• 제목/요약/키워드: inter-laboratory test

검색결과 66건 처리시간 0.028초

고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발 (Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex)

  • 이태웅;정래석;정승아;김정현;심영훈;김인규;박창원
    • 약학회지
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    • 제57권3호
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    • pp.226-233
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    • 2013
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

한국 신생아 집단검사의 과거, 현재, 미래 (The Past, Present, Future of Newborn Screening in Korea)

  • 이동환
    • 대한유전성대사질환학회지
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    • 제14권1호
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    • pp.1-9
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    • 2014
  • Many inborn errors of metabolism can be completely cured with early detection and early treatment. This is why neonatal screening on inborn errors of metabolism is implemented worldwide. In 1991, the Ministry of Health & Social affairs adopted a nationwide service program for neonatal screening of phenylketonuria, galactosemia, maple syrup urine disease, homocystinuria, histidinemia and congenital hypothyroidism for newborns delivered from low class pregnant women registered in health centers. Government decreased the test items from six to two, PKU and congenital hypothyroidism to increase test numbers with same budget from 1995. 78 laboratories wanted to participate for neonatal screening test in 1999. Government decided to screen six items of PKU, congenital hypothyroidism, maple syrup urine disease, homocystinuria, galactosemia and congenital adrenal hyperplasia from 2006. In 2014, thirteen laboratories are participating. Inter laboratory quality control was started 6 times a year from 1994. In case a patient with an inherited metabolic disease is diagnosed by screening of government program, special milk is provided at government's expense. According to the government project, from 1997 to 2013, 7,080,569 newborns were screened. 144 PKU, 2.451 congenital hypothyroidism were detected. So incidence of PKU is 1/49,170 and congenital hypothyroidism is 1/2,888. The cost benefit of performing screening procedures coupled with treatment has been estimated to be as high as 1.77 times in PKU, 11.11 times in congenital hypothyroidism than cost without screening. By January 2007, many European countries had expanded of their newborn screening programs by inclusion of Tandem mass spectrometry. We are trying to increase the budget to test all newborns for Tandem mass spectrometry from 2016. We are considering four to five central laboratories which cover all newborns and are equipped with tandem mass spectrometer & enzyme immunoassay for TSH, 17OHP & enzyme colorimetric assay for galactose. And I hope to expand test including Wilson disease screening test and lysosomal storage diseases.

Establishment of an Analytical Method for Azorubine, an Undesignated Food Colorant in Korea

  • Kim, Min-ji;Park, Ju-hee;Suh, Hee-Jae;Lee, Chan
    • 한국식품위생안전성학회지
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    • 제31권5호
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    • pp.311-318
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    • 2016
  • 국내 미지정 색소인 azorubine에 대한 우리나라의 공인분석법을 설립하기 위해 제외국의 공인분석법들(유럽연합의 EFSA, 영국의 FSA, 우리나라의 식품의약품안전평가원)이 비교되었다. 재현된 HPLC 방법들 중 FSA의 분석법이 가장 우수한 분석 결과를 나타내어 azorubine분석법으로 최종 선정되었다. Azorubine 분석을 위한 위 세 기관의 전처리 방법은 모두 낮은 회수율을 나타내었다. 따라서 식품의약품안전평가원의 전처리법을 개선한 새로운 전처리 방법이 개발되었다. 최종 선정된 HPLC 분석법과 본 연구를 통해 개발된 새로운 식품 전처리법에 대한 분석법 밸리데이션을 실시하였다. 검증 실험에서 음료류에서 97~103%, 빵 및 과자류에서 95~101%, 기타 식품에서 93~102%의 회수율을 나타내었고, 실험실간 교차검증에서 -1.29~0.26의 z-score를 보여 신뢰할 수 있는 것으로 판단되었다. 이 결과로부터 본 연구에서 확립된 전처리법 및 분석법은 미지정 색소 azorubine이 사용된 식품검사에 활용될 수 있는 분석법으로 확인되었다.

신 흡수제(KoSol-5)를 적용한 0.1 MW급 Test Bed CO2 포집 성능시험 (0.1 MW Test Bed CO2 Capture Studies with New Absorbent (KoSol-5))

  • 이정현;김범주;신수현;곽노상;이동욱;이지현;심재구
    • 공업화학
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    • 제27권4호
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    • pp.391-396
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    • 2016
  • 한전 전력연구원에서 개발한 고효율 아민계 습식 $CO_2$ 흡수제(KoSol-5)를 적용하여 0.1 MW급 Test Bed $CO_2$ 포집 성능시험을 수행하였다. 500 MW급 석탄화력발전소에서 발생되는 연소 배가스를 적용하여 하루 2톤의 $CO_2$를 처리할 수 있는 연소 후 $CO_2$ 포집기술의 성능을 확인하였으며 또한 국내에서는 유일하게 재생에너지 소비량을 실험적으로 측정함으로써 KoSol-5 흡수제의 성능에 대한 신뢰성 있는 데이터를 제시하고자 하였다. 그리고 주요 공정변수 운전 및 흡수탑 인터쿨링 효율 향상에 따른 에너지 저감 효과를 테스트하였다. 흡수탑에서의 $CO_2$ 제거율은 국제에너지기구 산하 온실가스 프로그램(IEA-GHG)에서 제시하는 $CO_2$ 포집기술 성능평가 기준치($CO_2$ 제거율: 90%)를 안정적으로 유지하였다. 또한 흡수제(KoSol-5)의 재생을 위한 스팀 사용량(재생에너지)은 $2.95GJ/tonCO_2$가 소비되는 것으로 산출되었는데 이는 기존 상용 흡수제(MEA, Monoethanol amine)의 평균 재생에너지 수준(약 $4.0GJ/tonCO_2$) 대비 약 26% 저감 된 수치이다. 본 연구를 통해 한전 전력연구원에서 개발한 KoSol-5 흡수제 및 $CO_2$ 포집 공정의 우수한 $CO_2$ 포집 성능을 확인할 수 있었고, 향후 본 연구에서 성능이 확인된 고효율 흡수제(KoSol-5)를 실증급 $CO_2$ 포집플랜트에 적용할 경우 $CO_2$ 포집비용을 크게 낮출 수 있을 것으로 기대된다.

Real-time hybrid simulation of a multi-story wood shear wall with first-story experimental substructure incorporating a rate-dependent seismic energy dissipation device

  • Shao, Xiaoyun;van de Lindt, John;Bahmani, Pouria;Pang, Weichiang;Ziaei, Ershad;Symans, Michael;Tian, Jingjing;Dao, Thang
    • Smart Structures and Systems
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    • 제14권6호
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    • pp.1031-1054
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    • 2014
  • Real-time hybrid simulation (RTHS) of a stacked wood shear wall retrofitted with a rate-dependent seismic energy dissipation device (viscous damper) was conducted at the newly constructed Structural Engineering Laboratory at the University of Alabama. This paper describes the implementation process of the RTHS focusing on the controller scheme development. An incremental approach was adopted starting from a controller for the conventional slow pseudodynamic hybrid simulation and evolving to the one applicable for RTHS. Both benchmark-scale and full-scale tests are discussed to provide a roadmap for future RTHS implementation at different laboratories and/or on different structural systems. The developed RTHS controller was applied to study the effect of a rate-dependent energy dissipation device on the seismic performance of a multi-story wood shear wall system. The test specimen, setup, program and results are presented with emphasis given to inter-story drift response. At 100% DBE the RTHS showed that the multi-story shear wall with the damper had 32% less inter-story drift and was noticeably less damaged than its un-damped specimen counterpart.

비교숙련도 시험을 통한 도시대기분진에 대한 중성자방사화분석법의 품질관리 (Quality Control on Neutron Activation Analysis for Urban Dust by the Proficiency Test)

  • 문종화;김선하;정용삼
    • 분석과학
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    • 제15권5호
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    • pp.433-438
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    • 2002
  • 국제원자력기구로부터 제공받은 2종 (V-50, P-50)의 인공적으로 준비된 여과지상의 도시분진시료중의 미량원소를 중성자방사화분석법을 사용하여 비파괴 분석하였다. 중성자방사화분석의 품질관리를 위해 미국표준기술원의 인증표준물질 (Urban Particulate Matter, NIST SRM1648)이 사용되었으며 여과지상의 분진시료에서는 약 20종의 원소를 분석하였다. 측정결과는 실험실간 비교 및 숙련도 평가를 위하여 중성자방사화분석법, 하전입자유도 X-선 방출분광법, 유도결합플라즈마 질량분석법 등을 이용한 세계 40개국, 49개 실험실의 분석값들과 함께 통계처리 되었다. 통계 처리한 결과, 본 실험실의 분석값들의 Z-score가 ${\pm}2$ 이내에 들어오는 결과를 얻었으며, 숙련도 시험도 분석된 모든 원소의 정확도와 정밀도가 기준에 통과되는 신뢰성 있는 결과를 얻어 현재 수행하고 있는 대기분진시료들의 분석품질관리가 적합함을 입증하였다.

해수 중 엽록소 a 측정방법에 대한 실험실 간 비교연구 (An Inter-Laboratory Comparison Study on Chlorophyll a Determination in Seawater)

  • 문초롱;강동진;박미옥;노재훈;유신재;문정언;신경훈;김윤숙;최중기;서영상
    • 한국해양학회지:바다
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    • 제19권1호
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    • pp.76-87
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    • 2014
  • 해양식물플랑크톤 생물량 및 일차생산력을 추정하기 위한 자료로서 이용되는 해수 중 엽록소 a의 농도는 고성능 액체크로마토그래피(High Performance Liquid Chromatography, HPLC), 형광법(Fluorometry), 분광광도법(Spectrophotometry)등의 분석방법으로 측정된다. 본 연구에서는 여러 실험실에서 이러한 방법들로 분석된 엽록소 a 자료를 통용하기 위한 기초자료로서 활용하고자 우리나라 주변 해역의 현장 시료를 이용한 상호비교실험을 실시하여 엽록소 a 분석 실험실 및 분석 방법간의 차이를 비교하였다. 상호비교실험은 엽록소 a 표준색소(R0) 및 동중국해(R1)와 동해해역(R2)에서 채수된 해수 현장 시료를 이용하여 총 3회 시행되었다. 참가실험실은 각각 HPLC(6개 실험실), 형광법(4개 실험실), 분광광도법(3개 실험실)으로 시료를 분석하였다. 표준색소와 현장시료의 측정결과에서 얻은 실험실 내 정밀도는 변동계수로 평가되었으며, 표준색소(R0)에서 9% 미만, 현장시료에서는 R1: 0.8~20%(평균 6.1%), R2: 4~21%(평균 13.2%)의 정밀도를 보였다. 전체 현장시료의 모집단에서 z-test를 이용하여 이상치를 제거한 측정결과들의 중앙값을 기준 값으로 평가한 HPLC, 형광법, 분광광도법 간의 차이는 20%이내였다. 이러한 차이는 현장시료의 균질성 및 실험실 내의 정밀도를 고려한 차이(R1: 8%, R2: 15%)와 유사한 값을 보였다. 비교결과로 미루어 볼 때, 측정값들간의 차이는 분석방법의 차이보다는 실험실 간 차이가 더 크다고 볼 수 있다. 따라서 각 실험실에서 생산된 자료는 분석 방법이 다르더라도 약 20% 이내에서는 동일한 결과를 생산한다고 볼 수 있으므로 타 실험실에서 서로 다른 방법으로 분석된 엽록소 a의 자료를 활용하는 경우에는 약 20%의 차이에 대한 고려가 필요하다.

Bioavailability Test of TestoTM Tablets (Methyltestosterone, 25 mg) in Male Healthy Volunteers by a Gas-chromatography/Mass Selective Detector

  • Kwon, Oh-Seung;Kim, Hye-Jung;Pyo, Hee-Soo;Kim, Dae-Duk;Chung, Youn-Bok
    • Journal of Pharmaceutical Investigation
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    • 제35권5호
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    • pp.383-388
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    • 2005
  • A simple and specific method for determination of methyltestosterone (MT) has been established by a gas chromatography/mass selective detector and applied in plasma of healthy male volunteers received a single oral dose of 50 mg MT $(Testo^{TM}\;tablets,\;25\;mg)$ for bioavailability test. This method involves using liquid-liquid extraction of the sample with diethyl ether and derivatization with MSTFA. MT showed good resolution in this condition. The detection limit of quantitation was 5 ng/ml. A good linearity (r>0.996) was obtained at the range of 5-250 ng/ml of MT. Intra-day precision and accuracy were 2.76-12.56% and 0.39-8.01 %, and inter-day precision and accuracy were 2.29-17.69% and 0.42-7.99%, respectively. The established method was applied on bioavailability test of MT in human volunteers. The value of $AUC_{0\;to\;last}$ to last was $264.5{\pm}123.9\;ng{\cdot}hr/ml$ and that of $AUC_{0\;to\;inf}$ was determined to be $275.2{\pm}126.5\;ng{\cdot}hr/ml$. The values of $C_{max}$ and $T_{max}$ were $95.9{\pm}67.1\;ng/ml$ and $1.13{\pm}0.9\;hr$, respectively. The mean elimination half-life $(t_{1/2})$ was $4.4{\pm}0.9\;hr$. This analytical method is suitable and useful for the pharmacokinetics and bioequivalence studies of MT.

Mechanics of the slaking of shales

  • Vallejo, Luis E.
    • Geomechanics and Engineering
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    • 제3권3호
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    • pp.219-231
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    • 2011
  • Waste fills resulting from coal mining should consist of large, free-draining sedimentary rocks fragments. The successful performance of these fills is related to the strength and durability of the individual rock fragments. When fills are made of shale fragments, some fragments will be durable and some will degrade into soil particles resulting from slaking and inter-particle point loads. The degraded material fills the voids between the intact fragments, and results in settlement. A laboratory program with point load and slake durability tests as well as thin section examination of sixty-eight shale samples from the Appalachian region of the United States revealed that pore micro-geometry has a major influence on degradation. Under saturated and unsaturated conditions, the shales absorb water, and the air in their pores is compressed, breaking the shales. This breakage was more pronounced in shales with smooth pore boundaries and having a diameter equal to or smaller than 0.060 mm. If the pore walls were rough, the air-pressure breaking mechanism was not effective. However, pore roughness (measured by the fractal dimension) had a detrimental effect on point load resistance. This study indicated that the optimum shales to resist both slaking as well as point loads are those that have pores with a fractal dimension equal to 1.425 and a diameter equal to or smaller than 0.06 mm.

여천지역 준설.매립토의 침강압밀 특성

  • 송정락;백승훈;여유현
    • 한국지반공학회:학술대회논문집
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    • 한국지반공학회 1992년도 가을학술발표회 논문집
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    • pp.55-60
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    • 1992
  • Hydraulically filled ground is formed by the settling of soil grains from the mixture of soil grains and water. It was generally known that the settling speed of the soil grains in governed by Stokes low. In the case of clayed dredged material, the shape of soil grains is not round, the surface of the soil grains is relatively large compared to the weight of soil grains and inter-grain ionic force is relatively large compared to the wight of soil grains. By this reason the settling and consolidation behavior of hydraulically filled quite different from that of Stokes law. This study investigated the settling and consolidation behavior of hydraulically filled materials of Yeochon industrial complex by large scale laboratory settling & consolidation container. The test results showed tat actual settling speed of soil grains in quite large compared to that of Stokes law. It was turned out that this phenomenon was due to the aggregation of soil grains. Also, it was truned out that the void ration and water content after the completion of settling process was 8.7 and 322% respectively. The consolidtion settlement of clayey hydraulic fill material was predicated better by "incremental small strain" consolidation concept than classical Terzaghj's consolidation concept (infinitesimal strain).

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