• Title/Summary/Keyword: reconstituted

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Development and Validation of the Determination of Sorafenib in Human Plasma using Tandem Mass Spectrometry Coupled with Liquid Chromatography (고속액체크로마토그래피 텐덤질량분석기법을 이용한 사람 혈장 내 소라페닙 농도분석법의 개발 및 검정)

  • Park, Daejin;Lee, Sunggon;Kim, Woomi
    • Journal of Life Science
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    • v.22 no.11
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    • pp.1456-1462
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    • 2012
  • Sorafenib is a multikinase inhibitor and an oral anticancer drug approved for the treatment of patients with advanced renal cell carcinoma and those with unresectable hepatocellular carcinoma. The purpose of this study was to develop an efficient method of the determination of sorafenib in human plasma using tandem mass spectrometry coupled with liquid chromatography (LC/MS/MS) and validate the method by the guidelines of the Korean Food and Drug Administration (KFDA). Plasma samples ($100{\mu}l$) were added with chlorantraniliprole as an internal standard and then mixed with the 0.1% formic acid-containing extraction solution composed of isopropyl alcohol and ethyl acetate (1:4, v/v). After centrifugation, the supernatant was concentrated at $45^{\circ}C$ under negative pressure and centrifugal force. The residue was reconstituted with a mobile phase and injected into the HPLC instrument using a reverse phase Waters XTerra$^{TM}$ C18 column (particle size $3.5{\mu}m$). Liquid chromatography was carried out within the run time of 5 min using a mobile phase composed of buffer (0.1% formic acid and 10 mM ammonium formate), methanol, and acetonitrile (1:6:3, v/v/v). The analytes were monitored by tandem mass spectrometry in the multiple reaction monitoring method programmed to detect sorafenib at 'm/z 465.2 ${\rightarrow}$ 252.5' and chlorantraniliprole at 'm/z 484.4 ${\rightarrow}$ 286.2' with positive electrospray ionization mode ($ES^+$). The result showed the proper linearity ($r^2$ > 0.99) over the range of 2,000-5,000 ng/ml with good accuracy (90.7-103.9%) and precision (less than 10%). The newly developed method using LC/MS/MS was validated by the guideline of KFDA and identified as more sensitive compared to the previous methods.

Manufacturing and Establishment of the 2nd National Standard for Varicella Vaccine (수두생바이러스백신 국가표준품 (2차) 제조 및 확립에 관한 연구)

  • Kim, Yeon-Hee;Kim, Do-Keun;Sohn, Yeo-Won;Han, Eui-Ri;Kim, Seok-Hwan;Lim, Jong-Mi;Won, Yun-Jung;Yoon, Heui-Seong;Jo, Moon-Hee;Kim, Kwan-Soo;Kim, Jae-Ok
    • KSBB Journal
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    • v.25 no.6
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    • pp.572-576
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    • 2010
  • Biological products, such as live varicella vaccine, are composed of biological substances derived from biological organisms. It is very difficult to identify these biologics' characteristics by analysis of simple physical and chemical methods alone. So the reference material is essential in order to evaluate the quality of bilogics. The 1'st national standard for varicella live vaccine was manufactured, established in 2002 and 2003, and have been used for the manufacturer's quality control and national lot release since then. As the lack of its availability and the decrease of its stability, this study was initiated by National Institute of Food and Drug Safety Evaluation (NiFDS) in 2008 to manufacture and establish the 2nd national standard for varicella live vaccine. The candidate material was manufactured from one of domestic manufacterers and the joint research of the NiFDS and manufacturers of varicella live vaccine was conducted to estimate of the reliable virus content. In the collaborative study, 3 laboratories including NiFDS performed the virus content test more than 7 times and all assay results were statistically analyzed. The mean coefficient of variation (CV) was 1.24%, and the geometric mean titre (GMT) variation range of each laboratory was low. On the basis of the results of this study, the candidate material of 2nd national standard for varicella live vaccine was assigned a potency of 4.26 log10 pfu/0.5 mL, when reconstituted in 0.7 mL.

The Interpretation of Korean Traditional Garden in the View of Complexity Theory - Focusing on Soswaewon Garden - ('복잡성(Complexity) 이론'에 의한 한국 전통정원의 해석 - 한국의 명원 소쇄원을 중심으로 -)

  • Jang, Il-Young;Shin, Sang-Sup
    • Journal of the Korean Institute of Traditional Landscape Architecture
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    • v.28 no.2
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    • pp.75-85
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    • 2010
  • The purpose of this study is to attempt new analysis on Soswaewon Garden(瀟灑園) where is Korea's traditional garden, focusing on which the tendency of its change is a relational-formation tool similar to the Eastern Mode of Thought, with paying attention to conversion as the new view of world. Accordingly, the aim is to reanalyze by connecting with Soswaewon Garden based on the theory of complexity, which tries to look at the whole through relationship rather than characteristics in individual components. Given summarizing findings, those are as follows. First, it was found that complexity shown in space and open system of physical dimension was characterized by 'event(situation)', 'non-determination' and 'homogeneous relationships between part and whole', and a variety of techniques introduced the nature positively. In particular, it was found that there were many cases of topographic usage, since the Soswaewon Garden selected its construction site proactively and was a product from architectural works in compliance with a given flow of natural topography. This has a nature of open text in the situation of emergent behaviors. Second, it was found that complexity shown in experiences and open system on the invisible dimension was characterized primarily by 'event(situation)' and 'relationships of interactive response between actors and environment', and various techniques appeared as a space for interactive combination of nature and daily experiences. This is typical of bilateral harmony based on interactions between subject and object, and between mankind and nature, and becomes also a space to accommodate temporary emergent behaviors in our life. Third, the compositional elements are reconstituted as space of organic property with dismantling steady relations. Especially, 'Soswaewon Garden's 48 poems(瀟灑園四十八詠)' will be the origin of the emotionally spatial experience to the current performers. Ultimately, the performer in the space of Soswaewon Garden simultaneously becomes a creator of space, and will generate new space with intertextuality with environment. Therefore, Soswaewon Garden becomes a place of binding me and the other together while maintaining mutual relationship based on organic thinking between a human being and nature and between the whole and a part.

The Establishment of Labor Archive and Its New Development Strategy : An Attempt to Build Participatory Archive of the Institute of Labor History in SKHU (노동아카이브의 형성과 발전방향 모색 성공회대 노동사연구소의 '참여형 아카이브' 시도를 중심으로)

  • Lee, Chongkoo;Lee, Jaeseong
    • The Korean Journal of Archival Studies
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    • no.41
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    • pp.175-212
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    • 2014
  • In 2001 a large amount of labor record have been donated from Jeontaeil Labor Archive-Institute to SungKongHoe University(SKHU). Institute of Labor History in SKHU was established in the wake of the installation of the labor archive. Development of oral archive raised the awareness of the various relationships between the use and production of labor record. Interviewees of oral testimony expressed dissatisfaction and the role of the researchers was not sufficiently exhibited. Examining the main cases of Korea union movement history, we can find contradictions between the use and production of labor record clearly. Interval of interpretation and memory was too big between the parties of 'democratic' union movement in the 1970s. While among the parties who took part in Guro Alliance Strike of 1985, there is a group that remains in the "winner" in history on the one hand, but "loser" on the other without any reasonable criterion. Active intervention of the record users(researchers) is very limited. Among citizens or workers how will be resolved such "struggle of memory" in due process can not be seen. This is one of the reasons why labor archive is not rooted in the region. In this paper, I present a methodological alternatives for the production and use of records through the construction of participatory labor archive. Further, the reconstituted contents of the "documenting locality" strategy by complementing the theoretical part of the method of participation. The study of local and locality requires a "scale" dimension that will make up the identity recognition space, a memory and identity, a social relationship rather than the dimension of the physical space. Alternative "documenting locality" strategy will be able to contribute to solve the problems that occur between the production and use of the recording in labor archive.

Developmental Potentials of Clone Embryos Derived from Bovine Fetal Fibroblast Cells (소 태아섬유아세포 유래 복제란의 발육능에 관한 연구)

  • Cheong, H.T.;Kwon, D.J.;Park, Y.S.;Hwang, H.S.;Park, C.K.;Yang, B.K.;Kim, C.I.
    • Korean Journal of Animal Reproduction
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    • v.24 no.1
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    • pp.49-57
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    • 2000
  • This study was conducted to investigate the developmental potential of cloned embryos derived from bovine fetal fibroblast cells, and the effect of quiescent treatment, passage number and origin of donor cells on in vitro development of cloned embryos. Fetal skin and liver-derived fibroblast cells were transferred to enucleated oocytes after serum starvation or nontreatment (cycling). After electrofusion. reconstituted embryos were activated with $Ca^{++}$-ionophore and cycloheximide, and cocultured for 7~9 days with BRL cells. Some blastocysts were transferred to recipient cows 7~8 days post estrus. The development rate to the blastocyst stage of serum starved cell-derived embryos was higher (25.3%) than that of actively dividing cells-derived embryos (15.9%), The rates of blastocyst formation were 23.1~25.0% after transfer of cell passaged 4 to 6 times, and 23.8 and 25.2% after transfer of fetal skin and liver cells, respectively. After embryo transfer, 34.4% and 15.6% of recipient cows were pregnant on Day 60 and 120, respectively, and one male calf was produced from skin-derived vitrified blastocyst. The result of this study showed that the development of cloned embryos. was enhanced by quiescent treatment, but did not different among the cells passaged 4 to 6 times, and between skin and liver cells. This result also confirms that offspring can be obtained from the vitrified clone embryo derived from fetal skin cell.

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Effects of Activation Regimens of Recipient Cytoplasm, Culture Condition of Donor Embryos and Size of Blastomeres on Development of Reconstituted Bovine Embryos (수핵 난자의 활성화 방법과 공핵 수정란의 배양체계 및 할구의 크기가 소 핵이식 수정란의 발달에 미치는 영향)

  • 심보웅;조성근;이효종;박충생;최상용
    • Korean Journal of Animal Reproduction
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    • v.22 no.4
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    • pp.425-435
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    • 1998
  • To improve the efficiency of nuclear transplantation in bovine, in this study the development in vitro of nuclear transferred (NT) embryos was compared by different activation regimens of the enucleated oocytes. The effect of developmental stage and culture system of donor nuclei on fusion and development in vitro of NT embryos were also evaluated. Oocytes were collected from Hanwoo ovaries obtained from slaughterhouse and matured in Ham's F-10 supplemented with hormones. After 20~22 h maturation, the oocytes were vortexed to be free from cumulus cells and subsequently their nucleus and the first polar body were removed. Enucleated oocytes were divided into 3 groups for activation; the oocytes of group I were activated with ionomycin for 5 min and subsequently incubated in 6-dimetylarninopurine (DMAP) for 4 h, Those of group II were treated with DMAP for 4 h at 39 h after onset of in vitro maturation (IVM) and those of group III were kept in room temperature ($25^{\circ}C$) for 3 h at 39 h after onset of IVM. After in vitro fertilization (IVF) the embryos for muclear donor were cultured either by group culture (20 embryos /50 ${mu}ell$ drop) or individually (1 embryo /50 ${mu}ell$ drop) for 4 day and 5 day. At day 4 and 5 after IVF, blastomeres were separated in calcium-magnesium free medium, and then classified into small (day 5: $\leq$ 38 ${\mu}{\textrm}{m}$, day 4: $\leq$ 46 ${\mu}{\textrm}{m}$) and large (day 5 : $\geq$ 38 ${\mu}{\textrm}{m}$, day 4 ; $\geq$ 46 ${\mu}{\textrm}{m}$). The separated blastomeres were replaced into enucleated and activated recipient cytoplasm. The blastomere-oocyte complexes were fused by electrically. The NT embryos were cultured in TCM-199 containing 10% FCS in 39$^{\circ}C$, 5% $CO_2$ incubator for 7 day. The results obtained were summarized as follows; There were no differences in fusion and development to blastocyst between groups as group I (68%, 10%), group II (75%, 14%) and group III (73%, 9%), respectively. However, the cell number in blastocyst of NT embryos in group III were significantly fewer than in the other groups (P<0.05). No differences in fusion and development to blastocyst were found between individual or group cultured and between small or large blastomeres of day 4 and day 5 donor embryos. From these results, it was concluded that the combination of ionomycin and DMAP, or treatment of DMAP at 39 h after onset of IVM were useful for the efficient of production of NT bovine embryos, and the individual cultured embryos could be simply used as donor nuclei for NT bovine embryo.

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An accuracy analysis of Cyberknife tumor tracking radiotherapy according to unpredictable change of respiration (예측 불가능한 호흡 변화에 따른 사이버나이프 종양 추적 방사선 치료의 정확도 분석)

  • Seo, jung min;Lee, chang yeol;Huh, hyun do;Kim, wan sun
    • The Journal of Korean Society for Radiation Therapy
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    • v.27 no.2
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    • pp.157-166
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    • 2015
  • Purpose : Cyber-Knife tumor tracking system, based on the correlation relationship between the position of a tumor which moves in response to the real time respiratory cycle signal and respiration was obtained by the LED marker attached to the outside of the patient, the location of the tumor to predict in advance, the movement of the tumor in synchronization with the therapeutic device to track real-time tumor, is a system for treating. The purpose of this study, in the cyber knife tumor tracking radiation therapy, trying to evaluate the accuracy of tumor tracking radiation therapy system due to the change in the form of unpredictable sudden breathing due to cough and sleep. Materials and Methods : Breathing Log files that were used in the study, based on the Respiratory gating radiotherapy and Cyber-knife tracking radiosurgery breathing Log files of patients who received herein, measured using the Log files in the form of a Sinusoidal pattern and Sudden change pattern. it has been reconstituted as possible. Enter the reconstructed respiratory Log file cyber knife dynamic chest Phantom, so that it is possible to implement a motion due to respiration, add manufacturing the driving apparatus of the existing dynamic chest Phantom, Phantom the form of respiration we have developed a program that can be applied to. Movement of the phantom inside the target (Ball cube target) was driven by the displacement of three sizes of according to the size of the respiratory vertical (Superior-Inferior) direction to the 5 mm, 10 mm, 20 mm. Insert crosses two EBT3 films in phantom inside the target in response to changes in the target movement, the End-to-End (E2E) test provided in Cyber-Knife manufacturer depending on the form of the breathing five times each. It was determined by carrying. Accuracy of tumor tracking system is indicated by the target error by analyzing the inserted film, additional E2E test is analyzed by measuring the correlation error while being advanced. Results : If the target error is a sine curve breathing form, the size of the target of the movement is in response to the 5 mm, 10 mm, 20 mm, respectively, of the average $1.14{\pm}0.13mm$, $1.05{\pm}0.20mm$, with $2.37{\pm}0.17mm$, suddenly for it is variations in breathing, respective average $1.87{\pm}0.19mm$, $2.15{\pm}0.21mm$, and analyzed with $2.44{\pm}0.26mm$. If the correlation error can be defined by the length of the displacement vector in the target track is a sinusoidal breathing mode, the size of the target of the movement in response to 5 mm, 10 mm, 20 mm, respective average $0.84{\pm}0.01mm$, $0.70{\pm}0.13mm$, with $1.63{\pm}0.10mm$, if it is a variant of sudden breathing respective average $0.97{\pm}0.06mm$, $1.44{\pm}0.11mm$, and analyzed with $1.98{\pm}0.10mm$. The larger the correlation error values in both the both the respiratory form, the target error value is large. If the motion size of the target of the sine curve breathing form is greater than or equal to 20 mm, was measured at 1.5 mm or more is a recommendation value of both cyber knife manufacturer of both error value. Conclusion : There is a tendency that the correlation error value between about target error value magnitude of the target motion is large is increased, the error value becomes large in variation of rapid respiration than breathing the form of a sine curve. The more the shape of the breathing large movements regular shape of sine curves target accuracy of the tumor tracking system can be judged to be reduced. Using the algorithm of Cyber-Knife tumor tracking system, when there is a change in the sudden unpredictable respiratory due patient coughing during treatment enforcement is to stop the treatment, it is assumed to carry out the internal target validation process again, it is necessary to readjust the form of respiration. Patients under treatment is determined to be able to improve the treatment of accuracy to induce the observed form of regular breathing and put like to see the goggles monitor capable of the respiratory form of the person.

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