• Title/Summary/Keyword: KFDA

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Preparation and Characteristics of Snack Using Conger Eel Frame (붕장어 Frame을 이용한 스낵의 제조 및 특성)

  • Kim, Hye-Suk;Kang, Kyung-Tae;Han, Byung-Wook;Kim, Eun-Jung;Heu, Min-Soo;Kim, Jin-Soo
    • Journal of the Korean Society of Food Science and Nutrition
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    • v.35 no.10
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    • pp.1467-1474
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    • 2006
  • Fish-frames, which are left after obtaining fillets or muscle during fish processing, consists of useful food components, such as muscle, collagen, calcium, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). This study was carried out to prepare snack using conger eel frame (SF) for human consumption and also to elucidate food component characterization of the snack. The results of volatile basic nitrogen suggested that conger eel frame was a suitable material for preparing snack. Based on the results of sensory evaluation and costs, starch syrup was an optimal sweetener for preparing snack using conger eel frame. The starch syrup-treated SF appeared safe because the moisture content and peroxide value were below the safety limits described in the guideline of Korea Food and Drug Administration (KFDA). Starch syrup-treated SF was similar in the pattern of fatty acid composition to soybean oil, whereas EPA and DHA were detected in SF. The total content of amino acid in starch syrup-treated SF was 23.9% based on 100 g of raw material. The maj or amino acids were aspartic acid, glutamic acid, glycine and alanine. The total contents of calcium and phosphorus in starch syrup-treated SF were 4.9% and 2.8%, respectively. The Ca/P of starch syrup-treated SF was 1.9, which is a good ratio for absorption of calcium. The SF made with starch syrup was superior in EPA and DHA compositions, total amino acid, calcium and phosphorus contents to commercial snack using eel frame.

Development of Dissolution Testing Method for Piracetam Tablets and Fenoterol Hydrobromide Tablets in Korean Pharmaceutical Codex (고시 수재 의약품 중 피라세탐 정 및 브롬화수소산페노테롤 정의 용출시험법 개발)

  • Kim, Eun-Jung;Lee, Jin-Ha;Park, Chan-Ho;Sohn, Kyung-Hee;Kim, In-Kyu;Kim, Dong-Sup;Sah, Hong-Kee;Choi, Hoo-Kyun
    • YAKHAK HOEJI
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    • v.55 no.4
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    • pp.324-331
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    • 2011
  • Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.

The Blocking Effect of Sunscreen Materials on Blue Light (자외선 차단제의 블루라이트 차단효과에 관한 연구)

  • Chung, Sang Uk;Lee, Si Eun;Choi, Sun Young;Moon, Kwon Ki;Lim, Sora;Kim, Hae Kyoung;Park, Jong Ho
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.44 no.2
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    • pp.183-189
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    • 2018
  • Blue light is the highest energy wavelengths in the visible light region and induces skin aging and active oxygen. Studies on harmful mechanism of skin are under way. Research on blue light blocking materials in cosmetics and formulation studies are in the early stage, and the test methods related to blue light blocking measurement are not established. The blue light blocking efficacy was established by referring to the test method of the sunscreen in vitro test(COLIPA guideline, ISO 24443, FDA Final Rule on Sunscreen Testing and Labeling). The blue light blocking effect was evaluated for 17 kinds out of 27 kinds of sunscreen raw materials suggested in KFDA guideline. The Effect was 14.97% for zinc oxide and 16.32% for bishexyloxyphenol methoxyphenyl triazine, 35.47% for methylene bis-benzotriazolyltetramethylbutylphenol, and 65.96% for titanium dioxide. In addition, the effect of micro-titanium dioxide was twice as high as that of the nano-titanium dioxide. The results suggested that the light blocking effect test method can be used to search for blue light blocking materials and study cosmetic formulations.

Survey of radioactive contamination in imported foodstuffs (수입 식품중의 방사능 오염실태 조사)

  • Lee, Wan-No;Lee, Haeng-Pil;Chung, Kun-Ho;Kim, Hee-Reyoung;Cho, Young-Hyun;Choi, Geun-Sik;Lee, Chang-Woo;Chung, Hyung-Wook;Lee, Eun-Ju;Sho, You-Sup;Lee, Jong-Ok
    • Journal of Radiation Protection and Research
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    • v.31 no.3
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    • pp.141-148
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    • 2006
  • Surveys of radioactive contamination were performed for imported foodstuffs in 2003. The following samples among imported foodstuffs were selected from markets and Korea Food and Drug Administration(KFDA); the imported samples from country associated with the Chernobyl nuclear accident, the samples produced around the nuclear power plants or nuclear tests, the foodstuffs reported as radioacitive contamination materials in foreign country. After pretreatments such as drying and homogenization, samples were analyzed. The $^{137}Cs$ radionuclide was only measured among the regulation radionuclides($^{137}Cs,\;^{134}Cs,\;^{131}I$) of food code. All foodstuffs except Inonotus Obliquus(Chaga mushooms) are less than 17.0 Bq/kg or below the minimum detectable activity(MDA). The activity concentrations of Chaga mushrooms from Russia ranged up to 131.25 Bq/ltg which is almost 35 % of the maximum permitted level of food code. The fraction of imported foodstuffs having meaningful radioactivity is small, however, the radioactive contamination survey of imported foodstuffs is still needed.

Survey of Preservatives and UV Filter Ingredients of Distributed Sunblock Products in Korea (국내 유통 자외선 차단 기능성화장품 중 살균보존제 및 자외선차단성분 사용실태조사)

  • Park, Jeong Hee;Kim, Jong Pil;Kim, Jin A;Seo, Kye Won;Kim, Eun Sun;Seo, Jumg Mi
    • Journal of the Society of Cosmetic Scientists of Korea
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    • v.43 no.4
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    • pp.381-390
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    • 2017
  • This study was conducted to determine 16 preservatives and 18 UV filter ingredients levels in 100 sunblock products. The order of detection rates of preservatives was phenoxyethanol (n=61), benzoic acid (n=19), methyl paraben (n=11), benzyl alcohol (n=8), propyl paraben (n=7). Also the order of detection rates of UV filter ingredients was titanium dioxide (n=81), ethylhexyl methoxycinnamate (n=69), zinc oxide (n=48), ethylhexyl salicylate (n=48), bis-ethylhexyloxyphenol methoxyphenyltriazine (n=44). The content of the detected preservatives and UV filter ingredients was within maximum allowed amount established by KFDA. In addition, preservatives and UV filter ingredients, which were not labeled in the products, were detected in 31 and 2 products respectively.

The Effects of Somatid on the Cytotoxicity of Cancer Cells and Human Papillomavirus Type 16 E6 and E7 Oncogenes (생기액(生肌液)의 세포독성 및 자궁경부암 바이러스 (HPV 16 type) 암 유발인자 E6와 E7의 작용에 미치는 효과)

  • Joung, Ok;Cho, Young-Sik;Cho, Cheong-Weon;Lee, Kyung-Ae;Shim, Jung-Hyun;Cho, Min-Chul;Lee, Hong-Soo;Yeom, Young-Il;Kim, Sang-Bom;Park, Sue-Nie;Yoon, Do-Young
    • YAKHAK HOEJI
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    • v.44 no.4
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    • pp.340-346
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    • 2000
  • Cervical cancer is one of the leading causes of female death from cancer worldwide with about 500,000 deaths per year. A strong association between certain human papilloma viruses (HPV types 16 and 18) and cervical cancer has been well known. An extract of natural products, named as Somatid, has been used to investigate whether this agent has the ability of inhibiting the oncogenes E6 and E7 of HPV type 16. This Somatid inhibited the proliferation of human cervical cancer cell lines (C-33A, SiHa, CaSki) and HaCaT keratinocytes in a dose response manner, In vitro binding assay and ELISA showed that Somatid inhibited the in vitro biding of E6 and E6AP which are essential for the binding and degradation of the tumor suppressor p53. In addition, Somatid inhibited the in vitro binding of E7 and Rb which is essential tumor suppressor for the control of cell cycle. The levels of mRNA for E6 and E7 were also decreased by Somatid. Our data suggested that Somatid inhibited the oncogenecity of E6 and E7 of HPV 16 type, thus can be used as a putative anti-HPV agent for the treatment of cervical carcinomas caused by HPV.

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Development of Direct Competitive Enzyme-Linked Immunosorbent Assay using Monoclonal Antibody (MAb) against Sulfamthazine (SMZ) and Establishment of Application Condition for Milk Sample (설파메타진에 단클론성 항체를 이용한 직접경쟁효소면역분석법의 개발과 우유 시료 적용 조건 확립)

  • Shim, Won-Bo;Mun, Chun-Sun;Kim, Jung-Sook;Choe, Ju-Mi;Kim, Ji-Hun;Park, Seon-Ja;Kang, Sung-Jo;Chung, Duck-Hwa
    • Korean Journal of Food Science and Technology
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    • v.38 no.2
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    • pp.176-182
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    • 2006
  • Sensitive and specific monoclonal antibody (MAb) was produced from hybridoma (1H11-5) obtained by fusion of myeloma cell (V653) and spleen cell isolated from mouse immunized sulfamthazine (SMZ)-HG-KLH. Direct competitive ELISA was developed for rapid detection of SMZ in milk samples using MAb against SMZ with optimized conditions between MAb and SMZ-HG-HRP conjugate, and applicable conditions for analysis of milk samples were established. Detection range of immunoassay was 0.1 to 100 ppb. Recoveries from spiked raw milk and processed milk samples averaged 82.1-120.7 and 82.1-97.1%, respectively.

Risk Assessment of Mercury through Food Intake for Korean Population (식품 중 수은 위해평가)

  • Choi, Hoon;Park, Sung-Kug;Kim, Mee-Hye
    • Korean Journal of Food Science and Technology
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    • v.44 no.1
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    • pp.106-113
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    • 2012
  • The present study was conducted to assess the dietary exposure to mercury and the associated risks for Koreans resulting from their food intake. The probabilistic approach in the Monte Carlo simulation was used to estimate dietary exposures. Based on several reports regarding heavy metals published by KFDA in the 2000s, 178 types of representative foods were selected and data were collected on the occurrence of mercury. The contents of mercury in foods ranged: agricultural products 0.1 (fruits)-45.4 ${\mu}g/kg$ (mushrooms), 3.7 ${\mu}g/kg$ (meat), and 9.3 (Echinodermata, chordata)-194.9 ${\mu}g/kg$ (fish). Others categories investigated were alcoholic beverages (0.7 ${\mu}g/kg$) and processed food (4.4 ${\mu}g/kg$). The mean and 95th percentile for exposure to dietary mercury were 4.29 and 12.48 ${\mu}g/day$, corresponding to 13.6% and 39.7% of PTWI (Provisional Tolerable Weekly Intake), respectively. Therefore, overall level of mercury exposure for Koreans through food intake is below levels recommended by JECFA, indicating the least possibility of risk, and is less than or similar to levels reported in other countries.

Bioequivalence of EtodolTM Tablet to KuhnillodineTM Tablet (Micronized Etodolac 200 mg) (건일로딘 정(미결정에토돌락 200 mg)에 대한 에토돌 정의 생물학적동등성)

  • Lee, Jung-Ae;Lee, Yun-Young;Cho, Tae-Seob;Park, Young-Joon;Moon, Byoung-Seok;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.4
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    • pp.319-325
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    • 2004
  • A bioequivalence of $Etodol^{TM}$ tablets (Yuhan corporation) and $Kuhnillodine^{TM}$ tablets (Kuhnil Pharm. Co., Ltd.) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Single 200 mg dose of etodolac of each medicine was administered orally to 24 healthy male volunteers. This study was performed in a $2{\times}2$ crossover design. Concentrations of etodolac in human plasma were monitored by a high-performance liquid chromatography. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was performed using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Etodol^{TM}/Kuhnillodine^{TM}$ were 1.01-1.10 and 0.87-1.06, respectively. This study demonstrated a bioequivalence of $Etodol^{TM}$ and $Kuhnillodine^{TM}$ with respect to the rate and extent of absorption.

Bioequivalence of BestidineTM Tablet to Dong-A GasterTM Tablet (Famotidine 20 mg) (동아가스터 정(파모티딘 20 mg)에 대한 베스티딘 정의 생물학적동등성)

  • Park, Chang-Hun;Joung, Sun-Koung;Choi, Mee-Hee;Kim, Ho-Hyun;Lee, Ye-Rie;Lee, Hee-Joo;Lee, Kyung-Ryul
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.505-511
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    • 2004
  • A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.