• Title/Summary/Keyword: food safety regulation

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Analysis of Clinical Research Trends in Korean Medicine : Using a Clinical Research Information Service(CRIS) of Korea Centers for Disease Control & Prevention(KCDC) (질병관리본부 임상연구정보서비스(CRIS)를 활용한 한의약 임상연구 동향 분석)

  • Jang, Hye-Kyoung;Jung, In Chul;Park, So Jung;Park, Yang Chun
    • Journal of Society of Preventive Korean Medicine
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    • v.24 no.2
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    • pp.43-55
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    • 2020
  • Objectives : The general and specific characteristics inherited in Korean traditional medicine research is to be identified and on the basis of this, the role of researchers, research institutes and government organizations is to be presented. Method : Analysis data targeted 399 cases of traditional medicine researches out of 696 cases, excluding overlapped 297 cases, that are relevanttokey-words, 'Oriental Medicine' and 'Herbal Prescription' registered in the National Institutes of Health Clinical Research Information Service(CRIS) as of 31 December, 2019. Including the regulation of the Ministry of Food and Drug Safety, research fund supporting, type of mediation, targeting disease and so forth, frequency analysis was carried out in order to confirm the general and specific characteristics of traditional medicine. Results : As a result of analyzing the data, researches of medicines(herbal medicines) and mediation(acupuncture, moxibustion) and were identified as the most and in the case of the targeting disease, it appeared in the order of targeting the research on musculoskeletal system and the healthy person.

Seasonal variation of physicochemical factor and fecal pollution in the Hansan-Geojeman area, Korea

  • Park, Young Cheol;Kim, Poong Ho;Jung, Yeoun Joong;Lee, Ka Jeong;Kim, Min Seon;Go, Kyeong Ri;Park, Sang Gi;Kwon, Soon Jae;Yang, Ji Hye;Mok, Jong Soo
    • Fisheries and Aquatic Sciences
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    • v.19 no.4
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    • pp.17.1-17.9
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    • 2016
  • The seasonal variation of fecal coliforms (FCs) and physicochemical factors was determined in seawaters of the Hansan-Geojeman area, including a designated area for oyster, and in inland pollution sources of its drainage basin. The mean daily loads of FCs in inland pollution sources ranged from $1.2{\times}10^9$ to $3.1{\times}10^{11}$ most probable number (MPN)/day; however, the pollutants could not be reached at the designated area. FC concentrations of seawaters were closely related to season, rainfall, and inland contaminants, however, within the regulation limit of various countries for shellfish. The highest concentrations for chemical oxygen demand (COD) and $chlorophyll-{\alpha}$ in seawaters were shown in the surface layer during August with high rainfall, whereas the lowest for dissolved oxygen (DO) in the bottom layer of the same month. Therefore, it indicates that the concentrations of FC, COD, DO, and $chlorophyll-{\alpha}$ of seawaters were closely related to season and rainfall.

Single-dose Intramuscular-injection Toxicology Test of Water-soluble Carthami-flos and Cervi cornu parvum Pharmacopuncture in a Rat Model

  • Park, Sunju;Sun, Seung-Ho
    • Journal of Pharmacopuncture
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    • v.18 no.3
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    • pp.42-48
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    • 2015
  • Objectives: The aim of the study is to investigate both the single-dose intramuscular injection toxicity and the approximate lethal dose of water-soluble Carthami-flos and Cervi cornu parvum pharmacopuncture (WCFC) in male and female Sprague-Dawley (SD) rats. Methods: The study was conducted at Biotoxtech Co. according to the Good Laboratory Practice (GLP) regulation and the toxicity test guidelines of the Ministry of Food and Drug Safety (MFDS) after approval of the Institutional Animal Care and Use Committee. Dosages for the control, high dose, middle dose and low dose groups were 0.5 mL/animal of saline and 0.5, 0.25 and 0.125 mL/animal of WCFC, respectively. WCFC was injected into the muscle of the left femoral region by using a disposable syringe (1 mL, 26 gauge). The general symptoms and mortality were observed 30 minutes, 1, 2, 4, and 6 hours after the first injection and then daily for 14 days after the injection. The body weights of the SD rats were measured on the day of the injection (before injection) and on the third, seventh, and fourteenth days after the injection. Serum biochemical and hematologic tests, necropsy examinations, and histopathologic examinations at the injection site were performed after the observation period. Results: No deaths, abnormal clinical symptoms, or significant weight changes were observed in either male or female SD rats in the control or the test (0.125, 0.25, and 0.5 mL/animal) groups during the observation period. No significant differences in hematology and serum biochemistry and no macroscopic abnormalities at necropsy were found. No abnormal reactions at injection sites were noted on the topical tolerance tests. Conclusion: The results of this single-dose toxicity study show that WCFC is safe, its lethal doses in male and female SD rats being estimated to be higher than 0.5 mL/animal.

Fusarium graminearum의 ZEB2 동형단백질에 의한 지랄레논 생합성 자가조절

  • Park, Ae Ran;Lee, Yin-Won
    • 한국균학회소식:학술대회논문집
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    • 2016.05a
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    • pp.27-27
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    • 2016
  • The ascomycete fungus Fusarium graminearum is the most common pathogen of Fusarium head blight (FHB), a devastating disease for major cereal crops worldwide. FHB causes significant crop losses by reducing grain yield and quality as well as contaminating cereals with trichothecenes and zearalenone (ZEA) that pose a serious threat to animal health and food safety. ZEA is a causative agent of hyperestrogenic syndrome in mammals and can result in reproductive disorders in farm animals. In F. graminearum, the ZEA biosynthetic cluster is composed of four genes, PKS4, PKS13, ZEB1, and ZEB2, which encode a reducing polyketide synthase, a nonreducing polyketide synthase, an isoamyl alcohol oxidase, and a transcription factor, respectively. Although it is known that ZEB2 primarily acts as a regulator of ZEA biosynthetic cluster genes, the mechanism underlying this regulation remains undetermined. In this study, two isoforms (ZEB2L and ZEB2S) from the ZEB2 gene in F. graminearum were characterized. It was revealed that ZEB2L contains a basic leucine zipper (bZIP) DNA-binding domain at the N-terminus, whereas ZEB2S is an N-terminally truncated form of ZEB2L that lacks the bZIP domain. Interestingly, ZEA triggered the induction of both ZEB2L and ZEB2S transcription. In ZEA producing condition, the expression of ZEB2S transcripts via alternative promoter usage was directly or indirectly initiated by ZEA. Physical interaction between ZEB2L and ZEB2L as well as between ZEB2L and ZEB2S was observed in the nucleus. The ZEB2S-ZEB2S interaction was detected in both the cytosol and the nucleus. ZEB2L-ZEB2L oligomers activated ZEA biosynthetic cluster genes, including ZEB2L. ZEB2S inhibited ZEB2L transcription by forming ZEB2L-ZEB2S heterodimers, which reduced the DNA-binding activity of ZEB2L. This study provides insight into the autoregulation of ZEB2 expression by alternative promoter usage and a feedback loop during ZEA production.

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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.

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.

An Investigation of the Hazards Associated with Cucumber and Hot Pepper Cultivation Areas to Establish a Good Agricultural Practices (GAP) Model (오이와 고추생산 환경에서의 GAP 모델 개발을 위한 위해요소 조사)

  • Shim, Won-Bo;Lee, Chae-Won;Jeong, Myeong-Jin;Kim, Jeong-Sook;Ryu, Jae-Gee;Chung, Duck-Hwa
    • Korean Journal of Food Science and Technology
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    • v.46 no.1
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    • pp.108-114
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    • 2014
  • To analyze the hazards associated with cucumber and hot pepper cultivation areas, a total of 72 samples were obtained and tested to detect the presence of biological (sanitary indicative, pathogenic bacteria and fungi) and chemical hazards (heavy metals and pesticide residues). The levels of sanitary indicative bacteria (aerobic plate counts and coliforms) and fungi were ND-7.2 and ND-4.8 log CFU/(g, mL, hand, or $100cm^2$) in cucumber cultivation areas, and ND-6.8 and 0.4-5.3 log CFU/(g, mL, hand, or $100cm^2$) in hot pepper cultivation areas. More specifically, the soil of hot pepper cultivation areas was contaminated with coliforms at a maximum level of 5.6 log CFU/g. Staphylococcus aureus was detected only in glove samples at a level of 1.4 log CFU/$100cm^2$ and Bacillus cereus was detected in the majority of samples at a level of ND-4.8 log CFU/(g, mL, hand, or $100cm^2$). Listeria monocytogenes, Escherichia coli O157:H7, and Salmonella spp. were not detected. Heavy metal (Zn, Cu, Ni, Pb, and Hg) chemical hazards were detected at levels lower than the regulation limit. Residual insecticides were not detected in cucumbers; however, hexaconazole was detected at a level of 0.016 mg/kg (maximum residue limit: 0.3 mg/kg) in hot peppers.

Monitoring and Risk Assessment of Pesticide Residues in Herbal Medicines in Incheon (인천광역시 유통 한약재의 잔류농약 실태 조사 및 위해평가)

  • Min-jeong Kang;Sung-Hee Kwon;Sun-Hoi Kim;Mi-Sook Yeom;Byung-Kyu Park;Hee-jeong Lee;Ji-Hyeung Kim;Kwang-sig Joo;Myung-je Heo;Mun-ju Kwon
    • Journal of Food Hygiene and Safety
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    • v.39 no.2
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    • pp.118-127
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    • 2024
  • This study investigated the levels of 345 pesticide residues in 50 herbal medicines sold in Incheon metropolitan city to determine their safety. Pesticide residues are harmful substances that can cause serious health problems owing to their toxicity and carcinogenicity. The analysis of pesticide residues in the samples was conducted using the quick, easy, cheap, effective, rugged, and safe (QuEChERS) method, known for its high analysis efficiency, to analyze a wide range of pesticides for which no standards have been set. The analysis was cross-validated with the pretreatment method outlined in the Korea Pharmacopoeia. Among the 50 samples encompassing 24 different herbs, 22 pesticide residues were detected in 24 samples, covering 7 distinct herbs, resulting in a detection rate of 48%. It is noteworthy that, except for two cases, all detected pesticides were those for which no standards were set. However, after conducting a risk evaluation considering the daily dosage of herb, it was determined that the levels of pesticide residues were within safe limits. Pesticides with high frequency within the same category of herbs were detected, indicating the necessity for continuous monitoring and regulation. In addition, comparative analysis using the pretreatment method outlined in the Korean Pharmacopoeia, yielded similar results, suggesting the possibility of analyzing pesticide residues in herbs using the QuEChERS method. The study emphasizes the importance of continuous monitoring of pesticide residues in herbs and the development of high-efficiency reliability analysis methods should continue to ensure consumer safety.

Safety Evaluation of Recombinant Human Factor VIII(GC-γ AHF) (유전자 재조합 Human Factor VIII(GC-γ AHF)의 안전성에 관한 연구)

  • 김민영;손장원;신민기;배미옥;김현우;최진혁;김준성;문서현;김정현
    • Toxicological Research
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    • v.18 no.1
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    • pp.87-98
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    • 2002
  • This study was conducted to evaluate the safety of a recombinant human Factor VIII(GC-$\gamma$ AHF) manufactured by Korea Green Cross Company with different technology according to the Regulation of Korean Food and Drug Administration (l 998. 12. 3). In acute toxicity test, both genders of Sprague-Dawley rats and Beagle dogs were administered intravenously with GC-$\gamma$ AHF of three doses (3,125, 625 and 125 IU/kg), and single dose of 3,125 IU/kg, respectively. No dead animal and abnormal autopsy findings were found in Control and GC-$\gamma$ AHF treated group. Therefore, the 50% lethal dose ($LD_{50}$) of GC-$\gamma$ AHF was conidered to be higher than 3,125 IU/kg in rats and dogs. In the four weeks repeated intravenous toxicity study, GC-$\gamma$ AHF was administrated intravenosly to both genders of rats and dogs with 3 doses (500, 150, 50 IU/kg). There were neither dead animals nor significant changes of body weights during the experimental Period. In addition, no significant GC-$\gamma$ AHF related changes were found in clinical sign, urinalysis and other finding. Statistically changes were observed in hematological, biochemical and organ weight parameters of treated groups: however these changes were not dose dependent. No histopathological lesion were observed in both control and treated animals. Above data suggest that no observed adverse effect level of test materials in rats and dogs might be over 500 IU/kg/day in this study. In ocular irritation test, any injury on iris, conjunctiva and cornea in rabbits were not observed. The acute ocular irritation index (A.O.I.), mean ocular irritation index (M.O.I.) and Day-7 individual ocular irritation Index (I.O.I.) of GC-$\gamma$ AHF were 0. In the primary skin Irritation test, the primary irritation index (P.I.I.) oj GC-$\gamma$ AHF were 0. Therefore, the GC-$\gamma$ AHF is considered not to have the primary skin and eye toxicity in rabbits. In active systemic anaphylaxis (ASA) test, GC-$\gamma$ AHF and GC-$\gamma$ AHF emulsified with Freund's complete adjuvant (FCA) did not induce any symptom of anaphylactic shock in guinea pigs. In passive cutaneous anaphylxis (PCA) test, after sensitization with antisera of GC-$\gamma$ AHF sensitized mice, blue spots were observed on the hypodermis of back of rats, but diameter of each spot was smaller than 5 mm in each test groups except the positive control group. Based on the results of this study, GC-$\gamma$ AHF is not conidered to have any antigenic potential. In conclusion, at levels of up to 500 IU/kg, GC-$\gamma$ AHF did not produce treatment-related toxicity under the conditions of these acute-, four week repeated-toxicity, primary skin and eye toxicity, and antigenicity test.

The Recent Trend of the National and International Standard of Manufacturing Quality Control for Diagnostic X-ray Equipment (진단용엑스선장치 제조품질관리에 관한 국내.외 규격의 동향)

  • Choi, In-Seok;Kim, Jung-Min;Jeong, Hoi-Woun;Min, Jung-Whan;Lee, In-Su
    • Journal of radiological science and technology
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    • v.32 no.1
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    • pp.1-15
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    • 2009
  • Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

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