultural Products)

  • 이한솔;박지수;이수정;신혜선;김지영;윤상순;정용현;오재호
    • 한국환경농학회지
    • /
    • 제39권3호
    • /
    • pp.246-252
    • /
    • 2020
  • BACKGROUND: Pesticides are broadly used to control weeds and pests, and the residues remaining in crops are managed in accordance with the MRLs (maximum residue limits). Therefore, an analytical method is required to quantify the residues, and we conducted a series of analyses to select and validate the quick and simple analytical method for tolpyralate in five agricultural products using QuEChERS (quick, easy, cheap, effective, rugged and safe) method and LC-MS/MS (liquid chromatography-tandem mass spectrometry). METHODS AND RESULTS: The agricultural samples were extracted with acetonitrile followed by addition of anhydrous magnesium sulfate, sodium chloride, disodium hydrogencitrate sesquihydrate and trisodium citrate dihydrate. After shaking and centrifugation, purification was performed with d-SPE (dispersive-solid phase extraction) sorbents. To validate the optimized method, its selectivity, linearity, LOD (limit of detection), LOQ (limit of quantitation), accuracy, repeatability, and reproducibility from the inter-laboratory analyses were considered. LOQ of the analytical method was 0.01 mg/kg at five agricultural products and the linearity of matrix-matched calibration were good at seven concentration levels, from 0.0025 to 0.25 mg/L (R2≥0.9980). Mean recoveries at three spiking levels (n=5) were in the range of 85.2~112.4% with associated relative standard deviation values less than 6.2%, and the coefficient of variation between the two laboratories was also below 13%. All optimized results were validated according to the criteria ranges requested in the Codex Alimentarius Commission (CAC) and Ministry of Food and Drug Safety (MFDS) guidelines. CONCLUSION: In conclusion, we suggest that the selected and validated method could serve as a basic data for detecting tolpyralate residue in imported and domestic agricultural products.

Seasonal Changes in the Microbial Communities on Lettuce (Lactuca sativa L.) in Chungcheong-do, South Korea

  • Woojung Lee;Min-Hee Kim;Juyeon Park;You Jin Kim;Eiseul Kim;Eun Jeong Heo;Seung Hwan Kim;Gyungcheon Kim;Hakdong Shin;Soon Han Kim;Hae-Yeong Kim
    • Journal of Microbiology and Biotechnology
    • /
    • 제33권2호
    • /
    • pp.219-227
    • /
    • 2023
  • Lettuce is one of the most consumed vegetables worldwide. However, it has potential risks associated with pathogenic bacterial contamination because it is usually consumed raw. In this study, we investigated the changes in the bacterial community on lettuce (Lactuca sativa L.) in Chungcheong-do, South Korea, and the prevalence of foodborne pathogens on lettuce in different seasons using 16S rRNA gene-based sequencing. Our data revealed that the Shannon diversity index showed the same tendency in term of the number of OTUs, with the index being greatest for summer samples in comparison to other seasons. Moreover, the microbial communities were significantly different between the four seasons. The relative abundance of Actinobacteriota varied according to the season. Family Micrococcaceae was most dominant in all samples except summer, and Rhizobiaceae was predominant in the microbiome of the summer sample. At the genus level, the relative abundance of Bacillus was greatest in spring samples, whereas Pseudomonas was greatest in winter samples. Potential pathogens, such as Staphylococcus and Clostridium, were detected with low relative abundance in all lettuce samples. We also performed metagenome shotgun sequencing analysis on the selected summer and winter samples, which were expected to be contaminated with foodborne pathogens, to support 16S rRNA gene-based sequencing dataset. Moreover, we could detect seasonal biomarkers and microbial association networks of microbiota on lettuce samples. Our results suggest that seasonal characteristics of lettuce microbial communities, which include diverse potential pathogens, can be used as basic data for food safety management to predict and prevent future outbreaks.

위해평가 및 모니터링 수행을 위한 표본크기 추정연구: 식품 중 중금속 모니터링 데이터를 중심으로 (Sample Size Estimation for Risk Assessment and Monitoring Based on Heavy Metal Monitoring Data from Food Items)

  • 강희승;고아라;정다현;하미라;황명실;홍진환;황인균;윤혜정
    • 한국식품위생안전성학회지
    • /
    • 제30권2호
    • /
    • pp.127-131
    • /
    • 2015
  • 본 연구에서는 기존에 수행된 식품 중금속 모니터링 데이터를 이용하여 위해평가 및 모니터링을 수행할 때 요구되는 표본 수를 추정하고자 하였다. 중금속 3종 (카드뮴, 납 및 수은)과 17개의 식품을 대상으로 2,400개의 모니터링 데이터를 선정하여 연구에 활용하였다. 기존의 연구에서 수행된 모니터링 데이터의 표준편차와 오차범위 및 신뢰구간 값(95, 99% CI)을 활용하여 표본 수 추정공식에 따라 계산하였다. 표본 수 추정 공식에 따라 표본 크기를 추정한 결과, 95% 신뢰구간에서 카드뮴의 경우 계산된 표본의 크기는 최소 8개에서 최대 90개, 납의 경우 최소 7개에서 최대 1,062개, 수은의 경우 최소 11개에서 최대 238개로 각각 추정되었다. 식품 중 중금속 데이터의 표준 편차와 오차범위가 표본 수를 추정하는데 가장 큰 영향을 주는 것으로 나타났다. 본 연구에서는 모니터링 데이터의 특성을 반영하여 표본 크기를 추정하고자 하였으며, 이는 향후 위해평가 및 모니터링 수행 계획을 수립하기 위한 표본 수를 결정하는 기초연구로 활용될 수 있을 것이다.

Rapid determination and quantification of hair-growth compounds in adulterated products by ultra HPLC coupled to quadrupole-orbitrap MS

  • Lee, Ji Hyun;Park, Han Na;Kang, Gihaeng;Kim, Nam Sook;Park, Seongsoo;Lee, Jongkook;Kang, Hoil
    • 분석과학
    • /
    • 제32권2호
    • /
    • pp.56-64
    • /
    • 2019
  • Recently, a number of adulterated products, which are advertised as hair-growth enhancer have been emerged among those who suffer hair loss disease. For continuous control of illegal products, in this study, a rapid and sensitive method for simultaneous screening of 12 compounds that enhance hair-growth was established to protect public health by ultrahigh-performance liquid chromatography coupled to quadrupole-orbitrap mass spectrometry (UHPLC-Q-Orbitrap-MS). Fragmentation pathways of them were proposed based on $MS^2$ spectral data obtained using the established method. In this analysis, the LODs and LOQs ranged from 0.05 to 50 ng/mL and from 0.17 to 167 ng/mL, respectively. The square of the linear correlation coefficient ($R^2$) was determined as more than 0.995. The intra- and inter-assay accuracies were respective 88-112 % and 88-115 %. Their precision values were measured within 5 % (intra-day) and 10 % (inter-day). Mean recoveries of target compounds in adulterated products ranged from 84 to 115%. The relative standard deviation of stability was less than 12 % at $4^{\circ}C$ for 48 h. The method was employed to screen 14 dietary supplements advertised to be effective for the treatment of hair loss. Some of the products (~21 %) were proven to contain synthetic drugs that promote hair growth such as triaminodil, minoxidil, and finasteride.

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
    • /
    • 제34권3호
    • /
    • pp.191-197
    • /
    • 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.

액체크로마토그래프-질량분석기를 이용한 정성 및 정량 오류의 확인 (Identification of Pitfalls Related to the Analysis of Liquid Chromatography-Tandem Mass Spectrometry and Liquid Chromatography-Time of Flight Mass Spectrometry)

  • 권진욱;조윤제;이규식
    • 한국환경농학회지
    • /
    • 제34권3호
    • /
    • pp.230-237
    • /
    • 2015
  • BACKGROUND: To identify the sources of inaccuracy in LC/MS/MS methods used in the routine quantitation of small molecules are described and discussed. METHODS AND RESULTS: Various UPLC coupled to triple quadrupole mass spectrometer and time of flight (TOF) were used to identify the potential sources of inaccuracy and inducing the pitfalls of qualification and quntitation during the veterinary drug residue analysis. Some of stable isotope labelled veterinary drugs, which were used as internal standards, presented "cross-talk", regardless of manufactures of mass spectrometer and types of spectrometer. Group of sulfonamides also presented inaccuracy qualification and quantitation due to the multi-residue analytical method with the same fragment ions at the close retention times. CONCLUSION: The phenomena of "cross-talk" occurring between subsequently monitored transition from stable isotope labelled and isotope non-labelled authentic chemical were identified. To prevent errors and achieve more accurate data during the analysis of small molecules by LC/MS/MS SRM method, Followings should be taken care of and kept checking; purity and concentration of stable isotope as an internal standard, prevention of carry-over during the separation in column, minimizing the ion suppression by matrix effect, identification of retention time, precursor ion and product ion, and full knowledge of data processing including smoothing and peak integration.

Neurotoxicity of Synthetic Cannabinoids JWH-081 and JWH-210

  • Cha, Hye Jin;Seong, Yeon-Hee;Song, Min-Ji;Jeong, Ho-Sang;Shin, Jisoon;Yun, Jaesuk;Han, Kyoungmoon;Kim, Young-Hoon;Kang, Hoil;Kim, Hyoung Soo
    • Biomolecules & Therapeutics
    • /
    • 제23권6호
    • /
    • pp.597-603
    • /
    • 2015
  • Synthetic cannabinoids JWH-018 and JWH-250 in 'herbal incense' also called 'spice' were first introduced in many countries. Numerous synthetic cannabinoids with similar chemical structures emerged simultaneously and suddenly. Currently there are not sufficient data on their adverse effects including neurotoxicity. There are only anecdotal reports that suggest their toxicity. In the present study, we evaluated the neurotoxicity of two synthetic cannabinoids (JWH-081 and JWH-210) through observation of various behavioral changes and analysis of histopathological changes using experimental mice with various doses (0.1, 1, 5 mg/kg). In functional observation battery (FOB) test, animals treated with 5 mg/kg of JWH-081 or JWH-210 showed traction and tremor. Their locomotor activities and rotarod retention time were significantly (p<0.05) decreased. However, no significant change was observed in learning or memory function. In histopathological analysis, neural cells of the animals treated with the high dose (5 mg/kg) of JWH-081 or JWH-210 showed distorted nuclei and nucleus membranes in the core shell of nucleus accumbens, suggesting neurotoxicity. Our results suggest that JWH-081 and JWH-210 may be neurotoxic substances through changing neuronal cell damages, especially in the core shell part of nucleus accumbens. To confirm our findings, further studies are needed in the future.

국내 유통 농산물의 잔류농약 모니터링 및 위해평가-2013년 (Monitoring and Risk Assessment of Pesticide Residues for Circulated Agricultural Commodities in Korea-2013)

  • 김재영;이상목;이한진;장문익;강남숙;김남선;김희정;조윤제;정지윤;김미경;이규식
    • Journal of Applied Biological Chemistry
    • /
    • 제57권3호
    • /
    • pp.235-242
    • /
    • 2014
  • 본 연구는 국내 유통 농산물의 잔류농약 실태를 조사파악하고, 위해평가 등의 안전성 평가를 수행한 후 정부차원에서의 식품 위생/안전 정책 수립의 과학적 근거를 마련하고자 수행되었다. 시료 수거는 인구 백만 이상의 전국 9개 지역(서울, 부산, 인천, 대구, 대전, 광주, 울산, 창원 및 수원)을 선정한 후, 다소비 식품 중 대표적인 농산물 15품목(쌀, 감자, 대두, 사과, 배, 오렌지, 복숭아, 딸기, 바나나, 수박, 토마토, 오이, 애호박, 깻잎 및 무)을 선별하여 총 232건의 농산물을 수거하였다. 대상 농약은 단성분 분석으로 가능한 생장조정제 3종(dichlorprop, ethychlozate 및 6-benzylaminopurine) 및 다종다성분 분석 농약 280종, 총 283종을 선정하여 잔류농약 모니터링을 수행하였다. 분석 대상 농약들은 모니터링에 앞서 분석법을 개선하고 분석검체를 대표할 수 있는 농산물에 적용하여 국제적 기준인 CODEX 분석법 가이드라인에 준하여 분석법 검증을 수행한 후, 잔류농약 모니터링 분석법으로 사용하였다. 또한 모니터링에서 검출된 잔류농약을 대상으로 1일 섭취허용량(acceptable daily intake, ADI) 대비 1일 추정섭취량(estimated daily intake, EDI) 값으로 위해 평가를 수행하였다. 잔류농약 모니터링을 수행한 결과, 수거된 농산물 총 232건 중 163건(70.3%)에서는 농약이 검출되지 않았으며, 69건(29.7%)에서 잔류농약이 검출되었다. 검출된 농약 중 2건은 MRL을 초과하여 0.9%의 부적합률을 나타내었다. MRL을 초과한 잔류농약은 깻잎에서 검출된 chlorpyrifos와 복숭아에서 검출된 picoxystrobin이었으며, 부적합으로 나타난 chlorpyrifos 및 picoxystrobin을 포함한 검출 농약 33종에 대해 위해평가를 수행한 결과, ADI 대비 EDI는 0.00087~0.902%의 범위를 나타내었다. 이러한 결과를 통해 검출된 모든 농약은 위해도가 매우 낮은 것으로 판단됐으며, 유통되는 농산물은 잔류농약 측면에서 안전한 수준임을 확인하였다.

의료기기 허가.기술문서 원자재 작성 가이드라인 개발 (The Development for guideline of raw matrials on technical document of Medical Device)

  • 박기정;유규하;이성희;이창형;정진백;이재근;허찬회;김형범;최민용;김용우;황상연;정재훈;구자중;홍혜경;임경택;강세구;곽지영
    • 대한의용생체공학회:의공학회지
    • /
    • 제31권6호
    • /
    • pp.434-437
    • /
    • 2010
  • For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.