• Title/Summary/Keyword: 바이오 의약품

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The Recent Trend of the National and International Standard of Manufacturing Quality Control for Diagnostic X-ray Equipment (진단용엑스선장치 제조품질관리에 관한 국내.외 규격의 동향)

  • Choi, In-Seok;Kim, Jung-Min;Jeong, Hoi-Woun;Min, Jung-Whan;Lee, In-Su
    • Journal of radiological science and technology
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    • v.32 no.1
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    • pp.1-15
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    • 2009
  • Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

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Status and Prospect of Lactic Acid Bacteria with Antibiotic Resistance (항생제 내성을 가진 유산균의 현황과 전망)

  • Chon, Jung-Whan;Seo, Kun-Ho;Bae, Dongryeoul;Jeong, Dongkwan;Song, Kwang-Young
    • Journal of Dairy Science and Biotechnology
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    • v.38 no.2
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    • pp.70-88
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    • 2020
  • Lactic acid bacteria (LAB) form an essential part of the intestinal microbiota of the human body and possess the ability to stabilize the intestinal microbiota, strengthen immunity, and promote digestion as well as intestinal synthesis of vitamins, amino acids, and proteins. Hence, LAB are currently widely used in various products. However, due to the indiscriminate overuse of antibiotics in humans and livestock, bacterial resistance to antibiotics has been increasing rapidly, which has led to serious problems in the treatment of bacterial infections. Additionally, several reports have revealed that antibiotic-resistant LAB may infect people whose immune systems are not fully developed or whose immune systems are temporarily weakened. Therefore, it is imperative to consider the possibility of antibiotic-resistant LAB causing diseases in humans and animals, investigate the mechanism of action between antibiotics and LAB, and determine the relevant regulations for the safe use of LAB.

Legal Issues on Pharmacopunture (약침의 한방의료행위성에 대한 검토)

  • Jung, Kyu Won
    • The Korean Society of Law and Medicine
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    • v.19 no.1
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    • pp.3-20
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    • 2018
  • Pharmacopunture is a new combined method of acupunture and oriental drugs. Recently, this method is widely used to treat traffic accident patients in oriental medicine. However, there is no evidences of treatment, no information of effects and side-effects of this method, and no information of drugs used. In South Korea, western medicine and oriental medicine are regulated differently. When a new technology is invented in the area of western medicine, that method should pass several stages of clinical trials. After that processes, that method can be done as a medical practice. However, in the area of oriental medicine, there is no process like that. According to in South Korea, medical practice without license are composed of two behaviors. First type is that medical practice is done by a person who has no medical license. Second type is that medical practice is done by a person who has a medical license but the area of the license is different. Because of this reason, the distinction between the western medical practices and the oriental medical practices is very important. Medical practices are protected by license mainly because they can harm human life or body. When we invented new medical practice and try to practice it to the patients, we should consider the risk of that method whether it is western medical practice or oriental medical practice. It is not clear that the pharmcopunture which has been done is satisfied the standard of medical treatment.

Confidence Bounds following Adaptive Group Sequential Tests with Repeated Measures in Clinical Trials (반복측정자료를 가지는 적응적 집단축차검정에서의 신뢰구간 추정)

  • Joa, Sook Jung;Lee, Jae Won
    • The Korean Journal of Applied Statistics
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    • v.26 no.4
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    • pp.581-594
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    • 2013
  • A group sequential design can end a clinical trial early if a confirmed efficacy or a futility of study medication is found during clinical trials. Adaptation can adjust the design of clinical trials based on accumulated data. The key to this methodology is considered to control the overall type 1 error rate while maintaining the integrity of clinical trials. The estimation would be more complex and the sample size calculation will be more difficult if the clinical trials have repeated measurement data. Lee et al. (2002) suggested a repeated observation case by using the independent increments properties of the interim test statistics and investigated the properties of the proposed confidence interval based on the stage-wise ordering. This study extend Lee et al. (2002) to adaptive group sequential design. We suggest test statistics for the adaptation as redesigning the second stage of clinical trials and induce the stage-wise confidence interval of parameter of interests. The simulation will help to confirm the suggested method.

Safety Evaluation of Korean Mistletoe Extract (한국산 겨우살이 추출물의 안전성 평가)

  • Kim, Inbo;Jeong, Ju-Seong;Yoon, Taek Joon;Kim, Jong Bae
    • The Korean Journal of Food And Nutrition
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    • v.26 no.3
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    • pp.383-390
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    • 2013
  • Mistlero C was shown to be non-genotoxic in a series of genotoxicity tests, including a bacterial reverse mutation test and a combined in vivo mammalian erythrocyte micronucleus test. In a bacterial reverse mutation assay, no significant increases in the number of revertant colonies, compared to the negative control, was detected in $5,000{\mu}g/plate$ of Mistlero C. In addition, with Mistlero C, no changes were shown in the number of micronucleated polychromatic erythrocytes (MNPCE) among 2,000 polychromatic erythrocytes compared to the negative control. Mistlero C was administered orally in rats to investigate acute toxicity. The $LD_{50}$ values in rats were above 2,000 mg/kg. In a repeated dose, 13-week, oral toxicity study conducted in rats, no compound-related adverse effects were shown at doses of Mistlero C of up to 1,000 mg/kg body weight/day. The results of these studies support the safe use of Mistlero C in food for human consumption.

Establishment of Elution and Concentration Procedure for Rapid and Sensitive Detection of Norovirus in Foods of Diverse Matrices (다양한 매트릭스가 혼합된 식품을 대상으로 노로바이러스 신속검출을 위한 탈리 및 농축방법 확립)

  • Ahn, Jaehyun;Kwon, Youngwoo;Lee, Jeong-Su;Choi, Weon Sang
    • Journal of Food Hygiene and Safety
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    • v.30 no.2
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    • pp.150-158
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    • 2015
  • This article reports the development of an effective test procedure for detection of norovirus (NoV) in foods of diverse matrices. In this study, target foods included fermented milk, soybean paste, powders made from uncooked grains and vegetables, sesame leaves preserved in soy sauce, pickled mooli, and mooli. Viral recovery varied depending on the food matrices or elution buffers tested. Buffers were compared to determine effective elution buffers from artificially virus-contaminated foods. The conventional test procedure for concentrating viruses from food (elution-polyethylene glycol(PEG) precipitation-chloroform-PEG precipitation) was modified to save time by eliminating one PEG precipitation step. The modified procedure (elution-chloroform-PEG precipitation) was able to concentrate viruses more effectively than the conventional procedure. It also removed RT-PCR inhibitors effectively. The modified procedure was applied to target food for genogroup II NoV detection. NoV RNA was detected at the initial inoculum levels 3.125-12.5 RT-PCR units per 10-25 g tested food. The use of this newly established procedure should facilitate detection of low levels of norovirus in diverse foods.

Anti-Inflammatory Activity of Austroinulin from Stevia rebaudiana in LPS-induced RAW264.7 Cells (스테비아로부터 분리한 Austroinulin의 RAW264.7 세포에 대한 항염증 효과)

  • Byun, Myung-Woo
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.41 no.4
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    • pp.456-461
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    • 2012
  • The leaves of $Stevia$ $rebaudiana$ are well-known in Japan, Korea, and China as a natural sweetener. Medicinal uses of this plant originated in Paraguay and Brazil in the form of aqueous decoctions of the leaves used as a contraceptive agent and for the treatment of hyperglycemia. In the present study, the antioxidant, anti-hypertension, and anti-inflammatory activities of $S.$ $rebaudiana$ extracts are investigated for their use in food. The biologically-active compound was isolated and purified from $S.$ $rebaudiana$. The isolated compound was identified as austroinulin ($C_{20}H_{34}O_3$; molecular weight 322) by mass, IR spectrophotometry, 1D, and 2D-NMR. Austroinulin was characterized as a diterpenoid possessing a 3-methylpenta-2,4-dienyl at C-9. When subjected to an inflammatory mediator inhibitory assay from lipopolysaccharide (LPS)-activated macrophages, the austroinulin inhibited the enhanced production of nitric oxide (NO) and inducible nitric oxide synthase (iNOS) expression (10 ${\mu}g$/mL=67.9 and 45.1%, respectively). This was significant and dose-dependent. The results suggest that austroinulin from $S.$ $rebaudiana$ inhibited the NO and iNOS in RAW 264.7 cells.

Optimization of Anion-exchange Chromatography for the Separation of Agarase from Culture Broth of Pseudoalteromonas sp. (Pseudoalteromonas sp. 배양액으로부터 아가레이즈 분리를 위한 음이온교환 크로마토그래피 최적화)

  • Kim, Yu-Na;Lee, Jae-Ran;Kim, Mu-Chan;Kim, Sung-Bae;Chang, Yong-Keun;Hong, Soon-Kwang;Kim, Chang-Joon
    • Korean Chemical Engineering Research
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    • v.49 no.6
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    • pp.840-845
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    • 2011
  • Degradation products of agarose are biologically active and thus used as an ingredient in pharmaceuticals or functional cosmetics. Furthermore, it has been strongly considered as a substrate for bio-ethanol fermentation. Recently, we isolated new agarase-producing microorganism, Pseudoalteromonas sp. from south sea of Korea. In this study, we aimed to separate and purify the agarase from culture broth of this strain. Separation of agarase was performed by ion- exchange chromatography on DEAE-Sepharose resin. Equilibrium pH and volume ratio of resin to the amount of protein were optimized for the efficient adsorption of protein. 410 ${\mu}g$ of protein was completely adsorbed to 3 mL of resin at pH 7.5. The total amount of eluted protein increased as NaCl concentration increased to 400 mM at isocratic elution. Agarase was separated by linear gradient elution of NaCl (0~1,000 mM). Three major protein peaks were observed and the presence or absence of agarase in these eluted proteins was measured by Lugol's staining technique. Only six eluted protein fractions showed strong agarase activity.

Extraction Equilibria of Succinic Acid by Using Aqueous Two Phases System Containing Imidazolium Ionic Liquids and Salts (이미다졸계 이온성액체와 염을 포함한 수상이성분계를 이용한 숙신산의 추출 평형)

  • Lee, Yong Hwa;Kang, Jeong Won;Hong, Yeon Ki;Kim, Ki-Sub
    • Clean Technology
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    • v.20 no.4
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    • pp.349-353
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    • 2014
  • Succinic acid is an important precursor in industries producing biopolymers, pharmaceutical and food additives and green solvents. However, due to the high price of petroleum and the global $CO_2$ emission, the biological production of succinic acid from renewable biomass is a novel process due to the fixation of $CO_2$ into succinate during fermentation. In this study, aqueous two phase systems based on imidazolium ionic liquids/$K_2HPO_4$ were used as an effective separation and concentration process for succinic acid. Experimental results show that aqueous two phase systems can be formed by adding appropriate amount of imidazolium ionic liquids to aqueous $K_2HPO_4$ solutions in the presence of succinic acid. It can be found that the ability of imidazolium ionic liquids for phase separation followed the order [HMIm][Br]${\fallingdotseq}$[OMIm][Br]>[BMIm][Br]>[EMIm][Br]. The maximum value of extraction efficiency for succinic acid was about 90% and the amount of coextracted water into top phase is proportional to the chain length of cation in imidazolium ionic liquids. It was concluded that the aqueous two phase systems composed of imidazolium ionic liquids/$K_2HPO_4$ was effective for the selective extraction and concentration of succinic acid.

Acceleration of DNCB-induced Early-apoptosis via Activation of Corticotropin Releasing Factor in the Hair Root of NC/Nga Mice (DNCB로 유도된 NC/Nga 아토피피부염마우스에서 부신피질자극호르몬방출인자 활성에 따른 모발세포의 초기세포사멸 연구)

  • Park, Gunhyuk;Jang, Eunyoung;Kim, Seongbae;Han, Eunyoung;Kim, Yong-ung
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.43 no.4
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    • pp.281-287
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    • 2017
  • Stress in skin plays a significant role in both the direct/indirect regulation of cellular processes occurring in hair, which in turn affect the hair cycle. However, experimental data regarding the effects of stress-related corticotropin releasing factor (CRF) released by stress on the apoptotic process involved in hair is limited. Therefore, we investigated the acceleration of early-stage apoptosis induced by atopy-related stress using a 2,4-dinitrochlorobenzene NC/Nga mice model. Expression of CRF, its related proteins, annexin V, and mitochondrial dysfunction were measured by immunohistochemical analyses. Atopic stress strongly stimulated stress hormones response, such as CRF and adrenocorticotropic hormone, in outer epithelial sheath of the hair. Moreover, its stress induced mitochondrial damage and early-stage apoptosis of cells in hair root. These findings suggest that hair damage due to apoptosis in atopy model is accelerated in a high CRF environment. Importantly, the effect of stress-related CRF on apoptosis processes involved in atopy dermatitis-related hair loss, suggests that the CRF-regulating development or maintenance materials may provide effective therapeutic strategies for hair health.