• 한국식품위생안전성학회지
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• 제33권1호
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• pp.58-64
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• 2018

본 연구는 소의 가식부위(근육, 신장, 간장, 지방) 중에서 세팔렉신을 효과적으로 정량분석하기 위한 LC-MS/MS법을 확립하고 이를 검증하기 위해 수행되었다. 확립된 LC-MS/MS에 대해 특이성, 검출한계, 정량한계, 정확도 및 정밀도에 대한 검증을 통하여 유효성을 확인하였다. 표준 용액을 이용하여 검량성을 작성한 결과, $r^2$ > 0.999 이상의 직선성을 나타내었으며, 세팔렉신에 대한 검출한계와 정량한계는 각각 2~10과 $6{\sim}30{\mu}g/kg$으로 나타났다. 또한, 회수율은 83.9~106.8%로 나타났으며, 상대표준편차는 2.3~14.8%로 나타나 정확성이 우수하였다. 이는 식품의약품안전처의 잔류동물용의약품 분석법에서 제시한 기준에 모두 적합한 수준이었다. 따라서 본 연구를 통해 개발된 LC-MS/MS법은 향후 소의 가식부위 중 세팔렉신을 분석하는데 효과적으로 활용될 수 있을 것으로 사료된다.

• Parasites, Hosts and Diseases
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• 제54권3호
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• pp.291-299
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• 2016

Human hydatid disease (cystic echinococcosis, CE) is a chronic parasitic infection caused by the larval stage of the cestode Echinococcus granulosus. As the disease mainly affects the liver, approximately 70% of all identified CE cases are detected in this organ. Optical molecular imaging (OMI), a noninvasive imaging technique, has never been used in vivo with the specific molecular markers of CE. Thus, we aimed to construct an in vivo fluorescent imaging mouse model of CE to locate and quantify the presence of the parasites within the liver noninvasively. Drug-treated protoscolices were monitored after marking by JC-1 dye in in vitro and in vivo studies. This work describes for the first time the successful construction of an in vivo model of E. granulosus in a small living experimental animal to achieve dynamic monitoring and observation of multiple time points of the infection course. Using this model, we quantified and analyzed labeled protoscolices based on the intensities of their red and green fluorescence. Interestingly, the ratio of red to green fluorescence intensity not only revealed the location of protoscolices but also determined the viability of the parasites in vivo and in vivo tests. The noninvasive imaging model proposed in this work will be further studied for long-term detection and observation and may potentially be widely utilized in susceptibility testing and therapeutic effect evaluation.

• Journal of Pharmaceutical Investigation
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• 제41권4호
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• pp.255-262
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• 2011

Method using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) was developed and validated for the determination of pregabalin in plasma samples. Acquisition was performed by monitoring the transitions: m/z 160.1${\rightarrow}$142.2 for pregabalin and m/z 423.2${\rightarrow}$207.1 for losartan (as an internal standard). After cold acetonitrileinduced protein precipitation of the plasma samples, separation was performed with C18 column by isocratic mobile phase consisted of 10 mM ammonium acetate and acetonitrile (15:85, v/v). Results were linear over the concentration ranged from 0.1 to $10{\mu}g$/mL and the correlation coefficients (r) were $\geq0.99$. Intra- and inter-day precisions were $\leq6.02$ and $\leq11.04%$, respectively, and intra- and inter-day accuracies were 96.60-101.09 and 98.10-102.60%, respectively. This validated method was successfully applied to a bioequivalence study of two formulations of pregabalin, Daewoong pregabalin capsule (Daewoong Pharm. Co., Ltd.) and Lyrica$^{(R)}$ capsule (Pfizer Korea Ltd.) in twenty eight healthy Korean volunteers. The subjects received a single oral dose of each formulation (150 mg as pregabalin) in a randomized $2{\times}2$ crossover study and plasma samples were obtained from each subject at predetermined time intervals. Then, the pharmacokinetic parameters ($AUC_{0-t}$, $C_{max}$ and $T_{max}$) were calculated and statistically analyzed to assess the differences between two formulations. The 90% confidence intervals for the log-transformed data were acceptable range of log 0.8-log 1.25 (e.g., log 1.0048-log 1.0692 for AUC0-t, log 0.9142-log 1.0421 for $C_{max}$). Thus, $AUC_{0-t}$ and $C_{max}$ met the criteria of the Korea Food and Drug Administration (KFDA) for bioequivalence test indicating that Daewoong pregabalin capsule was bioequivalent to Lyrica$^{(R)}$ capsule.

• 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.

• 한국수산과학회지
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• 제42권6호
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• pp.561-568
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• 2009

We determined the contents of heavy metals in the muscle of wild and cultured fishes, collected from fish markets located in the eastern (Pohang), western (Gunsan), and southern (Tongyeong) coasts of Korea, from 2004 to 2005. As the results of monitoring the heavy metal contents in spring season, the wild fishes contained the range of Cd (0.01-0.08 mg/kg), Cr (ND-0.28 mg/kg), Cu (0.06-1.53 mg/kg), Hg (0.02-0.16 mg/kg), Mn (0.04-1.15 mg/kg), Ni (ND-0.09 mg/kg), Pb (0.03-0.41 mg/kg), and Zn (1.84-6.61 mg/kg). While for the cultured fishes, Cd (0.01-0.05 mg/kg), Cr (ND-0.17 mg/kg), Cu (0.05-0.61 mg/kg), Hg (0.02-0.13 mg/kg), Mn (0.03-0.17 mg/kg), Ni (ND-0.08 mg/kg), Pb (0.03-0.33 mg/kg), and Zn (2.06-6.20 mg/kg) were contained. In summer season, the contents of heavy metal in the muscle of the wild fishes were as follows: Cd (ND-0.11 mg/kg), Cr (0.01-0.37 mg/kg), Cu (0.21-1.31 mg/kg), Hg (0.01-0.11 mg/kg), Mn (ND-1.47 mg/kg), Ni (ND-0.26 mg/kg), Pb (0.06-0.48 mg/kg), and Zn (2.94-14.38 mg/kg). In comparison, the contents of heavy metal in the muscle of cultured fishes were Cd (ND-0.05 mg/kg), Cr (0.13-0.33 mg/kg), Cu (0.19-0.56 mg/kg), Hg (0.05-0.26 mg/kg), Mn (ND-0.14 mg/kg), Ni (ND-0.58 mg/kg), Pb (0.07-0.45 mg/kg), and Zn (2.43-7.53 mg/kg). Also the fall and the winter season, the heavy metal contents in the fishes showed almost similar with other season, however, Pb was lower and Zn was higher than both spring and summer season. The wild fishes contained the heavy metals a little more than the cultured fishes. We could not observe clear seasonal variation in the heavy metal contents of the fishes. The levels of Hg and Pb in all samples tested did not exceed the maximum permissible levels in the fishes set by the Korean Food & Drug Agency for safe human consumption.

• 대한화장품학회지
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• 제38권1호
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• pp.51-55
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• 2012

포름알데히드는 그 자체가 보존제로 또는 다른 보존제로부터 유리된 형태로 화장품에 일반적으로 존재한다. 포름알데히드는 낮은 농도로도 민감한 피부 반응을 일으킬 수 있으므로 화장품에서 그 사용을 규제하고 있다. 본 연구에서는 팩 및 마스크와 같은 화장품 114 품목을 시중에서 구입하여 포름알데히드의 함량을 분석하였다. 검사 품목의 36%에서 $0.3{\sim}9.7{\mu}g/mL$ (ppm) 수준의 포름알데히드가 검출되었다. 포름알데히드 유리 보존제를 함유한다고 표시되어 있는 12개 제품의 포름알데히드 함량을 조사하였다. Imidazolidinyl urea를 사용한 화장품 10품목과 1,3-Dimethylol-5,5-dimethylhydantoin (DMDM hyantoin)을 사용한 화장품 2품목에서 평균 $1.7{\mu}g/mL$ (ppm)의 포름알데히드가 검출되었다. 식품의약품안전청 고시 최대 허용 포름알데히드 농도 0.2 % (2,000 ppm)을 고려할 때, 이번 조사에서 분석한 화장품에서는 비교적 낮은 수준의 포름알데히드 함량을 보였다.

• 한국직업건강간호학회지
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• 제9권1호
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• pp.5-17
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• 2000

The occupational health nursing guideline for primary care was developed by the Korean Academic Society of occupational health nursing and the organization for occupational health nurses (currently known as the Korean Association of Occupational Health Nurses) in 1993. Since then, there have been many changes in the health care environment and job performance of occupational health nurses. Appropriate revisions are necessary of the guidelinea based on this background. The purpose of this study was to describe the use of the occupational health nursing guideline for primary care and to analyze the characteristics of primary care activities by occupational health nurses. The questionnaire was mailed to 150 occupational health nurses(OHNs) with the response rate of 64%. The results can be summarized as follows; 1. 65.6% of OHNs have been using the guideline for primary care and 75.9% of them agreed that the guideline was be helpful for their job. 2. Common symptom care, emergency care and chronic illness care were more frequently implemented than occupational disease care by OHNs. In manufacturing industries, emergency care was more frequently implemented than chronic illness care in contrast to the service industries. 3. Most frequent common symptoms treated by OHNs were indigestion, diarrhea, abdominal pain, headache, and coughing. In the case of chronic illness, OHNs more frequently treated diseases of the gastro-intestinal system, skin and sensory organs, and the respiratory system. Emergency care for bruises, burn, and abrasions was more frequently provided. VDT syndrome was the most common occupational disease cared by OHNs in manufacturing and service industries. 4. OHNs prescribed the medicine for external application more frequently than internal medicine. Remedy for colds, analgesics, vitamins, and digestives were more frequently used. From these results, we suggest that the guideline should be revised to emphasize the activities consisting problem finding such as health assessment, physical examinations, monitoring and screening, and to renew the drug list in the range of over- the counter medication (OTC). In the future, the guideline will include the strategies for the role as the case manager.

• 한국임상약학회지
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• 제28권3호
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• pp.230-237
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• 2018

Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-the-counter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, "possible" (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while "possible" (44.0%) and "unlikely" (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-the-counter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.

• 농촌의학ㆍ지역보건
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• 제18권2호
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• pp.105-119
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• 1993

The purpose of this study was to evaluate the program for the control of acute respiratory infections(ARI) in children in a Korean rural area(Yonchon county). Evaluating the program, we focused on the pattern of prescription and appropriateness of antibiotics prescribed by the health personnel who had participated in the ARI Control Program. It was implemented at the primary health care setting in rural area, such as district hospital, health subcenters, and health posts. During six-months programme monitoring period, medical records were reviewed and collected data were analysed by the pediatrician, research coordinator of this study. The baseline data were collected from medical records of the same period(six months) of one year before the implementation of the ARI programme. The study results were as follow : 1. Common cold was the most prevalent disease(78.7%. 594 cases) among the all ARI cases (755 cases). The less frequent cases were bronchitis(11.9%), acute pharyngitis(5.2%), and pneumonia(1.8%). 2. Significant reduction in the use of antibiotics was observed after the programme implementation. Ninety three(15.7%) of 594 common cold cases were received antibiotics compared with 282(35.2%) of 802 in the baseline period. In the cases of bronchitis and acute pharyngitis, the reduction rates were 15.1% and 23.2% respectively compared to the baseline period. 3. Mean duration of antibiotics prescription was 1.81-1.75 days, similar to the baseline data. 4. The appropriateness rate of antibiotics prescriptions were 84.3%(common cold), 35.6% (bronchitis) and 28.2%(acute pharyngitis). In the case of pneumonia, the antibiotics prescription was compatible to the criteria developed. 5. Pediatrician prescribed antibiotics more appropriately for all cases than general practitioners in health sub-center, and nurse practitioners in health posts. 6. Antibiotics therapy was shown to be of no effect in the treatment of the all ARI cases. At the 5 and 10 days check-up of common cold cases after visits, proportion of improved patients were 58.3% in the antibiotics-used group and 51.4% in the control group. In the other cases of ARI, the patterns of response were similar to common cold. None of the differences in outcome between the antibiotics-used and control group was statistically significant. This ARI programme may have substantial a substantial impact on antibiotics use at the public health institutions(district hospital, health subcenters, health posts) which are of major domain for primary health care in Korean rural areas.

• Neonatal Medicine
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• 제18권1호
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• pp.130-136
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• 2011

목적: Chloral hydrate는 검사 시 진정 목적으로 흔히 사용하는 약물이나 신생아에 관해서는 충분한 연구가 이루어지지 않고 있다. 이에 저자들은 신생아중환자실에서 chloral hydrate의 사용 시에 나타나는 부작용의 빈도와 그에 영향을 미치는 요소에 대해 알아보고자 한다. 또한 chloral hydrate만으로 진정이 되지 않아 추가 약물을 투여하는 경우 부작용이 증가하는지에 관해 알아보고자 한다. 방법: 2010년 3월부터 2011년 2월까지 가톨릭대학교 서울성모병원 신생아중환자실에서 검사 시 진정 목적으로 chloral hydrate를 사용한 104명을 대상으로 의무기록을 후향적으로 조사하였다. 결과: Chloral hydrate 투여 시 부작용은 41.3%에서 나타났으며 산소 포화도 감소(18.8%), 무호흡 증가(17.5%), 서맥 증가(10%), 수유량 감소(3.8%)가 있었다. Chloral hydrate 투여 시부작용은 chloral hydrate 투여 시기에 산소 투여 여부와 관련이 있었다(odds ratio [OR], 10.911: 95% confidence interval [CI], 2.082-57.178). 추가 약물 투여는 chloral hydrate 투여 시 산소 투여 여부와 관련이 있었고(OR, 4.151: 95% CI, 1.455-11.840) chloral hydrate 단독 투여 군에 비해 수유량 감소를 제외하고는 부작용에 유의한 차이가 없었다. 결론: 진정 요법이 필요한 검사 시 산소를 투여하고 있는 신생아에서 chloral hydrate의 사용은 부작용이 나타날 가능성이 높고 추가 약물 투여의 가능성이 높다. 추가 약물 투여가 필요한 경우에는 진정 유도 후 나타나는 수유량 감소에 주의하면서 진정을 유도할 수 있겠다.