• Title/Summary/Keyword: Drug monitoring

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Monitoring of Fake Anti-impotence Drugs (불법유통 발기부전치료제 유사제품 조사 연구)

  • Kim, Beom-Ho;Jeon, Jong-Sup;Lee, Myung-Jin;Park, Eun-Mi;Cho, Sang-Hun;Kwon, Hye-Jung;Yoon, Mi-Hye;Lee, Jong-Bok
    • Journal of Food Hygiene and Safety
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    • v.29 no.2
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    • pp.92-98
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    • 2014
  • The safety of fake anti-impotence drugs (fake Viagra : 26 samples, fake Cialis : 25 samples) distributed in Gyeonggi province was studied by monitoring the concentrations of anti-impotence pharmaceutical ingredient and their analogues. The concentrations of anti-impotence pharmaceutical ingredient 4 specis and their analogues 17 specis were estimated using by HPLC/PDA, LC-MS/MS. The range of concentration of sildenafil in fake viagra was 40~199 mg/tablet, among them the portion of the concentrations of sildenafil over 150 mg/tablet exceeded 65%. 3 cases in tested samples contained sildenafil and tadalafil. The range of concentration of sildenafil in fake cialis was 102~249 mg/tablet, among them the portion of the concentrations of sildenafil over 150 mg/tablet exceeded 88%. One case in tested samples contained demethylhongdenafil (90 mg/tablet). These results indicate that there were many fake anti-impotence drug contained high level of anti-impotence pharmaceutical ingredients, a sustainable monitoring and the blocked distribution of fake anti-impotence drugs recommended.

Clinical and Bacteriologic Characteristics of Retreated Tuberculosis Patients (재치료 폐결핵환자의 임상적 세균학적 특성)

  • Oh, Seoung-Joon;Yoon, Ki-Heon;Yoo, Jee-Hong;Kang, Hong-Mo
    • Tuberculosis and Respiratory Diseases
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    • v.42 no.1
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    • pp.19-24
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    • 1995
  • Background: Although pulmonary tuberculosis is effectively controlled with 6 months or 9 months short course standard regimens, comparable numbers of treatment failures ensued because of inadequate treatment mainly due to patient's poor compliance. Indequate treatment with standard regimens during initial treatment may cause emergence of drug resistance and prolong the duration of chemotherapy. Also it may make the patient lesser compliant and finally increase the morbidity and the mortality. Methods: A clinical study was done to evaluate clinical and bacteriological characteristics of 94 patients who were retreated for pulmonary tuberculosis. Results: 1) 62 of the 94 patients were male and 32 patients were female. Mean age is 51 years old in male and 45 years old in female. 2) The extent of the disease on the chest radiograph was minimal in 10(11.1%) patients, moderate in 31(33.3%) patients, and far advanced in 52(55.6%) patients. 3) On sputum bacteriologic examination, 73(77.7%) patients were positive in sputum AFB smear and/or culture for Mycobacterium tuberculosis. 4) Results of drug sensitivity test performed in 42 patients showed that the resistance to one drug is in 9(20.5%) patients, two drugs in 18(40.8%) patients, and more than three drugs in 14(31.8%) patients. 5) Poor patient's compliance was the leading cause of the retreatment of pulmonary tuberculosis(43.6%) 6) Only 24(25.5%) patients of the 94 retreatment patients were successfully treated and 39(41.6%) patients were dropped out during follow-up. Conclusion: We concluded that poor patient's compliance was the most important cause of treatment failure not only in primary treatment patients but also in retreatment patients. Primary treatment of pulmonary tuberculosis should be completed under strict monitoring of the patient because significant number of retreatment patients had multiple drug resistance and poor outcome.

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Establishments of Lead Standards through Monitoring Heavy Metals in Calcium, Chitosan, and Propolis Health Foods (칼슘, 키토산, 프로폴리스 건강보조식품중 중금속 모니터링을 통한 납기준 제정)

  • Kim, Mee-Hye;Chung, So-Young;Sho, You-Sub;Kim, Myung-Chul;Kim, Chang-Min
    • Korean Journal of Food Science and Technology
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    • v.33 no.5
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    • pp.525-528
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    • 2001
  • This study was conducted to estimate the contents of heavy metals in some health foods available on Korean markets. The samples were digested with microwave system, then analyzed using GF-AAS for the contents of lead (Pb), cadmium (Cd) and arsenic (As). The contents of mercury (Hg) were determined using a mercury analyzer. The average values of Hg, Pb, Cd and As in calcium (Ca) health foods were 0.007, 1.08, 0.02 and 0.48 mg/kg respectively. Those values in chitosan health foods were 0.001, 0.36, 0.01 and 0.03 mg/kg respectively. Those values in propolis health foods were 0.013, 4.96, 0.01 and 0.13 mg/kg, respectively. The health foods that contained cow bone powders had the highest lead contents. Based on the variation in lead contents of those products, it could be possible that they might be contaminated through raw materials and/or manufacuring process. Some propolis products were also very high in lead contents. There could be risks for some population, especially the aged who overtake those health foods, to have heavy intake of lead. Therefore, we established the lead standards of 3.0, 2.0 and 5.0mg/kg less than for Ca, chitosan and propolis health foods respectively, based on the Codex method.

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A Monitoring for the Management of Microbiological Hazard in Rice-cake by Climate Change (기후변화에 따른 떡류의 미생물학적 위해관리를 위한 권역별 모니터링)

  • Choi, Song-Yi;Jeong, Se-Hee;Jeong, Myung-Seop;Park, Ki-Hwan;Jeong, Young-Gil;Cho, Joon-Il;Lee, Soon-Ho;Hwang, In-Gyun;Bahk, Gyung-Jin;Oh, Deog-Hwan;Chun, Hyang-Sook;Ha, Sang-Do
    • Journal of Food Hygiene and Safety
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    • v.27 no.3
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    • pp.301-305
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    • 2012
  • This study was conducted to investigate the microbiological contamination levels in rice cakes and rice flour due to climate change in three areas classified to their temperature and precipitation. We investigated the contamination levels of total aerobic bacteria, coliforms, Escherichia coli, Bacillus cereus, Staphylococcus aureus, Clostridium perfringens of rice flour and 3 rice cakes such as Garaetteok, Sirutteok and Gyeongdan. Contamination levels of total aerobic bacteria in rice flour were 4.9 log CFU/g. In a total of 70 rice flour, yeasts & molds and coliforms were detected in 42 and 52 samples at the levels of 43 CFU/g and 1.29 log CFU/g, respectively. S. aureus were detected in only 1 rice flour (1.66 log CFU/g) out of 70. In an investigation of contamination levels in rice cakes, the population of total aerobic bacteria were highest in Gyeongdan (5.18 log CFU/g) and coliforms were highest in Gareattock (2.93 log CFU/g). There was no detection of E. coli and B. cereus except for only 1 Gareattock (1.20 log CFU/g). There were no differences of contamination levels among the three areas. If constant monitoring of rice cakes and rice flour is conducted on the basis of this study, it is expected to be able to analyze the change of contamination levels in rice cakes and rice flour due to climate change.

Development and Validation of the Determination of Sorafenib in Human Plasma using Tandem Mass Spectrometry Coupled with Liquid Chromatography (고속액체크로마토그래피 텐덤질량분석기법을 이용한 사람 혈장 내 소라페닙 농도분석법의 개발 및 검정)

  • Park, Daejin;Lee, Sunggon;Kim, Woomi
    • Journal of Life Science
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    • v.22 no.11
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    • pp.1456-1462
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    • 2012
  • Sorafenib is a multikinase inhibitor and an oral anticancer drug approved for the treatment of patients with advanced renal cell carcinoma and those with unresectable hepatocellular carcinoma. The purpose of this study was to develop an efficient method of the determination of sorafenib in human plasma using tandem mass spectrometry coupled with liquid chromatography (LC/MS/MS) and validate the method by the guidelines of the Korean Food and Drug Administration (KFDA). Plasma samples ($100{\mu}l$) were added with chlorantraniliprole as an internal standard and then mixed with the 0.1% formic acid-containing extraction solution composed of isopropyl alcohol and ethyl acetate (1:4, v/v). After centrifugation, the supernatant was concentrated at $45^{\circ}C$ under negative pressure and centrifugal force. The residue was reconstituted with a mobile phase and injected into the HPLC instrument using a reverse phase Waters XTerra$^{TM}$ C18 column (particle size $3.5{\mu}m$). Liquid chromatography was carried out within the run time of 5 min using a mobile phase composed of buffer (0.1% formic acid and 10 mM ammonium formate), methanol, and acetonitrile (1:6:3, v/v/v). The analytes were monitored by tandem mass spectrometry in the multiple reaction monitoring method programmed to detect sorafenib at 'm/z 465.2 ${\rightarrow}$ 252.5' and chlorantraniliprole at 'm/z 484.4 ${\rightarrow}$ 286.2' with positive electrospray ionization mode ($ES^+$). The result showed the proper linearity ($r^2$ > 0.99) over the range of 2,000-5,000 ng/ml with good accuracy (90.7-103.9%) and precision (less than 10%). The newly developed method using LC/MS/MS was validated by the guideline of KFDA and identified as more sensitive compared to the previous methods.

Microbiological Status and Guideline for Raw Chicken distributed in Korea (국내 유통 닭고기의 미생물 수준과 위생관리기준 적합성)

  • Kim, Hye-Jin;Kim, Dongwook;Song, Sung Ok;Goh, Yong-Gyun;Jang, Aera
    • Korean Journal of Poultry Science
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    • v.43 no.4
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    • pp.235-242
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    • 2016
  • This study was conducted to investigate the microbiological sanitation status of raw chicken meat distributed in Korea, and potential changes in chicken breast quality during storage. The microbiological sanitation status analysis of raw chicken involved studying the results of microbiological monitoring for a 5-year period (2010~2014) by the Korean Food and Drug Administration. Furthermore, the microbiological status of raw chicken meat in meat packing centers and shops in Seoul/Gyeonggi, Kangwon, and Chungcheong Provinces was investigated from July to August 2015. The total bacterial counts of chicken meat in the packaging centers and meat shop of these Provinces were below the level specified in the Korean Meat Microbiological Guideline ($1{\times}10^7$ colony forming units [CFU]/g) and showed a similar microbiological sanitation status with results of the microbiological monitoring for the analyzed 5-year period. To evaluate the relationship between quality change and microbiological level of the meat distributed in Korea, the pH and microbiological and sensory quality characteristics of the chicken breast samples during storage at $4{\pm}2^{\circ}C$were determined. On day 4, the total bacterial count of the chicken breast was 6.76 log CFU/g, which was close to the official $1{\times}10^7CFU/g$ standard, the pH was 5.96, and the overall acceptability was reduced significantly (p<0.05). In particular, the aroma score was <5, indicating that the consumer panel expressed a negative perception even though the chicken contained a lower microbial level than that specified in the Korean microbiological guideline. These results suggest that the current Korean microbiological guideline for raw chicken meat may require a stricter level of up to $1{\times}10^6CFU/g$ to satisfy both meat safety standards and organoleptic quality for consumers.

A Pilot Study for the Remote Monitoring of IMRT Using a Head and Neck Phantom (원격 품질 보증 시스템을 사용한 세기변조 방사선치료의 예비 모니터링 결과)

  • Han, Young-Yih;Shin, Eun-Hyuk;Lim, Chun-Il;Kang, Se-Kwon;Park, Sung-Ho;Lah, Jeong-Eun;Suh, Tae-Suk;Yoon, Myong-Geun;Lee, Se-Byeong;Ju, Sang-Gyu;Ahn, Yong-Chan
    • Radiation Oncology Journal
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    • v.25 no.4
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    • pp.249-260
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    • 2007
  • Purpose: In order to enhance the quality of IMRT as employed in Korea, we developed a remote monitoring system. The feasibility of the system was evaluated by conducting a pilot study. Materials and Methods: The remote monitoring system consisted of a head and neck phantom and a user manual. The phantom contains a target and three OARs (organs at risk) that can be detected on CT images. TLD capsules were inserted at the center of the target and at the OARs. Two film slits for GafchromicEBT film were located on the axial and saggital planes. The user manual contained an IMRT planning guide and instructions for IMRT planning and the delivery process. After the manual and phantom were sent to four institutions, IMRT was planed and delivered. Predicted doses were compared with measured doses. Dose distribution along the two straight lines that intersected at the center of the axial film was measured and compared with the profiles predicted by the plan. Results: The measurements at the target agreed with the predicted dose within a 3% deviation. Doses at the OARs that represented the thyroid glands showed larger deviations (minimum 3.3% and maximum 19.8%). The deviation at OARs that represented the spiral cord was $0.7{\sim}1.4%$. The percentage of dose distributions that showed more than a 5% of deviation on the lines was $7{\sim}27%$ and $7{\sim}14%$ along the horizontal and vertical lines, respectively. Conculsion: Remote monitoring of IMRT using the developed system was feasible. With remote monitoring, the deviation at the target is expected to be small while the deviation at the OARs can be very large. Therefore, a method that is able to investigate the cause of a large deviation needs to be developed. In addition, a more clinically relevant measure for the two-dimensional dose comparison and pass/fail criteria need to be further developed.

Clinical Features and Management of Multidrug-Resistant Tuberculosis (다제 내성 폐결핵 환자의 임상상 및 치료에 대한 고찰)

  • Lee, Jae-Cheol;Lee, Seung-Jun;Kim, Gye-Soo;Yoo, Chul-Gyu;Cheong, Hee-Soon;Kim, Young-Whan;Han, Sung-Koo;Shim, Young-Soo
    • Tuberculosis and Respiratory Diseases
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    • v.43 no.1
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    • pp.14-21
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    • 1996
  • Objectives: Although outbreak of MDR Tb has been a recent problem in western countries, it has been a longstanding problem in Korea. The poor outcome of MDR Tb is mainly due to poor compliance, high rate of side reaction of secondary drugs, and limitation in number of available drugs. Thus, to improve the outcome of MDR Tb, it is crucial to make individualized adequate prescription based on the knowledge of the patterns of resistance to each drugs in the community as well as the natural history. The purpose of present study is to evaluate the clinical features of Korean MDR Tb patients including patterns of drug resistance and success rate of treatment which was prescribed according to the sensitivity tests. Methods: Retroscpective analysis of 71 Korean patients with MDR Tb was made. All strains isolated from patients showed resistence to at least two first line drugs. Patients profile, previous treatment history, patterns of drug resistance, outcome of treatment was analysed. Initial treatment regimen was selected according to the previous treatment history and was modified according to the sensitivity reports. The regimen was composed to include at least 4 sensitive drugs when possible. Results: The patients showed resistance to 4.1 drugs on average. 90% of them were resistant to INH and RFP. Among 71 patients, 35 patients(49%) had cavitary lesions in CXR. Treatment outcome was analysed in 55 patients. 35 patients(67%) were improved after treatment and 18 patients(33%) showed treatment failure. 5 patients showed primary resistance. Treatment outcome could be evaluated in 4 of them and all showed improvement after treatment. 14 patients(20%) had to change their regimens due to drug side effects. The most frequent side effect was elevation of liver enzymes(6 patients). Others included dizziness, hyperuricemia, tinnitus, skin rash, GI troubles. More than 50% of side effects developed within 3 months. In repeated drug sensitivity test, the concordance rate of resistance to INH was 100% and RFP 98%. EMB, PZA showed 80% concordance rate. But in the other drugs, the concordances were less than 50%. Operation was done in 5 patient - 1 patients as a adjunctive means of chemotherapy -. In that case, negative conversion of sputum AFB was done. Conclusion: 2/3 patients of multidrug-resistant tuberculosis were improved by appropriate prescription and regular medication suggesting that more aggressive management and monitoring is indicated in multidrug-resistant tuberculosis.

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Development of Analytical Method for Fenoxycarb, Pyriproxyfen and Methoprene Residues in Agricultural Commodities Using HPLC-UVD/MS (HPLC-UVD/MS를 이용한 농산물 중 fenoxycarb, pyriproxyfen 및 methoprene의 분석법 확립)

  • Lee, Su-Jin;Kim, Young-Hak;Song, Lee-Seul;Hwang, Yong-Sun;Lim, Jung-Dae;Sohn, Eun-Hwa;Im, Moo-Hyeog;Do, Jung-Ah;Oh, Jae-Ho;Kwon, Ki-Sung;Lee, Joong-Keun;Lee, Young-Deuk;Choung, Myoung-Gun
    • The Korean Journal of Pesticide Science
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    • v.15 no.3
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    • pp.254-268
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    • 2011
  • Fenoxycarb, pyriproxyfen and methoprene are juvenile hormone mimic insecticide. These insecticides have been widely used for mosquito, fly, scale insects, and Lepidoptera. The purpose of this study was to develop a simultaneous determination procedure of fenoxycarb, pyriproxyfen and methoprene residues in crops using HPLC-UVD/MS. These insecticide residues were extracted with acetone from representative samples of four raw products which comprised brown rice, apple, green pepper, and Chinese cabbage. The extract was diluted with saline water, and then n-hexane/dichloromethane partition was followed to recover these insecticides from the aqueous phase. Florisil column chromatography was additionally employed for final clean up of the extract. The analytes were quantitated by HPLC-UVD/MS, using a $C_{18}$ column. The crops were fortified with each insecticide at 3 levels per crop. Mean recovery ratios were ranged from 80.0 to 104.3% in four representative agricultural commodities. The coefficients of variation were less than 4.8%. Quantitative limit of fenoxycarb, pyriproxyfen, and methoprene was 0.04 mg/kg in crop samples. A HPLC-UVD/MS with selected-ion monitoring was also provided to confirm the suspected residues. The proposed simultaneous analysis method was reproducible and sensitive enough to determine the residues of fenoxycarb, pyriproxyfen and methoprene in the agricultural commodities.

Determination of cyromazine residues in agricultural commodities using HPLC-UVD/MS (HPLC-UVD/MS를 이용한 농산물 중 Cyromazine의 잔류분석법)

  • Song, Lee-Seul;Kim, Young-Hak;Lee, Su-Jin;Hwang, Young-Sun;Kwon, Chan-Hyeok;Do, Jung-Ah;Oh, Jae-Ho;Im, Moo-Hyeog;Chang, Woo-Suk;Lee, Young-Deuk;Choung, Myoung-Gun
    • The Korean Journal of Pesticide Science
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    • v.16 no.3
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    • pp.202-208
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    • 2012
  • A high-performance liquid chromatographic (HPLC) method was developed to determine residues of cyromazine, a triazine insecticide, in agricultural commodities. Cyromazine was extracted with 90% aqueous methanol from representative crops which comprised brown rice, oyster mushroom, oriental melon, watermelon, and Chinese cabbage. Following to evaporation of methanol in the extract, the aqueous concentrate was acidified to form the protonated cyromazine. Dichloromethane partition was then applied to remove nonpolar co-extractives in the aqueous phase. Strong cation-exchange chromatography using Dowex 50W-X4 resin was employed for final purification of the extract. Cyromazine was successfully separated on a Zorbax SB-Aq $C_{18}$ column showing high retention for polar compounds. Cyromazine was sensitively quantitated by ultraviolet absorption at 214 nm. Limit of quantitation (LOQ) of the method was 0.04 mg/kg irrespective of sample types. Each crops were fortified at 3 different concentrations of cyromazine for recovery test. Mean recoveries from samples fortified at LOQ~2.0 mg/kg in triplicate ranged 80.2~103.3% in five agricultural commodities. Relative standard deviations in recoveries were all less than 6%. A selected-ion monitoring LC/MS method with electrospray ionization in positive-ion mode was also provided to confirm the suspected residue. The proposed method was reproducible and sensitive enough to routinely determine and inspect the residue of cyromazine in agricultural commodities.