• Title/Summary/Keyword: 의약품 안전 관리

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Development and Validation of an Analytical Method for Determination of Fungicide Tridemorph in Agricultural Commodities Using LC-MS/MS (LC-MS/MS를 이용한 농산물 중 살균제 tridemorph의 시험법 개발 및 검증)

  • Pak, Won-Min;Do, Jung-Ah;Lim, Seung-Hee;Park, Shin-Min;Yoon, Ji-Hye;Lee, Dong-seouk;Chang, Moon-Ik
    • Journal of Food Hygiene and Safety
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    • v.32 no.4
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    • pp.290-297
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    • 2017
  • The purpose of this study was developed for the determination of tridemorph in agricultural commodities samples. Tridemorph residues in samples were extracted with acetonitrile, partitioned with saline water, and then purified using and aminopropyl ($NH_2$) SPE catridge. The purified samples were quantified and confirmed via liquid chromatograph-tandem mass spectrometer (LC-MS/MS) in positive ion mode using multiple reaction monitoring (MRM). Matrix-matched calibration curves were linear over the calibration ranges (0.005~2.5 ng) into a blank extract with $r^2$ > 0.999. The limits of detection and quantification were 0.001 and 0.005 mg/kg, respectively. The average recovery ranged between 75.9% and 103.7% at different concentration levels (LOQ, 10 LOQ, 50 LOQ, n = 5) with relative standard deviations (RSDs) less than 9.0%. An interlaboratory study was conducted to validate the method by Korea Advanced Food Research Institute. The average recovery ranged between 87.0% and 109.2% at different concentration levels (LOQ, $10{\times}LOQ$, $50{\times}LOQ$, n = 5) with relative standard deviations (RSDs) less than 8.0%. All values were consistent with the criteria ranges requested in the Codex guidelines (CAC/GL40, 2003) and Food Safety Evaluation Department guidelines (2016). The results prove that the developed analytical methods is accurate, effective and sensitive for tridemorph determination.

Problems and Verification System of Probiotics as Livestock-environment Improving Agent Produced and Circulated (축산 환경개선제로 생산.유통되는 생균제의 문제점 및 검증방안)

  • Lee, Eun-Young
    • Microbiology and Biotechnology Letters
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    • v.36 no.2
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    • pp.87-95
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    • 2008
  • Probiotics are live organisms that when administered in adequate amounts confer a health benefit on hosts. The administration of direct-fed microbials (DFM) such as lactobacilli and bacillus, may be a more direct approach to beneficially alter gastrointestinal microflora than altering dietary ingredients or supplementing with growth-promoting levels of antibiotics. It is apparent that microbes have an important influence on immune development and resistance to infection; that microbes are not static colonizers of our bodies, but are dynamic, symbiotic coresidents. And it can improve the surrounding environments; decrease the malodor caused by degrade the excrement. Recently, new paradigm such as environment protection and safe food have been settled. In domestic farm house, there is a great demand for probiotics as a substitute of antibiotics for the improvement of environmental quality and the production of a competitive goods. Probiotics circulated in a country have three categories: an animal medicine permitted by national veterinary research quarantine service (NVRQS), a support feed registered in city or country house, and not-registered goods. However, lots of unqualified goods were produced and circulated. And thus, it is in urgent need of evaluating the present situation and effect of probiotics. This study was conducted to evaluate the system of a probiotics as a livestock-environment improving agents for the alternation of antibiotics and quality control of it.

Monitoring of Veterinary Medicine Residues in Honey (벌꿀 중 동물용의약품 잔류량 모니터링)

  • Kang, Eun-Gui;Jung, Yung-Hyeun;Jung, Ji-Hye;Kim, Mi-Ran;Lee, Kyung-Jin;Jung, Jin-Joo;Park, Jong-Seok;Bahn, Kyeong-Nyeo;Jang, Young-Mi;Kang, Chan-Soon
    • Korean Journal of Food Science and Technology
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    • v.42 no.6
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    • pp.643-647
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    • 2010
  • This research was carried out to investigate residues of neomycin, streptomycin, dihydrostreptomycin, amitraz, 2,4-dimethylaniline (one of amitraz's metabolites), and coumaphos in honey in order to intensively control their use following the establishment of Korean maximum residue limits (MRLs) for veterinary drugs in honey in 2007. To monitor for residues, 110 honeys and food products with honey were collected and analyzed. The collected honeys included acasia, mixed flower, chestnut, rape flower, jujube, and native types. Neomycin, streptomycin, dihydrostreptomycin, oxytetracycline, and amitraz were not detected among samples. Coumaphos was found in the Korean acasia honey at 0.02 mg/kg, but its concentration was under the MRL (0.1 mg/kg) for coumaphos. According to the results, there were no violations of the Korean MRLs of veterinary drugs in honey.

A study on the application of drone in firefight field (소방분야의 드론 활용방안 연구 경향 분석)

  • Ha, Kang Hun;Kim, Jae Ho;Choi, Jae Wook
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.22 no.4
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    • pp.321-330
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    • 2021
  • By reviewing domestic and international papers, this study examines various fields in which drones are used, and based on the results, fields are suggested in which drones can be used for the work of firefighters. Overall, the research results show that drones are most commonly used for search (51%), disaster and fire monitoring (35%), and delivery (14%). Specifically, in the search field, using a drone is more efficient in terms of manpower, equipment, time, and cost than using people, which is the current practice. Secondly, in disaster and fire monitoring, drones can analyze and identify disasters and fire sites in real time. Therefore, it was confirmed that the use of drones is helpful in securing the safety of firefighters and identifying a disaster site. Third, research in logistics shows that drones can secure the so-called golden time in emergency situations by delivering rescue and relief supplies, emergency medicine, and blood in short order. In a rapidly changing disaster environment, and considering aging in firefighters, this study is meaningful in that it promotes drone utilization in the firefighting field by investigating basic data on drone utilization plans.

Microbiological Status and Guideline for Raw Chicken distributed in Korea (국내 유통 닭고기의 미생물 수준과 위생관리기준 적합성)

  • Kim, Hye-Jin;Kim, Dongwook;Song, Sung Ok;Goh, Yong-Gyun;Jang, Aera
    • Korean Journal of Poultry Science
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    • v.43 no.4
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    • pp.235-242
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    • 2016
  • This study was conducted to investigate the microbiological sanitation status of raw chicken meat distributed in Korea, and potential changes in chicken breast quality during storage. The microbiological sanitation status analysis of raw chicken involved studying the results of microbiological monitoring for a 5-year period (2010~2014) by the Korean Food and Drug Administration. Furthermore, the microbiological status of raw chicken meat in meat packing centers and shops in Seoul/Gyeonggi, Kangwon, and Chungcheong Provinces was investigated from July to August 2015. The total bacterial counts of chicken meat in the packaging centers and meat shop of these Provinces were below the level specified in the Korean Meat Microbiological Guideline ($1{\times}10^7$ colony forming units [CFU]/g) and showed a similar microbiological sanitation status with results of the microbiological monitoring for the analyzed 5-year period. To evaluate the relationship between quality change and microbiological level of the meat distributed in Korea, the pH and microbiological and sensory quality characteristics of the chicken breast samples during storage at $4{\pm}2^{\circ}C$were determined. On day 4, the total bacterial count of the chicken breast was 6.76 log CFU/g, which was close to the official $1{\times}10^7CFU/g$ standard, the pH was 5.96, and the overall acceptability was reduced significantly (p<0.05). In particular, the aroma score was <5, indicating that the consumer panel expressed a negative perception even though the chicken contained a lower microbial level than that specified in the Korean microbiological guideline. These results suggest that the current Korean microbiological guideline for raw chicken meat may require a stricter level of up to $1{\times}10^6CFU/g$ to satisfy both meat safety standards and organoleptic quality for consumers.

Study on Suggestions for the Nutritional and Hygienic Standards and Guidelines for Quality Certification in Children's Preferable Food (어린이 기호식품 품질인증을 위한 영양 및 위생기준 설정에 대한 연구)

  • Yun, Jee-Hye;Cho, Sun-Duk;Kim, Seo-Young;Lee, Eun-Ju;Park, Hye-Kyung;Kim, Myung-Chul;Kim, Gun-Hee
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.37 no.5
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    • pp.589-597
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    • 2008
  • The purpose of this study is to arrange for the systematic execution of safety control in children's foods through nutrition and hygiene standard suggestions and guidelines for quality certification system in children's preferable food. Aiming to achieve this objective, the study researched the present status of children’s preferable food sold near elementary schools, elicited the hazards and problems of those foods and selected nutritional and hygienic hazard components in those foods. To suggest the standards and guidelines for quality certification in children's preferable food, the study referred to sundry records, surveyed the practical cases of relevant policies and standards at home and abroad. We studied the standard of nutrition for the quality certification in those foods for sugar, fat, sodium, and additives (tar color: red No. 2 in a ban on use, caffeine), microorganism (aflatoxin $B_1$ (${\mu}g$/kg) and pathogenic bacteria (Staphylococcus aureus, Bacillus cereus, Salmonella spp.), which are the nutrients that may hamper health when taken in a large amount, and the standard for a diet restricted to under 200 kcal per one serving size. Results of distribution of processed foods (242 samples) by nutrition standards were as follows. In case of all ‘low’ level in total sugar, total fat and sodium, 0.4% of total samples was possible to be certified, In case of all ‘medium’ level in total sugar, total fat and sodium, maximumly 22.3% of total samples was possible to be certified. In case of all medium level in nutrients and $\leq$200 kcal/serving, 17.8% of total samples was possible to be certified. Certified food types was milk products and beverages.

The Fiduciary Duties of Doctor in Clinical Trials (임상시험에서 의사의 선량한 관리자의 주의의무)

  • Lee, Jiyoun
    • The Korean Society of Law and Medicine
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    • v.21 no.2
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    • pp.163-207
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    • 2020
  • Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.

The Comparison of Results Among Hepatitis B Test Reagents Using National Standard Substance (국가 표준물질을 이용한 B형 간염 검사 시약 간의 결과 비교)

  • Lee, Young-Ji;Sim, Seong-Jae;Back, Song-Ran;Seo, Mee-Hye;Yoo, Seon-Hee;Cho, Shee-Man
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.203-207
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    • 2010
  • Purpose: Hepatitis B is infection caused by Hepatitis B virus (HBV). Currently, there are several methods, Kits and equipments for conducting Hepatitis B test. Due to ununiformed methods, it would cause some differences. To manage these differences, it needs process evaluating function of test system and reagent using particular standard substance. The aim of this study is to investigate tendency of RIA method's reagent used in Asan Medical Center through comparing several other test reagents using national standard substance. Materials and Methods: The standard substance in National Institute of Food and Drug Safety Evaluation's biology medicine consists of 5 things, 4 antigens and 1 antibody. We tested reagents using A, B company's Kits according to each test method. All tests are measured repeatedly to obtain accurate results. Results: Test result of "HBs Ag Mixed titer Performance panel" is obtained match rate compared S/CO unit standard with RIA method and EIA 3 reagents, CIA 2 reagents is that company A's reagent is 94.4% (17/18), 83.3% (15/18), B is 88.9% (16/18), 77.8% (14/18). Test result of "HBs Ag Low titer Performance panel" is obtain that EIA 2 reagents is shown 7 posive results, CIA 3 reagents is 11, and RIA method's company A's reagent is 3, B is 2 of 13 in low panel. "HBV surface antigen 86.76 IU/vial" tested dilution. A is obtain positive results to 600 times(0.14 IU/mL), B is 300 times (0.29 IU/mL). Case of "HBV human immunoglobulin 95.45 IU/vial", A is shown positive result to 10,000 times (9.5 mIU/mL) and B is 4,000 times (24 mIU/mL). Test result of "HBs Ag Working Standards 0.02~11.52 IU/mL" is shown that Company A's kit concentration level was 0.38IU/mL, company B was 2.23 IU/mL and higher level of concentration was positive results. Conclusion: When comparing various test reagents and RIA method according to National Standard substances for Hepatitis B test, we recognized that there were no significant trends between reagents. For hepatitis B virus antigen-antibody titers even in parts of the test up to 600 times the antigen, antibodies to 10,000 times the maximum positive results could be obtained. Therefore, we confirmed that results from Asan Medical Center are performed smoothly by reagents and system for hepatitis B virus test.

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The Usefulness Evaluation of Radiation Shielding Devices in PET Scan Procedures (PET 검사 프러시저별 방사선 차폐기구의 유용성 평가)

  • Kim, Yeong-Seon;Seo, Myeong-Deok;Lee, Wan-Kyu;Jeong, Yo-Cheon;Kim, Sang-Wook;Seo, Il-Teak;Song, Jae-Beom
    • The Korean Journal of Nuclear Medicine Technology
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    • v.14 no.2
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    • pp.65-76
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    • 2010
  • Purpose: he use of PET scanners and the number of patient in Korea have been increased for recent several years dramatically. For this reason, technologists have more possibilities to be exposed to the radiation. The hospitals using PET scanners should make an effort to reduce the radiation exposure dose. The purpose of this study was to evaluate the radiation exposure does when using radiation shielding devices. The evaluation was performed through questionnaire survey and experiment. Materials and Methods: First, the technologists who had experience working in PET center in 2008-2009 were surveyed with questionnaire and TLD Figures, personal opinion of utilization of radiation shielding devices are analyzed. Second, we measured the shielding rate of shielding devices which have been using in PET study procedures. We divided the procedures into four steps; distribution, moving, injection of $^{18}F$-FDG and patient setup. Results: First, the results of this survey, using of L-block+Syringe shield, L-block, Syringe shield, No shield during the injection, were each 58.5%, 20%, 9%, 12.3%. The TLD values according to utilization of radiation shield, using both L-block+Syringe Shield and L-block showed the lower TLD values, and Syringe shield only or No shield showed the higher TLD values. Second, the results of experiments according to PET study procedures measured the shielding rates as follows. The shielding rates during the distribution using L-block, L-block+Apron shield were measured 97.4%, 97.7%. The shielding rates during the $^{18}F$-FDG delivery to the injection room using mobile Syringe shield, Syringe holder, Syringe shield carrier were each 81.7%, 98.9%, 99.7%. The shielding rates during the injection using Syringe shield, L-block, L-block+Syringe shield were measured each 51.9%, 98.3%, 98.7%. The shielding rates of Apron were measured in each 30, 60, 90, 120, 150 cm distance. The measurement were each 16.9%, 14.2%, 16.6%, 17.1%, 18.1%, 18.6%. Conclusion: The most effective method for radiation shielding is to using L-block during the $^{18}F$-FDG distribution and Syringe shield carrier during in moving $^{18}F$-FDG. For the $^{18}F$-FDG injection, L-block+Syringe shield have to be used. The shielding effect of Apron has shown average 16.4%. According to the survey of questionnaire, the operators recognized well risk of the radiation exposure but, tended ignore in working. The radiation dose according to recognition of radiation exposure risk was not relevant. but radiation dose according to utilization of radiation shield lower the more use it. The main reason of no use of shielding devices is cumbersome, 55% of the respondents answered. I'm sure, by use of radiation shield in all PET procedure, radiation exposure will be reduced considerably.

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Effects of the Enamel Erosion Caused by Certain Antipyretic and Analgesic Medicines for Children (일부 어린이 해열·진통제의 유치 법랑질 부식효과)

  • Cheun, Su-Kyung;Jeong, Moon-Jin;Ahn, Yong-Soon;Lee, Ye-Jin;Ko, Mi-Kyung;Jeong, Soon-Jeong;Lim, Do-Seon
    • Journal of dental hygiene science
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    • v.16 no.3
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    • pp.235-241
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    • 2016
  • This study was conducted to provide basic understanding regarding possible enamel erosion by three kinds of fist-aid antipyretic and analgesic medicines over a period of time, with comparison and analysis of the resulting deciduous teeth surface and microhardness changes. The analysis was performed using energy dispersive X-ray spectroscopy (EDX) and scanning electron microscope (SEM) to examine the surface erosion and changes. The Kruskal-Wallis test show differences in surface erosion and changes after 3, 5 and 8 days of treatment as well as before and after the treatment in each group. According to the results, there was no significant difference in the early deciduous teeth enamel surface microhardness (p>0.01). However there were signigicant changes after 3, 5, and 8 days (p<0.01). Calcim (Ca) and phosphorous (P) analysis using EDX showed significant differences in the enamel characteristics according to each tissue area after 8 days (p<0.05), but there was no significant difference in any of the areas for P content (p>0.05). In the surface observation with the SEM treatment with Children's Tylenol$^{(R)}$ tablet, which has the lowest pH, looked the roughest, followed by Brufen syrup for children and Children's Tylenol$^{(R)}$ suspension. Based on these results, it should be considered that antipyretic and analgesic medicines for children, which have lower pH values, may cause tooth erosion. Hence, it is necessary to give special attention to oral hygiene in young children or infants by brushing their teeth after such drugs are administered.