Analytical Science and Technology (분석과학)

The Korean Society of Analytical Sciences (한국분석과학회)
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Monitoring of preservatives in herbal liquid preparations

액상한약제제의 보존제 모니터링

  • Jeon, Jong-Sup (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Jo, Hyun-Ye (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kim, Bum-Ho (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Cho, Sang-Hun (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Park, Shin-Hee (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kim, Young-Sug (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Yoon, Mi-Hye (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Lee, Jeong-Bok (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment)
  • 전종섭 (경기도보건환경연구원 약품화학팀) ;
  • 조현례 (경기도보건환경연구원 약품화학팀) ;
  • 김범호 (경기도보건환경연구원 약품화학팀) ;
  • 조상훈 (경기도보건환경연구원 약품화학팀) ;
  • 박신희 (경기도보건환경연구원 약품화학팀) ;
  • 김영숙 (경기도보건환경연구원 약품화학팀) ;
  • 윤미혜 (경기도보건환경연구원 약품화학팀) ;
  • 이정복 (경기도보건환경연구원 약품화학팀)
  • Received : 2011.02.07
  • Accepted : 2011.03.02
  • Published : 2011.04.25
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Abstract

Quantitative HPLC analysis for the determination of in herbal liquid preparations was improved from the general test method besides the Korean Pharmacopeia. Good chromatographic separation of samples containing parabens, interferences, and other pharmaceutical excipients was effectively achieved by using acetonitrile water (containing 1% glacial acetic acid) mixture (30:70 v/v) as mobile phase. To monitor preservatives (benzoic acid, parabens, sorbic acid, dehydroacetic acid, and their salts) in herbal liquid preparations, a group of 47 samples was divided into two different group: preservative labeled group and unlabeled group. From the results, the contents of preservatives in 31 samples of preservative labeled group fell under KFDA regulations, and the contents of dehydroacetic acid in 6 samples of preservative labeled group were not followed by KFDA regulations. Preservatives were detected in 3 samples out of 10 samples in preservative unlabeled group.

본 연구에서는 기존 대한약전외 일반시험법 중 파라옥시안식향산에스텔 및 그 염류의 함량시험법의 이동상의 조성을 acetonitrile water (containing 1% glacial acetic acid) mixture (30:70 v/v)로 변화시켜 첨가제로 사용된 보존제성분과 제품에서 기인하는 방해물질과의 완전한 분리를 통하여 액상한약제제 분석의 효율성을 기하였다. 유통되고 있는 한약제제 중 액상제품 총 47품목을 대상으로 안식향산나트륨, 디히드로 초산나트륨, 파라옥시안식향산메칠, 파라옥시안식향산에칠, 파라옥시안식향산프로필 등 5종의 함량을 모니터링 하였다. 그 결과 액상한약제제 37품목 중 보존제가 표시된 31품목은 보존제가 표시된 함량에 맞게 함유되어 있었다. 안식향산과 디히드로초산이 함유된 7품목 중 6품목은 디히드로초산이 표시량에 비해 낮게 검출되었거나 검출되지 않았다. 보존제가 미표시된 10품목 중 3품목에서 보존제가 검출되었다. 3건 모두 안식향산이 검출되었고 그 중 2건에서 디히드로초산이 검출되었으며 1건에서 메틸파라벤이 검출되었다.

Keywords

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