• Bulletin of Food Technology
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• v.15 no.4
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• pp.73-101
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• 2002

21세기는 과학기술의 비약적인 발전으로 정보통신기술, 환경기술, 나노기술 그리고 생명과학에 의한 바이오기술이 고부가가치 지식산업으로서 국가경쟁력 강회를 위한 국가전략 핵심산업으로 대두되고 있습니다. 특히 바이오기술의 응용산업인 건강기능식품은 국민의 질병예방과 건강증진을 통한 삶의 질 향상에 이바지하고, 21세기 미래 고부가가치산업으로 발전할 것으로 기대하고 있습니다. 이러한 시기에 국민보건과 건강기능식품산업의 발전을 위한 건강기능식품에 관한 법률(건강기능식품법) 이 의원입법으로 국회에 상정되어 1년 이상의 검토를 거쳐 지난 7월 31일에 국회 본회의를 통과하였습니다. 그후 8월 26일자로 이 법을 정부에서 공포하였으며 내년 8월 26일부터는 발효할 예정입니다. 그러나, 건강기능식품법의 제정은 건강기능식품관련 제도의 완성이 아니라 시작입니다. 즉, 건강기능식품법의 기초는 마련하였지만, 그 하위법인 시행령, 시행규칙, 고시등이 제대로 된 모습을 갖추어야 비로소 국민이 만족하고, 산학연의 동반 발전을 이룰 수 있는 이 분야의 산업발전을 기할 수 있습니다. 그리고, 건강기능식품담당 정부부처인 식품의약품안전청은 현실적으로 그 하위법을 금년 말(2002년)이나 내년 초(2003년)에 준비한 후 입법 예고하여야하는 시간적 제약을 안고 있습니다. 이러한 연유로 단기간 내에 하위법을 준비하다 보면 자칫 애초에 정부와 산학연이 바라던 바와는 다른 엉뚱한결과를 초래할 우려가 있는 만큼, 법 제도의 명확한 방향설정이 매우 중요합니다. 그래서, 한국식품과학회 건강기능식품분과위원회는 이 문제의 중요성을 깊이 인식하고 산학연 전문가그룹(식품과학자, 영양과학자, 학계, 연구계, 기업계: 16인)을 구성하였습니다. 전문가그룹은 지난 7 - 8월, 2달 동안에 수 차례 회의를 통하여, 건강기능식품법 하위법 준비 중 핵심사항은 건강기능식품의 기능성 표시와 평가 라는 점에 착안하고, 이에 대하여 중점적으로 검토하였습니다. 그 이외에도 섭취량 설정 , 심사자료의 인증요건 , 기능성분의 표시 등에 대하여도 부수적으로 검토하였습니다. 그 결과, 동물실험을 이용한 기능성평가 방향 (이미 본지의 전호에서 게재한 바 있어생략)을 제외한 주요사항을 다음의 별도 기사로 각각 소개합니다. 또한, 이 내용은 지난 9월 13일, COEX에서 제1회 건강기능식품 전시회 및 학술세미나 행사의 일환으로서 개최된 학술세미나에서 발표하고 토론회를 거쳤습니다. 또한, 지난 10월 26일, 무주리조트에서 식품과학회 추계학술대회 행사의 일환으로 개최된 건강기능식품분과위원회의 토론회에서도 좋은 의견을 교환한 바 있습니다. 두 차례의 토론회를 통하여 건강기능식품분과위원회가 제안한 초안이 대체적으로 매우 바람직한 것으로 평가받았으며 많은 동의를 얻었습니다. 이어서 토론회의 내용을 반영한 식품과학회의 안을 최종적으로 준비하고 이를 11월초에 식품의약품안전청에게 정책 건의하였습니다. 다음의 별도기사에 덧붙여서, 토론회를 통하여 수정(또는 강조)하고자 하는 부분은 아래와 같습니다. 1) 동물실험 등에서 흡수, 대사 등으로 표기한 서술 용어는 흡수, 분포, 대사, 배설 로 대체합니다. 2) 기능성 평가방법의 표준화와 관련하여 분과위원회에서 제시한 안은 평가방법은 심의위원회가 사안에 따라 기능성 평가시에 그 평가방법의 적합성을 검토함이 바람직하다 라고 하였습니다. 그러나, 이를 부분적으로는 평가방법을 표준화할 필요가있다 로 수정하고자 합니다. 즉, 평가방법이 전혀 제시되지 않으면 막막함으로, 기본적인 방법이면서 여러사람들이 참고로 할만한 방법에 대하여는 표준화를 병행함이 더욱 좋겠다고 생각합니다. 또한, 표준방법으로 제시된 것만이 유일한 방법은 아니므로 다른 방법으로 평가하는 것도 가능함으로 제시합니다. 3) (가칭)건강기능식품 인체시험 관리지침과 관련하여 이는 식약청장이 정할 사안이지만, 그것은 국내 의약품 임상시험 관리지침 과는 뚜렷이 차별화되는 것으로 실제로는 의사의 도움없이도 인체시험을 시행할 수 있음을 명확히 할 필요가 있습니다.

• Korean Journal of Clinical Pharmacy
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• v.31 no.1
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• pp.53-60
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• 2021

Objective: To gather the opinions of hands-on workers for successful introduction of the Development Safety Update Report (DSUR) according to a five-year comprehensive plan for clinical trial development [Ministry of Food and Drug Safety, 2019]. Methods: We conducted a survey on considerations that industry stakeholders may have related to the enforcement of the DSUR. A questionnaire was distributed among pharmacovigilance specialists from 13 pharmaceutical companies in South Korea on June 4, 2020. The questionnaire comprised two sections: 1) current status of the Drug Safety Data Management System and 2) considerations on the implementation and management of the DSUR. Results: All respondents have agreed the introduction of DSUR is inevitable for regulatory harmonization and safety of trial subject. However, most respondents (85%) felt concern about additional workload with DSUR implementation. They answered that format and operation system of DSUR should be harmonized with those of international standards and authorities need to minimize double burden due to related report. Conclusion: All respondents asserted that domestic DSUR should be harmonized with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2F guidelines. Respondents from global companies also suggested regulatory authorities allow DSUR written in English to replace Korean version considering their deadline for submission. Moreover, every respondent agreed regulatory authorities need delicate effort when implementing mandatory submission of DSUR to ensure that even small pharmaceutical companies with no experience in DSUR can comply with the system.

• Korean Journal of Remote Sensing
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• v.37 no.2
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• pp.291-304
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• 2021

Updating a forest type map is essential for sustainable forest resource management and monitoring to cope with climate change and various environmental problems. According to the necessity of efficient and wide-area forestry remote sensing, CAS500-4 (Compact Advanced Satellite 500-4; The agriculture and forestry satellite) project has been confirmed and scheduled for launch in 2023. Before launching and utilizing CAS500-4, this study aimed to pre-evaluation the possibility of satellite-based tree species classification using RapidEye, which has similar specifications to the CAS500-4. In this study, the study area was the Chuncheon forest management complex, Gangwon-do. The spectral information was extracted from the growing season image. And the GLCM texture information was derived from the growing and non-growing seasons NIR bands. Both information were used to classification with random forest machine learning method. In this study, tree species were classified into nine classes to the coniferous tree (Korean red pine, Korean pine, Japanese larch), broad-leaved trees (Mongolian oak, Oriental cork oak, East Asian white birch, Korean Castanea, and other broad-leaved trees), and mixed forest. Finally, the classification accuracy was calculated by comparing the forest type map and classification results. As a result, the accuracy was 39.41% when only spectral information was used and 69.29% when both spectral information and texture information was used. For future study, the applicability of the CAS500-4 will be improved by substituting additional variables that more effectively reflect vegetation's ecological characteristics.

• Journal of Ginseng Research
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• v.26 no.3
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• pp.111-131
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• 2002

Korean ginseng (Panax ginseng C.A. Meyer) received a great deal of attention from the Orient and West as a tonic agent, health food and/or alternative herbal therapeutic agent. However, controversy with respect to scientific evidence on pharmacological effects especially, evaluation of clinical efficacy and the methodological approach still remains to be solved. Author reviewed those articles published since 1980 when pharmacodynamic studies on ginseng have intensively started. Special concern was paid on metabolic disorders including diabetes mellitus, circulatory disorders, malignant tumor, sexual dysfunction, and physical and mental performance to give clear information to those who are interested in pharmacological study of ginseng and to promote its clinical use. With respect to chronic diseases such as diabetes mellitus, atherosclerosis, high blood pressure, malignant disorders, and sexual disorders, it seems that ginseng plays preventive and restorative role rather than therapeutics. Particularly, ginseng plays a significant role in ameliorating subjective symptoms and preventing quality of life from deteriorating by long term exposure of chemical therapeutic agents. Also it seems that the potency of ginseng is mild, therefore it could be more effective when used concomitantly with conventional therapy. Clinical studies on the tonic effect of ginseng on work performance demonstrated that physical and mental dysfunction induced by various stresses are improved by increasing adaptability of physical condition. However, the results obtained from clinical studies cannot be mentioned in the indication, which are variable upon the scientist who performed those studies. In this respect, standardized ginseng product and providing planning of the systematic clinical research in double-blind randomized controlled trials are needed to assess the real efficacy for proposing ginseng indication. Pharmacological mode of action of ginseng has not yet been fully elucidated. Pharmacodynamic and pharmacokinetic researches reveal that the role of ginseng not seem to be confined to a given single organ. It has been known that ginseng plays a beneficial role in such general organs as central nervous, endocrine, metabolic, immune systems, which means ginseng improves general physical and mental conditons. Such multivalent effect of ginseng can be attributed to the main active component of ginseng,ginsenosides or non-saponin compounds which are also recently suggested to be another active ingredients. As is generally the similar case with other herbal medicines, effects of ginseng cannot be attributed as a given single compound or group of components. Diversified ingredients play synergistic or antagonistic role each other and act in harmonized manner. A few cases of adverse effect in clinical uses are reported, however, it is not observed when standardized ginseng products are used and recommended dose was administered. Unfavorable interaction with other drugs has also been suggested, which the information on the products and administered dosage are not available. However, efficacy, safety, interaction or contraindication with other medicines has to be more intensively investigated in order to promote clinical application of ginseng. For example, daily recommended doses per day are not agreement as 1-2g in the West and 3-6 g in the Orient. Duration of administration also seems variable according to the purpose. Two to three months are generally recommended to feel the benefit but time- and dose-dependent effects of ginseng still need to be solved from now on. Furthermore, the effect of ginsenosides transformed by the intestinal microflora, and differential effect associated with ginsenosides content and its composition also should be clinically evaluated in the future. In conclusion, the more wide-spread use of ginseng as a herbal medicine or nutraceutical supplement warrants the more rigorous investigations to assess its effacy and safety. In addition, a careful quality control of ginseng preparations should be done to ensure an acceptable standardization of commercial products.

• Journal of Digital Convergence
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• v.21 no.3
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• pp.33-39
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• 2023

This study is a performance evaluation of a blood sugar monitoring system that combines a PPG sensor, which is an evaluation device for blood glucose monitoring, and a DNN algorithm when monitoring capillary blood glucose. The study is a researcher-led clinical trial conducted on participants from September 2023 to November 2023. PPG-BGMS compared predicted blood sugar levels for evaluation using 1-minute heart rate and heart rate variability information and the DNN prediction algorithm with capillary blood glucose levels measured with a blood glucose meter of the standard personal blood sugar management system. Of the 100 participants, 50 had type 2 diabetes (T2DM), and the average age was 67 years (range, 28 to 89 years). It was found that 100% of the predicted blood sugar level of PPG-BGMS was distributed in the A+B area of the Clarke error grid and Parker(Consensus) error grid. The MARD value of PPG-BGMS predicted blood glucose is 5.3 ± 4.0%. Consequentially, the non-blood-based PPG-BGMS was found to be non-inferior to the instantaneous blood sugar level of the clinical standard blood-based personal blood glucose measurement system.

• Journal of Food Hygiene and Safety
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• v.27 no.1
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• pp.42-49
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• 2012

This study was carried out to investigate the toxicity of food Red No.2 in the Sprague-Dawley (SD) female rat for 4 weeks. SD rats were orally administered for 28 days, with dosage of 500, 1,000, 2,000 mg/kg/day. Animals treated with food Red No.2 did not cause any death and show any clinical signs. They did not show any significant changes of body weight, feed uptake and water consumption. There were not significantly different from the control group in urinalysis, hematological, serum biochemical value and histopathological examination. In conclusion, 4 weeks of the repetitive oral medication of food Red No.2 has resulted no alteration of toxicity according to the test materials in the group of female rats with injection of 2,000 mg/kg. Therefore, food Red No.2 was not indicated to have any toxic effect in the SD rats, when it was orally administered below the dosage 2,000 mg/kg/day for 4 weeks.

• Journal of Ginseng Research
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• v.29 no.1
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• pp.1-18
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• 2005

Ginseng Radix, the root of Panax ginseng C. A. Meyer has been used in Eastern Asia for 2000 years as a tonic and restorative, promoting health and longevity. Two varieties are commercially available: white ginseng(Ginseng Radix Alba) is produced by air-drying the root, while red ginseng(Ginseng Radix Rubra) is produced by steaming the root followed by drying. These two varieties of different processing have somewhat differences by heat processing between them. During the heat processing for preparing red ginseng, it has been found to exhibit inactivation of catabolic enzymes, thereby preventing deterioration of ginseng quality and the increased antioxidant-like substances which inhibit lipid peroxide formation, and also good gastro-intestinal absorption by gelatinization of starch. Moreover, studies of changes in ginsenosides composition due to different processing of ginseng roots have been undertaken. The results obtained showed that red ginseng differ from white ginseng due to the lack of acidic malonyl-ginsenosides. The heating procedure in red ginseng was proved to degrade the thermally unstable malonyl-ginsenoside into corresponding netural ginsenosides. Also the steaming process of red ginseng causes degradation or transformation of neutral ginsenosides. Ginsenosides $Rh_2,\;Rh_4,\;Rs_3,\;Rs_4\;and\;Rg_5$, found only in red ginseng, have been known to be hydrolyzed products derived from original saponin by heat processing, responsible for inhibitory effects on the growth of cancer cells through the induction of apoptosis. 20(S)-ginsenoside $Rg_3$ was also formed in red ginseng and was shown to exhibit vasorelaxation properties, antimetastatic activities, and anti-platelet aggregation activity. Recently, steamed red ginseng at high temperature was shown to provide enhance the yield of ginsenosides $Rg_3\;and\;Rg_5$ characteristic of red ginseng Additionally, one of non-saponin constituents, panaxytriol, was found to be structually transformed from polyacetylenic alcohol(panaxydol) showing cytotoxicity during the preparation of red ginseng and also maltol, antioxidant maillard product, from maltose and arginyl-fructosyl-glucose, amino acid derivative, from arginine and maltose. In regard to the in vitro and in vivo comparative biological activities, red ginseng was reported to show more potent activities on the antioxidant effect, anticarcinogenic effect and ameliorative effect on blood circulation than those of white ginseng. In oriental medicine, the ability of red ginseng to supplement the vacancy(허) was known to be relatively stronger than that of white ginseng, but very few are known on its comparative clinical studies. Further investigation on the preclinical and clinical experiments are needed to show the differences of indications and efficacies between red and white ginsengs on the basis of oriental medicines.

• Journal of Nutrition and Health
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• v.51 no.2
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• pp.140-152
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• 2018

Purpose: Recently, there has been a worldwide increase in the prevalence of food allergies in children and it may cause nutritional imbalance and poor quality of life for growing children due to dietary restrictions. This study was conducted to quantitatively measure the life burden and related factors of mothers who are the primary caretakers of food-allergic children. Moreover, we generated data for use as a scientific basis for the development of a disease management program to reduce the burden on life from raising food-allergic children. Methods: Mothers of 2,005 children aged 2 years or older and enrolled in Seoul Metropolitan Atopy Free Schools in 2016 who have had diagnosis of food allergy in their lifetime were surveyed. The burden on life of parents with food-allergic children was measured using 17 questions from the Food Allergy Quality of Life-Parental Burden (FAQL-PB) questionnaire, and subjects were asked to respond with a scale of 1 ~ 7. Results: We analyzed the effects of sociodemographic factors of parents and children and the accompanying allergic disease factors on the lives of parents. The number of restricted food items due to food allergy of a child and accompanying diagnosis of atopic dermatitis had a positive (+) effect on the life burden of the parents. Conclusion: Accurate oral food challenge for food allergies should be administered to prevent excessive restriction of food intake. Moreover, efforts should be taken to prevent morbidity accompanying food allergy and relieve symptoms of asthma, allergic rhinitis and atopic dermatitis.

• Journal of Dairy Science and Biotechnology
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• v.32 no.1
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• pp.17-29
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• 2014

GRAS probiotics can be used to modulate intestinal microbiota and to alleviate various gastrointestinal disorders. In several recent studies, researchers have explored the potential expansion and usability of probiotics to reduce the risk factors associated with diseases, including obesity, hypercholesterolemia, arterial hypertension, hyperhomocysteinemia, and oxidative stress. In this review, our aim was to clarify the mechanism underlying interactions between hosts (animal or human) and probiotics and the beneficial effects of probiotics on human health.