• Title/Summary/Keyword: food and drug

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Survey and Classification of Pharmaceutical Excipients (국내 의약품 첨가제 정보체계 연구)

  • Park, In-Sook;Park, Sang-Aeh;Kim, Eun-Jung;Park, Hyo-Min;Hong, Chong-Hui;Jnng, Joo-Yeon;Kim, Ho-Jung;Lee, Ji-Hyun;Han, Eui-Sik;Kang, Shin-Jung;Lee, Sun-Hee
    • Journal of Pharmaceutical Investigation
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    • v.36 no.4
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    • pp.239-243
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    • 2006
  • Due to the development of new dosage forms and the improvement or pharmaceutics, the pharmaceutical excipients have become more specified and diverse, and the reclassification on them became necessary. Also with the increasing interests on the kinds and usage amount, related provisions, and evaluation of the pharmaceutical excipients, the systemic and effective control of them was in its demand. Therefore, in this research, we provided the following information on excipients: the type, amount and specification. In order to provide the information, we investigated, analysed and summarized the excipients that are approved by KFDA and published $\ulcorner$Handbook of Pharmaceutical Excipients$\lrcorner$). This handbook is expected to be used as a reference in the development of the pharmaceutics and evaluation in them. As the importance of excipients in pharmaceutics are increasing, IPEC which consist of IPEC-America, IPEC-Europe and JPEC, PDG and ICH have tried to make an international harmonization on excipient. This current status was not an exception to Korea, therefore, the result of this research is expected to make a progress in the evaluation on the excipients to an advanced level.

Multi-class, Multi-residue Analysis of 59 Veterinary Drugs in Livestock Products for Screening and Quantification Using Liquid Chromatography-tandem Mass Spectrometry

  • Yu Ra Kim;Sun Young Park;Tae Ho Lee;Ji Young Kim;Jang-Duck Choi;Guiim Moon
    • Korean Journal of Environmental Agriculture
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    • v.41 no.4
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    • pp.288-309
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    • 2022
  • BACKGROUND: The objective of this study was to develop a comprehensive and simple method for the simultaneous determination of 59 veterinary drug residues in livestock products for safety management. METHODS AND RESULTS: For sample preparation, we used a modified liquid extraction method, according to which the sample was extracted with 80% acetonitrile followed by incubation at -20℃ for 30 min. After centrifugation, an aliquot of the extract was evaporated to dryness at 40℃ and analyzed using liquid chromatography combined with tandem mass spectrometry. The method was validated at three concentration levels for beef, pork, chicken, egg, and milk in accordance with the Codex Alimentarius Commission/Guidelines 71-2009. Quantitative analysis was performed using a matrix-matched calibration. As a results, at least 52 (77.6%) out of 66 compounds showed the proper method validation results in terms of both recovery of the target compound and coefficient of variation required by Codex guidelines in livestock products. The limit of quantitation of the method ranged from 0.2 to 1119.6 ng g-1 for all matrices. CONCLUSION(S): This method was accurate, effective, and comprehensive for 59 veterinary drugs determination in livestock products, and can be used to investigate veterinary drugs from different chemical families for safety management in livestock products.

Studies on Excipients for oral dosage forms of currently marketed drug products

  • Kang, Shin-Jung;Choi, Hyun-Ceol;Kim, Ho-Jeong;Park, Sang-Aeh;Kim, Ji-Sun;Kim, Tae-Hee
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.303.1-303.1
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    • 2003
  • Excipients of the drug products can sometimes affect the rate and extent of drug absorption. The changes in components or composition of them can also affect the pharmacological activity. So the quantity of excipients to be changed, the new excipients and atypically large amount of commonly used excipients should be considered as bioequivalence studies. (omitted)

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Genetic Analysis of Medicinal Plants in Adenophorae Radix Using DNA Barcode (DNA바코드를 활용한 사삼(沙蔘)의 종 감별)

  • Kim, Minkyeoung;Lee, Wookyu;Kim, Jaelim;Lee, Kiho;Choi, Yoorae;Kim, Jonghwan;Kang, Ilhyun;Kang, Juhye
    • Proceedings of the Plant Resources Society of Korea Conference
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    • 2019.10a
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    • pp.97-97
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    • 2019
  • 사삼(沙蔘, Adenophorae Radix)은 "대한민국약전외한약(생약)규격집(KHP)"에 잔대 Adenophora triphylla var. japonica Hara 또는 사삼(당잔대, A. stricta Miq.)의 뿌리로 수재되어 있으나, 형태학적으로 유사한 제니(모시대, A. remotiflorus Miquel), 층층잔대(윤엽사삼, A. tetraphylla (Thunb.) Fisch), 더덕 Codonopsis lanceolata (Sieb. et Zucc.)과 오 혼용 우려가 있어 이들을 구별하기 위한 종 감별법이 필요하다. 본 연구에서는 '사삼'과 오 혼용 우려가 있는 종들을 구별할 수 있는 유전자 마커 개발을 위하여 DNA 바코드로 활용되고 있는 유전자 부위를 분석하여 ITS (25%), atpB-rbcL (15%), atpF-atpH (14%), rpl16 (13%), trnL-F (10%), matK (9%), rpoC1 (7%)에서 변이율(percent of variable sites)을 확인하였다. 또한, 분석한 유전자 부위 중 종간 차이를 확인하기 용이한 matK 구간을 활용해 기원종인 잔대, 당잔대와 형태적으로 유사하여 오 혼용될 우려가 있는 층층잔대, 모시대 및 더덕을 감별 할 수 있는 유전자 마커를 개발하였다. 본 연구를 통해 얻어진 염기서열과 분자 마커는 '사삼'의 품질관리에 유용하게 활용 가능할 것으로 사료된다.

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Development of DNA Molecular Markers for the Discrimination of Adenophorae Remotiflori Radix Based on the DNA Analysis (DNA 분석을 이용한 제니(薺苨) 유전자 마커 개발)

  • Kim, Minkyeoung;Lee, Wookyu;Kim, Jaelim;Lee, Kiho;Choi, Yoorae;Kim, Jonghwan;Kang, Ilhyun;Kang, Juhye
    • Proceedings of the Plant Resources Society of Korea Conference
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    • 2019.10a
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    • pp.98-98
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    • 2019
  • 제니(薺苨, Adenophorae Remotiflori Radix)는 "대한민국약전외한약(생약)규격집(KHP)"에 모시대(Adenophora remotiflorus Miquel)의 뿌리로 수재되어있으나, 형태학적으로 유사한 잔대(A. triphylla), 당잔대(A. stricta) 및 더덕(Codonopsis lanceolata)과 오 혼용 우려가 있어 이들을 구별하기 위한 정확하고 객관적인 종 감별법이 필요하다. 본 연구에서는 '제니'의 기원인 모시대와 오 혼용 우려가 있는 종들을 구별 할 수 있는 유전자 마커를 개발하기 위하여 Genbank에 등록된 ycf2 구간을 활요하여 모시대와 잔대, 당잔대를 구분 할 수 있는 INDEL (insertion/deletion) 마커를 개발하였다. 또한, 보다 정확한 종감별을 위해 DNA 바코드로 활용되고 있는 유전자 부위의 염기서열을 분석하여 ITS (25%), atpB-rbcL (15%), atpF-atpH (14%), rpl16 (13%), trnL-F (10%), matK (9%), rpoC1 (7%)에서 변이율(percent of variable sites)을 확인하였다. 향후, 본 연구에서 개발된 INDEL 마커와 더불어 추가적으로 개발을 진행 중인 분자 마커는 한약재 '제니'의 품질관리에 활용 가능할 것으로 사료된다.

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A GC analytical method of phthalates in plasticized blood component preparations

  • Chang, Soo-Hyun;Jang, Seung-Jae;Choi, Don-Woong;Kim, Mi-Jeong;Kim, Hee-Sung;Jung, Ki-Sook;Chang, Seung-Yeup
    • Proceedings of the PSK Conference
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    • 2003.04a
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    • pp.276.3-277
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    • 2003
  • A simple, accurate GC analytical technique for the determination of phthalates. commonly used as plasticizers during the manufacturing process of PVC bags, in blood component preparations was developed and validated. The blood component preparations were extracted with n-hexane. The n-hexane layer was evaporated to dryness and the residue was dissolved in 1 $m\ell$ of n-hexane and analyzed by GC and GC/MS. (omitted)

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Bosentan and Rifampin Interactions Modulate Influx Transporter and Cytochrome P450 Expression and Activities in Primary Human Hepatocytes

  • Han, Kyoung-Moon;Ahn, Sun-Young;Seo, Hyewon;Yun, Jaesuk;Cha, Hye Jin;Shin, Ji-Soon;Kim, Young-Hoon;Kim, Hyungsoo;Park, Hye-kyung;Lee, Yong-Moon
    • Biomolecules & Therapeutics
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    • v.25 no.3
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    • pp.288-295
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    • 2017
  • The incidence of polypharmacy-which can result in drug-drug interactions-has increased in recent years. Drug-metabolizing enzymes and drug transporters are important polypharmacy modulators. In this study, the effects of bosentan and rifampin on the expression and activities of organic anion-transporting peptide (OATP) and cytochrome P450 (CYP450) 2C9 and CYP3A4 were investigated in vitro. HEK293 cells and primary human hepatocytes overexpressing the target genes were treated with bosentan and various concentrations of rifampin, which decreased the uptake activities of OATP transporters in a dose-dependent manner. In primary human hepatocytes, CYP2C9 and CYP3A4 gene expression and activities decreased upon treatment with $20{\mu}M$ $bosentan+200{\mu}M$ rifampin. Rifampin also reduced gene expression of OATP1B1, OATP1B3, and OATP2B1 transporter, and inhibited bosentan influx in human hepatocytes at increasing concentrations. These results confirm rifampin- and bosentan-induced interactions between OATP transporters and CYP450.

Study for Residue Analysis of Fluxametamid in Agricultural Commodities

  • Kim, Ji Young;Choi, Yoon Ju;Kim, Jong Soo;Kim, Do Hoon;Do, Jung Ah;Jung, Yong Hyun;Lee, Kang Bong;Kim, Hyochin
    • Korean Journal of Environmental Agriculture
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    • v.38 no.1
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    • pp.1-9
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    • 2019
  • BACKGROUND: Accurate and simple analytical method determining Fluxametamid residue was necessary in various food matrices. Additionally, fulfilment of the international guideline of Codex (Codex Alimentarius Commission CAC/GL 40) was required for the analytical method. In this study, we developed Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) method to determine the Fluxametamid residue in foods. METHODS AND RESULTS: Fluxametamid was extracted with acetonitrile, partitioned and concentrated with dichloromethane. To remove the interferences, silica SPE cartridge was used before LC-MS/MS (Liquid Chromatography-Tandem Mass Spectrometry) analysis with $C_{18}$ column. Five agricultural commodities (mandarin, potato, soybean, hulled rice, and red pepper) were used as a group representative to verify the method. The liner matrix-matched calibration curves were confirmed with coefficient of determination ($r^2$) greater than 0.99 at calibration range of 0.001-0.25 mg/kg. The limits of detection and quantification were 0.001 and 0.005 mg/kg, respectively. Mean average accuracies were shown to be 82.24-115.27%. The precision was also shown to be less than 10% for all five samples. CONCLUSION: The method investigated in this study was suitable to the Codex guideline for the residue analysis. Thus, this method can be useful for determining the residue in various food matrices as routine analysis.

CORRELATION BETWEEN SKIN IRRITATION AND CYTOTOXICITY OF ANTI-WRINKLE AGENTS

  • Lee, Eun-Hee;Hong, Jin-Tae;Lee, Jong-Kwon;Kim,Yong-Kyu;Park, Ki-Sook;Jung, Kyoung-Mi;Kwan, Jung-Hai;Lee, Sun-Hee;Yang, Ki-Hwa;Chung, Soo-Youn
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2001.05a
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    • pp.110-110
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    • 2001
  • To compare skin irritation and cytotoxicity of anti-wrinkle agents, we examined skin irritation of six anti-wrinkle agents (ascorbic acid, glycolic acid, all trans-retinoic acid, ginseng extract, retinol, EB) in New Zeland white rabbit.(omitted)

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