• Title/Summary/Keyword: Korea Food Drug Administration

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Residues Amounts of Cypermethrin and Diethofencarb in Ginseng Sprayed by Safe Use Guideline (살충제 Cypermethrin 및 살균제 Diethofencarb의 살포방법에 따른 인삼 중 잔류)

  • Lee, Ju-Hee;Kim, Young-Hwan;Jeon, Young-Hwan;Shin, Kab-Sik;Kim, Hyo-Young;Kim, Tae-Hwa;Park, Chan;Yu, Yong-Man;Kim, Jang-Eok
    • Korean Journal of Environmental Agriculture
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    • v.28 no.4
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    • pp.412-418
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    • 2009
  • This study is conducted in order to know the residue patterns of insecticide cypermethrin and fungicide diethofencarb in ginseng sprayed by various application methods. Two pesticides were sprayed separately on ginseng using traditional, soil and vinyl mulching applications. The vinyl mulching application was that head part of ginseng protected from pesticides. When cypermethrin was sprayed on ginseng by traditional application, its residue amount in ginseng was 0.25 mg/kg which exceeded 0.1 mg/kg, maximum residue limit(MRL) established by Korea Food & Drug Administration(KFDA). But in case of vinyl mulching and soil application, its residue amounts were 0.04 and 0.07 mg/kg, respectively. The residue amount of diethofencarb in ginseng was 3.01 mg/kg which exceeded the MRL, 0.3 mg/kg. Further, in case of vinyl mulching and soil application, its residue amounts were 1.71 and 9.39 mg/kg which exceeded the MRL 0.3 mg/kg. Although the residue amounts of both pesticides exceeded the MRLs for ginseng, we can explain that pesticides remained in head part of ginseng is probably the reason why higher pesticides residue levels were observed.

Selection and Characteristics of Bacteriocin-Producing Microorganism to Utilize in Anti-Bacterial Rice Brain Protein Film Production (항균성 미강 단백질 필름 개발을 위한 Bacteriocin 생성균주의 선별 및 특성)

  • Kim, Eun-Joung;Kim, Kyung-Mi;Han, Hye-Kyung;Kim, Young-Ho;Kwon, Ki-Sung;Bae, Dong-Ho
    • Applied Biological Chemistry
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    • v.46 no.4
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    • pp.285-290
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    • 2003
  • This study was conducted to select the bacteriocin-producing microoreanism cultivated in the rice bran culture and to characterize the produced bacteriocin for the further purpose of economical and anti-bacterial rice bran protein film. Pseudomonas putida 21025 was cultivated from rice bran and identified as a producer of a bacteriocin which showed bactericidal activity against Pseudomonas aeruginosa 9027. Bacteriocin produced by Pseudomonas putida 21025 showed a broad spectrum of activity against spoilage and soil bacteria. The activity of the bacteriocin produced by Pseudomonas putida 21025 decreased after 1 hr of staying at the temperature of $50^{\circ}C$, and with the presence of some organic solvents, except hexane and ethanol. However, the bacteriocin activity was stable throughout the pH ranges of 6-9 for 2 hrs, at the temperature lower than $50^{\circ}C$, and with the presence of ethanol for 3 hrs. The bacteriocin was partially purified by 50% ammonium sulfate precipitation followed by subsequent dialysis. Direct detection of the partially purified bacteriocin on SDS-PAGE suggested that it had an apparent molecular mass of about 21.6 kDa.

Comparison of Analytical Methods for DEHP Migration from PVC Bags for Blood Storage and Infusion; By Gas Chromatography and UV-vis Spectrophotometry (혈액·수액용 PVC 백에서 용출된 DEHP의 검출 분석 방법 비교; 기체 크로마토그래프와 분광 광도계)

  • Kim, Jung Hwan;Kim, Seong Hun;Choi, Hyeong Ki;Lee, Chang Hyung
    • Analytical Science and Technology
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    • v.15 no.1
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    • pp.72-79
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    • 2002
  • Di-(2-ethylhexyl)phthalate (DEHP) may be released from plasticized poly(vinyl chloride) (PVC) articles. In the cases of various methods for the quantitative analysis of migrating DEHP, there are much differences in migrating quantity according to the experimental methods. It is therefore important to make the comparison and analysis between these two results. A study of DEHP migration from blood and infusion bags has been carried out in different methods to evaluate the amount of DEHP migration using gas chromatograph and UV-vis spectrophotometry. Five PVC bags were cut into plane sheets in size of $40{\times}10{\times}0.4mm$, then were immersed in extraction solvent for an hour to release DEHP. It was determined by a gas chromatograph that $23.2{\sim}70.9{\mu}g/mL$ of DEHP was extracted. While extraction solvent was injected into PVC bags which were then placed for an hour to leach DEHP out. It was checked by a UV-vis spectrophotometer that the concentration of DEHP in extraction solvent was $24.8{\sim}41.3{\mu}g/mL$. Two results show different values according to the extraction conditions and experimental methods and the gas chromatographic results were converted into UV-vis spectroscopic results on condition that DEHP would be extracted equally per unit time and unit contact area. It was concluded that DEHP migrating amounts are approximately equal in two analytical methods.

Bioequivalence of Kuhnil Propiverine Hydrochloride Tablet to BUP-4 Tablet (Propiverine Hydrochloride 20 mg) (비유피-4 정(염산프로피베린 20 mg)에 대한 건일염산프로피베린 정의 생물학적동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Kim, Se-Mi;Park, Chan-Ho;Oh, In-Joon;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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    • pp.419-425
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two propiverine hydrochloride tablets, BUP-4 (Jeil Pharm. Co., Ltd.) and Kuhnil Propiverine Hydrochloride (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The propiverine release from the two propiverine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solutions, water and blend of polysorbate 80 into pH 6.8). Twenty six healthy male subjects, $23.73{\pm}2.79$ years in age and $67.04{\pm}7.93\;kg$ in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 20 mg as propiverine hydrochloride was orally administered, blood was taken at predetermined time intervals and the concentrations of propiverine in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t,\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the BUP-4 were 0.17%, 7.98% and 4.55% for $AUC_t,\;C_{max}\;and\;T_{max}$. respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.88){\sim}log(1.l2)\;and\;log(0.90){\sim}log(1.l5)\;for\;AUC_t\;and\;C_{max},\;respectively)$. Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil Propiverine Hydrochloride tablet was bioequivalent to BUP-4 tablet.

Downward Decrease of Non-adrenergic Non-cholinergic Relaxation in the Rabbit Gastric Body (토끼 위체에서 비-아드레날린 비-콜린성 이완반응의 하행성 감소)

  • Hong, Eun-Ju;Choi, Ji-Eun;Park, Mi-Sun;Kim, Myung-Woo;Choi, Su-Kyung;Hong, Sung-Cheul
    • YAKHAK HOEJI
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    • v.41 no.3
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    • pp.389-398
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    • 1997
  • Non-adenergic non-cholinergic (NANC) innervation on the circular muscle of the rabbit gastric body was investigated by observing the magnitudy of relaxations induced by the elec trical field stimulation (EFS). Strips were cut from the greater curvature of the gastric body and stimulated with 5s trains of 0.5 ms pulses at 1-20 Hz, 40 V. The EFS induced transient frequency-dependent contractons, followed by a slowly recovering relaxation ewpecially at higher frequency of the EFS. In the presence of atropine and guanethidine, the contractions were virtually abolished, while the frequency-dependent relaxations by the EFS remained unaffected. The magnitude of relaxations progressively decreased as the location of the strips gets closer to the bottom of the gastric body. The relaxations were ablished by tetrodotoxin, indicating that their orgin is the NANC nerve stimulation. NG-nitro-L-arginine (L-NNA, 10-$100{\mu}M$), the inhibitor of nitric oxide (NO)-synthase, caused a concentration-dependent inhibition of the NANC relaxations. The inhibitory effects of L-NNA were not affected gy the location of the strips and were reversed by L-arginine, the precursor of NO-biosynthesis. Hemoglobin (20-$60{\mu}M$), a NO scavenger, inhibited the NANC relaxation s in a concentration-dependent manner. This inhibition was more prominent in the NANC relaxations observed in the lower portion of the gastric body and the relaxations induced ly lower frequencies of the EFS. Methyelne blue (10-$100{\mu}M$), an inhibitor of cytosolic guanylate cyclase, markedly inhibited the NANC relaxations, almost abolishing the response at a higher dose ($100{\mu}M$). These results suggest that NANX innervation of the rabbit gastric body progeressively decrease as he location of the strips gets closer to the bottom of the gastric body, and that the NANC relaxation is primarily mediated by NO-guanosine 3',5'-cyclic monophophate (cyclic GMP).

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Effects of Artemisia capillaris Methanol Extract on Organs in Tumor Cells Inoculated Mice Observed the Histopathology and Histomorphometry (조직병리학 및 Histomorphometry 기법으로 관찰한 종양 유발 마우스의 주요 장기에 인진쑥 Methanol 추출물이 미치는 영향)

  • Kim, Hong-Tae;Ku, Sae-Kwang;Kim, Ju-Wan;Jin, Tae-Won;Lim, Mee-Kyung;Kim, Ji-Eun;Chang, Hye-Sook;Yeo, Sang-Geon;Jang, Kwang-Ho;Oh, Tae-Ho;Lee, Keun-Woo
    • Journal of Veterinary Clinics
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    • v.25 no.4
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    • pp.249-256
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    • 2008
  • This experiment was conducted to investigate antitumor and immunomodulatory effects of Artemisia capillaris extracts against Hepa-lc1c7 and Sarcoma 180 cancer cells. In in vivo experimental tests using 210 ICR mice, on the $28^{th}$ day and the $42^{nd}$ day, all animals in vehicle controled HP (Hepa-lclc7 tumor cell inoculated vehicle control) and SP (Sarcoma 180 tumor cell inoculated vehicle control) showed tumor cells in the liver and spleen based on the histopathology. However, the incidences and the percentages of regions occupied by tumor cells were dramatically and dose-dependently decreased by mACH (Artemisia capillaris methanol extracts) treatment on the histomorphometry. Although the exact mechanism of inhibition of the incidences of tumor cells in the parenchyma whether inhibition of metastasis or proliferation is unclear, mACH dramatically reduce the percentages of regions occupied by tumor cells in the liver and spleen apart from the inoculation sites of Hepa-lclc7 and Sarcoma 180. In addition, they also effectively inhibit the abnormal changes on the kidney detected in the present study. The results suggest that Artemisia capillaris methanol extracts have prominent antitumor effects on the cancer cell lines Hepa-lclc7 and Sarcoma 180 m mice.

Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial (생물학적 동등성 시험을 위한 2×k 교차설계법의 통계적 고려)

  • Noh, So-Young;Park, Sang-Gue
    • The Korean Journal of Applied Statistics
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    • v.26 no.4
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    • pp.675-686
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    • 2013
  • The Korea Food and Drug Administration(KFDA) recommends the use of a $2{\times}2$ crossover design to assess the bioequivalence of generic drugs. However, a standard $2{\times}2$ crossover design for bioequivalence trials is often considered problematic due to ethical and economic issues as highly variable drugs are usually required by large numbers of subjects when designing the trial. To overcome this problem a $2{\times}4$ crossover design has been a recommended option as per US regulations; in addition, a $2{\times}3$ crossover design has also recently drawn special attention as an efficient alternative. The current KFDA regulation requires an ANOVA table for every bioequivalence study; however, ANOVA tables of $2{\times}4$ and $2{\times}3$ crossover designs have never been published in the literature. This study shows the derivation of tables of analysis of variance for a $2{\times}4$ cross-over design and a $2{\times}3$ cross-over design. We also suggest a sample size formulas for $2{\times}2$, $2{\times}4$ and $2{\times}3$ crossover designs to provide information on the selection of efficient designs for highly variable drugs.

Determination of Quality Factors for Cylindrical Ionization Chambers in kV X-rays: Review of IAEA Dosimetry Protocol and Monte Carlo Calculations and Measurements for N23333 and N30001 Chambers (kV X-선에서 원통형전리함의 선질인자 결정에 관한 연구: IAEA 프로토클 고찰과 N23333, N30001 전리함에 대한 몬테칼로 계산 및 측정)

  • Lee Kang Kyoo;Lim Chunil;Chang Sei Kyung;Moon Sun Rock;Jeong Dong Hyeok
    • Progress in Medical Physics
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    • v.16 no.2
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    • pp.53-61
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    • 2005
  • The quality factors for cylindrical ionization chambers for kV X-rays were determined by Monte Carlo calculation and measurement. In this study, the X-rays of 60-300 kV beam (lSO-4037) installed in KFDA and specified in energy spectra and beam qualities, and the chambers of PTW N23333 and N30001 were investigated. In calculations, the $R_{\mu}\;and\;R_{Q,Q_{0}}$ in IAEA dosimetry protocols were determined from the air kerma and the cavity dose obtained by theoretical and Monte Carlo calculations. It is shown that the N30001 chamber has a flat response of $\pm1.7\%$ in $110\~300kV$ region, while the response range of two chambers were shown to $\pm3\~4\%$ in $80\~250kV$ region. From this work we have discussed dosimetry protocol for the kV X-rays and we have found that the estimation of energy dependency is more important to apply dosimetry protocol for kV X-rays.

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Research on Outcome Indicators in Clinical Trials of Asthma, Cough, and Sputum by Reviewing Papers Searched from PubMed (해외논문고찰을 통한 천식 및 기침${\cdot}$가래 치료제의 유효성 평가지표 개발연구)

  • Oh, Mi-Hyune;Lee, Ji-Hyung;Jang, Bo-Hyoung;Jung, Sung-Ki;Sun, Seung-Ho;Ko, Ho-Yeon;Jun, Chan-Yong;Park, Jong-Hyeong;Ko, Seong-Gyu
    • The Journal of Internal Korean Medicine
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    • v.28 no.3
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    • pp.519-530
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    • 2007
  • Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

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Mouse Single Oral Dose Toxicity Test of Taraxaci Herba Aqueous Extracts (포공영(蒲公英) 추출물의 마우스 단회 경구투여 독성 실험)

  • Gu, Ja-Hwan;Kim, Se-Ran;Lee, Jin-Won;Park, Mee-Yeon;Choi, Hae-Yun;Kim, Jong-Dae
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.25 no.4
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    • pp.650-657
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    • 2011
  • The object of this study was to obtain acute information (single oral dose toxicity) of Taraxaci Herba (Dried total parts of Taraxacum platycarpum. H.Dahlstedt (Compositae)), has been traditionally used in Korean medicine for treating various inflammatory diseases. In order to observe the 50% lethal dose (LD 50), approximate lethal dosage (ALD) and target organs, test articles were once orally administered to female and male ICR mice at dose levels of 2,000, 1,000, 500 mg/kg according to the recommendation of Korea Food and Drug Administration Guidelines. The mortality and changes on body weight, clinical signs and gross observation were monitored during 14 days after single oral treatment of Taraxaci Herba aqueous extracts according to KFDA Guidelines with organ weights and histopathological observations of 12 types of principle organs. After single oral treatment of Taraxaci Herba aqueous extracts, we could not find any mortality and toxicological evidences up to 2,000 mg/kg treated group, the limited dosages in rodents at body and organ weights, clinical signs, gross and histopathological observations. Except for slight soft feces, which were detected in male mice treated with 2,000 mg/kg of Taraxaci Herba aqueous extracts at 1 day after end of treatment. The results obtained in this study suggest that the LD 50 and ALD of Taraxaci Herba aqueous extracts in both female and male mice after single oral treatment were considered as over 2,000 mg/kg because no mortalities were detected up to 2000 mg/kg that was the highest dose recommended by KFDA and OECD. However, it also observed that the possibility of digestive disorders, like diarrhea when administered over 2,000 mg/kg of Taraxaci Herba aqueous extracts in the present study, but these possibilities of digestive disorders can be disregard in clinical use because they ate transient in the highest dosages male only.