• 한국임상약학회지
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• 제16권2호
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• pp.123-130
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• 2006

The study was aimed to recommend the ways for improving regulatory system of quasi-drugs in governmental authority by comparing with other countries. According to the regulations, the scope of quasi-drugs includes 3 categories of 1) the health aids made of textile, rubber and paper, 2) the health aids which have very minimal effects or no any effects on humans, and 3) disinfectants and pesticides. In US, these quasi-drugs in Korea are classified into 5 categories of medical device, cosmetics, OTC drugs, dietary supplements and pesticides. To improve quasi-drugs administration in Korea, it is concluded that several measures should be implemented : 1) establish clear criteria for classifying into quasi-drugs and more detailed guidelines on designation of quasi-drugs, 2) reform current regulations to meet 3-categories characteristics, supplement detailed guidelines on quasi-drugs administration for effective application process, and update relevant regulations for efficacy, safety and quality, 3) update quasi-drug monographs, 4) re-evaluate current classification of individual quasi-drugs, 5) develop comprehensive list by ingredients, 6) reform post-marketing management system for safety and quality, 7) strengthen the review agency function by increasing the number of experts, 8) develop the database for quasi-drugs for effective information management.

• 대한화장품학회지
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• 제36권3호
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• pp.167-174
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• 2010

탈모 방지의 목적으로 사용되는 양모제는 현재 우리나라에서 의약외품이며 약사법으로 관리되고 있다. 최근 탈모에 대한 사회적 관심이 증가하면서 양모제에 대한 수요도 증가하고 있는 실정이지만 양모제는 생약추출물, 비타민류, 보존제 등 다양한 종류의 성분이 혼합되어 있어 분석이 쉽지 않다. 본 연구에서는 양모제의 주성분으로 많이 쓰이는 니코틴산아미드, 덱스판테놀, 살리실산, 초산토코페롤, 니코틴산벤질에 대한 동시분석법을 확립하고자 하였다. 시판 중인 양모제를 구입하여 $C_{18}$ 컬럼, 아세토니트릴과 인산염완충액을 용매로 사용하여 HPLC로 분석하였다. 검출은 자외부 흡광광도계를 이용하여 220, 270, 300 nm 파장에서 분석하였으며, $12.5{\sim}800\;{\mu}g/mL$ 농도범위에서 검량선을 작성하였다. 회수율은 액상기제의 경우 97.3 ~ 103.5 % (상대표준편차 0.9 ~ 2.8 %), 샴푸기제의 경우 101.9 ~ 115.9 % (상대표준편차 0.7 ~ 7.7 %)로 양호한 결과를 나타냈다. 시판중인 검체의 함량 시험결과 기준에 적합하였으며, 본 분석법을 이용하여 품질관리 및 추후 양모제 개발에 유용하게 활용함으로써 우수한 품질의 양모제 유통에 크게 기여할 것으로 기대된다.

• 대한화장품학회지
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• 제35권1호
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• pp.11-17
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• 2009

스테로이드 함유 표시가 없는 화장품에서 항염증 효과가 있는 글루코코티코스테로이드인 베타메타손프로피오네이트 성분이 검출되었다. 이 화장품은 외용스프레이 및 샴푸로서 주성분으로 아연피리치온을 함유하는 것으로 표기되어 있었다. 화장품에서 스테로이드 구조와 활성을 갖는 물질의 존재를 확인하기 위하여 실리카겔 박층판을 이용한 박층크로마토그래프를 사용하였으며 이 성분을 분리하기 위해 high-performance liquid chromatography (HPLC)를 이용하여 확인 및 정량을 수행하였다. 분취용 HPLC를 이용하여 스테로이드를 함유한 것으로 판단되는 분획을 모은 다음 nuclear magnetic resonance (NMR) 및 mass spectrometry (MS)를 이용하여 스테로이드 성분을 확인하였다. 스테로이드 표준물질로 베타메타손 17-프로피오네이트 및 베타메타손 21-프로피오네이트를 합성하여 사용하였고 이 표준물질과 HPLC 크로마토그램을 비교하여 스테로이드 성분의 함량을 분석하였다. 이 방법으로 아연피리치온 제제와 같은 일부 시판 화장품에서 스테로이드 성분을 확인하였고 reversed-phase high-performance liquid chromatography (RP HPLC) 상의 유지시간 비교를 통하여 스테로이드 성분을 정량한 결과 시험한 총 8종의 화장품 시료 중 2개 제품에서 0.005 ${\sim}$ 0.02%의 베타메타손프로피오네이트가 검출되었다.

• Communications for Statistical Applications and Methods
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• 제29권4호
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• pp.421-439
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• 2022

Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan et al. (2007) and Pan et al. (2014), gBOIN design by Mu et al. (2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next that determines the dose for the next cohort of patients, select, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.

• 한국학교보건학회지
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• 제19권2호
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• pp.89-104
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• 2006

Purpose： This study was to develop and verify the effects of drug misuse and abuse preventive program for middle school students. Methods：This research was a quasi experimental study under the nonequivalent control group with pretest-post test design which tried to protect children from the detrimental effect of drugs and develop a drug abuse prevention program for middle school students. Data was collected from October 10th to 21th, 2005. Subject consisted of 145 middle school students in Kyeonggi, experimental group-72, control group-73. Dick & Carey's(1996) educational system was applied, based on documents and materials online related to drug abuse in order to develop drug abuse prevention program. It's composed of 4 parts, 45 minute each. The evaluation instrument testing for the knowledge about drugs was a criterion of referenced test items modeled by Dick & Carey. The instrument for attitudes about drugs was modeled by Kim, Soyaja. A pre-test was taken on the knowledge and attitudes to drugs. The experimental students were given four sessions of drug abuse prevention education. A post-test similar to the pre-test questionnaire was given in 1 week, 4 weeks following the last session. Collected data was analyzed by using SAS 9.1 program. Results：Followings are the summarized result of study 1. The experimental group, that attended the drug abuse prevention program will have more knowledgable about drugs than the control group (F=27.31, p<.0001). 2. The experimental group, that attended the drug abuse prevention program displayed greater negativism attitude than the control group (F=0.58, p=0.4477). Conclusion：The results conclude that drug abuse prevention programs increase the knowledge of middle school students but doesn't change their attitude toward drugs. Therefore we need to offer them more systematic education to increase their knowledge so it will also improve their attitudes as well.

• 임상간호연구
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• 제24권1호
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• pp.56-66
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• 2018

Purpose: This quasi-experimental study was done to develop image-use medication education for older inpatients and to evaluate the effects on their knowledge, self-efficacy, and misuse of medication. Methods: Fifty nine elders (experimental group - 30, and control group - 29) received medication education once a week for 3 weeks. Data were collected before (pretest), right after (post 1), and 4 weeks after the program finished (post 2). Drug Use Knowledge Scale, Self-efficacy for Appropriate Medication Use Scale, and Drug Misuse Scale were used. Analysis included descriptive statistics, $x^2$ test, repeated measured ANOVA. Results: Findings showed significant differences in knowledge of medication and drug misuse between groups according to time(pretest, post 1, and post 2). At post 1 and post 2, knowledge and self-efficacy levels were significantly higher and misuse scores were lower in the experimental group compared to the control group. Conclusion: Findings indicate that elder-tailored medication education consisting of group education and individual guidance with images is effective and practical for medicine safety in elderly inpatients. Moreover, it could lead to a healthier life for elders, even elders with multiple chronic diseases and taking several medications.

• 대한의용생체공학회:의공학회지
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• 제44권1호
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Bulletin of the Korean Chemical Society
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• 제29권11호
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• pp.2125-2128
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• 2008

• KSBB Journal
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• 제26권3호
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• pp.217-222
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• 2011

Itraconazole is a triazole antifungal agent to inhibit most fungal pathogens. To improve the oral absorption and dissolution of poorly water-soluble itraconazole, microsponge system composed of $Eudragit^{(R)}$ E100 and polyvinyl alcohol(PVA) formulated by quasi-emulsion solvent diffusion method, and its physicochemical properties and pharmacokinetic parameters of itraconazole were studied. The microsponge of itraconazole were discrete free flowing micro sized particles with perforated orange peel like morphology as visualized by scanning electron microscope (SEM). Results showed that the drug loading efficiency, production yield, and particle size of itraconazole microsponge were affected by drug to polymer ratio, the volume of internal phase containing methylene chloride, stirring rate and the concentration of PVA used. Also, the results showed that the dissolution rate of itraconazole from the microsponges was affected by drug to polymer ratio. In other words, the release rate of itraconazole from microsponges was increased from at least 27.43% to 64.72% after 2 h. The kinetics of dissolution mechanism showed that the dissolution data followed Korsmeyer-Peppas model. Therefore, these results suggest that microsponge system can be useful for the oral delivery of itraconazole by manipulating the release profile.

• Macromolecular Research
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• 제10권5호
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• pp.246-252
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• 2002

In order to the development of the delivery device of long-acting local anesthetics for postoperative analgesia and control of chronic pain of cancer patient, fentnyl-loaded poly (L-lactide-co-glycolido) (PLGA, molecular weight, 5,000 g/mole; 50 : 50 mole ratio by lactide to glycolide) microspheres (FMS) were studied. FMS were prepared by an emulsion solvent-evaporation method. The influence of several preparation parameters such as initial drug loading, PLGA concentration, emulsifier concentration, oil phase volume, and fabrication temperature has been investigated on the fentanyl release profiles. Generally, the drug showed the biphasic release patterns, with an initial diffusion followed by a lag period before the onset of the degradation phase, but there was no lag time in our system. Fentanyl was slowly released from FMS over 10 days in vitro with a quasi-zero order property. The release rate increased with increasing drug loading as well as decreasing polymer concentration with relatively small initial burst effect. From the results, FMS may be a good formulation to deliver the anesthetic for the treatment of chronic pain.