• Title/Summary/Keyword: Drug monitoring

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Studies on the Contents of Naturally Occurring of Sulfite in Foods (식품중 천연유래 이산화황 함유량에 관한 연구)

  • Kim, Hee-Yun;Lee, Young-Ja;Hong, Ki-Hyoung;Kwon, Yong-Kwan;Ko, Hyun-Sook;Lee, Young-Kyong;Lee, Chul-Won
    • Korean Journal of Food Science and Technology
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    • v.32 no.3
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    • pp.544-549
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    • 2000
  • This study was performed to compare optimum analytical method for the contents of naturally occurring sulfur dioxide in foods and to investigate the contents of sulfur dioxide in foods in order to provide a fundamental data when distinguish between added and naturally occurring sulfur dioxide. The determination of the contents of sulfur dioxide in foods from the 20 kinds, 180 cases of samples has been analyzed by the optimized Monier-Williams method, modified Rankine method and Acid Distillation/Ion Chromatography. As a result of the study, the contents of naturally occurring sulfur dioxide in foods by the optimized Monier-Williams method showed from 1.02 to 43.87 ppm and highly content of 43.87, 15.37, 11.50, 11.21 and 10.60ppm were observed in garlic, platicodon, green onion, cabbage and onion, the others were less than 10.00ppm. The sulfur dioxide contents in green onion and garlic by modified Rankine method were showed to be 2.87 and 6.14ppm, respectively, the others were detected less than 2.50ppm. The contents of sulfur dioxide by Acid Distillation/Ion Chromatography showed 15.43, 9.82, 5.74, 5.37, 2.14 and 0.49ppm in garlic, cabbage, green onion, onion, potato and apple, respectively and the others were not detected. And the contents of sulfur dioxide in green onion, onion, cabbage and garlic showed higher levels of sulfur dioxide in these foods than the others because of the naturally occurring sulfur containing compounds. The optimized Monier-Williams method, which is the of official analytical method of Korean Food Code, was suitable for monitoring of sulfur dioxide of most foods. Acid Distillation/Ion Chromatography was thought to be adequate for sulfur containing foods such as green onion, onion and cabbage. In order to distinguish between added and naturally occurring sulfur dioxide, it is though to be need of the fundamental data for the contents of sulfur dioxide in sulfite-free foods and continue the investigation for it.

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Assessment and Corrective Measures of Child-care Foodservices by Sanitary Inspection Checklist Suggested by Korea Food and Drug Administration (식품의약품안전처의 위생점검표에 의한 육아지원기관 급식소 평가 및 개선대책)

  • An, Su-Jung;Moon, Hye-Kyung
    • Journal of the Korean Dietetic Association
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    • v.21 no.3
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    • pp.227-240
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    • 2015
  • The purpose of this study was to assess the hygiene status of 145 child-care foodservices, which were newly registered in the Center for the Children's Foodservice Management (CCFSM) in Changwon, Gyeongnam. Sanitary inspection checklist (40 food safety items) of Korea Food and Drug Administration (KFDA) was used by the CCFSM in Changwon, Gyeongnam. Average score from the total safety items in 145 child-care foodservices was 21.41 points out of 40 points. Score gaps between the lower group (71 foodservices, 13.92 points) and higher group (74 foodservices, 28.61 points) showed a significant difference (P<0.001). The top five priorities of sanitary measures needing corrective actions for child-care foodservices were as follows: 'provide hand washing and sanitizing tools, and supply manuals on how to wash hands properly', 'supply record form for access/inspection', 'conduct education for cooks on standards in the selection of sanitizer for raw vegetables and proper methods to wash and sanitize raw vegetables', 'provide a refrigerator and a freezer with installed thermometers and temperature record monitoring logs', 'encourage separation of contamination operating zone and clean zone or conduct training for cooks on ways to prevent cross-contamination by performing work separately by the hour'. For the higher group, most were national/public facilities (83.3%), whereas in the lower group, private facilities (62.1%) were more common than national/public ones (37.9%). Therefore, a significant difference (P<0.001) was detected in the two groups. These private facilities should be supported.

Prediction of Pharmacokinetics and Penetration of Moxifloxacin in Human with Intra-Abdominal Infection Based on Extrapolated PBPK Model

  • Zhu, LiQin;Yang, JianWei;Zhang, Yuan;Wang, YongMing;Zhang, JianLei;Zhao, YuanYuan;Dong, WeiLin
    • The Korean Journal of Physiology and Pharmacology
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    • v.19 no.2
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    • pp.99-104
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    • 2015
  • The aim of this study is to develop a physiologically based pharmacokinetic (PBPK) model in intra-abdominal infected rats, and extrapolate it to human to predict moxifloxacin pharmacokinetics profiles in various tissues in intra-abdominal infected human. 12 male rats with intra- abdominal infections, induced by Escherichia coli, received a single dose of 40 mg/kg body weight of moxifloxacin. Blood plasma was collected at 5, 10, 20, 30, 60, 120, 240, 480, 1440 min after drug injection. A PBPK model was developed in rats and extrapolated to human using GastroPlus software. The predictions were assessed by comparing predictions and observations. In the plasma concentration versus time profile of moxifloxcinin rats, $C_{max}$ was $11.151{\mu}g/mL$ at 5 min after the intravenous injection and $t_{1/2}$ was 2.936 h. Plasma concentration and kinetics in human were predicted and compared with observed datas. Moxifloxacin penetrated and accumulated with high concentrations in redmarrow, lung, skin, heart, liver, kidney, spleen, muscle tissues in human with intra-abdominal infection. The predicted tissue to plasma concentration ratios in abdominal viscera were between 1.1 and 2.2. When rat plasma concentrations were known, extrapolation of a PBPK model was a method to predict drug pharmacokinetics and penetration in human. Moxifloxacin has a good penetration into liver, kidney, spleen, as well as other tissues in intra-abdominal infected human. Close monitoring are necessary when using moxifloxacin due to its high concentration distribution. This pathological model extrapolation may provide reference to the PK/PD study of antibacterial agents.

A Study on the Policy Implication on the Management of Narcotics Distribution for Medical Use (의료용 마약류 유통 관리에 대한 고찰과 정책적 함의: 유통자료 및 청구자료 분석을 중심으로)

  • Yu, Su-Yeon;Cho, Hyunmin;Kang, Hyeun Ah;Kim, Sukyeong
    • Korean Journal of Clinical Pharmacy
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    • v.25 no.4
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    • pp.280-285
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    • 2015
  • Objectives: To suggest direction for improving policies by understanding current management of narcotics or psychotropic drugs and analyzing their distributions and usage. Method: We conducted a comparison analysis between health insurance claims and the amount supplied to health care institutions for narcotics or psychotropic drugs through health insurance claims data and drug distribution supply data from 2010 to 2012 collected from Korea Pharmaceutical Information Service Center (KPIS). Furthermore, we carried out literature investigation and online search to comprehend the current management of narcotics drugs in Korea. Results: The amount supplied to medical institutions for all drugs in 2012 was 19.4 trillion won, which increased from 19.5 trillion in 2011 by 0.54%. For narcotic drugs, the amount supplied was 318.4 billion won in 2011 and increased to 335.1 billion won by 5.3% in 2012, which exceeded the rate of increase for the amount supplied for all drugs. The proportion of amount claimed in the total amount supplied to medical institutions for all drugs was 60.5% in 2012, whereas the proportion of amount claimed for narcotic drugs was 55.6%, which showed that narcotic drugs were used relatively less within health insurance. Furthermore, management of the current domestic distribution supply data focuses on manufacturing and medical institution supply stages. Conclusion: Hereafter, the management of narcotics or psychotropic drugs needs to be improved by reinforcing active monitoring in optimal prescription and usage in patients by collecting and analyzing information on drug usage of patients.

Application of Rapid Sample Preparation Method and Monitoring for Cholesterol Content in Chicken Egg and Egg powder

  • Park, Jung-Min;Jeong, In-Seek;Kwak, Byung-Man;Ahn, Jang-Hyuk;Leem, Donggil;Jeong, Jayoung;Kim, Jin-Man
    • Food Science of Animal Resources
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    • v.33 no.5
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    • pp.672-677
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    • 2013
  • The aim of this study was to develop sample preparation method and evaluate the exact cholesterol content in egg and egg powder purchased from Korean markets, and to determine whether significant differences exist among various egg products, since a variety of products are available in Korean markets and there are no recent databases for cholesterol. To evaluate the cholesterol content in chicken egg sold in Korean local market, a simple method using non-heated saponification to determine cholesterol for emulsified foods was applied. The results of recovery for egg and egg powder were in a range of 92.4-105.0%, with a relative standard deviation between 1.1% and 2.8% by using gas chromatography-flame ionization detector. Therefore, the total cholesterol content in whole egg was estimated between 160.8 and 226.3 mg/egg (AV(average) $186.8{\pm}3.5$), which is similar or lower than previously reported levels. The value for cholesterol in egg powder was estimated between 2.94 and 3.49 mg/g (AV $3.23{\pm}0.15$). We suggested method that can be applicable to chicken egg and egg powder matrix as providing rapid and accurate determination of cholesterol in egg and egg powder. This information will be helpful for processed food producers for deciding food labels of cholesterol content.

Pharmacokinetics of Astromicin Following a Single Intravenous Infusion in Healthy Korean Subjects (정상성인 한국인에서 아스트로마이신 1회 점적 주사후 약물동태학적 평가)

  • Bok, Hae Sook;Choi, Kyung Eob;Kim, Yeon Hwa;Peck, Kyong Ran;Song, Jae Hoon
    • Korean Journal of Clinical Pharmacy
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    • v.13 no.2
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    • pp.55-58
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    • 2003
  • Astromicin is an aminoglycoside antiviotic that is structually different from conventional aminoglycosides. Astromicin has been shown to be active against aerobic Gram-negative bacilli. The pharmacokinetics of astromicin were determined in 12 healthy volunteers ($65.5\pm5.23\;kg$ of body weight) following a 30-min continuous intravenous infusion at a dose of 200 mg. The plasma and urine samples were collected up to 24 h and drug concentrations were measured by a bioassay using Bacillus subtilis. Pharmacokinetic parameters were calculated by fitting individual concentration-time curve to a one-exponential decay model. The plasma levels were $16.9\pm1.68\;and\;1.05\pm0.346\l{\mu}g/ml$ at 0 h and 8 h after the infusion, respectively. The elimination half-life of astromicin was $1.86\pm0.360\;h$ The volume of distribution was $0.182\pm0.0164\;L/kg$, and the total body clearance was $5.25\pm1.74\;L/h$. These pharmacokinetic parameters were similar to these of gentamicin, tobramycin, and amikacin. Therefore, it is recommended that therapeutic drug monitoring of astromicin could be conducted in a similar fashion as the other aminoglycosides.

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Hydrophillic Interaction Chromatography-tandem Mass Spectrometry Method for Identification and Quantitation of 5-MeO-DIPT and its Metabolites in Rat Urine

  • Kim, Yoon;Kim, Un-Yong;In, Moon-Kyo;Lee, Jae-Ick;Kwon, Oh-Seung;Yoo, Hye-Hyun
    • Bulletin of the Korean Chemical Society
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    • v.32 no.4
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    • pp.1158-1164
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    • 2011
  • 5-Methoxy-N,N-diisopropyltryptamine (5-MeO-DIPT), a psychoactive tryptamine derivative, is a hallucinogenic drug of abuse. In this study, 5-OH-DIPT and its metabolites were identified and the quantitative method was developed and validated by using hydrophilic interaction chromatography-tandem mass spectrometry (HILICMS/MS). Chromatographic separation was achieved on an Atlantis HILIC silica column ($5{\mu}m$, $100{\times}2.1\;mm$). The metabolites of 5-MeO-DIPT in rat urine were characterized via Q1 scanning and product ion scanning. As a consequence, 5-MeO-IPT, 5-OH-DIPT, 6-OH-5-MeO-DIPT and their glucuronide conjugates were detected and identified as the metabolites of 5-MeO-DIPT. Subsequently, a quantitative method for 5-MeO-DIPT and its major metabolites, 5-MeO-IPT and 5-OH-DIPT, was developed in multiple reactions monitoring (MRM) mode. The calibration curves for all analytes evidenced good linearity over the concentration range of 1-1000 ng/mL with linear correlation co-efficients ($r^2$) in excess of 0.99. The intra- and inter-day accuracy and precision were 92.2-110.2% and 1.5-9.9%, respectively.

Recent Advancements of Treatment for Leptomeningeal Carcinomatosis

  • Gwak, Ho-Shin;Lee, Sang Hyun;Park, Weon Seo;Shin, Sang Hoon;Yoo, Heon;Lee, Seung Hoon
    • Journal of Korean Neurosurgical Society
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    • v.58 no.1
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    • pp.1-8
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    • 2015
  • Treatment of Leptomeningeal carcinomatosis (LMC) from solid cancers has not advanced noticeably since the introduction of intra-cerebrospinal fluid (CSF) chemotherapy in the 1970's. The marginal survival benefit and difficulty of intrathecal chemotherapy injection has hindered its wide spread use. Even after the introduction of intraventricular chemotherapy with Ommaya reservoir, frequent development of CSF flow disturbance, manifested as increased intracranial pressure (ICP), made injected drug to be distributed unevenly and thus, the therapy became ineffective. Systemic chemotherapy for LMC has been limited as effective CSF concentration can hardly be achieved except high dose methotrexate (MTX) intravenous administration. However, the introduction of small molecular weight target inhibitors for primary cancer treatment has changed the old concept of 'blood-brain barrier' as the ultimate barrier to systemically administered drugs. Conventional oral administration achieves an effective concentration at the nanomolar level. Furthermore, many studies report that a combined treatment of target inhibitor and intra-CSF chemotherapy significantly prolongs patient survival. Ventriculolumbar perfusion (VLP) chemotherapy has sought to increase drug delivery to the subarachnoid CSF space even in patients with disturbed CSF flow. Recently authors performed phase 1 and 2 clinical trial of VLP chemotherapy with MTX, and 3/4th of patients with increased ICP got controlled ICP and the survival was prolonged. Further trials are required with newly available drugs for CSF chemotherapy. Additionally, new LMC biologic/pharmacodynamic markers for early diagnosis and monitoring of the treatment response are to be identified with the help of advanced molecular biology techniques.

A Study of Adverse Events that Occurred after Taking Herbal Medicine - Focused on Children and Adolescents (한약 복용 후 발생한 유해사례에 대한 연구 - 소아·청소년을 중심으로)

  • Lee, Ji Hong;Yu, Sun Ae;Lee, Seung Yeon
    • The Journal of Pediatrics of Korean Medicine
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    • v.28 no.3
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    • pp.1-16
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    • 2014
  • Objectives The purpose of this study is to investigate the incidence and clinical features of adverse events associated with herbal medicine, and to analyze their causality and severity. Methods This study was carried out from 159 children and adolescents who took herbal medicine in the Department of Pediatrics, ${\bigcirc}{\bigcirc}$ Korean Medical Hospital from december, 2013 to april, 2014. The data was collected by survey in person or telephone. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to analyze causality for each adverse events. Results 1. 207 cases were surveyed from 159 children and adolescents who took one or more kinds of herbal medicine. 2. A total of 12 general adverse events (5.8%) were reported from the study. Among these adverse events, 8 cases (3.9%) were associated with herbal medicine. 3. Gastro-intestinal system disorders were most frequently reported (70%) as adverse events, which is followed by psychiatric disorders (15%), skin and appendages disorders (10%), urinary system disorders (5%). 4. The most common clinical symptom was abdominal pain (20%), followed by diarrhea (15%), loose stools (10%), vomiting (10%) and borborygmus (10%). 5. The severity of adverse drug reactions was mostly mild (87.5%), and moderate (12.5%). There was no severe case. Conclusions The adverse events from herbal medicine on children and adolescents were mostly minor, most of them could continue herbal medicines.

Bioequivalence Assessment of Acephyll® Capsule to Surfolase® Capsule (Acebrophylline HCl 100 mg) by Liquid Chromatography Tandem Mass Spectrometry

  • Nam, Kyung-Don;Seo, Ji-Hyung;Yim, Sung-Vin;Lee, Kyung-Tae
    • Journal of Pharmaceutical Investigation
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    • v.41 no.5
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    • pp.309-315
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    • 2011
  • A sensitive and specific liquid chromatographic method coupled with tandem mass spectrometry (LC-MS/MS) was developed for the analysis of ambroxol (active moiety of acebrophylline). After acetonitrile precipitation of proteins from plasma samples, ambroxol and the domperidone (internal standard, IS) were eluted on a C18 column. The isocratic mobile phase was consisted of 10 mM ammonium acetate and methanol (10 : 90, v/v), with flow rate at 0.2 mL/min. 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 379.2${\rightarrow}$264.0 and the m/z 426.2${\rightarrow}$175.1 transitions for ambroxol and the IS, respectively. Twenty four healthy Korean male subjects received two capsules (100 mg ${\times}$ 2) of either the test or the reference formulation of acebrophylline HCl in a 2 ${\times}$ 2 crossover study, this was followed by a 1week washout period between either formulation. $AUC_{0-t}$ (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 acceptable range of log 0.8 to log 1.25 (e.g., log 0.8964 - log 0.9910 for $AUC_{0-t}$ log 0.8690 - log 1.0750 for $C_{max}$). The major parameters, $AUC_{0-t}$ and $C_{max}$ met the criteria of Korea Food and Drug Administration for bioequivalence indicating that Acephyll$^{(R)}$ capsule (test) is bioequivalent to Surfolase$^{(R)}$ capsule (reference).