• 제목/요약/키워드: KFDA regulation

검색결과 37건 처리시간 0.019초

점안용 웅담.우황약침액의 안점막자극실험 (Eye Irritation Test of Fel Ursi & Bovis Calculus Pharmacopuncture Solutions for Eye Drop)

  • 서형식
    • 대한약침학회지
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    • 제11권3호
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    • pp.99-104
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    • 2008
  • Objective: This study was done to investigate the safety of Fel Ursi & Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods: The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Fel Ursi & Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, the author observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results: 1. After Fel Ursi & Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Fel Ursi & Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions: I suggested that Fel Ursi & Bovis Calculus pharmacopuncture solution didn't induced eye irritation in rabbits.

점안용 소염약침액의 안점막자극실험 (Eye Irritation Test of Soyeom Pharmacopuncture Solution for Eye Drop)

  • 서형식
    • 대한약침학회지
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    • 제11권2호
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    • pp.75-79
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    • 2008
  • Objectives This study was done to investigate the safety of Soyeom pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, the auther observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results 1. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Soyeom pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions I suggested that Soyeom pharmacopuncture solution didn't induced eye irritation in rabbits.

점안용 우황약침액의 안점막자극실험 (Eye Irritation Test of Bovis Calculus Pharmacopuncture Solutions for Eye Drop)

  • 서형식
    • 대한약침학회지
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    • 제11권2호
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    • pp.81-85
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    • 2008
  • Objective This study was done to investigate the safety of Bovis Calculus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration (2005. 10. 21, KFDA 2005-60). After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, the auther observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results 1. After Bovis Calculus pharmacopuncture solution was medicated in the left eye of the rabbits, there wasn't physical problem at 9 rabbits. 2. After Bovis Calculus pharmacopuncture solutionwas medicated in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions I suggested that Bovis Calculus pharmacopuncture solution didn't induced eye irritation in rabbits.

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
    • 동의생리병리학회지
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    • 제37권1호
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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.

일본과 한국의 기능성 유제품의 규격기준 및 시장현황에 관한 연구 (Investigation of Legal Regulation and Market Circumstances for Functional Dairy Products in Korea and Japan)

  • 박다정;이단원;박정민;신진호;김지연;전상록;송태석;윤성식;김진만
    • 한국축산식품학회지
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    • 제29권4호
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    • pp.523-532
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    • 2009
  • Changing health awareness has had an important effect on the functional food industry and is creating greater market opportunities. Unfortunately, there is no statement on functional dairy products in the Processing of Livestock Products Act. As a result, there is confusion in the market and legal difficulties with regard to the advertising of functional dairy products. This study was carried out to improve the current standardization of functional dairy products by comparing the domestic Health/Functional Food Act with the Japanese Health Promotion Law, and by investigating scientific data and articles from various literature and the Internet. In Japan, the Ministry of Health, Labor, and Welfare (MHLW) officially presented the Food with Health Claims (FHC) system that consists of Food with Nutrient Function Claims (FNFC), and innovated Food for Specified Health Uses (FOSHU). In 2005, the FOSHU system was changed to include several new subsystems: Current, Standardized, Reduction of disease risk, and Qualified FOSHU. Finally, to manufacture FOSHU, scientific evidence pertaining to such products must be examined by MHLW. Since FNFC was allowed, only 12 vitamins, ${\beta}-carotene$, and five minerals were approved, though without scientific evidence of efficacy. The Korean Health/Functional Food Act requires that health/functional foods (HFFs) be marketed in measured doses. There are two types of HFFs: generic and product-specific. There are 67 ingredients listed in the act for generic HFFs, and if an HFF has a new active ingredient, it is considered a product-specific HFF. Product-specific HFFs must be approved by the Korean Food and Drug Administration (KFDA). With the present standards, it is impossible to label and advertise functional dairy products with health/functional claims. Government agencies must cooperate to solve this problem, and standardization should be carried out by considering existing health/functional products and claims/indications from other countries.

식품 포장재로서 재활용 및 비재활용 종이 상자의 안전성 분석 (Evaluating Safety of Recycled and Non-recycled Paper-based Box for Food Packaging)

  • 오정민;신소향;권상조;조아름;김성진;이윤정;조헌주;한재준
    • 한국포장학회지
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    • 제18권1_2호
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    • pp.27-32
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    • 2012
  • 본 연구에서는 식품포장재로 이용되는 재활용 및 비재활용 종이류가 안전한지를 평가하기 위해 식품공전 규격에 준하여 실험하였다. 식품포장재 중에서도 피자상자를 선택하였는데, 이는 피자가 고온에서 조리되어 포장되며 다량의 기름 성분을 함유하여 오염물질이 이행될 가능성이 상대적으로 높을 것으로 예상됐기 때문이다. 식품공전에서는 PCBs, 납, 카드뮴, 수은, 6가크롬, 비소, 포름알데히드 및 형광증백제의 허용 잔존농도를 정하여 식품포장재로 이용되는 종이류에 잔존하는 유해물질을 규제하고 있다. PCBs의 여섯개의 표준품과 모든 시료의 피크가 일치하지 않았으므로 피자상자에는 PCBs가 잔존하지 않는 것으로 판단된다. 카드뮴, 수은, 6가크롬에 대한 재질규격 평가를 위한 분석이 추가적으로 필요하다고 사료된다. 비소와 납은 모든 시료에서 기준치의 10배 이하의 양이 검출되어 식품포장재로 사용되었을 때 안전성에 큰 영향을 미치지 않을 것으로 판단된다. 포름알데히드는 모든 시료에서 기준치보다 낮은 농도로 검출되었지만 잉크를 많이 함유하고 있는 표면에서 미량이지만 상대적으로 높게 검출되었다. 형광증백제는 비재활용 종이 소재의 상자에서는 검출되지 않았다. 그러나, 상자 내 피자 포장 유무나 잉크의 함량 정도에 상관없이 재생용지로 만들어진 상자 시료에서는 형광증백제가 검출되었다. 형광증백제는 불검출이 기준이므로 포함된 재활용지를 식품 포장으로 이용할 때는 식품과의 직접 접촉을 피하기 위해 중간에 안전성이 입증된 간지 등을 삽입하는 방법을 사용하여 최종 식품의 안전성에 영향을 주지 않는 것이 바람직할 것이다.

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시판 가공식품의 영양표시 실태 조사 (Prevalence of Nutrition Labeling and Claims on Processed, and Packaged Foods)

  • 권광일;박소현;이준형;김지영;유광수;이지선;김서영;성현이;남혜선;김종욱;이혜영;박혜경;김명철
    • 대한지역사회영양학회지
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    • 제12권2호
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    • pp.206-213
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    • 2007
  • This study investigated the prevalence of nutrition labeling and claims on processed and packaged foods. The final database consists of 1,287 foods, which were collected in two supermarkets in the Seoul area from September to November, 2006. An estimated 78% of KFDA-regulated processed, and packaged foods have nutrition labels. Nutrient content claims on food labels were identified in 21% of the foods which have nutrition labels. The prevalence of nutrition labels in this study is much higher than in previous studies due to the current expansion of the mandatory labeling regulation. However, false labeling and misleading contents claims were also identified. The food label is an important tool for enhancing the public's understanding of healthy choices of processed foods. Therefore, to maximize the benefits of the nutrition labeling regulation, industries, government agencies and health professionals should work together to help consumers make healthy dietary choices and improve their health.

16종 다용한약재의 산지별 As, Cd, Pb, Co, Cr 농도 및 특성고찰 -한국과 중국산의 평균농도, 최소-최대농도와 법적 허용농도초과비율을 중심으로- (As, Cd, Pb, Co, Cr Concentration and Property Evaluation in Frequently Using 16 Oriental Herbal Medicines -Mainly Average, Lowest, Highest Concentration and Percent Exceeding Value of Legal Allowance in Korean and Chinese Origines-)

  • 김기동;박해모;서용찬;이선동
    • 대한예방한의학회지
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    • 제16권3호
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    • pp.167-183
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    • 2012
  • Objective : Average, lowest, highest concentration and exceeding value of legal allowance of As, Cd, Pb, Co, Cr in frequently using 16 oriental herbal medicines in korea(Astragali Radix, Ginseng, Citri Unshii Pericarpium, Aurantii Fructus Immaturus, Angelicae Gigantis Radix, Cnidii Rhizoma, Paeoniae Radix, Rehmanniae Radix Preparata, Zingiberis Rhizoma Crudus, Zizyphi Fructus, Atractylodis Rhizoma Alba, Hoelen, Dioscoreae Rhizoma, Corni Fructus, Schisandrae Fructus, Lycii Fructus) was evaluated according to their origines (korea, china) and property was also discussed according to the medicinally active part and individuals regardless origines. Method : Korean and Chinese herbal medicines were evenly sampled from corresponding country nationwide. Pre-treatment was executed according to the KFDA(Korea Food and Drug Administration) regulation and analysis was performed according to the Korean Environmental Analysis QA/QC. Result : Not much difference was observed according to their origines. However, lowest, highest and percent exceeding value of legal allowance was showed some consistent differences according to the medicinally active part and individuals. Co and Cr was can not be evaluated since their legal regulation was not established yet. Conclusion : The average concentration of As, Cd, Pb, Co, Cr in frequently using 16 oriental herbal medicines in korea showed no noticeable difference according to their origines. Regardless the origin, some consistent differences were observed according to the individuals and medicinally active parts.

점안용 웅담.우황.사향 약침액의 안점막자극실험 (Eye Irritation Test of Fel Ursi, Bovis Calculus & Moschus Pharmacopuncture Solutions for Eye Drop)

  • 서형식
    • 대한약침학회지
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    • 제11권3호
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    • pp.105-111
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    • 2008
  • Objective: The aim of this study is to investigate the safety of Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution manufactured with freezing dryness method to use eye drop. Methods: The eye irritation test of this material was performed according to the Regulation of Korea Food & Drug Administration(2005. 10. 21, KFDA 2005-60). After Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution was applied eyewash in the left eye of the rabbits, the author observed eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Results: 1. After Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution was applied eyewash in the left eye of the rabbits, there wasn t physical problem at 9 rabbits. 2. After Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution was applied eyewash in the left eye of the rabbits, there wasn't eye irritation of the cornea, iris, conjunctiva at 1, 2, 3, 4 & 7day. Conclusions: In this study, it was observed that Fel Ursi, Bovis Calculus & Moschus pharmacopuncture solution didn't induced eye irritation in rabbits.

인체에 미치는 트랜스지방의 위해와 규제현황 (Hazardous Effect of Dietary Trans Fats on Human Health and Regulations)

  • 길복임;노정해
    • 한국식품조리과학회지
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    • 제23권6호
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    • pp.1015-1024
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    • 2007
  • Trans-fatty acids (TFAs) are defined as the sum of all unsaturated fatty acids that contain one or more non-conjugated double bonds in a trans configuration. Dietary trans- fatty acids originate from commercially hydrogenated oils and from dairy and meat fats. From the perspective of the food industry, partially hydrogenated vegetable oils are attractive because of their long shelf life, stability during deep-frying, and semisolidity, which can be customized to enhance the palatability of baked goods and fried foods. Although no definite differences have been documented so far between the metabolic and health effects of industrial and ruminant TFAs, the intake of industrially produced TFA has declined, and in Europe, the majority of TFAs are of ruminant origin. Due to the scientific evidence associating TFA intake with increased risk of coronary heart disease (CDH), the Korea Food and Drug Administration (KFDA) issued a final rule that requires the amount of trans fat present in foods to be declared on the nutrition label, by December 1, 2007. In addition, many food manufacturers who use partially hydrogenated oils in their products have developed, or are considering ways, to reduce or eliminate trans-fatty acids from certain food products.