약학회지 (YAKHAK HOEJI)

  • 제49권5호
  • /
  • Pages.392-398
  • /
  • 2005
  • /
  • 0377-9556(pISSN)
  • /
  • 2383-9457(eISSN)
대한약학회 (The Pharmaceutical Society of Korea)
권호 표지

아목시실린, 클라불란 산 및 시판 아목시실린-클라불란 산 복합제제의 안전성 비교연구

Comparative Study on the Stability of Amoxicillin, Clavulanic Acid and its Commercial Combination Products

  • 한상덕 (서울대학교 약학대학 신의약품개발연구센터) ;
  • 김종국 (서울대학교 약학대학 신의약품개발연구센터)
  • Han, Sang-Dug (Research Center for New Drug Development, College of Pharmacy, Seoul National University) ;
  • Kim, Chong-Kook (Research Center for New Drug Development, College of Pharmacy, Seoul National University)
  • 발행 : 2005.10.01
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초록

In this study, we evaluated the stability of amoxicillin (AMX) and clavulanic acid (CLA) in aqueous solution, and compared the stability of AMX and CLA in commercial combination products. In aqueous solutions, the degradation of AMX ($t_{90}=8.88\;day\;at\;10^{circ}C$) and CLA ($t_{90}=3.53\;day\;at\;10^{circ}C$) occurred rapidly. From the pH-rate profile, AMX and CLA were the most stable at the range of pH 5.5 and 6.0. After reconstitution of commercial dry syrups, the contents of AMX and CLA in suspensions were gradually decreased for 7 days. However, AMX and CLA in dispersible tablet were not changed at all. The contents of CLA in the dispersible tablet ($87.92\%$) and dry syrups (2.16 and $3.91\%$) were remained in the accel­erated stability test ($75\%\;RH,\;at\;40^{circ}C$) after 10 hours. And the colors of the dry syrups were rapidly changed from white to yellow. From these results, we concluded that the dispersible tablet could overcome the stability problems of dry syrups.

키워드

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