• Title/Summary/Keyword: Ministry of Food and Drug Safety in Korea

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Bambusae Caulis in Taeniam Applicable for Medical Indications Associated with Inflammation

  • Hyo Jae Choi;Yugyeong Gwak;Ji Yeon Lee;Min Jung Kwun;Jun-Yong Choi;Myungsoo Joo
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.37 no.1
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    • pp.14-18
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    • 2023
  • Jukyeo (竹茹; Bambusae Caulis in Taeniam: BCT) is an herbal medicine made from the inner part of the bamboo stem of Phyllostachys nigra Munro var. henonis Stapf ex Rendle or Phyllostachys bambusoides Siebold et Zuccarini. Although medical literature published in China and Korea decades ago introduced BCT as a remedy for reducing vomiting, fever, and hematemesis, decoctions containing BCT as a main herb (君藥) in Korea have been approved only for treating neurologic symptoms. Here, we discuss the anti-inflammatory function of BCT. Combined with the clinical usage of a BCT-containing decoction in treating inflammatory diseases in Japan, we raise the possibility of repurposing the BCT-containing decoctions for treating inflammatory diseases. The anti-inflammatory activity of BCT was mainly assessed by using RAW 264.7 cells. The regulation of NF-κB, Nrf2 and A20 activities was determined by western blot and quantitative RT-PCR. The list of decoctions containing BCT currently approved in Korea was obtained from the Korean Ministry of Food and Drug Safety (KFDA). BCT suppressed the activity of pro-inflammatory factor NF-κB elicited by LPS, activated an anti-inflammatory factor Nrf2, and induced A20 that is known to block several inflammatory pathways simultaneously, suggesting that BCT can suppress inflammation via at least 3 different pathways. KFDA approved 11 decoctions containing BCT as a major herb, including Gamiondam-tang (加味溫膽湯; GOT), for treating neurologic disorders. Interestingly, Jukyeoondam-tang (竹茹溫膽湯; JOT), whose composition is almost identical to GOT except for one herb, has been used to treat inflammatory pulmonary disorders including Covid-19 pulmonary infection in Japan Given the anti-inflammatory function of BCT evidenced by medical literature and experimental results and the clinical usage of JOT in treating inflammatory pulmonary disorders, we suggest a repurposing and extension of the BCT-containing decoctions approved in Korea to treating inflammatory diseases.

A Comparison of Salty Taste Assessment, Dietary Attitude and Dietary Behavior among Adult and Senior Women by Region and by Age in Korea (전국 권역별, 연령별 여자 성인과 노인의 짠맛 미각판정치, 식태도 및 식행동 비교)

  • Jiang, Lin;Jung, Yun-Young;Kim, Hyung-Sook;Nam, Gi-Seon;Yun, Jin-Sook;Kim, Jong-Wook;Lee, Yeon-Kyung
    • Korean Journal of Community Nutrition
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    • v.20 no.2
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    • pp.109-119
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    • 2015
  • Objectives: The purpose of this study was to compare and analyze the results of salty taste assessment, dietary attitudes, and dietary behaviors among adult and senior women by region and by age. The results generated from this was expected to provide fundamental data for implementing a nationwide salt reduction education program. Methods: The salty taste assessment tool was applied to 4,064 subjects from 15 areas in Korea. Also, a survey of dietary attitude and dietary behavior related to salt intake was conducted for all subjects participated in this study. Results: The salty taste assessment scores by region and by age were the lowest in capital (p < 0.01) and was highest among the 70+ year age group (p < 0.01). The dietary attitude scores and dietary behavior scores showed that Gyeongsang was the highest (p < 0.001) and the capital was the lowest. The dietary attitude scores were highest at 20&30's followed by 40's and 70's group (p < 0.001). Dietary behavior scores showed that 20's~30's and 40's groups were higher than the other age groups (p < 0.001). The score of 'I like kimchi' was $3.46{\pm}0.88$, which was the highest among 10 dietary behavior questions. The score of 'I eat a lot of kimchi' was $3.30{\pm}0.90$, which was the highest among 10 dietary behavior questions related to salt intake. The scores of salty taste assessment had significant positive correlations between the scores of dietary attitude (p < 0.001), dietary behavior (p < 0.001) and self-awareness (p < 0.001). Conclusions: Based on the results of salty taste assessment, we observed a tendency that older people and regions except the capital had higher preference for salty taste. Our results suggested the necessity for a nationwide salty reduction education program tailored for regions and for different age groups.

Quality comparison of musk products using a chromatographic pattern analysis (사향의 크로마토그램 패턴 분석을 통한 품질비교 연구)

  • Cho, Chong Woon;Gao, Dan;Kang, Jong Seong;Jung, Hyo won;Park, Yong-Ki
    • The Korea Journal of Herbology
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    • v.36 no.4
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    • pp.41-50
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    • 2021
  • Objectives : This study is to check the quality of Moschus products in Korean markets using a chromatographic analysis. Methods : We collected musk products, two genuine products from Russia (A, B), two authentic products from Hong Kong (C) and Korea (D), the Ministry of Food and Drug Safety (MFDS) standard (E), and two fire ants products (E, F). Results : For identification, TLC analysis of 60% ethanol extracts of each product showed that A, B, C, and E have the suitable patterns before color development at 365 nm UV light for the MFDS regulation in Korea. A clear red spot was observed from the E at Rf 0.6 with 365 nm UV light after color development, but this spot was not found in A and B. For the purity test, a distinct violet spot with Rf 0.87 was observed from the A and B in TLC analysis of methanol extracts of each product at white light, however, this spot was not matched with the impurities of E and F. In HPLC-UV pattern analysis, a similar peak pattern was shown in A, B and E, and similar peaks were observed C, although the similarity was weaker than that of A, B, and E. The F and G showed different peak patterns compared with the peak patterns of other samples. Conclusions : Hence, it is considered that the test methods need flexibility in application for identification and purity test depending on the type of sample.

Changes and Perspects in the Regulation on Medical Device Approval Report Review, etc. : Focus on Traditional Korean Medical Devices (의료기기 허가·신고·심사 등에 관한 규정 변화와 전망 : 한의 의료기기 중심으로)

  • DaeJin Kim;Byunghee Choi;Taeyeung Kim;Sunghee Jung;Woosuk Kang
    • Journal of Society of Preventive Korean Medicine
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    • v.28 no.1
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    • pp.31-42
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    • 2024
  • Objective : In order to understand the changes in domestic approval regulations applicable to traditional Korean medical device companies, this article will explain the major amendments 「Regulation on Medical Device Approval Report Review, etc.」 from 2005 to the present on a year-by-year basis, and provide a counter plan to the recent changes in approval regulations. Methods : We analysed the changes in approval regulatory amendments related to the traditional Korean medical devices from 2005 to the present. Results : The Ministry of Food and Drug Safety is continuously improving medical device approval regulations to ensure the global competitiveness of domestic medical devices and contribute to the improvement of public health. Recent major approval regulatory amendments include the establishment of a review system for software medical devices and digital therapeutics, the recognition of real world evidence materials, the introduction of a biological evaluation of medical devices within a risk management process and a medical device approval licence renewal system. Conclusions : It is expected that the range of medical devices available to Korean medicine doctors will continue to expand in the future through the provision of non-face-to-face medical services and the development of advanced and new medical devices, as well as wearable medical devices and digital therapeutics. In order to increase the market entry potential of traditional Korean medical devices that incorporate advanced technologies such as digital technology and AI-based diagnosis and prediction technology, it is urgent that the government provide significant support to traditional Korean medical device companies to improve approval regulatory compliance.

Inhibitory effect of ethanol extract of Gryllus bimaculatus on platelet aggregation and glycoprotein IIb/IIIa activation (쌍별귀뚜라미 에탄올 추출물의 혈소판응집반응과 당단백질 IIb/IIIa 활성화 억제 효과)

  • Hyuk-Woo Kwon;Man Hee Rhee;Jung-Hae Shin
    • Journal of Applied Biological Chemistry
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    • v.66
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    • pp.236-243
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    • 2023
  • Platelets act a fundamental role in primary- and secondary-hemostasis, however, platelet activation may cause thrombosis simultaneously. Therefore, control of platelet aggregation is crucial in preventing thrombosis-mediated diseases. Recently, the development of insect materials is attracting attention. Among the highly nutritious functional food sources, insects such as two-spotted cricket (Gryllus bimaculatus). Gryllus bimaculatus (G. bimaculatus) contains high protein and unsaturated fatty acids and has been registered as a food material September 2015 by the Ministry of Food and Drug Safety of Korea. In this study, we examined whether G. bimaculatus extract (GBE) inhibits platelet aggregation, intracellular calcium mobilization, thromboxane A2 production and glycoprotein IIb/IIIa (integrin αIIb/β3) activation. We investigated whether GBE can regulate signaling molecules, such as 1, 4, 5-triphosphate receptor type I, extracellular signal-regulated kinase, cytosolic phospholipase A2, mitogen-activated protein kinases p38, vasodilator-stimulated phosphoprotein, phosphatidylinositol-3 kinase, Akt, glycogen synthase kinase-3α/β, and SYK. Taken together, GBE is a potential therapeutic drug candidate to prevent platelet-related thrombosis and cardiovascular disease.

Sustainable Education Program for Middle School Students for the Global Environment (중학생 대상 지구환경을 위한 지속가능한 식생활교육 프로그램)

  • Lee, Young Eun;Yoo, Se Jong;Lee, Jung Woo;Koh, Jeewon;Kim, Yookyung
    • Journal of Korean Home Economics Education Association
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    • v.34 no.2
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    • pp.59-75
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    • 2022
  • The purpose of this study is to develop a sustainable dietary education program using garden vegetables for middle school students. Textbook analysis and demand survey were conducted before developing the program. Ten textbooks of technology and home economics for middle and high school students were analyzed and the results showed that none of the textbooks covered food gardening. Two hundred and six middle school students participated in the demand survey and the results revealed that students lack an understanding of food gardening despite high interest. Therefore, six sessions of a sustainable dietary education program using garden vegetables were developed based on a six-step DESIGN procedure. Then, the content validity of the program was evaluated by three experts and the program was revised based on the results. This dietary education program will lead students to live a sustainable diet, eventually benefiting the health and wellness of individuals, communities and ecosystems.

Differential Diagnosis of Human Sparganosis Using Multiplex PCR

  • Jeon, Hyeong-Kyu;Kim, Kyu-Heon;Sohn, Woon-Mok;Eom, Keeseon S.
    • Parasites, Hosts and Diseases
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    • v.56 no.3
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    • pp.295-300
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    • 2018
  • Human sparganosis was diagnosed by morphological and genetic analyses in Korea. The complete mitochondrial genomes of Spirometra erinaceieuropaei and S. decipiens isolated in Korea have been recorded. Present study was performed to provide information to diagnose the etiologic agent of sparganosis by multiplex PCR using mitochondrial genome sequences of S. erinaceieuropaei and S. decipiens. In an effort to examine the differential diagnosis of spirometrid tapeworms, multiplex PCR assays were performed on plerocercoid larvae of S. erinaceieuropaei and S. decipiens. The PCR products obtained using species-specific primers were positively detected in all PCR assays on mixture of S. erinaceieuropaei and S. decipiens DNA. S. erinaceieuropaei-specific bands (239 bp and 401 bp) were obtained from all PCR assays using a mixture of S. erinaceieuropaei-specific primers (Se/Sd-1800F and Se-2018R; Se/Sd-7955F and Se-8356R) and S. erinaceieuropaei template DNA. S. decipiens-specific bands (540 bp and 644 bp) were also detected in all PCR assays containing mixtures of S. decipiens-specific primers (Se/Sd-1800F and Sd-2317R; Se/Sd-7955F and Sd-8567R) and S. decipiens template DNA. Sequence analyses on these species-specific bands revealed 100% sequence identity with homologous regions of the mtDNA sequences of S. erinaceieuropaei and S. decipiens. The multiplex PCR assay was useful for differential diagnosis of human sparganosis by detecting different sizes in species-specific bands.

A 90 Day Repeated Dose-Oral Toxicity Study of Extracts from Astragalus membranaceus-Aboveground Parts in Rats (랫드를 이용한 황기의 지상부 추출물에 대한 90일 반복경구투여 독성시험)

  • Park, Yeong Chul;Lee, Ji Sun;Kim, Dong Yoon;Son, Hye Young;Lee, Jung Woo;Cheoi, Yu Soon;Kim, Kwang Ki;Yu, Chang Yeon;Chung, Ill Min;Im, Moo Hyeog;Lee, Kyung Jae;Choi, Ri Na;Shim, Hoon Seob;Lim, Jung Dae
    • Korean Journal of Medicinal Crop Science
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    • v.21 no.6
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    • pp.474-485
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    • 2013
  • Pharmacological studies and clinical practices have indicated that Radix Astragali, a dried root of Astragalus membranaceus possesses a lot of biological activities, including antioxidant, hepatoprotective, anti-diabetic, tonic, diuretic, antimicrobial, antiviral, and immunological activities. These biological activities approved by the modern pharmacological studies are mainly due to the constituents of Astragalus membranaceus including polysaccharides, saponins, flavonoids, amino acids, and trace elements. In resent, the main constituents in the root part showing a lot of biological activities has been isolated also from the aboveground parts such as leaves and sprouts in our laboratory. However, the safety evaluation for the aboveground parts of Astragalus membranaceus should be checked before expanding their application as one of food. In the study, a 90-day rat oral gavage study has been conducted with the extracts from Astragalus membranaceus-above-ground parts at doses of 1000, 3000, and 5000mg/kg/day. The following endpoints were evaluated: clinical observations, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Based on the analysis of these endpoints, it was estimated that NOEL (no observed effect level) for male rats and NOAEL (no observed adverse effect level) for female rats are 5000mg/kg/day of the water-extracts from Astragalus membranaceus-aboveground parts.

Development and Validation of the 'Food Safety and Health' Workbook for High School (고등학교 「식품안전과 건강」 워크북 개발 및 타당도 검증)

  • Park, Mi Jeong;Jung, Lan-Hee;Yu, Nan Sook;Choi, Seong-Youn
    • Journal of Korean Home Economics Education Association
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    • v.34 no.1
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    • pp.59-80
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    • 2022
  • The purpose of this study was to develop a workbook that can support the class and evaluation of the subject, 「Food safety and health」 and to verify its validity. The development direction of the workbook was set by analyzing the 「Food safety and health」 curriculum, dietary education materials, and previous studies related to the workbook, and the overall structure was designed by deriving the activity ideas for each area. Based on this, the draft was developed, and the draft went through several rounds of cross-review by the authors and the examination and revision by the Ministry of Food and Drug Safety, before the final edited version was developed. The workbook was finalized with corrections and enhancements based on the advice of 9 experts and 44 home economics teachers. The workbook consists of 4 areas: the 'food selection' area, with 10 learning topics and 36 lessons, the 'food poisoning and food management' area, with 10 learning topics and 36 lessons, the 'cooking' area, with 11 learning topics and 43 lessons, and the 'healthy eating' area, with 11 learning topics and 55 lessons, resulting in a total of 42 learning topics, 170 lessons. The workbook was designed to evenly cultivate practical problem-solving competency, self-reliance capacity, creative thinking capacity, and community capacity. In-depth inquiry-learning is conducted on the content, and the context is structured so that self-diagnosis can be made through evaluation. According to the validity test of the workbook, it was evaluated to be very appropriate for encouraging student-participatory classes and evaluations, and to create a class atmosphere that promotes inquiry by strengthening experiments and practices. In the current situation where the high school credit system is implemented and individual students' learning options are emphasized, the results of this study is expected to help expand the scope of home economics-based elective courses and contribute to realizing student-led classrooms with a focus on inquiry.

European Regulatory Science and Regulatory Science Expert Training Project (유럽의 규제과학 및 규제과학 인재양성 프로젝트)

  • Shin, Hocheol;Park, Jaehong;Kim, Jiwon;Baek, Dajung;Lee, Yun-ji;Jung, Sun-Young;Kang, Wonku;Kim, Hahyung;Choi, Young Wook;Kim, Eunyoung
    • Korean Journal of Clinical Pharmacy
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    • v.31 no.3
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    • pp.171-179
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    • 2021
  • Background: Need for regulatory science is emerging with the development of pharmaceutical industry. It is essential to train regulatory science experts to meet the needs of technology and regulations to evaluate advanced products. Major regulatory science countries are conducting the regulatory science activities and fostering the experts. Methods: Published literature and the relevant website of European Union (EU) were reviewed and criteria were developed. In particular, we focused on in depth descriptions of the Innovative Medicines Initiative program, which was conducted twice. Results: EU is striving to provide funding and training experts for the development of the regulatory science by horizon 2020 and regulatory science to 2025. Innovative medicines initiative (IMI) is a public-private partnership aimed at the development of the pharmaceutical industry, including the regulatory science. IMI education and training projects have provided various education and training course including short-term curriculum and master and doctoral course. The difference between South Korea's regulatory science expert training project in 2021 and the EU's IMI education and training projects is participation of pharmaceutical companies. While the pharmaceutical companies participate in the IMI project to select project topics and form a community, South Korea's project is focused on the Ministry of Food and Drug Safety and universities. Conclusion: Through successful active networks with regulatory party, pharmaceutical companies, and universities, a great innovative advance of regulatory science in South Korea is expected.