• Title/Summary/Keyword: 의약품

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Comparative Study on the Regulations about In-Use Stability, and Analysis the In-Use Stability Application on Approved Syrups - Focused on the Guidelines in US, Europe and Korea - (국내외 의약품 개봉 후 안정성 규정 비교와 국내 시럽제의 안정성 적용 현황 분석 - 미국, 유럽, 한국의 가이드라인을 중심으로 -)

  • Park, Onnuri;Jang, Kyoung won;Ha, Dong mun
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.21 no.3
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    • pp.137-146
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    • 2020
  • Syrup agents are often used after opening, and therefore, there is a high possibility of decreased quality. The Ministry of Food and Drug Safety (MFDS) published guideline on stability testing for pharmaceuticals after opening in December, 2016. We compared guidelines related to the period of use after opening between the United States of America (USA), Europe (EU), and Korea, and we analyzed whether the period of use or storage conditions is stated based on the data of drug approval for 4 dry syrups and 3 large packing syrups before and after the introduction of the guideline. First, in USA and EU, the period of use and storage conditions after opening should be listed on the label on the packaging container (as well as the expiration date), while in Korea, those are included in the area of precautions for use. Second, all of the analyzed drugs were not changed by the guidelines for establishing the new post-opening period of use, and they were only presented for the existing expiration date prior to the establishment of the guideline. Medicines that are used for multiple uses after opening may need improved instructions to ensure that the period of use and storage conditions are listed on the packaging according to stability evaluation after opening.

Elucidation of new anti-impotency analogue in food (식품 중 발기부전치료제 유사물질 규명)

  • Suh, Junghyuck;Choi, Jangduck;Park, Kunsang;Hu, Soojung;Yoon, Taehyung;Kim, Eunju;Han, Seungwoo;Kim, Sohee;Lee, Kwangho;Kwan, Sungwon;Kim, Deukjoon
    • Analytical Science and Technology
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    • v.22 no.4
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    • pp.345-353
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    • 2009
  • The new anti-impotency analogue was identified in food source. Detection of this analogue was accomplished through screening of food samples by liquid chromatography/photodiode array detector. The spectrum pattern of analogue compound was similar to that observed for hongdenafil which was analogue of sildenafil. This new compound was isolated and purified using the liquid-liquid extraction, thin layer chromatography, column chromatography and preparative HPLC. And then those structure were identified using analytical instruments such as HPLC/PDA, LC/MS/MS and NMR. The compound was given a name to oxohongdenafil which was replaced with acetyl oxoethylpiperazinyl residue instead of sulfonyl piperazine group of sildenafil. The regulation for the abovementioned analogue, oxohongdenafil, was established by Standard of Korean food code.

Determination of mandipropamid residues in agricultural commodities using high-performance liquid chromatography with mass spectrometry (고성능액체크로마토그래피를 이용한 농산물 중 Mandipropamid의 잔류분석법 확립)

  • Kwon, Chan Hyeok;Chang, Moon Ik;Im, Moo Hyeog;Choi, Hoon;Jung, Da I;Lee, Su Chan;Yu, Jin Young;Lee, Young Deuk;Lee, Jong Ok;Hong, Moo Ki
    • Analytical Science and Technology
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    • v.21 no.6
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    • pp.518-525
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    • 2008
  • Mandipropamid is a new mandelamide-type fungicide to control foliar Oomycete pathogens in some vegetables. An analytical method was developed to determine mandipropamid residues in agricultural commodities using high-performance liquid chromatography (HPLC) and liquid chromatography/mass spectrometry (LC/MS). Mandipropamid was extracted with methanol from grape, tomato, green pepper, Chinese cabbage and potato samples. The extract was diluted with saturated sodium chloride solution and distilled water, and dichloromethane partition was followed to recover the mandipropamid from the aqueous phase. Florisil column chromatography was employed to further remove interfering co-extractives prior to HPLC analysis. Reverse-phased HPLC was successfully applied to determine mandipropamid in sample extracts with the detection at its ${\lambda}_{max}$ (223 nm). Overall recoveries of mandipropamid from fortified samples averaged $99.8{\pm}1.7$ (n=6), $89.3{\pm}5.3$ (n=6), $98.7{\pm}2.2$ (n=6), $99.7{\pm}6.8$ (n=6) and $91.1{\pm}3.1$ (n=6) for grape, tomato, green pepper, Chinese cabbage and potato, respectively. Limit of quantification of the method was 0.02~0.04 mg/kg for all samples. A LC/mass spectrometry with selected-ion monitoring was also provided to confirm the suspected residue. The proposed method was reproducible and sensitive enough to determine the terminal residue of mandipropamid in agricultural commodities.

A Study on the Usage Patterns of Medicine Information Through Web Log Analysis (웹로그 분석을 통한 의약품 정보 검색 주제별 이용 패턴에 관한 연구)

  • Cho Kyoung-Won;Woo Young-Woon
    • Proceedings of the Korea Contents Association Conference
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    • 2005.11a
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    • pp.269-274
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    • 2005
  • There are lots of medicine information on the internet recently. But there is no specific research result about search patterns or acquisition methods of medicine information on web pages for lay people until now. In this paper, 1 analyzed the web log files of a certain company providing medicine information using the WiseLog tool. I analyzed three kinds of statistic result of the web log files such as the status of web page usage by types of users, the status of web page menu usage, and the status of search menu usage. As results, I proposed methods of supplement and improvement for companies providing medicine information on the internet.

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A Review on e-pedigree for Strengthening Global Supply Chain Management (글로벌 SCM 강화를 위한 e-pedigree에 대한 고찰)

  • Seo, Dong-Min;Han, Dae-Hee;Choi, Yong-Jung;Jung, Hae-June;Kim, Hyun-Soo
    • Proceedings of the Korean Society of Computer Information Conference
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    • 2010.07a
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    • pp.361-364
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    • 2010
  • 글로벌 시장환경체제에서 유통구조가 복잡해짐에 따라 제조사에서 유통업체 및 소비자까지 아우르는 전체 공급망에서 제품에 대한 이력추적관리는 투명한 유통구조를 형성시킬 뿐만 아니라 더 나아가 소비자들의 안전에 지대한 영향을 미친다. 세계보건기구(WHO)에 따르면 선진국에서 부정 전문의약품의 유통비중은 전체 의약품의 1% 정도이며 이를 미국에 적용할 경우(2006년 기준), 미국에서 유통된 34억 개 전문의약품 중 3,400만 개의 전문의약품이 가짜일 가능성이 있는 것으로 보고되고 있다. 이로 인해 미국 캘리포니아주에서는 유통망의 투명성과 소비자의 안전을 보고하기 위하여 2D 바코드나 RFID(Radio Frequency IDentification)를 통해 의약품 제조에서 약국까지의 유통과정 계보를 추적할 수 있도록 제약기업에 2015년부터 제품에 시리얼번호를 부착한 이력장치(serialized e-pedigree)를 시행할 예정이다. 따라서 본 연구에서는 국내 외적으로 물류/유통과정에서 제품의 위 변조를 예방하기 위한 e-pedigree에 현황 및 동태를 파악하고 국내 e-pedigree에 대한 방향성을 고찰하는데 그 목적이 있다.

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Ultrafiltration and Diafiltration Processes for Concentration and Formulation of Antibody-based Therapeutics (항체의약품 농축 및 제제화를 위한 한외여과 및 정용여과 공정)

  • Lee, Jieun;Lee, Jiyoon;Baek, Youngbin
    • Membrane Journal
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    • v.30 no.6
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    • pp.373-384
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    • 2020
  • Antibody-based therapeutics have been receiving great attention as a representative biopharmaceutical, in which many researches are also carried out for its commercialization. The downstream process is considered an important part of the manufacturing processes of antibody-based therapeutics since it directly affects the performance and stability of products. Ultrafiltration/diafiltration (UF/DF), mostly performed in final step during downstream process, are used for the final concentration and formulation of antibody-based therapeutics. This paper reviewed the major products of the UF membrane, process characteristics, and recent research trends in UF/DF.

수입식품등 검사지침

  • Korea Food Industry Association
    • Food Industry
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    • s.198
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    • pp.103-141
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    • 2007
  • 식품의약품안전청은 수입식품등 검사지침(식품의약품안전청 고시 제2007-42호, 2007. 6. 27)과 수입건강기능 식품 신고 및 검사세부처리규정(식품의약품안전청 고시 제2007-43호, 2007. 6. 27)을 발표했다. 관련내용은 판매를 목적으로 하거나 영업상 사용하기 위해 수입하는 식품, 식품첨가물, 기구 및 용기포장의 검사에 관한 세부지침과 수입건강기능식품의 신고 및 검사에 관한 세부처리규정을 정해 검사업무의 형평성, 공정성, 신속성, 효율성을 위해 개정고시하였다. 본란에서는 관련 고시내용 전문을 게재함으로서 식품제조업체 및 식품등수입 판매업자등의 이해를 돕고자 한다.

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