Establishment of Dissolution Specifications for Octylonium Bromide Tablets and Pinaverium Bromide Tablets

브롬화옥틸로늄 정과 브롬화피나베륨 정의 용출규격 설정

  • Lee, Ryun-Kyung (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) ;
  • Lee, Yoon-Ae (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) ;
  • Shim, Jee-Youn (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) ;
  • Kim, Min-A (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) ;
  • Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Park, Hye-Rim (Korea Food & Drug Administration, Osong Health Technology Administration Complex) ;
  • Kim, Hee-Sung (Korea Food & Drug Administration, Osong Health Technology Administration Complex) ;
  • Song, Young-Mi (Korea Food & Drug Administration, Osong Health Technology Administration Complex) ;
  • Lee, Su-Jung (Korea Food & Drug Administration, Osong Health Technology Administration Complex) ;
  • Sah, Hong-Kee (College of Pharmacy, Ewha Womans University) ;
  • Choi, Hoo-Kyun (College of Pharmacy, Chson University) ;
  • Kim, Young-Ok (Korea Food & Drug Administration, Osong Health Technology Administration Complex) ;
  • Kim, Dong-Sup (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) ;
  • Cho, Tae-Yong (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration)
  • 이륜경 (대구지방식품의약품안전청 유해물질분석과) ;
  • 이윤애 (대구지방식품의약품안전청 유해물질분석과) ;
  • 심지연 (대구지방식품의약품안전청 유해물질분석과) ;
  • 김민아 (대구지방식품의약품안전청 유해물질분석과) ;
  • 손경희 (식품의약품안전평가원) ;
  • 박혜림 (식품의약품안전청) ;
  • 김희성 (식품의약품안전청) ;
  • 송영미 (식품의약품안전청) ;
  • 이수정 (식품의약품안전청) ;
  • 사홍기 (이화여자대학교 약학대학) ;
  • 최후균 (조선대학교 약학대학) ;
  • 김영옥 (식품의약품안전청) ;
  • 김동섭 (식품의약품안전평가원) ;
  • 조태용 (대구지방식품의약품안전청 유해물질분석과)
  • Received : 2011.08.05
  • Accepted : 2011.09.21
  • Published : 2011.10.31

Abstract

To secure the good quality of pharmaceutical products, dissolution specifications for Octylonium bromide tablets and Pinaverium bromide tablets are needed to be established, which are enrolled in KPC (Korea Pharmaceutical Codex) with having no appropriate specifications. For establishing dissolution specifications, a number of experiments based on the "Guideline of Dissolution Testing for Solide Oral Dosage Forms" were performed. The results of this study will be used for revising KPC and it is expected to contribute to the incessant production of quality ensured drugs.

Keywords

References

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