• 제목/요약/키워드: capsule

검색결과 1,210건 처리시간 0.035초

가바펜틴 400밀리그람 캡슐의 생물학적동등성시험 (Bioequivalence Test of Gabapentin 400 mg Capsules)

  • 김세미;강현아;조혜영;신새벽;류희두;윤화;이용복
    • 약학회지
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    • 제52권3호
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    • pp.195-200
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    • 2008
  • Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

GEANT4를 이용한 치료용 I-131 캡슐의 안정성 시뮬레이션 (Safety Simulation of Therapeutic I-131 Capsule Using GEANT4)

  • 정영환;김병철;심철민;서한경;권용주;한동현
    • 핵의학기술
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    • 제18권2호
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    • pp.57-61
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    • 2014
  • 국내 갑상선암 환자의 발병률이 증가함에 따라 방사성요오드 치료가 필요한 환자가 증가하고 있다. 방사성 요오드 치료에 이용되고 있는 캡슐용기들 중 1.1 GBq과 5.5 GBq의 국산제품에 설계도면을 바탕으로 차폐체를 구현한 후 366 keV 이상에 감마선들에 대하여 캡슐용기의 방사선 누설선량을 GEANT4 전사모사를 이용하여 평가하였다. 치료용 I-131 캡슐용기 누설선량을 측정하기 위해 각각의 용기에 대하여 용기 표면에서 10 cm 거리 및 100 cm 거리에서의 누설선량을 측정하였다. 용기표면에서 10 cm 거리와 100 cm 거리에서의 누설선량 측정은 방사형으로 발생되는 방사선을 위치별로 측정하기 위해 $10{\times}10{\times}10cm^3$ 부피의 정육면체 형태의 물 팬텀(phantom)을 상부, 상부측면, 측면, 하부측면, 하부 다섯 방향에 설치하여 누설선량을 계산하였다. 용기별로 5개 방향에서 용기표면으로 부터 10 cm, 100 cm 거리에서 전산모사를 수행한 결과 법적 허용기준인 10 cm 거리에서 2.0 mSv/h, 100 cm 거리에서 0.02 mSv/h 이하의 선량 규정과 비교하였을 때 법적기준치보다 현저히 낮은 누설선량이 방출되는 것을 확인하였다.

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현가장치 내 감쇠 제어를 이용한 캡슐트레인 승차감 향상 연구 (Study of the Capsule Train Ride Comfort Improvement by using the Damping Control in Suspension System)

  • 이진호;임정열;유원희;이관섭
    • 한국산학기술학회논문지
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    • 제21권10호
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    • pp.547-557
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    • 2020
  • 본 연구에서는 캡슐트레인의 승차감 향상을 위하여 캡슐트레인 모델 내의 현가장치에 감쇠 제어 장치를 적용하고 그 효과를 검토하였다. 캡슐트레인의 부상 방식으로 사용되는 초전도 유도 반발식 부상은 별도의 부상제어가 필요 없고 부상 공극이 큰 장점이 있다. 하지만, 본 부상 방식은 공극 변화량이 크고 외부로부터 유입되는 진동에 대한 작은 감쇠 특성으로 인해 캡슐트레인의 승차감을 저하시키는 단점이 있다. 본 연구에서는 캡슐트레인의 승차감 향상을 위해서 1차 및 2차 현가장치 내에 적용되는 감쇠 제어 장치를 고려하였다. 1차 현가장치에 적용되는 감쇠 제어 장치는 외란에 의해 발생하는 진동이 대차로 전달되는 것을 감소시키는 역할을 하고, 2차 현가장치 적용되는 감쇠 제어 장치는 대차의 진동이 차체로 전달되는 것을 감소시키는 역할을 한다. 감쇠 제어가 승차감에 미치는 효과를 검토하기 위하여 캡슐트레인 모델을 기반으로 한 동특성 해석 시뮬레이션을 수행하였다. 검토 결과, 현가장치 내 감쇠 제어를 통해 ISO 기준의 승차감 규격을 만족할 수 있음을 확인하였다.

Bioequivalence of Cholicerin Soft Capsule to Gliatilin Soft Capsule (Choline Alphoscerate 400 mg)

  • Kang, Hyun-Ah;Kim, Se-Mi;Kang, Seung-Rae;Kang, Min-Sun;Lee, Sang-No;Kwon, In-Ho;Yoo, Hee-Doo;Kim, Yoon-Gyoon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • 제40권2호
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    • pp.109-115
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    • 2010
  • The purpose of the present study was to evaluate the bioequivalence of two choline alphoscerate soft capsules, Gliatilin soft capsule (Daewoong Pharmaceuticals Co., Ltd.) and Cholicerin soft capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Serum concentrations of choline after oral administration of choline alphoscerate were determined using a validated LC/MS/MS method. This method showed linear response over the concentration range of 0.5-20 ${\mu}g$/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 100 ${\mu}L$ of serum was 0.5 ${\mu}g$/mL which was sensitive enough for pharmacokinetic studies. Thirty six healthy male Korean volunteers received each medicine at the choline alphoscerate dose of 1200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Blood samples were taken at predetermined time intervals up to 8 hr. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 8 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters, indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Cholicerin/Gliatilin were log0.9998-log1.1172 and log0.9938-1.0944, respectively. These values were within the acceptable bioequivalence intervals of log0.80-log1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Cholicerin soft capsule and Gliatilin soft capsule are bioequivalent.

캡슐내시경을 위한 HBC시스템 구현 (An Implementation of HBC System for Capsule Endoscope)

  • 김기윤
    • 한국인터넷방송통신학회논문지
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    • 제18권3호
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    • pp.215-221
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    • 2018
  • 본 논문에서는 캡슐 내시경을 위한 HBC(Human Body Communication) 시스템의 종합적인 설계 방법을 제시하였다. 먼저 환자 몸에 부착된 다수의 패치로부터 수신되는 신호를 차동 연산을 통해 합성하는 방법을 제시하고 이를 통한 신호 SNR을 수학적으로 유도하였다. 캡슐에서 보내는 HBC 송신신호를 동기화하기 위한 방법으로 PN 코드를 이용한 대략적 타이밍 동기 방법과 ZCD(Zero Crossing Detector)를 통한 Manchester, NRZ, RZ 변조 기법간의 미세 타이밍 동기 성능을 분석하였다. 아울러 HBC 신호 프레임을 Rician 및 Rayleigh 채널 환경에서 적용하였을 때의 등화 성능을 LMS 및 RLS 알고리즘을 적용하여 평가하였다.

생활폐기물 수거 방법의 비교 연구 (A Comparative Study of Waste Collection Technologies)

  • 정영훈;서상호;김형호
    • 한국유체기계학회 논문집
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    • 제16권3호
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    • pp.48-53
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    • 2013
  • Due to the urbanization, lots of people are living in cities. It is very convenient to live in the cities for the people but at the same time, the highly populated city has several environmental problems. During delivery process of large amount of municipal waste generated from the cities, the automobile emission and traffic jam have been occurred. The waste collection in the cities has been mainly done by using labour force and delivery truck. This is the conventional waste collection up to now. Recently, new technologies like automated waste collection system and capsule transportation have been introduced. Conventional waste collection mainly relied on the labour force and truck delivery does not need to invest a lot of money for the start-up. However, it requires to pay the operational cost both for the labour force and the truck delivery. On the contrary to this conventional waste collection, the automated waste collection and capsule transportation require high initial investment cost. However, the automated waste collection and capsule transportation can reduce significantly the pollutants emission, traffic jam by the waste trucks and actual waste collection cost per ton. In dealing with the waste collection in the cities, new waste collection technologies could be properly combined with the conventional waste collection for the effective municipal waste treatment.

봉과 링 조합형 아이스캡슐을 적용한 축열시스템의 열전달 해석 (Heat Transfer Analysis of a Thermal Storage System using the Ice Capsule of Bar and Ring Module)

  • 김명수;최형권;변성광
    • Journal of Advanced Marine Engineering and Technology
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    • 제32권2호
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    • pp.268-275
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    • 2008
  • The shape and array of ice capsules are very important factors in ice thermal storage system because the heat transfer rate of the system strongly depends upon them. In this paper, a new type of ice capsule composed of bar and ring module is proposed to increase the efficiency of the ice thermal storage system. To investigate the heat transfer rate of the proposed ice capsule, numerical analysis of the incompressible Navier-Stokes equations is performed to compare the proposed bar and ring system with the conventional ice capsules. It is shown that the ice capsule composed of bar and ring has a higher heat transfer rate and a low outlet temperature than the conventional ice capsules for various packing ratios and entrance velocities. Furthermore, it is found that the optimal entrance velocity exists between 0.005 m/s and 0.007 m/s from the present numerical analysis.