• 제목/요약/키워드: Medical products

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국내와 대만의 전통약제제 생산.허가.보험등재 관련 제도 (A Comparative Analysis of the Systems Related to the Production, Authorization, and Listing for Insurance of Herbal Medicine Products in South Korea and Taiwan)

  • 손지형;임사비나;이은경;김동수;김윤지;정홍강;김용호
    • 대한한의학회지
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    • 제33권3호
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    • pp.147-159
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    • 2012
  • Objectives: Systems related to the production, authorization, and listing for insurance of herbal medicine products were compared between South Korea and Taiwan to illuminate herbal medicine products system issues in South Korea. Methods: Papers, and laws and policies related to the production, authorization, and listing for insurance of herbal medicine products in South Korea and Taiwan are analyzed to create the primary documents. The documents from South Korea were screened with the advice of a specialist, while those from Taiwan have been verified through local investigation and with the help of a related specialist. The screened documents were then compared and analyzed in the order of the systems related to the production, authorization, and listing for insurance of herbal medicine products. Results: The systems related to the production of herbal medicine products satisfy GMP requirements in both countries, while Taiwan has more specialized systems related to the production of herbal medicine products and a more strict authorization program as compared to South Korea. While South Korea has most of the herbal medicine products classified as non-prescription drugs, Taiwan has them as prescription drugs. And while South Korea does not allow new herbal medicine products to be listed for insurance, Taiwan allows for once-a-year application toward listing for insurance. Conclusions: In order to ensure the safe and effective use of herbal medicine products, systems related to the production, authorization, and listing for insurance of herbal medicine products are to be established, while the categorization of medicine products principally used by Korean medicine doctors should be prepared. Furthermore, prescription by a Korean medicine doctor for new drugs made with natural products and their listing for insurance need to be encouraged.

약사법규 중의 기존한약서 활용에 대한 고찰 (Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act)

  • 엄석기
    • 대한한의학회지
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    • 제35권3호
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    • pp.135-154
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    • 2014
  • Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

Shisha Smoking and Associated Factors among Medical Students in Malaysia

  • Al-Naggar, Redhwan A.;Bobryshev, Yuri V.
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권11호
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    • pp.5627-5632
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    • 2012
  • Background: The aim of the study was to determine the prevalence of shisha smoking and associated factors among medical students in Malaysia. Materials and Methods: A cross-sectional study was conducted at the Management and Science University from December 2011 until March 2012. The questionnaire consisted of five sections including socio-demographic, social environment, knowledge about shisha, psychosocial factors, and personal shisha smoking behavior. Obtained data were analyzed using Statistical Package for the Social Sciences (SPSS 13). T-test was used to determine the relationships between shisha smoking and socio-demographic characteristic. Results: A total number of 300 medical students participated in this study. Mean age was $22.5{\pm}2.5$ years. The majority were female, Malay, single, from urban areas (67%, 54%, 97%, 73%; respectively). The prevalence of shisha smoking among medical students was found to be 20%. The study revealed that many students believed that shisha does not contains nicotine, carbon monoxide, does not lead to lung cancer, dental problems and does not lead to cardiovascular diseases (25%, 20.7%, 22.3%, 29%, 26.7%; respectively). Age and sex were found to be significantly associated with smoking shisha status among medical students (p=0.029, p<0.001; respectively). Furthermore, having parents, siblings and friends smokers of shisha were found to be significantly associated with shisha smoking status (p<0.001, p<0.001, p<0.001; respectively). Furthermore, family problems, problems with friends, financial problems and university life were found to significantly associated with shisha smoking status among medical students (p<0.001, p=0.002, p<0.001, p=0.002; respectively). Conclusions: There is a high prevalence of shisha smoking and a poor knowledge about its impact on health among medical students. More attention is needed to focus on medical education in this regard. The policies that are currently employed in order to reduce the cigarettes smoking should be applied to shisha smoking and shisha products.

Obestatin is present in saliva: alterations in obestatin and ghrelin levels of saliva and serum in ischemic heart disease

  • Ozbay, Yilmaz;Aydin, Suleyman;Dagli, A. Ferda;Akbulut, Mehmet;Dagli, Necati;Kilic, Nermin;Rahman, Ali;Sahin, Ibrahim;Polat, Veli;Ozercan, H. Ibrahim;Arslan, Nadi;Sensoy, Dogan
    • BMB Reports
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    • 제41권1호
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    • pp.55-61
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    • 2008
  • Ghrelin and obestatin are a single gene products and are a multiple functional peptides that regulates energy homeostasis, and food intake. In the present work, we studied the secretion of ghrelin and its co-secreted peptide obestatin in 44 patients with ischemic heart disease with that of 27 healthy matched controls. Here we first conducted using an immunohistochemistry assay to screen whether human salivary glands have any obestatin immunoreactivity. Then, serum and saliva obestatin and acylated ghrelin levels were determined by using Radioimmunoassay. Our immunohistochemical analysis demonstrated that obestatin was localized in the striated and excretory duct of human salivary gland. We also report for the first time that obestatin, like ghrelin, is present in human salivary gland and saliva. No evidence of the role of obestatin or ghrelin saliva levels in the context of ischemic heart disease was found. Salivary ghrelin and obestatin levels are correlated in controls with the blood levels. Determination of salivary values could represent a non-invasive alternative to serum ones that can be useful in clinical practice.

유럽의 새로운 의료기기 규제제도 MDR (New Medical Device Regulations (MDR) in Europe)

  • 정현우;염호준;박상수
    • 문화기술의 융합
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    • 제8권5호
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    • pp.29-37
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    • 2022
  • 2017년 새롭게 제정된 유럽의 새 의료기기 규제법인 MDR은 기존의 CE 적합성 인증을 받은 의료기기 제품들이 새로운 CE의 MDR규정에 맞춰 2024년 5월까지 인증을 받도록 요구하고 있다. 새로운 MDR 적합성 요구사항은 기존보다 강화된 의료기기 임상평가 및 임상 조사를 요구하며 또한 문서화된 시판후 임상 추적 자료의 제출을 요구한다. 한국의 의료기기 업체들도 새로운 MDR 요구사항을 맞춰 적합인정을 받아야 하나, 새로우 규정을 정확히 이해하지 못하여 산업계의 혼란은 계속 되고 있다. 본 연구에서는 한국과 미국의 의료기기 관련 규정을 알아보고, 또한유럽의 의료기기법인 MDR을 기존의 유럽 의료기기 지침인 MDD와 비교함으로써 유럽 의료기기법의 요구 사항들을 이해하는데 도움이 되고자 한다.

In situ ruminal degradation characteristics of dry matter and crude protein from dried corn, high-protein corn, and wheat distillers grains

  • Lee, Y.H.;Ahmadi, F.;Choi, D.Y.;Kwak, W.S.
    • Journal of Animal Science and Technology
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    • 제58권9호
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    • pp.33.1-33.7
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    • 2016
  • Background: The continuing growth of the ethanol industry has generated large amounts of various distillers grains co-products. These are characterized by a wide variation in chemical composition and ruminal degradability. Therefore, their precise formulation in the ruminant diet requires the systematic evaluation of their degradation profiles in the rumen. Methods: Three distillers grains plus soluble co-products (DDGS) namely, corn DDGS, high-protein corn DDGS (HP-DDGS), and wheat DDGS, were subjected to an in situ trial to determine the degradation kinetics of the dry matter (DM) and crude protein (CP). Soybean meal (SBM), a feed with highly degradable protein in the rumen, was included as the fourth feed. The four feeds were incubated in duplicate at each time point in the rumen of three ruminally cannulated Hanwoo cattle for 1, 2, 4, 6, 8, 12, 24, and 48 h. Results: Wheat DDGS had the highest filterable and soluble A fraction of its DM (37.2 %), but the lowest degradable B (49.5 %; P < 0.001) and an undegradable C fraction (13.3 %; P < 0.001). The filterable and soluble A fraction of CP was greatest with wheat DDGS, intermediate with corn DDGS, and lowest with HP-DDGS and SBM; however, the undegradable C fraction of CP was the greatest with HP-DDGS (41.2 %), intermediate with corn DDGS (2.7 %), and lowest with wheat DDGS and SMB (average 4.3 %). The degradation rate of degradable B fraction ($%\;h^{-1}$) was ranked from highest to lowest as follows for 1) DM: SBM (13.3), wheat DDGS (9.1), and corn DDGS and HP-DDGS (average 5.2); 2) CP: SBM (17.6), wheat DDGS (11.6), and corn DDGS and HP-DDGS (average 4.4). The in situ effective degradability of CP, assuming a passage rate of $0.06h^{-1}$, was the highest (P < 0.001) for SBM (73.9 %) and wheat DDGS (71.2 %), intermediate for corn DDGS (42.5 %), and the lowest for HP-DDGS (28.6 %), which suggests that corn DDGS and HP-DDGS are a good source of undegraded intake protein for ruminants. Conclusions: This study provided a comparative estimate of ruminal DM and CP degradation characteristics for three DDGS co-products and SBM, which might be useful for their inclusion in the diet according to the ruminally undegraded to degraded intake protein ratio.

아토피성 피부로 건조함을 가진 대상자에 대한 왕지네로부터 분리한 펩타이드 Scolopendrasin-I 함유 기능성 화장품의 기능성 및 안전성을 평가하기 위한 임상적 연구 (A Clinical Study for the Efficacy and Safety of Functional Cosmetics Containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans in Patients with Dry Skin due to Mild Atopic Dermatitis)

  • 박혜수;김태준;박신용;김희택
    • 한방안이비인후피부과학회지
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    • 제32권3호
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    • pp.23-36
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    • 2019
  • Objectives : The purpose of this study is to confirm the efficacy and safety of "Functional cosmetics containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans" on dry skin due to mild atopic dermatitis. Methods : A total of 24 patients who visited Semyung Oriental Medical Center from November 1st, 2018 to December 20th, 2018 were included in the study. In this study, the patients were treated with Functional cosmetics containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans. For 4 weeks of gross examination, instrumental assessment were made before and after the study to evaluate how well the products for treatment group in recovering the dry skin barriers by mild atopic dermatitis. Results : 1. In the primary endpoint, Skin Hydration showed a statistically significant increase in treatment group in baseline, 2 weeks and 4 weeks. 2. In the primary endpoint, Transepidermal Water Loss(TEWL) showed a statistically significant decrease in treatment group between Baseline and 4 weeks. 3. In the secondary endpoint, Skin pH showed a statistically significant decrease in treatment group between baseline and 4 weeks. 4. To evaluate the safety of the products for the human body, Adverse events, SCORAD Index Assessment were conducted; There were no severe adverse events during this study. And SCORAD Index showed a statistically significant decrease in treatment group in baseline, 2 weeks and 4 weeks. Therefore, it is suggested that products, if used for certain period, should be safe for the human body. Conclusions : According to the above experiments, it is suggested that "Functional cosmetics containing peptide Scolopendrasin-I isolated from the Scolopendra subspinipes mutilans" should be effective for dry skin due to mild atopic dermatitis.

Microbial Subversion of Heparan Sulfate Proteoglycans

  • Chen, Ye;Gotte, Martin;Liu, Jian;Park, Pyong Woo
    • Molecules and Cells
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    • 제26권5호
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    • pp.415-426
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    • 2008
  • The interactions between the host and microbial pathogen largely dictate the onset, progression, and outcome of infectious diseases. Pathogens subvert host components to promote their pathogenesis and, among these, cell surface heparan sulfate proteoglycans are exploited by many pathogens for their initial attachment and subsequent cellular entry. The ability to interact with heparan sulfate proteoglycans is widespread among viruses, bacteria, and parasites. Certain pathogens also use heparan sulfate proteoglycans to evade host defense mechanisms. These findings suggest that heparan sulfate proteoglycans are critical in microbial pathogenesis, and that heparan sulfate proteoglycan-pathogen interactions are potential targets for novel prophylactic and therapeutic approaches.

Regulation of amyloid precursor protein processing by its KFERQ motif

  • Park, Ji-Seon;Kim, Dong-Hou;Yoon, Seung-Yong
    • BMB Reports
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    • 제49권6호
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    • pp.337-343
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    • 2016
  • Understanding of trafficking, processing, and degradation mechanisms of amyloid precursor protein (APP) is important because APP can be processed to produce β-amyloid (Aβ), a key pathogenic molecule in Alzheimer's disease (AD). Here, we found that APP contains KFERQ motif at its C-terminus, a consensus sequence for chaperone-mediated autophagy (CMA) or microautophagy which are another types of autophagy for degradation of pathogenic molecules in neurodegenerative diseases. Deletion of KFERQ in APP increased C-terminal fragments (CTFs) and secreted N-terminal fragments of APP and kept it away from lysosomes. KFERQ deletion did not abolish the interaction of APP or its cleaved products with heat shock cognate protein 70 (Hsc70), a protein necessary for CMA or microautophagy. These findings suggest that KFERQ motif is important for normal processing and degradation of APP to preclude the accumulation of APP-CTFs although it may not be important for CMA or microautophagy.

Lipid Peroxidation and Antioxidant Vitamin Status in Oral Cavity and Oropharyngeal Cancer Patients

  • Marakala, Vijaya;Malathi, M.;Shivashankara, A.R.
    • Asian Pacific Journal of Cancer Prevention
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    • 제13권11호
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    • pp.5763-5765
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    • 2012
  • Background: This study was conducted to determine levels of lipid peroxidation and antioxidant vitamin status in patients with oral cavity and oropharyngeal cancer. Methods: The study group consisted of a total number of 80 subjects between the age 40-68 years, 40 with clinically and histopathologically proved cases of oral cavity and oropharyngeal cancer and 40 normal healthy, age and sex matched volunteers as controls. Levels of lipid peroxidation products as malondialdehyde (MDA) and antioxidant vitamins as vitamin A and vitamin C were estimated and compared between the two groups. Results: There was a statistical significant difference in the mean MDA, plasma vitamin A and vitamin C in the oral and oropharyngeal cancer patients compared with the healthy controls (p<0.0001). Conclusions: Lipid peroxidation (MDA) is higher and plasma antioxidant vitamins like vitamin A and vitamin C were lower in oral cavity and oropharyngeal cancer patients than healthy controls.