• Title/Summary/Keyword: Drug component analysis

검색결과 98건 처리시간 0.032초

FDA 부작용 보고 시스템 데이터베이스를 이용한 Cyclosporine과 Tacrolimus의 주요 약물이상사례 및 실마리 정보 분석 (Analysis of Important Medical Adverse Events and Signals Related with Cyclosporine and Tacrolimus Using the FDA Adverse Event Reporting System (FAERS) Database)

  • 차승현;임지현;송윤경
    • 한국임상약학회지
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    • 제32권4호
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    • pp.352-361
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    • 2022
  • Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.

호흡기를 통한 약액 전달을 위한 진세노사이드 초미세입자 분무장치 제작 (Fabrication of an ultra-fine ginsenoside particle atomizer for drug delivery through respiratory tract)

  • 이병철;박진수;양웅모
    • 대한융합한의학회지
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    • 제2권1호
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    • pp.5-12
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    • 2021
  • Objectives: The purpose of this study is to fabricate an ultra-fine ginsenoside particle atomizer that can provide a new treatment method by delivering ginsenoside components that have a therapeutic effect on respiratory diseases directly to the lungs. Methods: We fabricated the AAO vibrating mesh by using the micromachining process. The starting substrate of an AAO wafer has a 350nm pore diameter with 50㎛ thickness. A photomask having several 5㎛ opening holes with a 100㎛ pitch was used to separate each nanopore nozzle. The photoresist structure was optimized to pattern the nozzle area during the lift-off process precisely. The commercial vibrating mesh was removed from OMRON's NE-U100 product, and the fabricated AAO vibrating mesh was installed. A diluted sample of 20mL with 30% red ginseng concentrate was prepared to atomize from the device. Results: As a result of liquid chromatography analysis before spraying the ginsenoside solution, ginsenoside components such as 20S-Rg3, 20R-Rg3, and Rg5 were detected. After spraying through the AAO vibrating mesh, ginsenosides of the same component could be detected. Conclusion: A nutrient solution containing ginsenosides was successfully sprayed through the AAO vibrating mesh with 350 nm selective pores. In particular, during the atomizing experiment of ginsenoside drug solution having excellent efficacy in respiratory diseases, it was confirmed that atomizing through the AAO vibrating mesh while maintaining most of the active ingredients was carried out.

통초(通草)와 목통(木通) 추출물이 monosodium iodoacetate(MIA)로 유발된 골관절염 동물 모델에 미치는 효과 (Effects of Tetrapanax papyrifer stem and Akebiae quinata stem on a rat model of monosodium iodoacetate-induced osteoarthritis)

  • 이상남;서부일
    • 대한본초학회지
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    • 제38권6호
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    • pp.29-44
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    • 2023
  • Objectives : This study was planned to evaluate the therapeutic effectiveness and possible underlying mechanism of TPE (Tetrapanax papyrifer stem(inner part of the stem Extract) and AQE (Akebiae quinata stem Extract) on osteoarthritis. Methods : Osteoarthritis models were induced through intra-articular injection of MIA (monosodium iodoacetate) 50 μL with 80 mg/ml in rats. Excluding the normal group, Osteoarthritis-induced rats were divided into 4 groups (Control, INDO, TPE, AQE). The drug concentrations were indomethacin 5 mg/kg, TPE 200 mg/kg, and AQE 200 mg/kg, and were orally administered once a day for a couple of weeks. After drug supplementation, the effects of TPE and AQE were measured with serum diagnosis, western blotting, and histopathological staining. Results : It was found that the DPPH and ABTS free radical erasure ability of AQE was better than that of TPE. AQE administration improved rear limb overload and it led to relieving pain. Both PTE and AQE significantly reduced the expression of inflammatory mediators COX-2, iNOS, and inflammatory cytokine IL-1β and IL-6 by inhibiting the phosphorylation of IκBα and deactivating the pathway of NF-κBp65. On the other hand, TNF-α was significantly reduced only by administration of AQE. In addition, histopathological analysis showed that the administration of AQE compared to PTE suppressed cartilage degeneration and effectively suppressed damage to proteoglycan, a component of ECM. Conclusion : Reviewing these experimental results, TPE and AQE possessed the effect of delaying the progress of osteoarthritis and protecting cartilage. In addition, the results of this study show that AQE has a better cartilage protection effect than TPE.

Spring rod를 사용한 척추경 나사못과 동반 시술된 Flexible cage의 생체역학적 효과 (Biomechanical Efficacy of a Combined Flexible Cage with Pedicle Screws with Spring rods: A Finite Element Analysis)

  • 김영현;박은영;김원현;황성필;박경우;이성재
    • 대한의용생체공학회:의공학회지
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    • 제38권1호
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    • pp.9-15
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    • 2017
  • Recently, flexible cages have been introduced in an attempt to absorb and reduce the abnormal load transfer along the anterior parts of the spine. They are designed to be used with the pedicle screw systems to allow some mobility at the index level while containing ROM at the adjacent level. In this study, a finite element (FE) study was performed to assess biomechanical efficacies of the flexible cage when combined with pedicle screws with flexible rods. The post-operated models were constructed by modifying the L4-5 of a previously-validated 3-D FE model of the intact lumbar spine (L2-S1): (1) Type 1, flexible cage only; (2) Type 2, pedicle screws with flexible rods; (3) Type 3, interbody fusion cage plus pedicle screws with rigid rods; (4) Type 4, interbody fusion cage plus Type 2; (5) Type 5, Type 1 plus Type 2. Flexion/extension of 10 Nm with a compressive follower load of 400N was applied. As compared to the Type 3 (62~65%) and Type 4 (59~62%), Type 5 (53~55%) was able to limit the motion at the operated level effectively, despite moderate reduction at the adjacent level. It was also able to shift the load back to the anterior portions of the spine thus relieving excessively high posterior load transfer and to reduce stress on the endplate by absorbing the load with its flexible shape design features. The likelihood of component failure of flexble cage remained less than 30% regardless of loading conditions when combined with pedicle screws with flexible rods. Our study demonstrated that flexible cages when combined with posterior dynamic system may help reduce subsidence of cage and degeneration process at the adjacent levels while effectively providing stability at the operated level.

Vitamin C Tablet Assay by Near -Infrared Reflectance spectrometry

  • Kargosha, Kazem;Ahmadi, Hamid;Nemati, Nader
    • 한국근적외분광분석학회:학술대회논문집
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    • 한국근적외분광분석학회 2001년도 NIR-2001
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    • pp.4111-4111
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    • 2001
  • When a drug is prepared in a tablet, the active component represents only a small portion of the dosage form. The other components of the formulation include materials to assist in the dissolution, antioxidants, coloring agents and bulk fillers. The tablets are tested using approved testing methods usually involving separation and subsequent quantification of the active component. Tablets may also be tested by near-Infrared Reflectance spectrometry (NIRS). In the present study, based on NIRS and multivariate calibration methods, a novel and precise method is developed for direct determination of ascorbic acid in vitamin C tablet. Two different tablet formulations were powdered in three different sizes, 63-125 ${\mu}{\textrm}{m}$, and examined. Spectral region of 4750-4950 $cm^{-1}$ / was used and optimized for quantitative operations. Partial least squares (PLS) and multiple linear regression (MLR) methods were performed for this spectral region. The results of optimized PLS and MLR methods showed that reproducibility increase with decreasing grain size and standard error of calibration (SEP) of less than 1% w/w of ascorbic acid and a correlation coefficient of 0.998 can be achieved. The PLS method showed better results than MLR. Seven overdose and underdose samples (prepared in the laboratory to match marketed products) were tested by proposed and iodometric standard methods. A correlation between NIRS predicted ascorbic acid values and iodomet.ic values was calculated ($R^2$=0.9950). Finally, the direct analysis of individual intact tablets in their unit-dose packages (Blistering in aluminum and PVC foils) obtained from market were also carried out and a correlation coefficient of 0.9989 and SEP of 0.931% w/w of ascorbic acid were achieved.

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노박덩굴에 함유된 celastrol 성분의 파킨슨병을 유발시킨 쥐에서의 도파민 신경세포 보호효과 (Protective Effects of Celastrol, the Triterpenoid Component of Celastrus Orbiculatus, on Dopaminergic Neuronal Cells in 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine-lesioned Parkinson's Disease Rats)

  • 이갑득;김광진;박용기
    • 대한한의학회지
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    • 제29권4호
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    • pp.94-103
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    • 2008
  • Objectives: The aim of this study was to determine whether celastrol, the triterpenoid component of Celastrus orbiculatus, offers neuroprotection against Parkinson's disease (PD) in mice administered 1-methyl-4-phenyl-1,2,3,6- tetrahydropyridine(MPTP). Methods: We examined how celastrol affected MPTP-induced neuronal loss of tyrosine hydroxylase (TH)-positive dopaminergic neurons in substantia nigra pars compacta (SNpc) in the midbrain of mice. C57BL/6J mice were divided into four groups: (1) saline-saline, (2) saline-celastrol, (3) MPTP-saline, and (4) MPTP-celastrol. The mice were injected intraperitoneally (i.p.) with four administrations of MPTP (18mg/kg) at 2 h intervals and then i.p. administered celastrol (3mg/kg) two times at 12 h after last celastrol administration. Expression of TH on the SNpc of brain tissues were analyzed at 7 days after the treatments by immunohistochemistry and Western blot. Results: Immunohistochemical analysis using TH antibody showed that celastrol provided significantly protective effects against MPTP-induced loss of TH-positive dopaminergic neurons in the SNpc region of the midbrain of mice. Our Western blot study also showed that celastrol significantly inhibits the MPTP-induced neuronal damage via the up-regulation of TH protein levels in MPTP mice. Conclusions: The present results suggest that it may be possible to use celastrol for the prevention of nigral degenerative disorders including PD, caused by exposure to toxic substances.

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측백엽(側柏葉)이 인간 유래 악성 흑색종 세포의 유전자 발현에 미치는 영향 (Effects of Thujae Orientalis Folium (TOF) on Gene Expression of Human melanoma cells (SK-MEL-2))

  • 정민영;김종한;박수연;최정화
    • 한방안이비인후피부과학회지
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    • 제23권2호
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    • pp.81-108
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    • 2010
  • Objective : Thujae Orientalis Folium (TOF) can cool the blood and stop bleeding, eliminate phlegm and relieve cough in Oriental medicine. In addition, the fresh is used alone externally. Recently, TOF is known to have anti-tumor component. And also known to have tyrosinase inhibitory effect. Method : For these reasons, this study was designed to investigate anti-cancer and whitening activities of TOF. In this experiment, effects of TOF on proliferation rates of melanoma cells and on changes in genetic profiles were investigated. The genetic profile for the effect on human derived melanoma cell, SK-MEL-2, was measured using microarray technique, and the functional analysis on these genes was conducted. Results : Total 541 genes were up-regulated and 1,079 genes down-regulated in cells treated with TOF. Genes induced by TOF were mainly concerned with anti-cancer effects and apoptosis. Genes suppresed by TOF were related in extracellular signalling pathway. The network of total protein interactions was measured using cytoscape program, and some key molecules, such as THAP1, MAX1, STAM2, SMAD6, CYCS, PEX5, PSEN1, NONO, MAP2K7 and CREB1 that can be used for elucidation of therapeutical mechanism of medicine in future were identified. Conculusion : These results suggest possibility of TOF as anti-cancer drug for human melanoma. In addition, the present author also suggest that related mechanisms are involved in inhibition of several cancer pathway, activation of apoptosis pathway and suppression of general metabolic pathway.

뼈 연화 고등어(Scomber japonicus) 가공품의 식품성분 특성 (Food Component Characteristics of Bone-softened Mackerel Scomber japonicus Product)

  • 박선영;김용중;강상인;이정석;김진수
    • 한국수산과학회지
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    • 제51권6호
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    • pp.623-631
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    • 2018
  • The present study investigated the food component characteristics of a bone-softened mackerel Scomber japonicus product (FC-M). The proximate composition of the FC-M was 57.4% moisture, 25.2% crude protein, 14.1% crude lipid, and 2.7% ash. The energy in the FC-M was 241.5 kcal/100 g, which corresponds to 8.9-16.1% of the daily energy intake recommended for Koreans ${\geq}6$ years of age. Regardless of type of taste, there were no significant differences in taste intensity when the FC-M was compared to a control (canned mackerel) but the odor intensity was significantly higher. Although there were no significant differences in hardness, the Hunter color values of redness and yellowness were significantly lower than those of the control. The sensory score for the FC-M was significantly superior to that of the control. The total amino acid content in the FC-M was 24.12 g/100 g and the major amino acids were aspartic acid, glutamic acid, leucine, and histidine. The major fatty acids in the FC-M were 16:0, 18:1n-9, 20:5n-3, and 22:6n-3 and the FC-M was a good source of minerals.

건강기능식품공전 시험법의 크로마토그래프법 조건의 조정 및 비타민C에 대한 적용성 평가 연구 (Optimizing analytical method in Health Functional Food code with adjustable chromatographic parameters: A case study of vitamin C)

  • 신정훈;정유성;최용석;한상범;이동규
    • 분석과학
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    • 제37권3호
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    • pp.143-154
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    • 2024
  • 건강기능식품공전은 기능성 원료의 지표(기능)성분에 대해 시험법을 고시하고 있다. 본 연구에서는 공전에서 제공하는 비타민C 시험법을 개선하고 정량을 위한 크로마토그래프법 조건의 조정 가능 범위에 대한 데이터를 검토하였다. 우선적으로 이동상 조건인 용매 조성, 염 농도, pH, 컬럼 온도를 조정해 보았으며, 특히 pH의 조절에 따라 완충용액으로부터 유래한 피크가 목적 성분인 비타민C와 명확히 분리될 수 있음을 개선된 시험법으로 확인하였다. 고정상 규격인 컬럼 내경, 컬럼 길이 및 고정상 입자 크기의 조정에 따라 성분의 머무름시간이 일부 조정되었으나, 이론단수는 유사한 수치를 나타냄으로써 목적 성분의 분리 및 정량적 분석에 영향을 주지 않았다. 변경된 컬럼 규격에 따른 유량 변경식은 USP <621> Chromatography 및 국내 식품의약품안전처의 [의약품 등 시험방법 밸리데이션 가이드라인 해설서]에서 제시하는 공식을 근거로 컬럼 규격(내경, 길이, 입자 크기)을 고려한 새로운 공식을 도출하였으며, 비타민 복합제에 대한 적용성 평가 결과, 변경된 고정상 및 유량에도 비타민C에 대한 높은 선택성을 보였다. 결론적으로, 크로마토그래프법 조건 일부의 변경을 통해서 비타민C를 최적으로 분리 및 검출할 수 있음을 확인하였으며, 등용매 용리를 활용하는 시험법에서 액체크로마토그래피의 이동상 및 고정상 조건을 조정 가능함을 확인하였다.