• 제목/요약/키워드: HR Quality

검색결과 841건 처리시간 0.035초

Bioequivalence Study of Toriem® Tablet to Motilium-M® Tablet (Domperidone Maleate 12.72 mg) Evaluated by Liquid Chromatography/Tandem Mass Spectrometry

  • Ryu, Ju-Hee;Choi, Sang-Jun;Lee, Myung-Jae;Lee, Jin-Sung;Kang, Jong-Min;Tak, Sung-Kwon;Seo, Ji-Hyung;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • 제39권1호
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    • pp.65-71
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    • 2009
  • The aim of the present study was to evaluate the bioequivalence of two domperidone maleate tablets, Motilium-$M^{(R)}$ Tablet (Janssen Korea Ltd., reference product) and $Toriem^{(R)}$ Tablet (Daewon Pharm. Co., Ltd., test product). Domperidone was extracted by liquid-liquid extraction using tert-butyl methyl ether and separated in less than 3 min on $C_{18}$ reverse-phase column using an isocratic elution. A tandem mass spectrometer, as detector, was used for quantitative analysis in positive mode by a multiple reaction monitoring mode to monitor the m/z $426.1{\rightarrow}119.1$ and the m/z $837.4{\rightarrow}158.2$ transitions for domperidone and the internal standard (roxithromycin), respectively. Calibration curves, from $0.05{\sim}50$ ng/mL of domperidone, showed correlation coefficients (r) higher than 0.9941. Intra day and inter day precision (C.V. %) for quality control were ranged from 10.04 to 16.09% and from 10.87 to 18.69%, respectively. The lower limit of quantification (LLOQ) of domperidone was 0.05 ng/mL. The method described is precise and sensitive and has been successfully applied to the study of bioequivalence of domperidone in 24 healthy Korean volunteers. Twenty-four healthy male Korean volunteers received a single dose of each medicine ($2{\times}12.72\;mg$ domperidone maleate) in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of domperidone were monitored for over a period of 24 hr after the administration. $AUC_{0-t}$ (the area under the plasma concentration-time curve) was calculated by the linear trapezoidal rule. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. The 90% confidence intervals for the log transformed data were within acceptable range of log 0.8 to log 1.25 (e.g., $log\;0.92{\sim}log\;1.05$ for $AUC_{0-t}$, $log\;0.81{\sim}log\;1.05$ for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of KFDA for bioequivalence indicating that $Toriem^{(R)}$ tablet is bioequivalent to Motilium-$M^{(R)}$ tablet.

침지용매에 따른 숙지황의 품질특성 (Quality Characteristics of Rehmannia radix Preparata with Pre-soaking Solvents)

  • 우관식;송대식;이준수;이희봉;정헌상
    • 한국식품과학회지
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    • 제39권3호
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    • pp.289-294
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    • 2007
  • 숙지황의 제조에 미치는 침지용매의 영향을 살펴보기 위하여 건지황을 막걸리와 증류수에 24시간 침지한 후 구증구포하여 숙지황을 제조하면서 증수에 따른 catalpol, 5-HMF, polyphenol, flavonoid, 항산화활성 및 ACE 저해활성 등을 분석하였다. Catalpol 함량은 건지황에서 631.4ppm으로 나타났으며, 증수가 증가할수록 급격히 감소하였고 막걸리 침지는 8증(75.84 ppm)까지, 증류수 침지 처리구는 9증(61.27 ppm)까지만 검출되었다. 5-HMF, 총 폴리페놀, 총 플라보노이드 함량은 증수가 증가할수록 증가하였으며, 5-HMF는 막걸리 침지는 13증(0.40%) 이후에, 증류수 침지 처리구는 11증(0.40%) 이후에 시판 숙지황의 함량과 비슷하였고 총 폴리페놀 함량과 총 플라보노이드 함량은 막걸리와 증류수침지 처리구 모두 14증에서 가장 높은 함량을 나타내었다. 전자공여능은 건지황과 시판 숙지황 모두 1 mg/mL의 농도에서 각각 19.44 및 52.49%이었으며, 막걸리와 증류수침지 시료 모두 14증에서 각각 66.80 및 75.60%로 증가하였다. 총 항산화력도 처리증수가 증가할수록 증가하였다. ACE 저해활성은 건지황과 시판 숙지황 모두 1 mg/mL의 농도에서 각각 28.70 및 49.37%로 이었으며, 처리증수가 증가할수록 증가하여 막걸리와 증류수침지 시료 모두 10증에서 각각 93.23 및 94.78%로 가장 높은 활성을 나타내었다.

생쥐 2-세포배아에 의한 시험관아기 배양용 대아제대혈청의 절적평가에 관한 연구 (Quality Assay of Human Fetal-Cord Serum for Human IVF-ET with Mouse 2-Cell Embryos)

  • 문신용;신창재;정구민;오선경;방명걸;장윤석
    • Clinical and Experimental Reproductive Medicine
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    • 제16권2호
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    • pp.139-146
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    • 1989
  • The purpose of this study was to examine the qualitative variation of human fetal-cord sera (HCS) and to accept the sera in human lVF-ET program. One hundred and sixteenth RCS were tested with 1772 2-cell embryos of F1 (C57BL x CBA) virgin mice, Ten to sixteenth embryos were cultured in m-KRB medium with a aliquot of each serum (10%, v/v) or with bovine serum albumin(O.4%, w/v) as a control medium. Embryonic development were recorded at every 24hr for 4 days by such events as cellular compaction, cavitation, and hatching. In the control groups of eight assays, 98.1%(106/ 108) of 2-ce1l embryos developed above expanded blastocyst and the embryonic development was unified through the tests. But the developmental pattern in medium with each serum was various. Namely, the sera that supported development of 100% 2-cell embryos to above morula, early blastocyst, expanded blastocyst and hatching blastocyst was 45,7%(53/116) , 35.3%(41/116), 15.5%08/116.) and 6.9-%(8/116), respectively. And the sera that supported development of above 80% 2-cell embryos to the each embryonic stage was 92.2% (107/116), 83.6%(97/116), 63.8%(74/116) and 36.2%(42/116), respectively. Meanwhile two kinds of toxic pattern to the embryonic development were observed in some sera. The first pattern is that some sera arrested development of most embryos in pre- or post-stage of morula or blastocyst. The second pattern is that some sera promoted or arrested a part of embryos in the same dish. The ability of serum was depended on the batch of serum. Finally we could accept 69%(80/116) of the tested sera for human IVF-ET program. The base line for acceptance was the ability that supported above 80% 2-ce1l embryos to blastocyst. But some deterious sera were contained in this range. We cut off about 10% of the sera (83.6% , 97/116) that passed the baseline. This final percent of sera was similar to that of grade N of this study.

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GPS 관측자료에 나타난 초대형 지자기 폭풍 기간 동안 한반도 상공 전리층 양상 (Ionospheric Behaviors Over Korea Peninsula During the Super Geomagnetic Storm Using GPS Measurements)

  • 정종균;최병규;백정호;지건화;조정호
    • Journal of Astronomy and Space Sciences
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    • 제26권4호
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    • pp.467-478
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    • 2009
  • 2003년 10월 28일에 X18 급의 태양 플레어가 발생한 다음날인 10월 29일부터 10월 31일까지 할로윈 이벤트로 불리는 초대형 지자기 폭풍이 전 지구적으로 발생하였다. 할로윈 이벤트 기간 동안 한반도 상공 전리권 양상을 살펴보기 위해서 GPS 신틸레이션 S4 지수와 GPS 토모그래피 기법을 사용한 최대 전자밀도($NmF_2$)의 변화를 날짜별로 분석하였다. GPS 신호손실과 신틸레이션의 총 발생 횟수는 10월 28일과 29일이 각각 1,094회와 1,387회로 30일과 31일의 604회와 897회에 비해 높게 나타났다. 이는 지자기 폭풍이 반드시 전리권 교란을 발생하지 않음을 의미 한다. 그러므로 지자기 폭풍이 아닌 전리권 교란을 감시하기 위해서는 지자기 교란 지수보다 S4 지수가 유용할 것이다. 전리권 전자밀도 변화 양상은 GPS 토모그래피 기법으로 산출된 전리권 최대전자밀도($NmF_2$) 값을 날짜별로 분석하였다. 10월 28일에 가장 높은 $NmF_2$ 값을 보이고 있다. 이는 안양 이온존데에서 관측된 $NmF_2$ 값의 변화와 일치되는 경향을 보이며, 전자밀도가 낮은 30일과 31일에 GPS 신틸레이션과 신호손실 총 발생회수가 낮게 나타나는 양상을 보이고 있다. 결론적으로 지자기 폭풍과 GPS 신호 품절의 상관성은 나타나지 않고 있으나 전자멸도가 감 소할수록 GPS 신호품질은 양호한 것으로 나타나고 있다. 향후 장기관측 자료 분석을 통해 평상시와 지자기 폭풍 기간 동안의 GPS 신호품질과 전자멸도 변화에 대해 연구가 진행될 것이다.

혈액투석환자에서 영양상태와 필수아미노산 섭취의 관련성 연구 (Association of the Nutritional Status and Essential Amino Acids Intake in Hemodialysis Patients)

  • 김혜진;김수안;손정민
    • Journal of Nutrition and Health
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    • 제39권7호
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    • pp.617-623
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    • 2006
  • The mortality and morbidity rate of hemodialysis patients (HD) remain high. Among many factors, protein and calorie malnutrition has been shown to be a major risk factor for increased mortality in the HD patients population. Malnutrition can be caused by insufficient amino acid intake, nutrient losses in dialysate, oxidant stress and muscle catabolism. In this study, we evaluated the association of markers of nutritional status and essential amino acids intake in HD patients. We investigated nutritional status of 41 HD patients (mean age: $64.2\;{\pm}\;11.5\;y$, men: 24, women: 27) by measuring anthropometric, biochemical parameters and food intakes by using 24 hr recall methods. Subject's total energy intake and total protein intake were $1,648.0\;{\pm}\;397.31\;kcal/day,\;79.2\;{\pm}\;27.2\;g/day$:, respectively. The animal protein intake was $42.7\;{\pm}\;22.1\;g/day$, essential amino acids intake was $23.4\;{\pm}\;9.92\;g/day$, and the ratio of essential amino acids to total protein intake was $29.6\;{\pm}\;5.42%$. There were significantly positive correlation between muscle mass and lean body mass with serum creatinine level (r=0.435, p<0.01; r=0.435, p<0,01). There were also significant positive correlation in muscle mass and lean body mass with pre hemodialysis blood urea nitrogen (preHD BUN) (r=0.329, p<0.05; r=0.329, p<0.05). There were no significant correlation in total energy intake and total protein intake per kg ideal body weight (IBW) to muscle mass and lean body mass. However, there were significantly positive correlation between the ratio of essential amino acids and muscle mass and lean body mass (r=0.368, p<0.05; r=0.405, p<0.01). And serum hematocrit concentration was positively correlated with the ratio of essential amino acids (r=0.032, p<0.05). The results of this study indicate that strong associations exist in essential amino acid intakes with malnutrition than total protein intakes in HD patient. In conclusion, specialized nutrition education should be necessary to efficiently improve the quality of protein intakes.

하수처리를 위한 막결합형 $A_2O$공정에서 최적 내부 순환율 및 MLSS 농도에 관한 연구 (A Study on the Optical Internal Recycle Rate and MLSS Concentration of Membrane Coupled $A_2O$ Process for Wastewater Treatment)

  • 김관엽;김진모;김형수;이상백;박유진;배성수
    • 멤브레인
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    • 제15권2호
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    • pp.114-120
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    • 2005
  • 본 연구의 목적은 도시 하수처리를 위한 막결합형 $A_2O$공정에 관해 실제적인 정보를 얻고자 하는 것이다. 공경 $0.25\;{\mu}m$의 평판형 정밀여과막을 공기가 주입되는 호기조에 침지시켜 처리수는 저압으로 여과된다. 인공폐수를 대상으로 최적의 처리수질과 장기운전의 안정성 확보를 위한 내부반송율과 MLSS 농도 등의 최적 운전인자를 산정하고자 하였다. 내부반송은 각각 호기조에서 무산조로 반송한 것을 type 1, 무산조에서 혐기조로 반송한 것을 type 2라고 규정지었다. 플럭스는 15 LMH, type 1을 2Q로 고정하고 실험하였을 때 최적의 운전 조건은 MLSS 농도는 11,000 mg/L, type 2가 IQ로 나타났다. 이때, BOD $COD_{cr}$, T-N, T-P의 제거율이 각각 $97.3\%,\;94.2\%,\;64.0\%,\;63.0\%$로 타 내부반송율보다 효과적이었다.

지중해담치, Mytilus galloprovincialis의 발생 최적조건 (Optimal Conditions for the Embryonic Development of Mussel, Mytilus galloprovincialis)

  • 성찬경;김기범;서진영;이창훈;류태권;한기명;최진우;김용현
    • 한국패류학회지
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    • 제21권1호
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    • pp.25-31
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    • 2005
  • The embryos of marine bivalves have been commonly used in bioassays for the quality assessment of marine environments. Although several standard protocols for developmental bioassay with bivalves have been already proposed, there have been few trials for applying these protocols in environmental assessment, or for developing new protocol with Korean species. So, there is a strong need to establish the standard bioassay protocols using bivalves commonly found in Korean waters. Prior to developing a new protocol, it is essential to know the optimum conditions for the reliable bioassay procedures. Here, we established the purpose of this study to determine the optimum bioassay conditions for successful development of a common mussel, Mytilus galloprovincialis. The conditions considered as critical for developmental bioassay, and determined in this study were; (1) temperature, (2) salinity, and (3) initial density of embryo. The optimal temperature for developmental bioassay of M. galloprovincialis was determined as $15^{\circ}C$. At this temperature, the required time for the embryo to become veliger larva was 48 hr. The acceptable range of salinity for the embryotoxicity test using M. galloprivincialis was from 30 to 35 psu, which was narrower than that of the natural habitat of adult populations. The optimum density of embryo at the beginning of bioassay was 100 embryos/ml. Over this density, the proportion of normally developed larvae decreased significantly. The results obtained in this study will serve as a basis for preparation of the standard bioassay protocol using embryo of M. galloprovincialis.

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Hot Wall Epitaxy (HWE)에 의한 성장된 $ZnIn_2S_4/GaAs$ 에피레이어의 광학적 특성 (Optical Properties of $ZnIn_2S_4/GaAs$ Epilayer Grown by Hot Wall Epitaxy method)

  • 홍광준;이관교
    • 한국전기전자재료학회:학술대회논문집
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    • 한국전기전자재료학회 2004년도 추계학술대회 논문집 Vol.17
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    • pp.175-178
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    • 2004
  • The stochiometric mixture of evaporating materials for the $ZnIn_2S_4$ single crystal thin film was prepared from horizontal furnace. To obtain the $ZnIn_2S_4$ single crystal thin film, $ZnIn_2S_4$ mixed crystal was deposited on throughly etched semi-insulating GaAs(100) in the Hot Wall Epitaxy(HWE) system. The source and substrate temperature were $610^{\circ}C$ and $450^{\circ}C$, respectively and the growth rate of the $ZnIn_2S_4$ sing1e crystal thin film was about $0.5\;{\mu}m/hr$. The crystalline structure of $ZnIn_2S_4$ single crystal thin film was investigated by photoluminescence and double crystal X-ray diffraction(DCXD) measurement. The carrier density and mobility of $ZnIn_2S_4$ single crystal thin film measured from Hall effect by van der Pauw method are $8.51{\times}10^{17}\;cm^{-3}$, $291\;cm^2/V{\cdot}s$ at $293_{\circ}\;K$, respectively. From the photocurrent spectrum by illumination of perpendicular light on the c - axis of the $ZnIn_2S_4$ single crystal thin film, we have found that the values of spin orbit splitting ${\Delta}S_O$ and the crystal field splitting ${\Delta}Cr$ were 0.0148 eV and 0.1678 eV at $10_{\circ}\; K$, respectively. From the photoluminescence measurement of $ZnIn_2S_4$ single crystal thin film, we observed free excition $(E_X)$ typically observed only in high quality crystal and neutral donor bound exciton $(D^{o},X)$ having very strong peak intensity The full width at half maximum and binding energy of neutral donor bound excition were 9 meV and 26 meV, respectively, The activation energy of impurity measured by Haynes rule was 130 meV.

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Changes of physiochemical properties of LOX-3 null rice lines stored at different storage temperatures and periods

  • Shin, Woon-Chul;Kim, Jeong-Ju;Park, Hyun-Su;Jeong, Jong-Min;Baek, Man-Kee;Nam, Jeong-Kwon;Park, Seul-Gi;Kim, Choon-Song;Cho, Young-Chan;Kim, Bo-Kyeong
    • 한국작물학회:학술대회논문집
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    • 한국작물학회 2017년도 9th Asian Crop Science Association conference
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    • pp.69-69
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    • 2017
  • Due to the lack in storage facility, considerable amount of rice is stocked in the open air, which causes increased stale flavor and deteriorates palatability and merchantable quality. Lipoxygenase-3(LOX-3) is involved in the production of volatile constituents in stored rice, and the development of stale flavor is delayed in LOX-3 null rice. LOX activity in the rice grain is localized in bran fraction and the tropical Japonica cultivar 'Dawdam' was reported that the absence of LOX-3 is inherited as a simple recessive trait. Also, it was reported that the peroxidation of unsaturated fatty acids occurs at lower levels in the 'Dawdam' bran fraction during storage than in rice varieties with LOX-3. This study was conducted to develop LOX-3 null rice lines using 'Dawdam' and investigate changes of physicochemical properties of the lines stored at different storage temperatures and periods. So we analyzed texture, toyo glossiness value, germination rate and lipoxygenase activity of 15 LOX-3 null rice lines on the condition of which rough rice had been stored at different temperatures (high temperature condition at $35^{\circ}C$ and low temperature condition at $15^{\circ}C$ for 4months. Hardness and stickiness of the lines tendered to be increased when it was stored at high temperature and adhesiveness, springiness, cohesiveness and chewiness was not considerably different according to storage temperatures and periods. The germination rate of HR29062-B-98-2-1-B among LOX-3 null rice lines was higher than another lines, 99.3, 94.0% after 4months stored at low temperature and high temperature, respectively. The lipoxygenase activity was 3,304, 1,601unit/mg protein after 4months stored at low temperature and high temperatures, respectively. So, it is thought that this line will be useful to breed rice varieties with high storability after tested on agricultural traits.

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P53 and MDM2 Over-expression and Five-year Survival of Kidney Cancer Patients Undergoing Radical Nephrectomy - Iranian Experience

  • Abolhasani, Maryam;Salarinejad, Sareh;Asgari, Mojgan
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권12호
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    • pp.5043-5047
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    • 2015
  • Background: Relatively little is known with certainty about the status and role of p53 or MDM2 in predicting prognosis and survival of renal cell carcinoma. The present study aimed to determine the value of P53 and MDM2 over-expression, alone and simultaneously, to predict five-year survival of patients with kidney cancer in Iran. Materials and Methods: Patients with kidney cancer referred to Hasheminejad Kidney Center between 2007 and 2009, underwent radical nephrectomy and had pathology reports of clear cell, papillary or chromophobe renal cell carcinoma were included in our cohort study. Other histological types of renal cell carcinoma were not included. The patients with missed, incomplete or poor quality paraffin blocks were also excluded. Overall ninety one patients met the inclusion and exclusion criteria. To assess the histopathological features of the tumor, immunohistochemical (IHC) staining of formalin fixed, paraffin-embedded tumor samples were performed. The five-year survival was determined by the patients' medical files and telephone following-up. Results: In total, 1.1% of all samples were revealed to be positive for P53. Also, 20.8% of all samples were revealed to be positive for MDM2.The patients were all followed for 5 years. In this regard, 5-year mortality was 30.5% and thus 5-year survival was 85.3%. According to the Cox proportional hazard analysis, positive P53 marker was only predictor for patients' 5-year survival that the presence of positive p53 increased the risk for long-term mortality up to 2.8 times (HR=2.798, 95%CI: 1.176-6.660, P=0.020). However, the presence of MDM2 could not predict long-term mortality. In this regard, analysis by the ROC curve showed a limited role for predicting long-term survival by confirming P53 positivity (AUC=0.610, 95%CI: 0.471-.750, P=0.106). The best cutoff point for P53 to predict mortality was 0.5 yielding a low sensitivity (32.0%) but a high specificity (97.9%). In similar analysis, measurement of MDM2 positivity could not predict mortality (AUC=0.449, 95%CI: 0.316-.583, P=0.455). Conclusions: The simultaneous presence of both P53 and MDM2 markers in our population is a rare phenomenon and the presence of these markers may not predict long-term survival in patients who undergoing radical nephrectomy.