• Title/Summary/Keyword: Drug Processing

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Current State and Applications of the Electronic Clinical Trial Process in Korea (국내 임상시험 전자화 현황과 적용방안)

  • Wang, Boram;Choi, Inyoung
    • The Journal of the Korea Contents Association
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    • v.13 no.4
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    • pp.281-289
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    • 2013
  • As the number of clinical trials conducted in Korea increases, the need of the Electronic Data Capture (EDC) system for effective clinical data management is also increased. Recently, the Korea Food and Drug Association published 'Guideline for the Electronic Clinical Trial Data Management and Processing' and it would be the foundation for establishing regulation of electronic clinical data management. In this research, we conducted the survey regarding adoption rate of EDC system in clinical trials in hospitals, Contract Research Organizations (CRO), and pharmaceutical companies. And the perceived importance and the ease of application for the Guideline were investigated. The adoption rates of EDC system was 77.6% but it mostly applied to less than five trials. Also EDC system was mostly used in phase I and phase II trials and the utilization rate of CRO was the highest. The perceived importance for the Guideline was high among all three organizations but, in case of the perceived ease of its application, CRO was the highest. Also, the perceived importance of the clinical data standard was high and the standard for data collection was mostly required. However, the comprehension for the global standard of the electronic data was relatively low, so that education is required. This result would be the foundation to increase the electronic clinical trials and develop proper regulation and principles for clinical data standards in Korea.

Studies on Substitution Effect of Chitosan against Sodium Nitrite in Pork Sausage (돈육 소시지에 첨가한 키토산의 아질산염 대체 효과에 관한 연구)

  • Youn, Sun-Kyoung;Park, Sun-Mee;Kim, Yeoun-Ju;Ahn, Dong-Hyun
    • Korean Journal of Food Science and Technology
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    • v.33 no.5
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    • pp.551-559
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    • 2001
  • Sodium nitrite which is added in processing of meat process product to develope color and to keep bacteria from growing, produces toxic substance after reacting, bring about deterioration by oxidation and toxic substance. So natural material is needed to substitute this sodium nitrite for. Chitosan which is made of chitin by processing of deacetylase, has various function of antibiosis and antimutation. We studied about the substitution effect of chitosan against sodium nitrite in pork sausage. As a result, of storing the sausage, antimicrobial effect of sodium nitrite was detected by 0.35% of chitosan(M.W. 30 kDa). This chitosan had same color developing effect even though addition content of sodium nitrite reduced until 15 ppm which is less than 1/10 of standard level. And chitosan decreased fast a residual nitrite. This result shows that chitosan inhibited a formation of nitrosamine.

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Anti-inflammation and hangover relief effects of Schisandra chinensis (SC) and Lycium chinense (LC) water extracts depending on drug processing and fermentation (포제 및 발효 가공에 따른 오미자와 구기자 물 추출물의 항염증 및 숙취해소 효과)

  • Kim, Ha-Rim;Kim, Sang-Jun;Kim, Sol;Kim, HongJun;Jeong, Seung-Il;Yu, Kang-Yeol;Kim, Seon-Young
    • Herbal Formula Science
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    • v.26 no.4
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    • pp.295-306
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    • 2018
  • Schisandra chinensis (SC) and Lycium chinense (LC) were widely distributed in Asia and the fruit has been used traditionally for medicinal herbs. The processing method was solid-state fermentation using Aspergillus oryzae for 48 h after stir-frying treatment at $220^{\circ}C$ for 12 min. In this study, in vitro the anti-inflammatory effect and in vivo hangover reduction were compared to unprocessed SC and LC water extract. Anti-inflammatory effects have been evaluated in pro-inflammatory mediators which were secreted by lipopolysaccharide (LPS)-induced RAW 264.7 macrophages. Nitric oxide (NO) was determined using Griess reaction. Proinflammatory cytokines such as tumor necrosis factor $(TNF)-{\alpha}$ and interleukin $(IL)-1{\beta}$ were measured by enzyme-linked immunosorbent assays (ELISA). Alcohol dehydrogenase (ADH) and acetaldehyde dehydrogenase (ALDH) activities were compared to processed SC or LC and mixtures thereof (1:1). In vivo study was compared to hangover relief in alcohol-fed mice. After administering a mixture of SC and LC (300 mg/kg) water extract (1:1), mice were fed 3 g/kg of ethanol. Serum was collected at 1, 3, and 5 h intervals to analyze ethanol and acetaldehyde levels using a colorimetric assay kit. The processed SC and LC water extracts compared to raw materials significantly inhibited LPS-induced NO and inflammatory cytokine production in RAW 264.7 cells. The results of the hangover mouse model are also consistent with anti-inflammatory effects. These results suggest that processed SC and LC extracts may be functional materials for the treatment of inflammation and hangover.

Effectiveness Evaluation of Displacement Accommodatable Pressure Measuring Jig for Quality Assessment of Pressure Application Device (압력 인가 장치의 품질관리를 위한 변위 수용이 가능한 압력 측정용 지그의 유효성 평가)

  • Mun, Chang-Su;Jun, Sung-Chul;Noh, Si-Cheol
    • Journal of the Institute of Convergence Signal Processing
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    • v.21 no.2
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    • pp.61-66
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    • 2020
  • Recently, a variety of electric anesthetics devices have been developed and used in clinical practice to reduce the fatigue of the operator during local anesthesia for dental procedures and to compensate for the disadvantages of manual anesthesia device. In this electric anesthesia injection device, the accurate and constant delivery of pressure for drug infusion is a very important performance factor. In order to evaluate the accuracy of the transfer pressure, a small pressure gauge using a load cell is often used, but since the elastic body inside the load cell may not be able to accommodate a sufficient displacement, an error may occur when evaluating pressure performance. For these reasons, in this study, we proposed and evaluated a silicon-chrome steel (Si-Cr steel) spring jig that can accommodate relatively large displacements that can be used when evaluating the performance of a pressure-controlled pressure application device using a load cell type pressure gauge. As a result of the pressure transmissibility test and repeated measurement results using a commercial dental anesthesia injection device, a more stable result was obtained when using a spring jig, and it was confirmed that the frequency of abnormally high measurement was reduced.

Study on the Korean wild ginseng(SANSAM) in cosmetics

  • Lee, C. W.;Lee, K. W.;K. K. Bae;Kim, C. H.
    • Proceedings of the SCSK Conference
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    • 2003.09b
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    • pp.26-31
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    • 2003
  • Korean Ginseng is a medicinal herb which grows naturally in korea. an ancient country situated in north-eastern Asia. Its medical use was already well known to herb doctors in this region about five thousand years ago since the effectiveness of korean ginseng has been recognized through practical use for a long time. Korean Ginseng has always been regarded as a devine cure. The name "Ginseng" can be found in various medicinal books. many of which were written as early as B.C. 100. In the records of many chinese medical books. dating from the inception of publishing, it was noted that Korean Ginseng was of the highest level of quality. Korean Ginseng originally grew in the mountains of korea. However, this wild Korean Ginseng(js called SANSAM) could not meet the ever-increasing demands. and from the 16th century. it has been cultivated on farms for mass processing and supplying in korea(js called INSAM). It was already recognized in korea a long time ago(B.C. 57 - A.D. 668) that Korean Ginseng possessed the qualities of panacea, tonic and rejuvenator, and had other medicinal properties as well. The effectiveness of Korean Ginseng is widely recognized among south-eastern Asians as well as Chinese. As its effect has been proved scientifically. Korean Ginseng is now becoming the ginseng for all human beings in the world. Korean ginseng is differently called according to processing method. Dried thing is Insam(white ginseng), boiled or steamed is Hongsam(red ginseng). 장뇌삼(long headed ginseng) is artificially grown in the mountain no in field for a long time. So the body is thin and some long. but ingredients are concentrated. Korean wild ginseng(SANSAM) is rare in these days but we developed cosmetic ingredient. The scientific name of Korean Ginseng is Panax Ginseng. It has acknowledge as a natural mysterious cure among the notheastern peoples. because of its broad medicinal application. The origin of the word" Panax" derived from panacea. a Greek word meaning cure-all. According to the classification method of herb medicines in the Chinese medicinal book. "God-Farmer Materia Medica(A.D. 483-496) korean Ginseng was described as the superlative drug: panacea. tonic and rejuvenator. We studied skin immunological effect. collagen synthesis. cell growth and whitening effect of SANSAM extract. IN cosmetics.. SANSAM extract had skin fibroblast cell growth effect. recover damaged skin in the sun and protect fine wrinkle. Also. In hair product.. inhibits hairless, white hair.its hairless, white hair.

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Current Status and Trends of the Ginseng Industry and Research in North Korea (북한의 인삼 산업 현황과 연구 동향)

  • Seungjae Joo
    • Journal of Ginseng Culture
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    • v.6
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    • pp.80-104
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    • 2024
  • Ginseng, a representative medicinal plant of South Korea, is also highly valued in North Korea. However, due to limited access to information about North Korea, the actual cultivation, research and development trends, and related industry status of ginseng in North Korea are not well known. In this study, we aimed to understand the current status and research trends of the ginseng industry in North Korea based on limited available literature. In the North Korean pharmacopoeia, ginseng is referred to as "Koryo ginseng" and is defined as the roots of 6-year-old ginseng cultivated in the Kaesong region. The pharmacopoeia includes 22 types of ginseng preparations. In addition, 10 ginseng preparations are included in North Korea's Essential Drug List, and various health supplements, cosmetics, and toothpastes containing ginseng have been developed, distributed, and sold. Since 2014, the ginseng industry and research in North Korea have become more active overall. During this period, the ginseng cultivation area in Kaesong has been significantly expanded, and the facilities have been renovated. The Kaesong Koryo Ginseng Processing Plant has been equipped with sterilized, modernized facilities since 2016 and has been in operation. Since 2017, there has been a growing interest in quality control research, leading to the introduction of quality management regulations and certification systems in 2019. In the 1990s, there was significant research on ginseng product development, and since the 2000s, studies on the pharmacological effects and clinical research of ginseng have been reported. Additionally, research on ginseng cultivation and ginseng processing industries to increase yield has been emphasized. Ginseng, as a representative medicinal crop of Korea, holds great importance for both South and North Korea. Given its significance and the potential for synergy through mutual cooperation, ginseng serves as an ideal subject for inter-Korean exchange and collaboration.

Legal Issues on the Collection and Utilization of Infectious Disease Data in the Infectious Disease Crisis (감염병 위기 상황에서 감염병 데이터의 수집 및 활용에 관한 법적 쟁점 -미국 감염병 데이터 수집 및 활용 절차를 참조 사례로 하여-)

  • Kim, Jae Sun
    • The Korean Society of Law and Medicine
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    • v.23 no.4
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    • pp.29-74
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    • 2022
  • As social disasters occur under the Disaster Management Act, which can damage the people's "life, body, and property" due to the rapid spread and spread of unexpected COVID-19 infectious diseases in 2020, information collected through inspection and reporting of infectious disease pathogens (Article 11), epidemiological investigation (Article 18), epidemiological investigation for vaccination (Article 29), artificial technology, and prevention policy Decision), (3) It was used as an important basis for decision-making in the context of an infectious disease crisis, such as promoting vaccination and understanding the current status of damage. In addition, medical policy decisions using infectious disease data contribute to quarantine policy decisions, information provision, drug development, and research technology development, and interest in the legal scope and limitations of using infectious disease data has increased worldwide. The use of infectious disease data can be classified for the purpose of spreading and blocking infectious diseases, prevention, management, and treatment of infectious diseases, and the use of information will be more widely made in the context of an infectious disease crisis. In particular, as the serious stage of the Disaster Management Act continues, the processing of personal identification information and sensitive information becomes an important issue. Information on "medical records, vaccination drugs, vaccination, underlying diseases, health rankings, long-term care recognition grades, pregnancy, etc." needs to be interpreted. In the case of "prevention, management, and treatment of infectious diseases", it is difficult to clearly define the concept of medical practicesThe types of actions are judged based on "legislative purposes, academic principles, expertise, and social norms," but the balance of legal interests should be based on the need for data use in quarantine policies and urgent judgment in public health crises. Specifically, the speed and degree of transmission of infectious diseases in a crisis, whether the purpose can be achieved without processing sensitive information, whether it unfairly violates the interests of third parties or information subjects, and the effectiveness of introducing quarantine policies through processing sensitive information can be used as major evaluation factors. On the other hand, the collection, provision, and use of infectious disease data for research purposes will be used through pseudonym processing under the Personal Information Protection Act, consent under the Bioethics Act and deliberation by the Institutional Bioethics Committee, and data provision deliberation committee. Therefore, the use of research purposes is recognized as long as procedural validity is secured as it is reviewed by the pseudonym processing and data review committee, the consent of the information subject, and the institutional bioethics review committee. However, the burden on research managers should be reduced by clarifying the pseudonymization or anonymization procedures, the introduction or consent procedures of the comprehensive consent system and the opt-out system should be clearly prepared, and the procedure for re-identifying or securing security that may arise from technological development should be clearly defined.

Establishment of Sample Preparation Method to Enhance Recovery of Food-borne Pathogens from Produce (농산물 중 식중독세균 검출을 위한 전처리법 확립)

  • Kim, Se-Ri;Choi, Song-Yi;Seo, Min-Kyoung;Lee, Ji-Young;Kim, Won-Il;Yoon, Yohan;Ryu, Kyoung Yul;Yun, Jong-Cul;Kim, Byung-Seok
    • Journal of Food Hygiene and Safety
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    • v.28 no.3
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    • pp.279-285
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    • 2013
  • To establish sample preparation method for detection of food-borne pathogens from lettuce, perilla leaves, cucumber, pepper, and cherry tomato, the influences of diluent composition, processing time, and proportion of diluent to sample were examined. Each produce was inoculated with 6.0 log $CFU/cm^2$ of Escherichia coli O157:H7, Salmonella Typhimurium, Listeria monocytogenes, Staphylococcus aureus, and Bacillus cereus. Each produce was treated with 0.1% peptone water, and D/E neutralizing broth. Processing time of produce was 30, 60, 90, and 120s, and the proportion of diluent to sample was 2 : 1, 4 : 1, 9 : 1, and 19 : 1. The number of bacteria after treatment of D/E neutralizing broth was higher than that of 0.1% peptone water (P<0.05). In cherry tomato, the population of S. typhimurium recovered from treated with D/E broth was higher than that recovered from treated with 0.1% peptone water by 1.05 log $CFU/cm^2$ (P<0.05). No difference in numbers of pathogens was observed in processing time. Optimum proportion of diluent to perilla leaf, iceberg lettuce, cucumber, green pepper, and tomato was 9 : 1, 4 : 1, 2 : 1, 2 : 1, and 2 : 1, respectively. These data suggest that D/E neutralizing broth should be recommend as diluent, and the diluent volume applied to produce should be determined in proportion to produce surface area per weight (g).

Changes of the Substances during Composting of Seafood Processing Wastewater Sludge (수산가공폐수슬러지의 퇴비화과정중 물질변화)

  • Lee, Hong-Jae;Back, Song-Bum;Kim, Woo-Seong;Park, Hyun-Geoun;Heo, Jong-Soo
    • Journal of the Korea Organic Resources Recycling Association
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    • v.9 no.3
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    • pp.55-69
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    • 2001
  • To study the possibility of agricultural utilization of seafood processing wastewater sludges, the changes of temperature and humus, the form of organic matter and nitrogen and the germination ratio of plant during the composting were investigated. The results were summarized as follows. Temperature was rapidly increased at early stage of composting, reached to $67{\sim}76^{\circ}C$ in highest temperature at 3~5 days, and then decreased gradually fallen to $40{\sim}50^{\circ}C$ at 19 days after composting, at the point was upset firstly. The third upset was conducted at 60days after composting, and then the temperature was little changed. The contents of total organic matters in the compost for composting were down 4.5~8.0%. Ether extractable materials, resins and hemicellulose contents of the organic matters for composting were decreased with 35~77%, 32~69% and 19~30%, respectively. And cellulose, lignins and unknown materials contents in the organic matters for composting were increased a little, but water soluble polysaccharides of organic matters were little changed. Total nitrogen, amino sugar and amino acid nitrogen contents in the compost for composting were decreased with 20~42%, 11~49% and 23~65%, respectively. The contents of humic acid in the compost for composting were little changed, but contents of fulvic acid in the compost for composting were decreased gradually. Germination ratio of radish, chinese cabbage and cucumber were over 90%, when the compost produced at 30 days after composting was tested on plant germination.

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A Double-Blind Comparison of Paroxetine and Amitriptyline in the Treatment of Depression Accompanied by Alcoholism : Behavioral Side Effects during the First 2 Weeks of Treatment (주정중독에 동반된 우울증의 치료에서 Paroxetine과 Amitriptyline의 이중맹 비교 : 치료초기 2주 동안의 행동학적 부작용)

  • Yoon, Jin-Sang;Yoon, Bo-Hyun;Choi, Tae-Seok;Kim, Yong-Bum;Lee, Hyung-Yung
    • Korean Journal of Biological Psychiatry
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    • v.3 no.2
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    • pp.277-287
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    • 1996
  • Objective : It has been proposed that cognition and related aspects of mental functioning are decreased in depression as well as in alcoholism. The objective of the study was to compare behavioral side effects of paroxetine and amitriptyline in depressed patients accompanied by alcoholism. The focused comparisons were drug effects concerning psychomotor performance, cognitive function, sleep and daytime sleepiness during the first 2 weeks of treatment. Methods : After an alcohol detoxification period(3 weeks) and a washout period(1 week), a total of 20 male inpatients with alcohol use disorder (DSM-IV), who also had a major depressive episode(DSM-IV), were treated double-blind with paroxetine 20mg/day(n=10) or amitriptyline 25mg/day(n=10) for 2 weeks. All patients were required to have a scare of at least 18 respectively on bath the Hamilton Rating Scale far Depression(HAM-D) and Beck Depression Inventory(BDI) at pre-drug baseline. Patients randomized to paroxetine received active medication in the morning and placebo in the evening whereas those randomized to amitriptyline received active medication in the evening and placebo in the morning. All patients performed the various tasks in a test battery at baseline and at days 3, 7 and 14. The test battery included : critical flicker fusion threshold for sensory information processing capacity : choice reaction time for gross psychomotor performance : tracking accuracy and latency of response to peripheral stimulus as a measure of line sensorimotor co-ordination and divided attention : digit symbol substitution as a measure of sustained attention and concentration. To rate perceived sleep and daytime sleepiness, 10cm line Visual analogue scales were employed at baseline and at days 3, 7 and 14. The subjective rating scales were adapted far this study from Leeds sleep Evaluation Questionnaire and Epworth Sleepiness Scale. In addition a comprehensive side effect assessment, using the UKU side effect rating scale, was carried out at baseline and at days 7 and 14. The efficacy of treatment was evaluated using HAM-D, BDI and clinical global impression far severity and improvement at days 7 and 14. Results : The pattern of results indicated thai paroxetine improved performance an mast of the lest variables and also improved sleep with no effect on daytime sleepiness aver the study period. In contrast, amitriptyline produced disruption of performance on same tests and improved sleep with increased daytime sleepiness in particular at day 3. On the UKU side effect rating scale, mare side effects were registered an amitriptyline. The therapeutic efficacy was observed in favor of paroxetine early in day 7. Conclusion : These results demonstrated thai paroxetine in much better than amitriptyline for the treatment of depressed patients accompained by alcoholism at least in terms of behavioral safety and tolerability, furthermore the results may assist in explaining the therapeutic outcome of paroxetine. For example, and earlier onset of antidepressant action of paroxetine may be caused by early improved cognitive function or by contributing to good compliance with treatment.

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