• Title/Summary/Keyword: Complex Samples Analysis

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Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex (고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Jeong, Seung-A;Kim, Jeong-Hyun;Shim, Young-Hun;Kim, In-Kyu;Park, Chang-Won
    • YAKHAK HOEJI
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    • v.57 no.3
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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.

Development of Analytical Method for Ambroxol Hydrochloride and Clenbuterol Hydrochloride Formulation in Korean Pharmaceutical Codex (고시수재 의약품 중 암브록솔염산염 및 클렌부테롤염산염 함유 제제의 함량 시험법 개선)

  • Lee, Tae-Woong;Jeong, Rae-Seok;Park, Soo-Jin;Choi, Lan;Shim, Young-Hun;Choi, Bo-Kyung;Kwak, Hyo-Sun
    • YAKHAK HOEJI
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    • v.58 no.3
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    • pp.190-199
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    • 2014
  • The Korean Pharmaceutical Codex (KPC) analytical method of ambroxol hydrochloride and clenbuterol hydrochloride formulation is complicated and needed to carry out multiple processes during the test. To improve the low efficiency 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 hydrochloride 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 ${\mu}g/ml$ for ambroxol, 0.021 ${\mu}g/ml$ for clenbuterol syrup and 0.073 ${\mu}g/ml$ for clenbuterol tablets. 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 manufactured products. This analytical method will be used for revising the monograph of ambroxol hydrochloride and clenbuterol hydrochloride formulation in next supplement of KPC.

Recapitulation of previously reported associations for type 2 diabetes and metabolic traits in the 126K East Asians

  • Choi, Ji-Young;Jang, Hye-Mi;Han, Sohee;Hwang, Mi Yeong;Kim, Bong-Jo;Kim, Young Jin
    • Genomics & Informatics
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    • v.17 no.4
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    • pp.48.1-48.6
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    • 2019
  • Over the last decade, genome-wide association studies (GWASs) have provided an unprecedented amount of genetic variations that are associated with various phenotypes. However, previous GWAS were mostly conducted in European populations, and these biased results for non-Europeans may result in a significant reduction in risk prediction for non-Europeans. An issue with the early GWAS was the winner's curse problem, which led to misleading results when constructing the polygenic risk scores (PRS). Therefore, more non-European population-based studies are needed to validate reported variants and improve genetic risk assessment across diverse populations. In this study, we validated 422 variants independently associated with glycemic indexes, liver enzymes, and type 2 diabetes in 125,872 samples from a Korean population, and further validated the results by assessing publicly available summary statistics from European GWAS (n = 898,130). Among the 422 independently associated variants, 284, 320, and 361 variants were replicated in Koreans, Europeans, and either one of the two populations. In addition, the effect sizes for Koreans and Europeans were moderately correlated (r = 0.33-0.68). However, 61 variants were not replicated in both Koreans and Europeans. Our findings provide valuable information on effect sizes and statistical significance, which is essential to improve the assessment of disease risk using PRS analysis.

Proteome Analysis of Mouse Adipose Tissue and Colon Tissue using a Novel Integrated Data Processing Pipeline

  • Park, Jong-Moon;Han, Na-Young;Kim, Hokeun;Hwang, Injae;Kim, Jae Bum;Hahm, Ki-Baik;Lee, Sang-Won;Lee, Hookeun
    • Mass Spectrometry Letters
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    • v.5 no.1
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    • pp.16-23
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    • 2014
  • Liquid chromatography based mass spectrometry (LC-MS) is a key technology for analyzing highly complex and dynamic proteome samples. With highly accurate and sensitive LC-MS analysis of complex proteome samples, efficient data processing is another critical issue to obtain more information from LC-MS data. A typical proteomic data processing starts with protein database search engine which assigns peptide sequences to MS/MS spectra and finds proteins. Although several search engines, such as SEQUEST and MASCOT, have been widely used, there is no unique standard way to interpret MS/MS spectra of peptides. Each search engine has pros and cons depending on types of mass spectrometers and physicochemical properties of peptides. In this study, we describe a novel data process pipeline which identifies more peptides and proteins by correcting precursor ion mass numbers and unifying multi search engines results. The pipeline utilizes two open-source software, iPE-MMR for mass number correction, and iProphet to combine several search results. The integrated pipeline identified 25% more proteins in mouse epididymal adipose tissue compared with the conventional method. Also the pipeline was validated using control and colitis induced colon tissue. The results of the present study shows that the integrated pipeline can efficiently identify increased number of proteins compared to the conventional method which can be a breakthrough in identification of a potential biomarker candidate.

Factors Related to the Self-Rated Health Status among Korean Elderly - Analysis of the 2016 Korean National Health and Nutrition Examination Survey - (한국노인의 주관적 건강상태 인식 관련 요인 - 2016 국민건강영양조사 자료 분석 -)

  • Park, Kyung-Ae
    • Journal of the Korean Dietetic Association
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    • v.24 no.4
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    • pp.344-360
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    • 2018
  • This study examined the sociodemographic factors, health-related habits, chronic diseases, dietary habits, and nutrient intake according to the self-rated health status in a group aged over 65 years by analyzing the nationally representative Korean survey data. A total of 1,510 subjects were analyzed among the participants of the 2016 Korean National Health and Examination Survey (KNHANES). Statistical analyses for complex samples were performed using the SPSS software package (version 19.0) The study subjects were divided into two groups (healthy group vs. unhealthy group) based on their self-rated health status. The percentage of the healthy group was 66.5%. Gender, age, education level, household income, job (P<0.001, respectively), marital status, and basic living allowance (P<0.05, respectively) were significant sociodemographic variables of the self-rated health status. Alcohol consumption (P<0.01), aerobic physical activity, stress, quality of life, not feeling very well, depression and activity restriction (P<0.001, respectively) were also significant health-related variables of the self-rated health status. Blood glucose, anemia (P<0.05, respectively), and chewing problems (P<0.001) were significant chronic disease-related variables of the self-rated health status. Adequate intakes of protein, dietary fiber, phosphorus, thiamin, niacin, vitamin C (P<0.001, respectively), calcium, sodium, potassium (P<0.01, respectively), iron, vitamin A, and riboflavin (P<0.05, respectively) were also significant variables of the self-rated health status. In complex samples multiple logistic regression analysis, the self-rated health status was influenced significantly by the aerobic physical activity (P<0.01), stress level (P<0.05), depression (P<0.001), quality of life (P<0.001), not feeling very well (P<0.001), activity restriction (P<0.001), chewing problem (P<0.05), and adequate intake of iron (P<0.05). These results suggest that activity restriction, mental health, adequate iron intake, and physical activity may be associated with the self-rated health status in the elderly.

Non-isothermal TGA Analysis on Thermal Degradation Kinetics of Modified-NR Rubber Composites (비등온 TGA에 의한 개질NR고무복합재료지 열분해 Kinetics에 관한 해석)

  • Oh, Jeong-Seok;Lee, Joon-Mann;Ahn, Won-Sool
    • Polymer(Korea)
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    • v.33 no.5
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    • pp.435-440
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    • 2009
  • Thermal degradation behavior of CR (chloroprene) -modified NR (natural rubber) compounds, having different sulfur/accelerator compositions, was studied by non-isothermal TGA method. Data were analyzed using both Kissinger and Flynn-Wall-Ozawa analysis to assess the activation energies. Activation energy obtained from Kissinger analysis was $147.0{\pm}2.0$ kJ/mol for all samples, showing little effect of sulfur/accelerator composition changes in the samples. On the other hand, activation energy from Flynn-Wall-Ozawa analysis exhibited much variations with conversion, showing average value of $211.6{\pm}19.0$ kJ/mol. From the results, it was considered that whole thermal degradation processes of the samples were composed of complex multiple step processes, of which reaction mechanisms were different from each other.

Trace Analysis as TBDMS Derivatives of Organic Acids in Aqueous Samples (TBDMS 유도체로서 수용액 시료중의 유기산 미량분석 연구)

  • Kim, Gyeong Rye;Kim, Jeong Han;Park, Hyeong Guk
    • Journal of the Korean Chemical Society
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    • v.34 no.4
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    • pp.352-359
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    • 1990
  • An effecient gas chromatographic method is described to be used routinely for the rapid profiling and identification of biochemically important organic acids. It involves the solid-phase extraction of organic acids from aqueous samples using Chromosorb P as the solid sorbent and diethyl ether as the eluting solvent, with subsequent triethylamine treatment. The resulting triethylammonium salts of acids were directly converted to volatile tert-butyldimethylsiyl derivatives, which were simultaneously analyzed by two capillary columns of different polarity, DB-5 and DB-1701, under the identical temperature programming condition. The retention index (RI) and area ratio (AR) values of each peak measured on DB-5 and DB-1701 enabled rapid identification of acids by computer RI library search and AR comparison. The application of the present method to the organic acid profiling of various complex samples is demonstrated.

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Specific Detection of DNA Using Quantum Dots and Magnetic Beads for Large Volume Samples

  • Kim, Yeon-Seok;Kim, Byoung-Chan;Lee, Jin-Hyung;Kim, Jung-Bae;Gu, Man-Bock
    • Biotechnology and Bioprocess Engineering:BBE
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    • v.11 no.5
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    • pp.449-454
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    • 2006
  • Here we present a sensitive DNA detection protocol using quantum dots (QDs) and magnetic beads (MBs) for large volume samples. In this study, QDs, conjugated with streptavidin, were used to produce fluorescent signals while magnetic beads (MBs) were used to isolate and concentrate the signals. The presence of target DNAs leads to the sandwich hybridization between the functionalized QDs, the target DNAs and the MBs. In fact, the QDs-MBs complex, which is bound using the target DNA, can be isolated and then concentrated. The binding of the QDs to the surface of the MBs was confirmed by confocal microscopy and Cd elemental analysis. It was found that the fluorescent intensity was proportional to concentration of the target DNA, while the presence of non-complementary DNA produced no significant fluorescent signal. In addition, the presence of low copies of target DNAs such as 0.5 pM in large volume samples up to 40mL was successfully detected by using a magnet-assisted concentration protocol which consequently results in the enhancement of the sensitivity more than 100-fold.

Analysis of ultra-low radionuclide concentrations in water samples with baromembrane method

  • Vasyanovich, Maxim;Ekidin, Aleksey;Trapeznikov, Alexander;Plataev, Anatoly
    • Nuclear Engineering and Technology
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    • v.53 no.1
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    • pp.253-257
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    • 2021
  • This work demonstrates the use of baromembrane method based on reverse osmosis (RO) process. The method is realized on mobile complex, which allows to concentrate and determine ultra-low activity of radionuclides in water cooling ponds of Russian nuclear fuel cycle enterprises. The existence level of radionuclide background creates difficult conditions for identification the contribution of liquid discharges enterprise, as standard monitoring methods have a very high detection level for radionuclides. Traditional methods for determining the background radionuclides concentrations require the selection of at least 500 liters (l) of water, followed by their evaporation to form a dry residue. This procedure with RO membranes requires at least 5 days. It is possible to reduce the time and energy spent on evaporation of hundreds of water liters by pre-concentrating radionuclides in a smaller sample volume with baromembrane method. This approach allows preliminary concentration of water samples from 500 l volume till 20 l volume during several hours. This approach is universal for the concentration of dissolved salts of any heavy metals, other organic compounds and allows the preparation of water countable samples in much shorter time compared to the traditional evaporation method.

Applying 3D U-statistic method for modeling the iron mineralization in Baghak mine, central section of Sangan iron mines

  • Ghannadpour, Seyyed Saeed;Hezarkhani, Ardeshir;Golmohammadi, Abbas
    • Geosystem Engineering
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    • v.21 no.5
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    • pp.262-272
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    • 2018
  • The U-statistic method is one of the most important structural methods to separate the anomaly from background. It considers the location of samples and carries out the statistical analysis of the data without judging from a geochemical point of view and tries to separate subpopulations and determine anomalous areas. In the present study, 3D U-statistic method has been applied for the first time through the three-dimensional (3D) modeling of an ore deposit. In order to achieve this purpose, 3D U-statistic is applied on the data (Fe grade) resulted from the drilling network in Baghak mine, central part of the Sangan iron mines (in Khorassan Razavi Province, Iran). Afterward, results from applying 3D U-statistic method are used for 3D modeling of the iron mineralization. Results show that the anomalous values are well separated from background so that the determined samples as anomalous are not dispersed and according to their positioning, denser areas of anomalous samples could be considered as anomaly areas. And also, final results (3D model of iron mineralization) show that output model using this method is compatible with designed model for mining operation. Moreover, seen that U-statistic method in addition for separating anomaly from background, could be very efficient for the 3D modeling of different ore type.