• 제목/요약/키워드: Healthy volunteers

검색결과 860건 처리시간 0.026초

LC/TOF-MS와 GC/TOF-MS를 이용한 인체 내 요시료 중 Superdrol과 그 대사체의 분석 (Determination of superdrol and its metabolites in human urine by LC/TOF-MS and GC/TOF-MS)

  • 최해민;염태우;팽기정;김연제
    • 분석과학
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    • 제24권3호
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    • pp.183-192
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    • 2011
  • 본 연구에서는 LC/ESI/MS 및 GC/MS로 superdrol을 인체에 경구투여 한 후 채취한 요시료 중에 함유된 superdrol 및 그 대사체의 분석법을 확립하고 이들의 체내 배설형태를 조사하였다. 액체-액체 추출에서 최적 추출 pH는 6.5 이고 최적 추출 용매는 diethly ether이였다. GC/MSD를 이용하여 superdrol과 그 대사체의 분석법에 대한 유효성을 점검한 결과, intra-day의 회수율은 89.7-113.2%, 정확도 91.8-113.8%, 재현성은 0.2-6.8%로 나타났고 inter-day의 회수율은 89.3-104.1%, 정확도는 95.2-103.0%, 재현성은 0.7-7.8%로 나타났다. LC/ESI/MS을 통해 얻은 blank urine과 dosed urine의 크로마토그램을 비교하여 superdrol의 대사체를 검출하였으며 Superdrol과 그 대사체를 유도체화 시켜 GC/TOF-MS로 확인하였다. 확보된 질량스펙트럼으로부터 superdrol M1의 경우 superdrol의 3-C 위치의 케톤기가 하이드록시기로 환원된 것으로 추정할 수 있었고 M2의 경우 superdrol의 D-ring에 하이드록시기가 첨가된 것으로 추정할 수 있었다. 또한, 효소가수분해과정을 비교해 본 결과 superdrol과 그 대사체들은 대부분 글루쿠론산 포합체를 형성하여 체외로 배설되는 것을 확인하였다. Superdrol 경구투여 후 채취한 요시료로부터 superdrol과 그 대사체의 배설양상을 조사한 결과, 모두 4.3 시간에서 최대배설량을 보였고 superdrol과 superdrol M1은 48시간까지도 미량검출 되어 체내 잔류성이 높은 물질임을 확인할 수 있었다.

한국인 입에 대한 생체계측학적 연구 (Anthropometric Analysis of the Mouth in Koreans)

  • 김순흠;김나연;이수향;최현곤;신동혁;엄기일;이정용;송우철;고기석
    • Archives of Plastic Surgery
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    • 제35권2호
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    • pp.139-146
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    • 2008
  • Purpose: The objective of this study is anthropometric analysis of mouth and lower face of Korean. The relationship of soft-tissue to underlying bony structures determine the overall aesthetics of the face. The goal of aesthetic surgery of the face is to achieve the ideal normal and enhance the aging face. The purpose of present study was to determine the change of the morphology of the mouth and lower face based on soft-tissue landmarks according to age group to facilitate prediction during aesthetic surgery. Methods: The standardized photographs of 2,018 healthy volunteers(18 to 79 years of age; 1,070 males, 948 females) were investigated. Age groups were classified into young, middle-aged, and elderly groups. Five and seven items were measured on frontal and lateral view photographs, respectively. Individual dimensions were compared in the three age groups and between males and females. Results: The width of mouth is 4.5 times larger than that of philtrum. Most of measured data decreased with age. However, woman's lip width of the mouth somewhat increased from the young to elderly. The width of lower face is 2.5 times larger than mouth in young age group and increased slightly from the young to middle-aged and thereafter slightly decreased to elderly group. Upper lip was more higher than lower lip and male lip was more higher than female. But male and female lip height is similar at old age. Conclusion: Most of Koreans showed prominent lower face because of the development or protrusion of the mandible. And the descent of soft-tissue around the mouth was one of the significant characteristics of senile change. The posterior retrusion of the subnasal was an another characteristic. This study will help to elucidate the age-related dimensional differences of the human being and to provide useful information for clinical applications in oral and aesthetic surgery.

정상적인 노화 과정에서 국소뇌포도당대사의 변화: FDG PET 연구 (Changes of Regional Cerebral Glucose Metabolism in Normal Aging Process : A Study With EDG PET)

  • 윤준기;김상은;이경한;최용;최연성;김병태
    • 대한핵의학회지
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    • 제35권4호
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    • pp.231-240
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    • 2001
  • Purpose: Normal aging results in detectable changes in the brain structure and function. We evaluated the changes of regional cerebral glucose metabolism in the normal aging process with FDG PET. Materials and Methods: Brain PET images were obtained in 44 healthy volunteers (age range 20-69 'y'; M:F = 29:15) who had no history of neuropsychiatric disorders. On 6 representative transaxial images, ROIs were drawn in the cortical and subcortical areas. Regional FDG uptake was normalized using whole brain uptake to adjust for the injection dose and correct for nonspecific declines of glucose metabolism affecting all brain areas equally. Results: In the prefrontal, temporoparietal and primary sensorimotor cortex, the normalized FDG uptake (NFU) reached a peak in subjects in their 30s. The NFU in the prefrontal and primary sensorimotor cortex declined with age after 30s at a rate of 3.15%/decade and 1.93%/decade, respectively. However, the NFU in the temporoparietal cortex did not change significantly with age after 30s. The anterior (prefrontal) posterior (temporoparietal) gradient peaked in subjects in their 30s and declined with age thereafter at a rate of 2.35%/decade. The NFU in the caudate nucleus was decreased with age after 20s at a rate of 2.39%/decade. On the primary visual cortex, putamen, and thalamus, the NFU values did not change significantly throughout the ages covered. These patterns were not significantly different between right and left cerebral hemispheres. Of interest was that the NFU in the left cerebellar cortex was increased with age after 20s at a rate of 2.86%/decade. Conclusion: These data demonstrate regional variation of the age-related changes in the cerebral glucose metabolism, with the most prominent age-related decline of metabolism in the prefrontal cortex. The increase in the cerebellar metabolism with age might reflect a process of neuronal plasticity associated with aging.

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메바코 정 (로바스타틴 20 mg)에 대한 로바로드 정의 생물학적 동등성 (Bioequivalence of Lovaload Tablet to Mevacor Tablet (Lovastatin 20 mg))

  • 송우헌;김정민;조성완;김재현;임종래;신희종;최영욱
    • Journal of Pharmaceutical Investigation
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    • 제28권4호
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    • pp.283-288
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    • 1998
  • Lovastatin, one of the potent cholesterol-lowering agents, is an inactive lactone prodrug which is metabolized to its active open acid, lovastatin acid (LVA). Bioequivalence study of two lovastatin preparations, the test drug ($Mevacor^{\circledR}$: Chungwae Pharmaceutical Co., Ltd.) and the reference drug ($Lovaload^{\circledR}$: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Fourteen healthy male volunteers, $23.9{\pm}3.9$ years old and $67.6{\pm}8.0$ kg of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 160 mg as lovastatin in a $2{\times}2$ crossover study. Plasma concentrations of lovastatin acid were analysed by HPLC method for 12 hr after administration. The extent of bioavailability was obtained from the plasma concentration-time profiles of total lovastatin acid after alkaline hydrolysis of the plasma samples. By alkaline hydrolysis, trace amounts of unmetabolized lovastatin were converted to lovastatin acid. The $AUC_{0-12hr}$ was calculated by the linear trapezoidal rule method. The $C_{max}$ and $T_{max}$ were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, $C_{max}$, and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 7.07, 5.77 and 1.18% for AUC, $C_{max}$, and $T_{max}$, respectively). Minimum detectable differences(%) between the formulations at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 17.2, 15.1, and 15.9% for AUC, Cmax, and Tmax, respectively). The 90% confidence intervals for these parameters were also within ${\pm}20%$ (e.g.. $-5.20{\sim}19.3$, $-5.00{\sim}16.5$, and $-10.2{\sim}12.5%$ for AUC, $C_{max}$, and $T_{max}$, respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of lovastatin were bioequivalent.

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프레팔시드 정(시사프리드 5 mg)에 대한 시사플 정의 생물학적 동등성 (Bioequivalence of Prepulsid Tablet to Cisaple Tablet (Cisapride 5 mg))

  • 곽손혁;남진경;장혁;한정희;우종수;이계주;박종우;구선회;황성주
    • Journal of Pharmaceutical Investigation
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    • 제30권1호
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    • pp.55-59
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    • 2000
  • Bioequivalence of two cisapride tablets, test drug ($Cisple^{\circledR}$ tablet: Hanmi Pharm Co., Ltd.) and reference drug ($Prepulsid^{\circledR}$ tablet: Janssen Pharm. Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty two healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 10 mg as cisapride in a $2{\times}2$ crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 36 hr and the plasma concentration of cisapride was determined by a HPLC method. $AUC_{0-36hr}$ (area under the plasma concentration-time curve from time zero to 36 hr), $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in $AUC_{0-36hr},\;C_{max}\;and\;T_{max}$ between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 5.38, 6.17 and 0.00% for $AUC_{0-36hr},\;C_{max}\;and\;T_{max},$ respectively). The powers $(1-\beta)$ for $AUC_{0-36hr},\;C_{max}\;and\;T_{max}$ were over 0.9. Minimal detectable differences $(\Delta)$ at ${\alpha}=0.05,\;1-{\beta}=0.8$ were less than 20% (i.e. 17.67, 14.84 and 19.72% for $AUC_{0-36hr},\;C_{max}\;and\;T_{max},$ respectively). The 90% confidence intervals $(\delta)$ for these parameters were also within ${\pm}20%$ $(i.e.\;-4.97\;{\le}{\delta}{\le}\;15.73,\;-2.53{\le}{\delta}{\le}\;14.86\;and\;-11.55{\le}{\delta}{\le}\;11.55$ for $AUC_{0-36hr},\;C_{max}\;and\;T_{max},$ respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of cisapride were bioequivalent.

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Bioequivalence of Samchundang Lercanidipine Tablet 10 mg to Zanidip Tablet (Lercanidipine Hydrochloride 10 mg) by Liquid Chromatography with Tandem Mass Spectrometry

  • Kim, Se-Mi;Kim, Hwan-Ho;Shin, Sae-Byeok;Kang, Hyun-Ah;Cho, Hea-Young;Kim, Yoon-Gyoon;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • 제37권5호
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    • pp.315-321
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    • 2007
  • The purpose of the present study was to evaluate the bioequivalence of two lercanidipine hydrochloride tablets, Zanidip tablet (LG Life Sciences Ltd., Korea, reference drug) and Samchundang Lercanidipine tablet 10 mg (Sam Chun Dang Pharm. Co. Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (amlodipine maleate) to human serum, serum samples were extracted using hexan-isoamyl alcohol (100:1, v/v). Compounds were analyzed by liquid chromatography/tandem mass spectrometry. This method showed linear response over the concentration range of 0.05-20 ng/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ng/mL which was sensitive enough for pharmacokinetic studies. Thirty healthy male Korean volunteers received each medicine at the lercanidipine hydrochloride dose of 20 mg in a $2\;{\times}\;2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of lercanidipine were monitored by an LC/MS/MS fer over a period of 24 hr after the administration. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 24 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 Samchundang Lercanidipine/Zanidip were log 0.9505-log 1.2258 and log 0.9987-log 1.2013, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Samchundang Lercanidipine tablet 10 mg and Zanidip tablet are bioequivalent.

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.

구강 호흡이 뇌기능에 미치는 영향에 관한 EEG 연구 (EEG Study for the Effects of Mouth Breathing on Brain Functions)

  • 이경진;이송이;박소영;장소라;강창기
    • 감성과학
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    • 제19권4호
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    • pp.119-126
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    • 2016
  • 본 연구는 구강 호흡이 뇌기능에 미치는 영향을 뇌전도(EEG : electroencephalogram)를 통해 관찰하고자 한다. 신체가 건강한 12명의 피험자(남성: 6명, 여성: 6명, 나이: 21~27, 비흡연자)는 뇌파를 측정하기 위해 두피에 전극을 부착한 상태로 휴지기 상태에서 비강(Rest_N) 및 구강 호흡(Rest_M)을 수행하였고, 영어 대본을 사용한 청각언어자극이 주어지는 상황에서 비강(Eng_N) 및 구강 호흡(Eng_M)을 수행하였다. 각각의 뇌파는 뇌의 기능별로 크게 4 구역(R1~R4)으로 나뉘어 FFT (Fast Fourier Transform)을 통해 각각의 채널별(e.g., Pf1 and Pf2) 및 주파수 대역별(${\alpha}$, ${\beta}$, ${\gamma}$, ${\theta}$)로 절대 파워(Absolute Power) 비율을 살펴보았다. 도출된 결과에서는 Rest_N과 Rest_M 상태의 뇌파는 서로 유의미한 차이를 보이지 않았다. 비강 호흡 수행 중 청각언어자극이 주어졌을 때(Rest_N/Eng_N)의 뇌파를 비교했을 경우, 뇌파의 활동이 휴지기 상태의 뇌파 활동보다 통계적으로 유의미하게 높은 것으로 나타났다. 하지만 같은 조건상에서 구강호흡을 했을 때(Rest_M/Eng_M)는 비강 호흡을 실시했을 때와 달리 대부분의 뇌 구역과 주파수 대역에서 유의미한 차이가 나타나지 않았다. 동일한 조건의 자극에도 불구하고 구강 호흡을 하는 경우는 뇌기능의 변화가 비강 호흡과 다른 결과를 나타내었다.

청년층과 노인층의 행동활성화체계 및 행동억제체계 민감도에 따른 뇌파의 1/f 스케일링 분석 (1/f scaling exponent of EEG depending on different sensitivities of behavioral activation and inhibition systems for young and elderly groups)

  • 진승현;김원식;노기용
    • 감성과학
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    • 제8권4호
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    • pp.415-422
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    • 2005
  • 본 연구에서는 행동활성화체계(Behavioral Activation System : BAS)와 행동억제 체계(Behavioral Inhibition System : BIS)의 성향이 청년층과 노인층의 뇌파 특성에 차이를 보이는지를 조사하였다. 실험은 19명의 청년층과 31명의 노인층을 대상으로 하여 이루어졌고, 안정 상태의 양측 전전두엽 뇌파를 측정하였다. 분석은 비선형 지수 중 하나인 1/f스케일링 지수를 사용하였다. 그 결과, BAS 성향에서 1/f스케일 지수가 유의한 차이를 보였다. 즉, 좌측 전전두엽(Fpl)에서는 청년층의 1/f스케일 지수가 노인층의 1/f스케일 지수보다 통계적으로 유의하게 높은 값을 보였고, 우측 전전두엽(Fp2)에서도 청년층이 노인층에 비해 높은 1/f스케일 지수를 나타내는 경향을 보였다. 1/f 스케일 지수가 클수록 복잡도는 감소하고, 반면 확률분포에 관련된 정보의 양은 증가하는 것으로 해석 가능하다. 본 연구를 통해, 주관적 평가 결과로서 행동 활성화체계가 강한 성향을 가진 경우, 노인층은 청년층에 비해 양측 전전두엽의 복잡도가 높은 상태임을 알 수 있다 본 연구의 결과는 BAS성향과 연령 사이의 연관성에 대한 가능성을 시사한다.

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3차원 MR 영상으로부터의 한국인 뇌조직확률지도 개발 (Development of Korean Tissue Probability Map from 3D Magnetic Resonance Images)

  • Jung Hyun, Kim;Jong-Min, Lee;Uicheul, Yoon;Hyun-Pil, Kim;Bang Bon, Koo;In Young, Kim;Dong Soo, Lee;Jun Soo, Kwon;Sun I., Kim
    • 대한의용생체공학회:의공학회지
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    • 제25권5호
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    • pp.323-328
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    • 2004
  • 대뇌조직 구분을 위한 실험적인 정보를 제공하기 위한 뇌조직 확률 지도를 개발하는 경우 개인마다 구조적으로 다양한 형태를 가진 뇌의 특성과 특히 인종간의 두드러진 차이론 반드시 고려해야 한다 본 연구에서는 특정 그룹에 대한 뇌조직 확률 지도를 제작하는데 필요한 절차를 알아보고 나이에 따른 그룹간의 뇌조직 확률 지도의 구조적인 차이를 살펴보고자 한다 피험자 그룹은 100명의 건강한 한국인이며 나이에 따라 두 그룹으로 분류하였다. 뇌 확률 지도의 기준 좌표계를 설정하기 위해 전체 그룹 내의 모든 피험자의 뇌 영상에 대한 평균 영상을 구하고, 각 뇌 영상을 기준 좌표계로 정규화 시킨다. 정규화 과정에서 얻어진 변환 매개 변수를 미리 각 뇌조직(회질, 백질, 뇌척수액)으로 분할된 피험자의 영상에 적용하고 각 그룹 내에서 변환된 뇌 조직 영상을 평균함으로써 뇌 조직 확률 지도를 완성하였다. 나이에 따른 구조적인 차이를 살펴보기 위해 그룹간 확률 값의 차이 영상을 구하였다. 이전 연구결과에서와 마찬가지로 나이가 증가함에 따라 뇌실이 확대되고 회질의 위축이 전체적인 뇌 영역에서 일어났다. 그러므로 우리는 대뇌 조직 분할을 위해 설험적인 정보들을 사용하고자 할 때는 특정 그룹에 대한 뇌 확률 지도를 사용할 것을 제안한다.