• Toxicological Research
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• 제31권3호
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• pp.307-312
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• 2015

Trans fat is a unsaturated fatty acid with trans configuration and separated double bonds. Analytical methods have been introduced to analyze trans fat content in foods including infrared (IR) spectroscopy, gas chromatography (GC), Fourier transform-infrared (FT-IR) spectroscopy, reverses-phase silver ion high performance liquid chromatography, and silver nitrate thin layer chromatography. Currently, FT-IR spectroscopy and GC are mostly used methods. Trans fat content in 6 vegetable oils were analyzed and processing effects including baking, stir-frying, pan-frying, and frying on the formation of trans fat in corn oil was evaluated by GC. Among tested vegetable oils, corn oil has 0.25 g trans fat/100 g, whereas other oils including rapeseed, soybean, olive, perilla, and sesame oils did not have detectable amount of trans fat content. Among cooking methods, stir-frying increased trans fat in corn oil whereas baking, pan-frying, and frying procedures did not make changes in trans fat content compared to untreated corn oils. However, the trans fat content was so low and food label can be declared as '0' trans based on the regulation of Ministry of Food ad Drug Safety (MFDS) (< 2 g/100 g edible oil).

• 약학회지
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• 제57권3호
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• pp.226-233
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• 2013

Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC). So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tablets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Ministry of Food and Drug Safety (MFDS). The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to establish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.

• 한국임상약학회지
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• 제25권3호
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• pp.171-177
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• 2015

Background: Androgenetic alopecia (AGA), one of alopecias, requires continuous treatment in order to prevent or stop it, and patient's compliance is very important. Currently, only two drugs (finasteride, minoxidil) have been approved for AGA by Food and Drug Administration of United States (US FDA). However, another ${\alpha}-2$ reductase inhibitor, dutasteride, is approved by Korea Ministry of Food and Drug Safety (MFDS) through a phase III trial. For treatment, pharmacotherapy of AGA usually combines topical minoxidil 7% with one of oral <${\alpha}-2$ reductase inhibitor. Objectives: We evaluated the comparative efficacy and adverse effect between topical minoxidil 7%/finasteride 1 mg and topical minoxidil 7%/dutasteride 0.5 mg pharmacotherapy for outpatients with AGA. Also we evaluated the relationship between therapeutic effect and regular hospital visit. Method: This study was performed retrospectively based on electronic medical record (EMR) data of total 98 patients (topical minoxidil 7% with dutasteride 0.5 mg ($Avodart^{(R)}$) or finasteride 1 mg ($Alopecia^{(R)}$, $Propecia^{(R)}$) with diagnosis of AGA from department of dermatology at a secondary hospital from January $1^{st}$, to May $31^{st}$, 2014. Results: The efficacy and adverse event of topical minoxidil 7%/dutasteride 0.5 mg (DUTA group) were 100% and 45.7%, and of topical minoxidil 7%/finasteride 1 mg (FINA group) were 92.1% and 33.3%, respectively. The mean onset time of responses and adverse events in the FINA group were 3.86 months and 4.43 months. Those in the DUTA group were 3.97 months and 5.06 months. Conclusion: Both FINA and DUTA group were highly effective, but the DUTA group showed higher efficacy and adverse effects than those in the FINA group. Dutasteride may be another alternative in AGA treatment.

• 한국임상약학회지
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• 제24권3호
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• pp.219-228
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• 2014

Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

• 대한약침학회지
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• 제18권3호
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• pp.42-48
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• 2015

Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

• 한국식품영양학회지
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• 제31권3호
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• pp.395-399
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• 2018

The objective of this study is to analyze characteristics of high sodium intaker and factors affecting sodium intake using the Korea National Health and Nutrition Examination Survey (KNHANES). For this study we used two statistical methods, the cluster analysis and one-way analysis of variance (ANOVA). Cluster analysis was used to classify groups of sodium intake. For the analysis of the factors affecting sodium intake, we applied the ANOVA. The average daily intake for Korean is about 3,783 mg sodium per day; this amount is high than recommendation of the WTO. The demographic characteristics of people with higher sodium intake were found to be men more so women, and younger men with a higher education. Height, weight and size of a person's waistline were also characteristics of those with higher sodium intake. Also worker, smoker, those without a hypertension diagnosis, as well as those with a higher the drinking rate and higher eating out frequency tended to have a higher intake of sodium. The Ministry of Food and Drug Safety (MFDS) had established a plan to reduce sodium intake to 3,500 mg per day to 2020. To achieve this goal, it is necessary to educate people about high sodium intake, particularly those at higher risk, according to the results of this study. Through these efforts, the social costs of high sodium intake could be reduced, improving national health.

• 한국약용작물학회지
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• 제24권6호
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• pp.451-457
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• 2016

Background: Leonurine is a the aerial part of Leonurus japonicus Houttuyn, which has been used as a traditional medicines and is registered in the Korean Pharmacopoeia. Methods and Results: In the present study we performed a heavy metals and thin layer chromatography and measured loss on drying, as well as the contents of total ash, acid-insoluble ash, ethanol soluble compounds, and leonurine, using 15 domestically collected L. japonicus samples. The methods were performed according to the 'crude drugs test of the general test, processes and apparatus', published by MFDS, Korea (2014). The purity test (heavy metals) indicated that levels of Pb and Hg were 0.35 - 3.64, and 0.001 ppm, respectively, whereas the levels of As and Cd were undetectable, and stachydrine was identified by thin layer chromatography ($R_f$ : 0.15). We found that 5.93 - 10.62% (average: $8.58{\pm}1.8%$) of the sample mass was lost during drying, and the contents of total ash, acid-insoluble ash, ethanol soluble compounds, and leonurine were 7.87 - 10.84% (average: $9.62{\pm}0.82%$), 0.99 - 1.76% (average: $1.38{\pm}0.24%$), 16.70 - 23.11% (average: $19.49{\pm}2.14%$) and 0.04 - 0.17% (average: $0.11{\pm}0.04%$) respectively. In addition, HPLC profiling detected leonurine (5.94 min), rutin (16.43 min) and myricetin (26.78 min). Conclusions: We hope that this the rusult of the present study will contribute to the standardization and quality control of Korean herbal medicines.

• 한국임상약학회지
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• 제28권2호
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• 한국ITS학회 논문지
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• 제16권6호
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• pp.29-41
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• 2017

본 연구에서는 개별 차량의 주행정보를 이용하여 대구광역시 도심부에서 네트워크 스케일의 거시 교통류 모형(Macroscopic Fundamental Diagram, MFD)을 추정하는 방법에 대해 고찰한다. 이를 위해 근거리 전용 통신(Dedicated Short Range Communication, DSRC) 방식으로 수집된 개별 차량의 원시 데이터 처리 방법 및 통행 정의 방법을 분석하고, 해당 자료를 활용하는 새로운 활용 방안을 제시한다. 이를 위해 프로브 자료인 DSRC 데이터와 교통량 조사 자료를 이용해 표본율을 산정하고 대구광역시 네트워크 내 MFD를 도출하는 방법을 설명한다. 도출된 MFD를 통해 시간적 재현성(reproducibility)의 확인과 선행 연구 가정 사항들에 대한 데이터 기반 검증을 수행하였으며, DSRC 자료의 새로운 활용 방법을 제시하고자 한다.

• 방사선산업학회지
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• 제8권2호
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• pp.133-140
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• 2014

The sterilization of health care products is widely used to choose conventional Ethylene Oxide gas sterilization in South Korea. But the method has brought serious issues because of the toxic residual gas and global warming of $CO_2$ evacuation after the sterilization process. This study is carried out to confirm the application possibility of gamma sterilization instead of Ethylene Oxide in sanitary aid products. Four kinds of products (gauze, menstrual pad, bandage, menstrual tampon) were treated with gamma irradiation of 15 kGy, then analyzed the achievement of the sterility assurance level (SAL) $10^{-6}$ through BI test. The cytotoxicity of accelerated samples of 6 months elapse evaluated by means of colony forming rate at various concentration of the extracts. pH and UV measurements at extract concentrations were tested according to the MFDS (Ministry of food & drug safety) guideline to verify a stability & safety of product sterilized. The results revealed that the extracts did not show any significant changes in cytoxicity assay as well as pH and UV values by gamma sterilization. All extract concentration was observed high cell viability, pH and UV values were calculated within the acceptable range prescribed by the guideline. It indicates that gamma sterilization could effectively substitute for conventional sterilization such as Ethylene Oxide sterilization in the sanitary aid products.