• 제목/요약/키워드: the standard of reference

검색결과 2,150건 처리시간 0.029초

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.

다양한 CAD/CAM 제조 방식으로 제작한 3본 고정성 임시 치과 보철물의 정확도 비교 (Accuracy comparison of 3-unit fixed dental provisional prostheses fabricated by different CAD/CAM manufacturing methods)

  • 이혁준;이하빈;노미준;김지환
    • 대한치과기공학회지
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    • 제45권2호
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    • pp.31-38
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    • 2023
  • Purpose: This in vitro study aimed to compare the trueness of 3-unit fixed dental provisional prostheses (FDPs) fabricated by three different additive manufacturing and subtractive manufacturing procedures. Methods: A reference model with a maxillary left second premolar and the second molar prepped and the first molar missing was scanned for the fabrication of 3-unit FDPs. An anatomically shaped 3-unit FDP was designed on computer-aided design software. 10 FDPs were fabricated by subtractive (MI group) and additive manufacturing (stereolithography: SL group, digital light processing: DL group, liquid crystal displays: LC group) methods, respectively (N=40). All FDPs were scanned and exported to the standard triangulated language file. A three-dimensional analysis program measured the discrepancy of the internal, margin, and pontic base area. As for the comparison among manufacturing procedures, the Kruskal-Wallis test and the Mann-Whitney test with Bonferroni correction were evaluated statistically. Results: Regarding the internal area, the root mean square (RMS) value of the 3-unit FDPs was the lowest in the MI group (31.79±6.39 ㎛) and the highest in the SL group (69.34±29.88 ㎛; p=0.001). In the marginal area, those of the 3-unit FDPs were the lowest in the LC group (25.39±4.36 ㎛) and the highest in the SL group (48.94±18.98 ㎛; p=0.001). In the pontic base area, those of the 3-unit FDPs were the lowest in the LC group (8.72±2.74 ㎛) and the highest in the DL group (20.75±2.03 ㎛; p=0.001). Conclusion: A statistically significant difference was observed in the RMS mean values of all the groups. However, in comparison to the subtractive manufacturing method, all measurement areas of 3-unit FDPs fabricated by three different additive manufacturing methods are within a clinically acceptable range.

시판 포장가공 식품의 영양표시 현황에 관한 조사연구 (A Study on the Current Nutritin Labeling Practices for the Processed Foods Retailed in the Supermarket in Korea)

  • 장순옥
    • Journal of Nutrition and Health
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    • 제30권1호
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    • pp.100-108
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    • 1997
  • Our current food hygiene law mandates nutrition label (NL) for the special nutrition foods, health support foods, instant foods, and foods with certain nutrient emphasized note, only. Currently more processed foods are bearing nutrition labels though the format is quite inconsistant. This study examined the status on current nutrition labeling practices for the processed foods that are retailed in the supermarket. The obtained information was assessed in the aspects of numerical data presentation on nutrients content, descriptive terms, health claim, and the format. The results are summarized as follows. 1) Foods with NL are limited to the food category specified by current hygiene law while voluntary nutition labeling is few. 2) Descriptive terms such as free, low, and sufficient are not substantiated with quantitative data. The efficacy of microelements which has not been clalified yet are overemphasized but major nutrients are ignored. 3) The regulations for the descriptive terms are set on the base of the nutrient content per 100g or 100ml under current nutrition labeling act. It would mislead consumers thus the definition for these descriptor be better set on the unit of the amount of food customary eaten at one time. For this the standard serving size should be set officially. 4) Quantitative nutrition information given on food products is difficult to compare because of the lack in formality. The title of NL, load and kinds of nutritents, order of nutrients listed, the unit of expression, RDA comparision, and reference RDA are inconsistant among the foods similar in dietary property. Uniform format is needed to give NL the credibility and usefulness. Proividing nutrition information to the consumers with NL is a worldwide practice though its efficacy has been controversial. Under newly legistered health promotion law in Korean nutrition education is esxpected to take part in to improve national nutrition condition and NL would education is expected to take part in to improve national nutrition condition and NL would be a potent tool for public nutritions education. It appears to be the time to mandate NL to all the processed foods in the market. The result of present study would initiate further consumer experiments related to NL. Various interest groups such as food and nutrition professions, public health organizations, government regulatory agencies, food producers and marketers, and consumer groups need to particepate and communicate for the legislation of NL and the development of NL format.

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일본 REDD+의 국가 전략 및 시사점 - 양국간 크레딧 메커니즘(JCM)을 중심으로 - (Implications for Japan's National REDD+ Strategies - Focused on Joint Credit Mechanism (JCM) -)

  • 박정묵;서환석;이정수
    • 한국산림과학회지
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    • 제105권2호
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    • pp.238-246
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    • 2016
  • 본 연구는 Post-2020을 대비하는 일본의 REDD+의 국가전략과 각 기관별 추진현황을 파악하고, JCM(Joint Credit Mechanism) REDD+ 가이드라인의 문제점에 대한 우리나라 REDD+의 대응 방안 및 시사점을 제시하는 것을 목적으로 한다. JCM-REDD+ 가이드라인의 기술적 한계를 보면, REDD+ 사업의 대상이 되는 산림의 적합성은 세이프가드 간섭이 적은 곳을 선점하는 문제가 있으며, 참조배출기준선의 설정은 기준연도에 따라서 추세선이 변화하기 때문에 배출량 차이가 발생할 수 있다. 또한, REDD+의 배출이동(누출)은 누출지역이 발생하였을 때, 누출면적과 관계없이 일정계수를 곱하여 산출하기 때문에 불확실성을 포함하고 있으며, 모니터링 실시방침은 국가 및 준국가 단위의 방법만을 제시하고 있어 프로젝트 단위의 방법론이 필요하다. 마지막으로 세이프가드에 대한 방침은 세부사항 없이 목록으로만 제시하고 있어 국제통용의 항목 규정이 필요하다. 이와 같은 문제점들은 크레딧의 분배와 계층적접근(Nested Approach) 등의 더블카운팅(Double Counting) 문제와도 관련이 있으며, 앞으로 우리나라는 이를 고려하여 REDD+ 사업을 시행해야 할 것이다.

Diagnostic Performance of Core Needle Biopsy for Characterizing Thyroidectomy Bed Lesions

  • So Yeong Jeong;Jung Hwan Baek;Sae Rom Chung;Young Jun Choi;Dong Eun Song;Ki-Wook Chung;Won Woong Kim;Jeong Hyun Lee
    • Korean Journal of Radiology
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    • 제23권10호
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    • pp.1019-1027
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    • 2022
  • Objective: Thyroidectomy bed lesions frequently show suspicious ultrasound (US) features after thyroid surgery. Fine-needle aspiration (FNA) may not provide definitive pathological information about the lesions. Although core-needle biopsy (CNB) has excellent diagnostic performance in characterizing suspicious thyroid nodules, no published studies have evaluated the performance of CNB specifically for thyroidectomy bed lesions. Therefore, we aimed to evaluate the diagnostic performance and safety of CNB for characterizing thyroidectomy bed lesions. Materials and Methods: A total of 124 thyroidectomy bed lesions in 113 patients (79 female and 34 male; age, 23-85 years) who underwent US-guided CNB between December 2008 and December 2020 were included. We reviewed the US imaging features of the target lesions and the histories of previous biopsies. The pathologic results, diagnostic performance for malignancy, and complications of CNB were analyzed. Results: All samples (100%) obtained by CNB were adequate for pathological analysis. Pathological analysis revealed inconclusive results in two lesions (1.6%). According to the reference standard, 50 lesions were ultimately malignant (40.3%), and 72 were benign (58.1%), excluding the two inconclusive lesions. The performance of CNB for diagnosing malignant thyroidectomy bed lesions in the 122 lesions had a sensitivity of 98.0% (49/50), a specificity of 100% (72/72), positive predictive value of 100% (49/49), and negative predictive value of 98.6% (72/73). Eleven lesions were referred for CNB after prior inconclusive FNA results in thyroidectomy bed lesions, for all of which CNB yielded correct conclusive pathologic diagnoses. According to the pathological analysis of CNB, there were various benign lesions (58.9%, 73/124) besides recurrence, including benign postoperative lesions other than suture granuloma (32.3%, 40/124), suture granuloma (15.3%, 19/124), remnant thyroid tissue (5.6%, 7/124), parathyroid lesions (4%, 5/124), and abscesses (1.6%, 2/124). No major or minor complications were associated with the CNB procedure. Conclusion: US-guided CNB is accurate and safe for characterizing thyroidectomy bed lesions.

99mTc-3PRGD2 SPECT/CT Imaging for Diagnosing Lymph Node Metastasis of Primary Malignant Lung Tumors

  • Liming Xiao;Shupeng Yu;Weina Xu;Yishan Sun;Jun Xin
    • Korean Journal of Radiology
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    • 제24권11호
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    • pp.1142-1150
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    • 2023
  • Objective: To evaluate 99mtechnetium-three polyethylene glycol spacers-arginine-glycine-aspartic acid (99mTc-3PRGD2) single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging for diagnosing lymph node metastasis of primary malignant lung neoplasms. Materials and Methods: We prospectively enrolled 26 patients with primary malignant lung tumors who underwent 99mTc-3PRGD2 SPECT/CT and 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/CT imaging. Both imaging methods were analyzed in qualitative (visual dichotomous and 5-point grades for lymph nodes and lung tumors, respectively) and semiquantitative (maximum tissue-to-background radioactive count) manners for the lymph nodes and lung tumors. The performance of the differentiation of lymph nodes with and without metastasis was determined at the per-lymph node station and per-patient levels using histopathological results as the reference standard. Results: Total 42 stations had metastatic lymph nodes and 136 stations had benign lymph nodes. The differences between metastatic and benign lymph nodes in the visual qualitative and semiquantitative analyses of 99mTc-3PRGD2 SPECT/CT and 18F-FDG PET/CT were statistically significant (all P < 0.001). The area under the receiver operating characteristic curve (AUC) in the semi-quantitative analysis of 99mTc-3PRGD2 SPECT/CT was 0.908 (95% confidence interval [CI], 0.851-0.966), and the sensitivity, specificity, positive predictive value, and negative predictive value were 0.86 (36/42), 0.88 (120/136), 0.69 (36/52), and 0.95 (120/126), respectively. Among the 26 patients (including two patients each with two lung tumors), 15 had pathologically confirmed lymph node metastasis. The difference between primary lung lesions in patients with and without lymph node metastasis was statistically significant only in the semi-quantitative analysis of 99mTc-3PRGD2 SPECT/CT (P = 0.007), with an AUC of 0.807 (95% CI, 0.641-0.974). Conclusion: 99mTc-3PRGD2 SPECT/CT imaging may notably perform in the direct diagnosis of lymph node metastasis of primary malignant lung tumors and indirectly predict the presence of lymph node metastasis through uptake in the primary lesions.

Effectiveness of Cognitive Behavioral Therapy Techniques for Control of Pain in Lung Cancer Patients: An Integrated Review

  • Phianmongkhol, Yupin;Thongubon, Kannika;Woottiluk, Pakapan
    • Asian Pacific Journal of Cancer Prevention
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    • 제16권14호
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    • pp.6033-6038
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    • 2015
  • Background: Experience of lung cancer includes negative impacts on both physical and psychological health. Pain is one of the negative experiences of lung cancer. Cognitive behavioral therapy techniques are often recommended as treatments for lung cancer pain. The objective of this review was to synthesize the evidence on the effectiveness of cognitive behavioral therapy techniques in treating lung cancer pain. This review considered studies that included lung cancer patients who were required to 1) be at least 18 years old; 2) speak and read English or Thai; 3) have a life expectancy of at least two months; 4) experience daily cancer pain requiring an opioid medication; 5) have a positive response to opioid medication; 6) have "average or usual" pain between 4 and 7 on a scale of 0-10 for the day before the clinic visit or for a typical day; and 7) able to participate in a pain evaluation and treatment program. This review considered studies to examine interventions for use in treatment of pain in lung cancer patients, including: biofeedback, cognitive/attentional distraction, imagery, hypnosis, and meditation. Any randomized controlled trials (RCTs) that examined cognitive behavioral therapy techniques for pain specifically in lung cancer patients were included. In the absence of RCTs, quasi-experimental designs were reviewed for possible conclusion in a narrative summary. Outcome measures were pain intensity before and after cognitive behavioural therapy techniques. The search strategy aimed to find both published and unpublished literature. A three-step search was utilised by using identified keywords and text term. An initial limited search of MEDLINE and CINAHL was undertaken followed by analysis of the text words contained in the title and abstract, and of the index terms used to describe the article. A second search using all the identified keywords and index terms was then undertaken across all included databases. Thirdly, the reference list of all identified reports and articles were searched for additional studies. Searches were conducted during January 1991- March 2014 limited to English and Thai languages with no date restriction. Materials and Methods: All studies that met the inclusion criteria were assessed for methodological quality by three reviewers using a standardized critical appraisal tool from the Joanna Briggs Institute (JBI). Three reviewers extracted data independently, using a standardized data extraction tool from the Joanna Briggs Institute (JBI). Ideally for quantitative data meta-analysis was to be conducted where all results were subject to double data entry. Odds ratios (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals were to be calculated for analysis and heterogeneity was to be assessed using the standard Chi-square. Where statistical pooling was not possible the finding were be presented in narrative form. Results: There were no studies located that met the inclusion requirements of this review. There were also no text and opinion pieces that were specific to cognitive behavioral therapy techniques pain and lung cancer patients.Conclusions: There is currently no evidence available to determine the effectiveness of cognitive behavioural therapy techniques for pain in lung cancer patients.

밥, 면, 소스류에 존재하는 수용성 비타민 B1, B2 그리고 B3 함량 검토 (Investigation of Water-Soluble Vitamin (B1, B2, and B3) Contents in Rice, Noodles, and Sauces)

  • 조진주;홍성준;부창국;신의철
    • 한국식품위생안전성학회지
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    • 제35권4호
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    • pp.398-410
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    • 2020
  • 본 연구에서는 13종의 밥류, 11종의 면류, 그리고 15종의 소스류에 함유되어 있는 수용성 비타민 B1 (thiamin), B2 (riboflavin), 그리고 B3 (niacin)의 함량을 확인하였다. 실험 결과에 대한 신뢰도를 확인하기 위해 검출한계(LOD)와 정량한계(LOQ)를 확인하였으며, 표준인증물질(SRM 1849a)을 통한 결과의 정확도를 확인하여 우수한 지표를 나타내었다. Thiamin에서 밥류의 경우 잡채밥이 가장 높은 함유량을 확인하였고, 면류의 경우 막국수, 그리고 소스류의 경우 토마토 스파게티소스가 가장 높은 함유량을 확인하였다. Riboflavin은 밥류의 경우 짜장밥, 면류의 경우 비빔국수, 소스류의 경우 강황카레 약간 매운맛에서 가장 높은 함유량을 확인하였다. Niacin에서는 밥류, 면류, 그리고 소스류에서 각각 치킨볶음밥, 잔치국수, 짜장소스에서 가장 높은 함유량을 확인하였다. 한국인 성인 남녀의 수용성 비타민 1일 섭취권장량에 대하여 식품에 함유되어 있는 양을 확인한 결과 강황카레 약간 매운맛에서 가장 높은 riboflavin의 함량이 남자의 경우 217.40%, 여자의 경우 271.75%로 가장 높은 함량을 확인하였다. 본 연구를 통해서 밥류, 면류, 그리고 소스류에 함유된 수용성 비타민에 대한 영양성분 데이터베이스를 구축하고, 1일 섭취권장량에 대한 식품에 함유된 수용성 비타민의 함량 확인을 통해 국민 식생활에 필요한 자료를 제공하고자 한다.

ALARA 개념(槪念)에 의한 기체상방사성물질(氣體狀放射性物質)의 환경방출한도(環境放出限度) 설정(設定) (Establishment of Release Limits for Airborne Effluent into the Environment Based on ALARA Concept)

  • 이병기;차문회;남순권;장시영;하정우
    • Journal of Radiation Protection and Research
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    • 제10권1호
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    • pp.50-63
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    • 1985
  • 농축인자법(濃縮因子法)(Concentration Factor Method)을 이용(利用)하여 결정피폭경로(決定被曝經路)를 분석(分析)한 후(後) 표준원전(標準原電)의 기체상방사성대기방출물(氣體狀放射性大氣放出物)에 대한 유도방출한도(誘導放出限度)(Derived Release Limits, DRL's)를 계산(計算)하였다. 이 방출한도(放出限度)는 핵시설(核施設) 주변(周邊)의 결정군구성개인(決定群構成個人)에 대(對)한 방사선(放射線) 피폭(被曝)을 관련피폭한도이하(關聯被曝限度以下)로 유지(維持)시키는 양(量)이다 본(本) 연구(硏究)에서는 1985년(年) 초(初) 미국(美國)의 환경보호청(環境保護廳)(EPA)에서 새로 권고(勸告)한 피폭한도(被曝限度)를 채택(採擇)하여 계산(計算)을 수행(遂行)하였다. 유도방출한도(誘導放出限度)(DRL)의 계산(計算)은 미국(美國)의 원자력(原子力) 규제위원회(規制委員會)(USNRC)가 규제지침(規制指針)(Reg. Guide) 1.109에서 제시(提示)하고 있는 선양평가(線量評價)모델을 표준(標準)모델로 사용(使用)하여 수행(遂行)하였으나, 동(同) 모델의 피폭경로분석(被曝經路分析)에서 우유(牛乳) 및 육류(肉類)의 섭취경로(攝取經路)는 국내(國內)의 현실상(現實狀) 무시가능(無視可能)한 것으로 고려(考慮)하여 본(本) 연구(硏究)에서 제외(除外)시켰다. 계산(計算)에서 고려(考慮)한 방출선원항(放出線源項)은 희유기체(稀有氣體), 요오드, 입자상원소(粒子狀元素) 및 삼중수소기체(三重水素氣體)였으며, 방출원(放出源)에서 북(北)쪽으로 1.3 km 거리에 위치(位置)하고 있는 주민영구거주지역(住民永久居住地域)을 대상(對象)으로 계산(計算)을 수행(遂行)하였다. 본(本) 연구(硏究)에서는 표준원전(標準原電)의 대상(對象)으로 고리원전(古里原電) 1호기(號機)를 선정(選定)하여 동원전(同原電)의 연간방출(年間放出)에 대(對)한 유도한도(誘導限度)를 계산(計算)하였으며, 1982년도(年度)의 실방출률(實放出率)과 비교(比較) 검토(檢討)하였다. 검토결과(檢討結果), 고리원전(古里原電) 1호기(號機)의 1982년도(年度)의 실방출률(實放出率)은 본(本) 연구(硏究)에서 구(求)해진 유도방출한도(誘導放出限度)보다 낮았으며, 방출물(放出物)에 의한 시설주변(施設周邊) 개인(個人)의 년간피폭선량(年間被曝線量)은 EPA에서 권고(勸告)하는 피폭한도이하(被曝限度以下)로 유지(維持)되었음을 알 수 있었다. 또한 본(本) 연구(硏究)에서 가장 결정적(決定的)인 피폭경로(被曝經路)는Co-60와 Cs-137과 같은 입자상침적방사핵종(粒子狀沈積放射核種)으로 오염(汚染)된 토양(土壤)에 의한 전신외부(全身外部) 피폭경로(被曝經路)였다.

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HepaRG 세포를 이용한 Bosentan 약물의 CYP450 효소활성 측정 (Measurement of CYP450 Enzymes Activity of Bosentan in HepaRG Cell)

  • 한경문;정정아;신지순;차혜진;배영지;김현욱;김영훈;성원근;강호일
    • 약학회지
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    • 제58권4호
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    • pp.255-261
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    • 2014
  • Poly-pharmacy has been on the rise because of aging of population and chronic disease. Most of drug metabolism happens in the liver by CYP isozymes and the metabolism by CYP450 enzymes. The Cytochrome P450 (CYP) is a superfamily of enzymes that catalyzes the oxidations of many endogenous and exogenous compounds. Primary human Hepatocytes (HH) are considered as the gold standard model for In vitro drug interaction studies. However, there are several limitations (cost, limited life span) for using HH cells. HepaRG cells are being used as a possible alternative. HepaRG cells were cultured in William E medium containing the positive control inducers (1A2: 10, 25, 50 ${\mu}M$ omeprazole, 2C9 and 2C19: 10 ${\mu}M$ rifampin, 3A4: 10, 25, 50 ${\mu}M$ rifampin) at $37^{\circ}C$, 5 % $CO_2$ in a humidified atmosphere. This study was to evaluate the induction of CYP isozymes (1A2, 2C9, 2C19 and 3A4) using LC-MS/MS. We evaluated the potential induction ability of Bosentan, as a drug of pulmonary artery hypertension, in HepaRG cells. For reference, dose of the Bosentan is determined to the basis of the $C_{max}$ (835 mg/ml) value. The enzyme activity demonstrated that CYP2C9 and 3A4 were induced up to 20 times by Bosentan. Like as In vivo, the enzyme activity of CYP2C9 and CYP3A4 is significantly induced in a dose-dependent by Bosentan.