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고시수재 의약품 중 암브록솔염산염 및 클렌부테롤염산염 함유 제제의 함량 시험법 개선
이태웅,정래석,박수진,최란,심영훈,최보경,곽효선 대한약학회 2014 약학회지 Vol.58 No.3
The Korean Pharmaceutical Codex (KPC) analytical method of ambroxol hydrochloride and clenbuterol hydro- chloride formulation is complicated and needed to carry out multiple processes during the test.1) To improve the low effi-ciency of analytical procedure that makes pharmaceutical laboratory consume much time and high cost to conduct the test of this formulation, this study was performed for simplifying the pretreatment process and optimizing conditions of the HPLC assay. The analytical procedure using HPLC was developed to establish analytical specification for ambroxol hydro-chloride and clenbuterol hydrochloride formulations. The newly developed analytical method has good linearity (R 2>0.999),specificity, precision (RSD<1.0%) and the recovery ranges of 98.50~101.84% for ambroxol, 98.29~101.35% for clenbuterol syrup and 98.66~101.71% for clenbuterol tablets. The LOQs were 0.204 μg/ml for ambroxol, 0.021 μg/ml for clenbuterol syrup and 0.073 μg/ml for clenbuterol tablets.2) The new method was performed with commercially available samples to confirm analytical conditions and validated to be suitable for saving time and cost to control the quality of routine man-ufactured products. This analytical method will be used for revising the monograph of ambroxol hydrochloride and clen-buterol hydrochloride formulation in next supplement of KPC.
고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발
이태웅,정래석,정승아,김정현,심영훈,김인규,박창원 대한약학회 2013 약학회지 Vol.57 No.3
Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo per- formance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC).1) 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 tab- lets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dos- age forms" of Ministry of Food and Drug Safety (MFDS).2) 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 estab- lish 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.1)
신현수,허옥순,이진하,김세은,주인선,신동우,강석종,박만종,김지연,김근희,강숙경,정래석,허숙진,소유섭,최장덕,문병우,김진수 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
본 연구는 패류중 중금속함량 측정을 위한 분석효율이 높고 간편한 분해법을 찾아내어 그 방법에 의끓 유종중인 패류중 중금속함량을 파악하고자 수행하였다. 시료를 분해시키는 Microwave와 습식, 건식회법을 비교한 결과 변형습식회화르가 가장 적합하였다. 변형습식회차딘는 려린0,3+C104+H2SOf의 혼찰산을 쪼 · j 1 (v/v)의 비율로 혼합하여 사용하였 을 때 회수을 Pb린틴. Cd 97.8, Cu 94.2, Zn 92.8%를 나타내었근 분해시간은 2~2.5시간 소요되었다. 유통중인 패류중 중금속함량 」최소~최대(평균), mgAgl 은 Pb 0.028~o.528(0.153), Cd 0.OO7~1,832(0.587), Cu 0.360~37.375(4.6691, Zn 6.317~233.2iO(38.881), Hg 0.001 ~O.151(0.012)mg/ltg으로 나타났다. 또한 유통중인 5종의 패류중 중금속평균항량이 생산지 하재지역에서 구입한 패류에 비해 모든 중금속언써 약간 높은 함량을 보였으나 오염된 수준이 아닌 자연함유량수준이었다. This study was conducted to improve the digestion method for the determination of heavy metals in shellfishes and to estimate the contents of heavy metal in commercial shellfishes by their digestion method. This digestion method was compared microwave with wet and dry ash digestion for shellfish samples, obtained results showed that the modified wet ash Ⅱ digestion was convenient and easy to use. For the modified wet ash Ⅱ digestion, The mixed acid of HNO₃+HClO₄+H₂SO₄(25:5:1, v/v) was used. Under this condition, Recoveries were Pb 94.3, Cd 97.8, Cu 94.2 and Zn 92.8% and digestion time was ∼2.5 hours. The contents of heavy metal [minimum∼maximum (mean), mg/kg in commercial shellfishes were as follows ; Pb:0.028∼0.528(0.153), Cd:0.007∼1.832(0.587), Cu:0.360∼37.375(4.669), Zn:6.317∼233.250(38.881), Hg:0.001∼0.151(0.013). The contents of heavy metal in commercial shellfishes of five species were slightly greater than those of shellfishes purchased at Hajae. There was no great difference between the contents of heavy metal of Hajae and those of shellfishes purchased at Whole market.
엄준호,변정아,박유경,서은채,이은미,김미라,선남규,김창수,정우영,정래석,나미애,이진하 한국식품위생안전성학회 2009 한국식품위생안전성학회지 Vol.24 No.1
Patulin, a mycotoxin mainly produced by Penicillium and Aspergillus, is found in various foods. In the present, a maximum acceptable level for patulin is established at 50 μg/kg(ppb) in apple juices and apple concentrates in Korea. But patulin may be detected in foods produced with other fruits. In the present study, patulin contamination was analyzed in 520 samples of fruit juices and beverages, and 50 samples of fruit juice concentrates. High performance liquid chromatography(HPLC) was applied to quantitatively analyze patulin levels in samples and liquid chromatography-mass spectrometry(LC/MS/MS) was used to remove false positive results. The results showed that three samples of 520 fruit juices and beverages and five samples of 50 fruit juice concentrates were contaminated by patulin, 9.8 - 18.0 μg/kg and 4.7 - 18.2 μg/kg respectively. Contaminated samples were produced with apple, orange or pear. This indicates that it is necessary to extend the regulatory range of patulin. In the other hands, the present study confirmed the effectiveness of LC/MS/MS analytical method to remove false positive results.
충청지역 집단급식소의 노로바이러스 실태조사와 환경요인의 영향
정우영,엄준호,김병조,윤민호,주인선,김창수,김미라,변정아,박유경,손상혁,이은미,정래석,나미애,육동연,강지연,허옥순 한국식품위생안전성학회 2010 한국식품위생안전성학회지 Vol.25 No.2
The purpose of this study was to examine the appearance of norovirus in the water for food in food service institutions and the influence of physicochemical and microbial factors of norovirus in order to work out basic data to predict the detection of norovirus. Among 82 samples of water for food in food service institutions, norovirus appeared in 7 samples and the rate of appearance was 8.5%. As for the type of norovirus, one samples contained GI type (genotype GI-6) and six samples contained GII type (genotype GII-2, GII-4, GII-12). In the regression model of prediction of norovirus, the rate of appearance was correlated with NH₃-N, total solids and the consumption of KMnO₄, out of such variables as NH₃-N, total solids, the consumption of KMnO4, depth, chloride and total colony counts, and its contribution rate for effectiveness was 78.60%. In order to examine the influential factor of environment upon the detection of norovirus, Pearson's correlation analysis was carried out. The predictable regression formula for appearance rate of norovirus was expressed as -1.818 + 42.677 [NH₃-N] + 0.023 [total solids] + 0.762[consumption of KMnO₄] -0.009 [depth] -0.146 [chloride] + 0.007 [total colony counts] (R = 0.904, R² = 0.818,adjusted R² = 0.786, p < 0.05). The most influential factors upon the detection of norovirus were NH₃-N, total solids and the consumption of KMnO₄. In other words, when the measured values of NH₃-N, total solids and the consumption of KMnO₄ were higher, the possibility of appearance of norovirus increased.
양성준(Seong Jun Yang),김영옥(Young Ok Kim),손경훈(Kyung Hun Son),이정표,정래석(Rae Sok Jung),양원준(Won Jun Yang),백옥진(Ock Jin Paek),이현경(Hyun Kyung Lee),최상숙(Sang Sook Choi) 대한약학회 2002 약학회지 Vol.46 No.4
A high-performance liquid chromatographic method for the simultaneous quantitative analysis of methylparaben (MP), ethylparaben (EP), propylparaben (PP), butylparaben (BP) and imidazolidinyl urea(IU) or diazolidinyl urea(DU) in cosmetics was studied by using a cyano-propyl column and 0.05M hexanesulfonic acid at 228 nm. Calibration curves were found to be linear in the 60-1000 μg/Ml range (parabens),100-1,250 μg/Ml range (IU) and the 120-2000μg/Ml range (DU). Linear regression analysis of the data demonstrates the efficacy of the method in terms of precision and accuracy. An extraction method is developed and validated in order to apply this chromatographic method to a commercial cosmetic cream. The precision of this method, calculated as the relative standard deviation (RSD) of the recoveries (0.46- 2.71%) was excellent for all compounds.
서정원 ( Jeong-won Seo ),이재옥 ( Jaeok Lee ),채규한 ( Gyuhan Chae ),도원임 ( Won-im Do ),이상훈 ( Sang-hun Lee ),정래석 ( Raeseok Jung ),신원 ( Won Shin ) 한국보건정보통계학회(구 한국보건통계학회) 2017 보건정보통계학회지 Vol.42 No.3
The aim of this study is to provide a method to apply the electronic data standard for electronic transmission of individual case safety reports (ICSRs) in Korea. In Korea, it is necessary to implement the ICH E2B guideline and the ICH MedDRA guideline within 5 years after approval to join ICH members in November 2016. With the spread of the internet network and the IT infrastructure worldwide, Data standardization has been developed not only by major countries such as the US, Europe, and Japan, but also by around the world. In addition, it is necessary to strengthen voluntary or mandatory reporting from consumers, pharmaceutical companies, and healthcare professionals by following the standardized electronic information exchange system for international sharing. This can be an opportunity to overcome limitations on the quality and quantity of information available at the time of authorization. Based on the data system applying the electronic standards, it is possible to search and prevent Korean inherent side effects by using the collected and analyzed information. The exchange of information of standardized data will enable regulatory authorities to communicate with data from different structure as well as many other countries with a single common document. We first reviewed the necessity of development of data standard for drug safety reporting. The ICH E2B guideline adopted as an international standard has been analyzed and the need for introduction into Korea has been examined. In major ICH regions like US, EU and Japan, regional implementation guides for E2B (R3) guideline were prepared and implemented in accordance with the guide. The guides and the status of these countries were compared and analyzed. Regional implementation guide for introducing ICH E2B, an international standard, in Korea was made which was reflecting domestic regulations such as pharmaceutical safety management regulations.