• 제목/요약/키워드: Safety Standard Guideline

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Quality Control of Majoon-e-Nisyan and its Acute Oral Toxicity Study in Experimental Rats

  • Shaikh, Masud;Husain, Gulam M.;Naikodi, Mohammed Abdul Rasheed;Kazmi, Munawwar H.;Viquar, Uzma
    • 셀메드
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    • 제11권1호
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    • pp.2.1-2.8
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    • 2021
  • The clinical condition Amnesia causes difficulty in learning new information and the inability to recall past events. It is primarily concerned with recent memory loss. Majoon-e-Nisyan (MJN) is a polyherbal Unani formulation, present in a semi-solid form. It is widely used potent drug of the Unani System of Medicine (USM) for treating Nisyan (amnesia). In the present study polyherbal Unani formulation, MJN has been studied for its quality control and acute toxicity. Standardization (quality control) of drugs deals with drug identity, drug quality and purity determination. Standardization of MJN had been done as per the Unani pharmacopoeial parameters approved by World Health Organization (WHO) - Pharmacognostical parameters, Physico-chemical parameters, high-performance thin-layer chromatography (HPTLC), microbial load, aflatoxin, and heavy metals. Solvents and chemicals used in the study were of analytical grade and used instrument were calibrated. By conducting an acute oral toxicity study in rats, the safety of MJN was assessed. The limit test method of OECD guideline 425 was followed in the study. Results of standardization and standard operating procedures (SOPs) for preparation of MJN may serve as the standard reference in the future. The data generated in the study for the quality control of MJN proved the quality of formulation and shows that MJN is not toxic in rats following acute dosing up to 2000 mg/kg bw. The data obtained in the paper for MJN may be used as a standard guideline for preparation of the formulation which can save time, cost, and resources for future research endeavours.

일반철도 유지보수 합리화를 위한 궤도틀림 기준 연구방향 (A Study of Track Irregularity Standard for Rational Track Maintenance)

  • 김수정;이병혁;이두재;엄종우
    • 한국철도학회:학술대회논문집
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    • 한국철도학회 2011년도 정기총회 및 추계학술대회 논문집
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    • pp.1624-1630
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    • 2011
  • Currently the train operating environment to affect track irregularity is changed rapidly such as speed-up, linear improvement and rolling stack upgrade. The recent track maintenance criteria of track irregularity was quoted from past Japan's, and the needs of revision of criteria are increased because of the rapid change in train operating environment. In case of enhance the track irregularity criteria, it secure driving safety and riding comfort but maintenance cost are increase. And also decrease ballast durability by frequent corrective work. In case of mitigate the criteria, it decrease driving safety and riding comfort, but save the maintenance cost. The study for enacting rational criteria did not carry out so far. In this study, survey the domestic and international track irregularity and case study for track irregularity inspection results and maintenance history for guideline of enacting irregularity criteria study.

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식품 중 제초제 클로피랄리드(Clopyralid)의 잔류 분석법 (Study for Residue Analysis of Herbicide, Clopyralid in Foods)

  • 김지영;최윤주;김종수;김도훈;도정아;정용현;이강봉;김효진
    • 한국환경농학회지
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    • 제37권4호
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    • pp.283-290
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    • 2018
  • 본 연구는 LC-MS/MS법을 적용하여 농산물에 함유된 pyridine계통의 제초제 Clopyralid의 잔류분석법을 확립하였다. 대표적인 농산물로는 귤, 고추, 대두, 감자 및 현미를 선정하였고 acetonitrile에 의해 추출된 성분을 QuEChERS법을 변경하여 정제법으로 사용하고 LC-MS/MS를 사용하여 분석법을 확립하였다. Clopyralid의 정량적 분석을 위한 최적 분석 조건을 확립하였으며, 검출한계는 0.001 mg/kg, 정량 한계(LOQ)는 0.01 mg/kg이었다. 각 대표 농산물에 대한 정량한계, 정량한계의 10배, 50배 수준에서 회수율을 검토한 결과 모든 처리 농도에서 81.7~105.8 %수준을 나타내었으며, 모든 수준에서 20 % 미만의 분석오차를 나타내어 잔류분석기준을 만족하였다. 본 연구에서 확립된 Clopyralid분석법은 검출한계, 회수율 및 분석오차에서 국제적 분석기준을 만족하는 분석법으로 농산물에 따라 정량분석법으로 사용 가능할 것으로 사료된다.

GC/MS를 이용한 식품 중 페놀 분석 (Determination of Phenol in Food using GC/MS)

  • 강영운;안지은;서정혁;박선희;윤혜정
    • 한국식품위생안전성학회지
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    • 제29권4호
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    • pp.312-315
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    • 2014
  • 페놀은 보통 대기로 배출되며 반감기가 비교적 짧은 물질로서 환경에 농축되는 경우는 드물다. 하지만, 누출사고가 발생되어 수계나 토양에 오염될 경우 페놀에 오염된 농수산물의 안전성을 확보하기 위하여 페놀을 정확하게 검출할 수 있는 시험법을 확립하고자 하였다. 식품 중 페놀을 초음파추출기로 추출하고 GPC로 정제하여 GC/MS로 분석하는 시험법을 확립하였으며, 시험법의 유효성 확인을 위한 실험 결과들이 AOAC 가이드라인에서 제시하는 Criteria를 만족함으로써 시험법의 신뢰성을 확보할 수 있었다. 확립된 시험법은 식품 중 페놀의 오염조사 및 이행률 조사에 활용될 수 있다.

Pre-clinical QT Risk Assessment in Pharmaceutical Companies - Issues of Current QT Risk Assessment -

  • Takasuna, Kiyoshi; Katsuyoshi, Chiba;Manabe, Sunao
    • Biomolecules & Therapeutics
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    • 제17권1호
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    • pp.1-11
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    • 2009
  • Since the Committee for Proprietary Medicinal Products (CPMP) of the European Union issued in 1997 a "points to consider" document for the assessment of the potential for QT interval prolongation by non-cardiovascular agents to predict drug-induced torsades de pointes (TdP), the QT liability has become the critical safety issue in the development of pharmaceuticals. As TdP is usually linked to delayed cardiac repolarization, international guideline (ICH S7B) has advocated the standard repolarization assays such as in vitro IKr (hERG current) and in vivo QT interval, or in vitro APD (as a follow up) as the best biomarkers for predicting the TdP risk. However, the recent increasing evidence suggests that the currently used above biomarkers and/or assays are not fully predictive for TdP, but also does not address potential new druginduced TdP due to the selective disruption of hERG protein trafficking to the cell membrane or VT and/or VF with QT shortening. There is, therefore, an urgent need for other surrogate markers or assays that can predict the proarrhythmic potential of drug candidate. In this review, we provide an ideal pre-clinical strategy to predict the potentials of QT liability and lethal arrhythmia of the drug candidates with recent issues in this field in mind, not at the expense of discarding therapeutically innovative drugs.

수산물 중 에톡시퀸의 LC-MS/MS 정량분석법 개발 (Development of LC-MS/MS Quantitation Method for Ethoxyquin in Fishery Products)

  • 신다솜;채영식;강희승;이수빈;조윤제;천소영;정지윤;이규식
    • 한국식품위생안전성학회지
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    • 제31권6호
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    • pp.432-438
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    • 2016
  • 본 연구는 수산물 중 에톡시퀸 정량시험법을 확립하여 국내 생산 및 수입 양식 수산물에 대한 잔류할 수 있는 동물용의약품인 에톡시퀸에 대한 안전관리 강화기반을 위해 마련되었다. LC-MS/MS를 이용하여 신속하고 효과적으로 정량성 및 정밀성을 확보하였으며, 확립된 시험법의 선택성, 정량한계 및 회수율에 대한 검증을 통하여 에톡시퀸 시험법으로서의 유효성을 확인하였다. 표준용액을 정량한계를 포함한 농도에 따라 검량선을 작성한 결과 $r^2$> 0.99 이상의 직선성을 확인하였으며, 산성용매로 추출 후 MCX 카트리지를 이용해 정제하였다. 본 실험에서의 검출한계는 0.001 mg/kg, 정량한계는 0.01 mg/kg 수준이었고, 평균 회수율은 81.3~107%이었다. 또한, 분석오차는 10% 이하로 정확성 및 재현성이 우수하였으며, CODEX 가이드라인 규정에 만족하는 수준이었다. 따라서, 개발된 시험법은 안전한 국내유통 수산물과 국민보건을 위해 지속적인 잔류실태조사에 활용되고, 수산물 중 잔류동물용의약품의 안전관리에 기여할 것으로 판단된다.

고속도로 교통사고에 대한 기하구조의 영향(한계효과)에 관한 연구 (A Study on Marginal Effect of Geometric Structure on Freeway Accident Frequencies)

  • 박민호
    • 대한교통학회지
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    • 제32권1호
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    • pp.73-81
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    • 2014
  • 이 연구는 고속도로에서 발생한 교통사고에 대한 기하구조의 영향을 알아보고자 시도되었다. 기하구조의 경우에는 지침 등에서 정하는 기준 권장값등이 있지만, 기존의 사고모형에서는 교통사고에 영향을 미치는 기하구조의 자료가 통합된 형태로 사용되어 혼합된 형태로 설치된 현실을 추정된 모형이 제대로 설명하지 못하는 단점이 있다. 따라서 이 연구에서는 기하구조를 기준값에 의해 세분화된 기하구조 자료를 사용함으로써, 현실을 반영한 모형을 추출하고자 하였다. 그리고 각 기하구조별 탄력성 분석을 통해 사고에 미치는 영향을 제시하였다. 이는 향후 교통안전을 고려한 기하구조의 지침 정립에 도움이 될 것으로 사료된다.

농약등록기준 준수 현황과 수도 및 엽채소류 사용량 조사 (Survey on Compliance of Pesticide Registration Standard and Pesticide Usage of Paddy Rice and Leaf Vegetables in Korea)

  • 김경선;김광호;김남숙;임양빈;이희동;김효경;유오종;오병렬;임건재;류갑희
    • 농약과학회지
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    • 제10권3호
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    • pp.183-188
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    • 2006
  • 농약 등록 후에 농업 생산 현장에서 사용되는 농약에 대한 사용실태 및 작물별 단위면적당 사용량을 조사하기 위하여 2003년부터 2004년까지 작물별 주산단지별, 재배면적을 감안하여 292명의 농가를 선정하여 조사하였다. 농약안전사용기준 준수사항은 벼, 엽채소류 재배농가 모두가 대체적으로 잘 지키고 있었다. 조사농민의 대부분은 농약의 선택정보와 구매결정은 시판상이나 농협판매담당자의 권고에 의하여 결정하고 있었다. 작물별 단위면적당 농약사용량은 벼 5.51 kg $ha^{-1}$, 노지배추 3.91 kg $ha^{-1}$, 시설배추 2.93 kg $ha^{-1}$, 상추 0.76 kg $ha^{-1}$, 시금치 0.55 kg $ha^{-1}$, 잎들깨 1.34 kg $ha^{-1}$, 부추 4.83 kg $ha^{-1}$, 열무 0.42 kg $ha^{-1}$로 조사되었다. 벼, 상추, 시금치, 잎들깨에서는 사용량이 4년 전에 비해 감소하였으나 배추는 농약사용량이 증가하였다.

Simultaneous Determination of 80 Unapproved Compounds using HPLC and LC-MS/MS in Dietary Supplements

  • Kwon, Jeongeun;Shin, Dasom;Kang, Hui-Seung;Suh, Junghyuck;Lee, Gunyoung;Lee, Eunju
    • Mass Spectrometry Letters
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    • 제13권3호
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    • pp.58-83
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    • 2022
  • We developed analytical methods using high performance chromatography (HPLC) and liquid chromatography tandem mass spectrometry (LC-MS/MS) for the simultaneous determination of 80 unapproved compounds in dietary supplements. The target compounds for analysis were unapproved ingredients (e.g., pharmaceuticals) that have potential adverse effects on consumers owing to accidental misuse, overuse, and interaction with other medication in dietary supplement. Two analytical methods were tested to identify the optimal validation results according to AOAC guideline. As a result, limit of quantification (LOQ) was 0.14-0.5 ㎍ mL-1; linearity (r2) was ≥ 0.99; accuracy (expressed as recovery) was 78.9-114%; precision (relative standard deviation) was ≤ 4.28% in the HPLC method. In the LC-MS/MS method, LOQ was 0.01-2 ng mL-1, linearity (r2) was ≥0.98, accuracy was 71.7-119%; precision was ≤ 12.5%. The developed methods were applied to 51 dietary supplements collected from 2019 to 2021 through MFDS alert system. Based on our previous monitoring study, major compounds were icariin, sibutramine, yohimbine, sildenafil, tadalafil, sennosides (A, B), cascarosides (A, B, C, D), and phenolphthalein. In this study, we re-analyzed samples of detected compounds, and evaluated the statistical difference using Bland-Altman analysis to compare two analytical approaches between HPLC and LC-MS/MS. These results showed a good agreement between two methods that can be used to monitor the unapproved ingredients in dietary supplements. The developed two methods are complementarily suitable for monitoring the adulteration of 80 unapproved compounds in dietary supplements.

랫드를 이용한 Methyl Acrylate의 아급성(13주) 흡입독성 연구 (Subacute(13-week) Inhalation Toxicity Study of Methyl Acrylate in Rats)

  • 한정희;박상용;강민구;정용현;양정선
    • 한국산업보건학회지
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    • 제22권4호
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    • pp.316-328
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    • 2012
  • Objectives: This study was designed to provide the information regarding chemicals classification and health hazard by evaluating the toxicological effect through repeated inhalation exposure of methyl acrylate(MA) in Sprague-Dawley(SD) rat for 13 weeks. Methods: According to the notification with Ministry of Labor(No. 2009-68) and OECD Test Guideline 413, the rats were exposed to MA at concentration of 0, 56, 168, 280 ppm via whole body inhalation for 6 hours per day, 5 days per week, for 13 weeks. All animals were observed for mortality, morbidity and the change of body weight and food consumption were determined during the exposure period. Necropsy finding, organ weight, hematology, clinical biochemistry and histopathological examination following exposure were also performed. Results: There were no death and abnormal clinical signs relate to exposure MA. However, At 160 ppm and 280 ppm exposure groups, body weight and food consumption showed statistically significant decrease and histopathological changes in lung, trachea, nasal cavity, larynx were observed. Conclusions: MA was mainly affected respiratory tract. It is consequently provided to be classified as category 2(0.2 mg/L/6h < category 2 ${\leq}$ 1.0 mg/L/6h) for specific target organ toxicity following repeated exposure according to Standard for Classification and Labeling of Chemical Substance and Material Safety Data Sheet. The NOAEL(no observable adverse effect level) of MA was also determined to be lower than 56 ppm.