• Title/Summary/Keyword: KFDA

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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- (16종 다용한약재의 산지별 As, Cd, Pb, Co, Cr 농도 및 특성고찰 -한국과 중국산의 평균농도, 최소-최대농도와 법적 허용농도초과비율을 중심으로-)

  • Kim, Kee-Dong;Park, Hae-Mo;Seo, Yong-Chan;Lee, Sun-Dong
    • Journal of Society of Preventive Korean Medicine
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    • v.16 no.3
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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.

A 6-Week Oral Toxicity Study of Oral Cholera Vaccine in Sprague-Dawley Rats

  • Baek, Yeong-Ok;Choi, Seuk-Keun;Shin, Seo-Ho;Koo, Kyo-Hwan;Choi, Ho-Young;Cha, Seung-Bum;Li, Yong-Chun;Yoo, Hyeon-Jeong;Lee, Joo-Young;Kil, Ki-Hyun;Kim, Hak-Soo;Kang, Min-Soo;Kang, Boo-Hyun;Kim, Kap-Ho;Bae, Jin-Sook
    • Toxicological Research
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    • v.28 no.4
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    • pp.225-233
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    • 2012
  • The present study was carried out to examine the toxicity and target organs of oral cholera vaccine (OCV) after repeated oral administration in Sprague-Dawley rats for 6 weeks (3 administrations, once every 2 weeks). OCV is an inactivated oral cholera vaccine that contains Vibrio cholerae and confers protection against cholera caused by V. cholera serogroups O1 (Inaba and Ogawa serotypes) and O139 (strain 4260B). The animals were orally administered either OCV placebo (negative control) or OCV at a dose equivalent to 240 times the anticipated human dose. Throughout the administration period, no significant change was detected in clinical signs, body weight, food or water consumption, urinalysis results, hematological and clinical biochemistry test results, organ weights, necropsy, or histopathological examination results. Minor changes were found in hematological and clinical biochemistry tests; however, these changes were within normal ranges. The above results suggest that oral administration of OCV in rats did not induce any toxicologically meaningful changes, and the target organs could not be determined. This study was conducted in accordance with the guidelines established by Good Laboratory Practice (2009-183, KFDA, December 22, 2009) and the OECD Principles of Good Laboratory Practice (1997).

Bioequivalence Evaluation of the Cisapride Formulation Produced by Dong Wha Pharmaceutical Co. (동화약품 시사프리드제제의 생물학적 동등성 평가)

  • 윤광희;박진영;박선주;조은희;유제만;김경식;정석재;이민화;심창구
    • Biomolecules & Therapeutics
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    • v.7 no.1
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    • pp.59-65
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    • 1999
  • A bioequivalence study of the Dong Wha Cisapril tablets(Dong Wha Pharm. Ind. Co., Ltd.) to the Prepulsid tablets(Janssen Korea Ltd.), formulations of cisapride, was conducted. Twenty four healthy Korean male subjects received each formulation at the dose of 5 mg as cisapride in a 2$\times$2 crossover study. There was a 1-week washout period between the doses. Plasma concentrations of cisapride were monitored by an LC/MS method for over a period of 36 h after each administration. AUC(area under the plasma concentration- time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 6.8, -6.6 and 1.8% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences(%) at $\alpha$=0.05 and 1-$\beta$=0.8 were all less than 20% in these parameters between the formulations (i.e., 16.5, 11.4 and 16.4% for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within 20% (i.e., -2.9~ 16.4, -13.2~0.1 and -7.8~ 11.4% for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the two formulations of cisapride are bioequivalent and, thus, may be prescribed interchangeably.hangeably.y.hangeably.

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Bioequivalence of Shinil Cefadroxil Capsule to Duricef Capsule (cefadroxil 500 mg) (듀리세프 캅셀(세파드록실 500 mg)에 대한 신일 세파드록실 캅셀의 생물학적 동등성)

  • 유호정;최민구;김경식;정석재;심창구
    • Biomolecules & Therapeutics
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    • v.10 no.4
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    • pp.303-308
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    • 2002
  • A bioequivalence study of Shin II Cefadroxil capsule (Shin II Pharm. Co. Ltd.) to Duricef capsule(Bo Ryung Pharm. Co. Ltd.), each containing 500 mg of cefadroxil, was conducted. Twenty three healthy Korean male subjects administered each formulation at the dose of 1 capsule (500 mg as cefadroxil) in 2 $\times$ 2 cross-over study. There was a I-week washout period between the doses. Plasma concentrations of cefadroxil were monitored for a period of 8 hr after each administration by an LC/UV method. Area under the plasma concentration-time curve up to 8 hr ($AUC_t$) was calculated by a linear trapezoidal method. $C_{max}$ was compiled from the plasma drug concentration-time data. ANOVA test was conducted for logarithmically transformed $AUC_t$ and $C_{max}$ The results showed that there are no significant differences in $AUC_t$ and $C_{max}$ between the two formulations: The differences between d1e formulations in these log transformed parameters were all for less than 20% (i.e., -0.57%, 3.84% for $AUC_t$ and $C_{max}$, respectively). The 90% confidence intervals for the log transformed data were within the acceptance range of log 0.8 to log 1.25 (i.e., log 0.94~log 1.04 and log 0.95~log 1.10 for $AUC_t$ and $C_{max}$, respectively). Based on d1e bioequivalence criteria of KFDA guidelines, the two formulations of cefadroxil were concluded to be bioequivalent.

Construction of a Knowledge Schema for Food Additive Information Using Ontology (온톨로지를 이용한 식품첨가물 정보 지식의 구축)

  • Kim, Eun-Kyoung;Kim, Yong-Gi
    • Journal of the Korean Institute of Intelligent Systems
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    • v.27 no.1
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    • pp.42-49
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    • 2017
  • Studies for efficient information retrieval and reuse of information resources using the ontology techniques are being in progress in various fields. In this paper, we build an ontology to provide a food additive information for consumers given by the KFDA and food safety information portal. Food additives were represented in OWL based knowledge using $Prot{\acute{e}}g{\acute{e}}$. We defined Class, Property, Relationships for providing food additives names, origins, purposes and basic information. In order to retrieve the information of the food additive, we built 679 instances with an ontology, and confirmed the results through DL Query queries. We can expect that the food additives ontology shown in this paper will help the integration and improvement of the information retrieval systems of the related fields in future.

Kinesin-1-dependent transport of the βPIX/GIT complex in neuronal cells

  • Shin, Eun-Young;Lee, Chan-Soo;Kim, Han-Byeol;Park, Jin-Hee;Oh, Kwangseok;Lee, Gun-Wu;Cho, Eun-Yul;Kim, Hyong Kyu;Kim, Eung-Gook
    • BMB Reports
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    • v.54 no.7
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    • pp.380-385
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    • 2021
  • Proper targeting of the βPAK-interacting exchange factor (βPIX)/G protein-coupled receptor kinase-interacting target protein (GIT) complex into distinct cellular compartments is essential for its diverse functions including neurite extension and synaptogenesis. However, the mechanism for translocation of this complex is still unknown. In the present study, we reported that the conventional kinesin, called kinesin-1, can transport the βPIX/GIT complex. Additionally, βPIX bind to KIF5A, a neuronal isoform of kinesin-1 heavy chain, but not KIF1 and KIF3. Mapping analysis revealed that the tail of KIF5s and LZ domain of βPIX were the respective binding domains. Silencing KIF5A or the expression of a variety of mutant forms of KIF5A inhibited βPIX targeting the neurite tips in PC12 cells. Furthermore, truncated mutants of βPIX without LZ domain did not interact with KIF5A, and were unable to target the neurite tips in PC12 cells. These results defined kinesin-1 as a motor protein of βPIX, and may provide new insights into βPIX/GIT complex-dependent neuronal pathophysiology.

Analysis of Scutellaria baicaleinsis Georgi (Scutellariae Radix) by LC-DAD and LC-ESI/MS

  • Yu, Youngbob;Choi, Pil-Son;Koo, Sungtae;Chang, Suhwan
    • Korean Journal of Plant Resources
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    • v.31 no.6
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    • pp.652-659
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    • 2018
  • In this study, baicalin, as a marker substance of Scutellariae Radix, was quantitatively analyzed by a high performance liquid chromatography-photodiode array detector (HPLC-DAD). We identified wogonoside, baicalein, and wogonin in the Scutellariae Radix by a high performance liquid chromatography-electrospray ionization-mass spectrometer (HPLC-ESI-MS). The baicalin was separated on a Xterra C18 column ($5{\mu}m$, $4.6{\times}250mm$) using mobile phase consisting of 38% acetonitrile in 0.68% phosphoric acid. The baicalin spectrum in the Scutellariae Radix extracts was coincided by comparing with UV-visible spectrum (200-550 nm) of baicalin standard in the library. The amount of baicalin in Scutellariae Radix was 10.46%, which is higher than KFDA's guideline. The marker substances of Scutellariae Radix showed a strong base peak $[M]^+$ in the positive detection mode following as; baicalin (m/z; $271[MH^+-sugar]^+$, $447[M+H]^+$), wogonoside (m/z; $285[MH^+-sugar]^+$, $461[M+H]^+$), baicalein (m/z; $271\;[M+H]^+$), wogonin (m/z; $285[M+H]^+$). These results are consistent with the fragment pattern and molecular weight of standard components from literature.

A Critical Review of 'Reconsideration about Nomenclature of Herbs Listed in the Korean Pharmacopoeia' ('대한민국약전에 수재된 식물성 한약재의 학명에 대한 재고' 의 논평)

  • Kim, Hui;Park, Soo Kyung;Chang, Kae Sun;Chang, Chin-Sung
    • The Korea Journal of Herbology
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    • v.28 no.5
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    • pp.29-31
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    • 2013
  • Objectives : 'Reconsideration about Nomenclature of Herbs Listed in the Korean Pharmacopoeia' was published by Doh and Lee with absolute misconception of nomenclature. A critical review of Doh and Lee's paper is given, to correct the confused the concept of nomenclature and to provide proper scientific name for taxa which are discussed. Methods : This paper discusses the proper usage, as mandated by the International Code of Nomenclature. Adherence to the rules described in this paper should reduce the present confusion in the nomenclature of scientific names listed in the Korean Pharmacopoeia. Results : Although Doh and Lee proposed four categories to correct the scientific names of the Korean Pharmacopoeia using available botanical databases, they failed to show how nomenclatural concepts are applicable due to misconception of legitimacy and the confusion about synonym. From a nomenclatural perspective, 'accepted name' or 'recommended name' is a subjective term which used to be employed for convenience in a certain databases or working group without nomenclatural meaning. Doh and Lee also pointed out the standardization of author citation. However, they missed the importance of author citation error such as basionym or validating authors. Conclusions : Doh and Lee were not able to solve nomenclatural problems of the Korea Pharmacopoeia due to lack of clarity on the nomenclature code. We strongly recommend that KFDA has to commence extensive nomenclatural review for the next revision of Korea Pharmacopoeia.

Single Oral Dose Toxicity Test of HBX-6 in Sprague-Dawley Rat (HBX-6의 Sprague-Dawley rat를 이용한 단회경구투여 독성시험)

  • Jin, Bo-Ram;Seo, Dong-Wook;Kim, Myoung-Seok;Lee, Kwang-Ho;Yoon, Il-Joo;Kim, Chang Eun;An, Hyo-Jin
    • The Korea Journal of Herbology
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    • v.33 no.1
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    • pp.71-76
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    • 2018
  • Objectives : This study was performed to investigate the single oral toxicity of HBX-6 in Sprague-Dawley (SD) rats. Methods : Twenty SD rats were randomly assigned to four groups of 5 rats each and were administrated singly to female and male SD rats, as an oral dose of 2000 mg/kg. HBX-6 is a newly combined Korean herbal medicine formula 30 % Ethanol extract derived from The Dongui Bogam. Now we are developing the prescription for the aim of improving benign prostatic hyperplasia (BPH) without undesirable side effects. HBX-6 is composed of nine medicinal herbs: Aconiti Lateralis Radix Preparata, Corni Fructus, Cistanchis Herba, Psoraleae Semen, Dendrobii Herba, Morindae Radix, Cuscutae Semen, Trigonellae Semen, Foeniculi Fructus. Animals were monitored for the mortality and changes in the body weight, clinical signs, gross observation and necropsy findings for the 14 days according to "Standard for Toxicity Study of Pharmaceuticals" of Korea Food and Drug Administration (KFDA) guideline and "Acute Oral Toxicity - Fixed Dose Procedure" of OECD Test Guideline. Results : We could not find any mortality. Compared with the control group, significant weight change was not observed in the experimental group. After administration, the more common symptoms were not observed. There were no gross abnormalities in all cases. Conclusions : Taken together, these results suggest that the approximate lethal dose of HBX-6 in both female and male SD rats were considered as over 2000 mg/kg.

Prediction Modeling through Quantification for Qualitative Variables (질적변수에 대한 계량화를 통한 사면붕괴 예측모형)

  • Na, Jong-Hwa;Yu, Hye-Kyung;Nam, Eun-Mi;Cho, Wan-Sup
    • Journal of Korea Society of Industrial Information Systems
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    • v.14 no.5
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    • pp.281-288
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    • 2009
  • The purpose of this paper is to provide the statistical models for landslide prediction through quantification and AHP methods. Quantification method is a statistical method of providing quantity to qualitative variables by analyzing the observed data. In this paper, we suggest the quantification process based on the results of cannonical correlation analysis. In contrast with the quantification method which is based on given data the AHP(Analytic Hierarchy Process) technique is a kind of method based on questionaire data which is usually taken from professionals. We analyze both the real data(provided from KIGAM) and questionaire data collected from professionals of various related area. We developed two kinds of evaluation table which provide the scores of land slide possibility and the logistic model providing the probability of occurring landslide. Finally we compare the performance and evaluate the stability of the suggested two models.