• 제목/요약/키워드: drug-related

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페노피브레이트 유연물질 표준품 대체시험법 개발 (Development of an Alternative Analytical Method without Related Substance Reference Standards for Fenofibrate in Korean Pharmacopoeia)

  • 김정현;김민영;권은경;이광문;최돈웅
    • 약학회지
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    • 제59권3호
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    • pp.98-106
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    • 2015
  • Analytical method for related substances can be categorized into two methods depending on the necessity of reference standard (RS). The analytical method of related substances with RS is fast and accurate, but it's very expensive and technically difficult to synthesize RS due to their complicated structure. Another method is using relative retention time (RRT) and relative response factor (RRF) which are already validated with RS. Validation of this method is not easy and time consuming, but once it has been developed, it can save cost and time. In this study, we developed the analytical method for related substances of fenofibrate using RRT and RRF. We validated the method by evaluating specificity, linearity, accuracy and precision according to the "Manual for Guideline Application for Validation of Analytical Procedures" of MFDS. Also, we calculated RRT and RRF between fenofibrate and fenofibrate related substances. The results of this study showed high specificity for fenofibrate and fenofibrate related substances. Correlation coefficient(r) of all substances were more than 0.99, and the recovery of fenofibrate, fenofibrate related substance I, II and III were 99.44%, 100.84%, 99.14% and 101.58%, respectively. Precision of fenofibrate and its related substances were ranged between RSD 0.29% and 0.93%. Quantification limits of fenofibrate, fenofibrate related substance I, II and III were determined to be $0.03{\mu}g/ml$, $0.05{\mu}g/ml$, $0.04{\mu}g/ml$ and $0.02{\mu}g/ml$, respectively by confirming signal to noise ratio of each chromatogram. The RRT for fenofibrate related substance I, II and III were determined to be 0.35, 0.41 and 1.34, respectively. Also, the RRF for fenofibrate related substance I, II and III were determined to be 1.28, 0.98 and 0.79, respectively. The developed method was applied to determine contents for fenofibrate related substances in commercial fenofibrate (active pharmaceutical ingredient). As a result, developed analytical methods of related substances will be used for revising the monograph of fenofibrate in Korean Pharmacopoeia revision and contribute quality control of drugs by improving cost and time consuming problem of RS.

A study of test method for impurities(related compounds) in pharmaceutical products

  • Ko, Yong-Seok;Jang, Seung-Jae;Kang, Chan-Soon;Choi, Bo-Kyung;Kim, Hye-Soo;Kim, Eun-Jung;Cho, Myoeng-Sin;Hong, Chong-Hui;Kim, Sang-Hyun
    • 대한약학회:학술대회논문집
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    • 대한약학회 2003년도 Proceedings of the Convention of the Pharmaceutical Society of Korea Vol.1
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    • pp.280.1-280.1
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    • 2003
  • The high-performance liquid chromatography method was performed for test method development of related compounds in pharmaceuticals. Using reverse-phase column and gradient elution of 1 % acetonitrile-acetonitrile: H20:triethylamine (70:30:0.5), lansoprazole, 2-hydroxybenzimidazole, 2-mercaptobenzimidazole, lansoprazole sulfone, lansoprazole sulfide could be individually identified and quantitated. (omitted)

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Inhibition of Cytochrome P450 Enzymes by Drugs-Molecular Basis and Practical Applications

  • Guengerich, F. Peter
    • Biomolecules & Therapeutics
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    • 제30권1호
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    • pp.1-18
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    • 2022
  • Drug-drug interactions are a major cause of hospitalization and deaths related to drug use. A large fraction of these is due to inhibition of enzymes involved in drug metabolism and transport, particularly cytochrome P450 (P450) enzymes. Understanding basic mechanisms of enzyme inhibition is important, particularly in terms of reversibility and the use of the appropriate parameters. In addition to drug-drug interactions, issues have involved interactions of drugs with foods and natural products related to P450 enzymes. Predicting drug-drug interactions is a major effort in drug development in the pharmaceutical industry and regulatory agencies. With appropriate in vitro experiments, it is possible to stratify clinical drug-drug interaction studies. A better understanding of drug interactions and training of physicians and pharmacists has developed. Finally, some P450s have been the targets of drugs in some cancers and other disease states.

청소년의 비치료적 약물사용에 관한 예측요인 (Predictive Factors of Adolescents' Illicit Drug Use)

  • 김희영
    • 지역사회간호학회지
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    • 제18권1호
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    • pp.136-145
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    • 2007
  • Purpose: This study was attempted to illuminate danger signals through an extensive analysis of factors influencing adolescents' illicit drug use. On this basis, it built predictive factors of adolescents' illicit drug use. Method: A questionnaire was distributed to 1,238 subjects living in Seoul, and of them 1,082 answers were analyzed using the SAS 8.2 program. Also logistic regression analysis was conducted based on the stepwise selection method for constructing the predictive factors. Results: The findings of this study are as follows. Individual-related factors were psycho-somatic symptoms, self-esteem, fortune delinquent experience, and sexual-violence delinquent experience. Home-related factors were insincerity, threatening and the assessment of the parent (rearer)-adolescent communication type. Society-related factors were affection of friends and friends' attitude toward delinquency. Conclusion: These findings of this study suggest that a broad intervention program should be provided to nurture wholesome youth culture related to illicit drug use. It is also recommended that a variety of individual, home and society-related programs should be developed for drug users.

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지역약국 약사의 처방중재 활동 평가 (Evaluation of Pharmacists' Intervention Activities in Community Pharmacy)

  • 구현지;성종미;정선영;정경혜
    • 한국임상약학회지
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    • 제34권1호
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    • pp.62-70
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    • 2024
  • Background: Drug-related problems have the potential to threaten patient health, and pharmacists are in a position to prevent such problems through prescription reviews and patient counseling, actively engaging in pharmaceutical care activities. This study aims to categorize and analyze the intervention activities of pharmacists in community pharmacies concerning drug-related problems, following international criteria. Methods: Over a six-month period, prescription interventions completed in a community pharmacy in Seoul were selected as the research subjects. The causes of interventions were classified according to the Pharmaceutical Care Network Europe (PCNE) drug-related problems (DRPs) classification system and the types and frequencies of DRPs were identified. Results: Among a total of 49,334 prescriptions, 527 interventions were completed, constituting approximately 1.07% of the daily average filled prescriptions. Individuals over 60 years of age represented more than 50%. The primary cause of DRPs was prescribing and drug selection issues, comprising 256 cases (48.58%), with specific subcategories including 109 cases of drug selection, 79 cases of treatment duration errors, 47 cases of dose selection, and 21 cases of inappropriate dosage form selection. Patient-related issues accounted for 204 cases (38.71%). Conclusion: The study demonstrated that the pharmacists' intervention in community pharmacies contributes to the safe use of medication by patients.

병원약제부의 약품식별업무와 질의응답업무에 관한 업무분석;한 대학병원의 경우 (Analysis on Drug Identification Service and other Drug-related Queries in a Hospital Pharmacy)

  • 최지홍;김정애;스리니바산샨무감;용철순;최한곤;유봉규
    • 약학회지
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    • 제52권4호
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    • pp.283-287
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    • 2008
  • Drug identification service and other drug-related query service are becoming increasingly important in hospital pharmacy. The goal of this research was to investigate current situation of the service in hospital pharmacy, which recently implemented the services as part of provision of advanced hospital pharmacy service in order to assure national health improvement. We investigated the report performed from November 2006 through April 2007 in a university hospital located in Daegu, Korea. Number of drug identification service performed was 81 cases during the first three months period (period I), but it increased to 222 cases during the second three months period (period II), which suggested that the service was welcomed by medical staff in the hospital. Time to process each case was about 30 minutes in the period I while it was only 16 minutes in the period II. Proportion of the unidentifiable cases remained at about 25% during the entire period, which suggests that the system for the identification task appears to have some limitations such as unsatisfactory support from the Korea Pharmaceutical Association, laws, and regulations. A vast majority of drug-related queries were mostly from physicians (60.5%) followed by nurses and pharmacists. Time to process each drug-related query was 10.6 minutes in the period I while it was 6.9 minutes in the period II. Queries answered immediately were about 70% of all queries in the period I, but increased to about 85% in the period II.

신규 졸업 간호사의 약물계산오류의 위험에 영향을 미치는 요인 (Predictors of Drug Dosage Calculation Error Risk in Newly Graduated Nurses)

  • 김명수;김정순;하원춘
    • Journal of Korean Biological Nursing Science
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    • 제16권2호
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    • pp.113-122
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    • 2014
  • Purpose: This study was to identify predictors of drug dosage calculation error risk in newly graduated nurses. Methods: A total of 115 newly graduated nurses who passed their employment examination, but didn't work for hospital yet, were recruited from a university hospital. The data were analyzed by descriptive statistics, $X^2$-test, t-test, ANOVA, Pearson correlation coefficients, and stepwise multiple regression using the SPSS 18.0 program. Results: The mean score of 'drug dosage calculation ability' was $0.81{\pm}0.16$ and the mean score of 'certainty of calculation' was $2.95{\pm}0.60$ out of a 5 point scale. The error risk of drug dosage calculation was positively related to anxiety for drug dosage calculations (r=.388, p<.001), but negatively related to interest and confidence in mathematics (r=-.468, p<.001), confidence related to dosage calculations (r=-.426, p<.001). The main predictors of error risk related drug calculations in newly graduated nurses were identified as interest and confidence in mathematics (${\beta}$=-.468, p<.001). This factor explained about 21.9% of the variance in error risk of drug dosage calculation. Conclusion: The strategies used to decrease the error risk related drug dosage calculation such as improving interest and confidence in mathematics should be developed and implemented.

일부 다빈도 질환에서 개원의의 의약품 처방에 영향을 미치는 요인 (Factors Influencing Physicians' Prescriptions in Some Frequent Diseases)

  • 박실비아;문옥륜;강영호
    • 보건행정학회지
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    • 제8권2호
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    • pp.166-190
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    • 1998
  • This study presents the status on drug prescription for clinic outpatients' bronchitis, gastritis, and gastric ulcer, and also the physician factors that affects their prescriptions. In this research project the physician factors are as follows: their demographic features, their work related features, education related features, drug information related features and drug promotion related features. The variables in drug prescriptions are drug expenses, daily drug expenses, days of medication, the highest price of the drugs used and the number of the different drugs used. Analysis of the use of prescription drugs was performed on NFMI(National Federation of Medical Insurance) 1994 medical expense claim data. Data on physicians' characteristics were collected by mailing surveys. Patients with secondary diseases were excluded. In this study, 388 adults with bronchitis, 1,038 children with bronchitis, 1,158 patients with gastritis, 369 patients with gastric ulcer were included. The older physicians tend to allow the lower drug costs: this explains that the older doctors who are more experienced less depend on the medicines. It can be also explained that doctors are likely to use the medicines that had been used for their intern and resident practice/training period. General practitioners give more intensive prescription compared to specialists. And specialists prescribed medicines to patients for longer period. The doctors' prescriptions for patients are largely affected by commercial sources. So objective and reliable sources for drug information is needed for patients' benefits. Physician factors explain better at the daily drug expenses, the drug price and the number of different drugs than days of medication. Gastric ulcer are better explained by the prescription model adopted in this study than other diseases.

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한방치료의 안전성 : 한약에 의한 약열과 시술관련 발열 (Safety of Oriental Medical Therapy: Drug Fever of Herbal Medicine and Procedure-related Fever)

  • 문수연;임경리;손준성
    • 대한한방내과학회지
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    • 제42권6호
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    • pp.1237-1244
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    • 2021
  • 목적: 약열과 시술관련 발열(시술열)은 원내 발열의 원인이다. 한방은 여러 라에서 시행되나, 이에 의한 약열과 시술열의 빈도에 대한 자료는 없다. 본 연구의 목적은 한방치료에 의한 약열과 시술열의 빈도를 확인하는 것이다. 방법: 2006년부터 8년간 서울의 한 대학 부속 한방병원에서 후향적으로 시행했다. 결과: 한약을 복용한 10800명의 환자 중 95건의 약열이 발생하였다(0.89%). 환자들의 체온은 38.37±0.58 ℃이었고, 발열은 평균 1일간 지속되었다. 호산구증, 독성간염, 피부발진이 각각 15.79%, 8.42%, 5.26%에서 발생하였다. 약열과 관련된 흔한 한약재는 감초, 당귀, 백출이었다. 한방 시술을 받은 8125명의 환자 중 16건의 시술열이 발생하였다(0.20%). 환자들의 체온은 38.26±0.51 ℃이었고, 발열은 평균 1일간 지속되었다. 뜸이 가장 흔한 원인으로, 침이 두 번째였다. 결론: 한방치료에 의한 약열 및 시술열의 빈도는 서양의학보다 높지 않다.

충북지역 노인들의 약물복용 및 영양상태 -IV. 약물복용 및 건강관련 습관(음주, 흡연, 운동)에 따른 영양상태의 차이- (Drug Use and Nutritional Status of the Elderly in Chungbuk Area -IV. Effects of Drug Use & Health-Related Habits (Alcohol Drinking, Cigarette Smoking & Exercise) on Nutritional Status-)

  • 한경희;김기남;박동연
    • 대한지역사회영양학회지
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    • 제3권3호
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    • pp.397-409
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    • 1998
  • The purposes of this study were to investigate the effects of drug use & the health-related habits(alcohol drinking, smoking and exercise) on the nutritional status of elderly. subjects were 362 free-living elderly aged over 65(male 131, female 231) in Chungbuk area. Interviews with questionaire on drug use, health-related habits, and nutrient intakes, anthropometric measurement and biochemical blood test were carried out from August to October in 1996. Energy intakes of the males who used drug were lower than those of males who did not use any drug, while energy intakes of the females who used drug were higher than those of females who did not. In biochemical indices, LDL-cholesterol level of the males who used drug was higher than that of males who did not have drug. serum triglycerides, VLDL-cholesterol and obesity degree(BMI & TS) of the females who used drug were higher than those of females who did not have drug. Alcohol drinking, smoking and exercise habits of the elderly who used drug had little effects on the nutrient intakes while those habits had considerable effects on biochemical indices and obesity degree. Among drug users, male drinkers showed higher triglycerides & HDL-cholesterol level, and female drinkers showed higher triglycerides and lower total cholesterol and LDL-cholesterol level, compared to non drinkers. Among female drug users, smokers showed lower body mass index(BMI) compared to non smokers. Males and females who had both drinking and smoking habits showed higher serum triglycerides and VLDL-cholesterol level. Especially females who had both drinking and smoking habits showed lower BMI & Tricep skinfold thickness compared to those who had netiher drinking nor smoking habits.

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