Safety Assessment of Oriental Medicines and Their Preparations

한약 및 한약제제의 안전성 평가

  • Jeong, Il-Hyung (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kim, Jong-Hwa (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Jeon, Jong-Sup (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) ;
  • Jo, Hyun-Ye (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kim, Young-Sug (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment)
  • 정일형 (경기도보건환경연구원 약품화학팀) ;
  • 김종화 (경기도보건환경연구원 약품화학팀) ;
  • 전종섭 (경기도보건환경연구원 약품화학팀) ;
  • 조상훈 (경기도보건환경연구원 약품화학팀) ;
  • 박신희 (경기도보건환경연구원 약품화학팀) ;
  • 조현례 (경기도보건환경연구원 약품화학팀) ;
  • 김영숙 (경기도보건환경연구원 약품화학팀)
  • Received : 2010.04.05
  • Accepted : 2010.08.11
  • Published : 2010.09.30

Abstract

This study was carried out to evaluate the safety of circulated oriental medicines and their related preparations in Gyeonggi-do. Total 366 samples (165 species) were analyzed about heavy metals, residual contents of sulfur dioxide ($SO_2$), and 68 samples were analyzed about preservatives. 17 samples (13 species, 4.6%) were exceeded the legal limit of heavy metal. The concentrations over the legal limit for Pb, Cd, As and Hg were 6.1~19.2 mg/kg, 0.4~0.7 mg/kg, 6.9 mg/kg and 0.7 mg/kg, respectively. In particular, the exceeding ratio (5.9%) of the legal limit of heavy metals in foreign products was 3.3 times more than domestic products (1.8%). 13 samples (10 species, 3.6%) exceeded the limit of residual sulfur dioxide and the concentration ranges were 105 to 428 mg/kg in domestic products, on the other hand foreign products were from 114 to 2,468 mg/kg. The mean concentration over the limit of residual sulfur dioxide of foreign products (804 mg/kg) was 2.4 times more than domestic products (338 mg/kg). In studying of the preservatives in oriental preparation, the contents of dehydroacetic acid (48.9~64.1%) in 3 samples of labeled solutions were under the labeled preservative contents and the contents of benzoic acid (139.9%) in 1 sample of labeled pill product was exceeded the labeled preservative contents. The numbers of the detected preservatives in unlabeled solutions, pills and granules were 4, 11 and 7, respectively.

본 연구는 경기도내 유통되고 있는 한약 및 한약제제에 대한 안전성을 평가하고자 한약 165종 366건에 대한 중 금속 및 잔류이산화황 오염 실태와 한약제제 68건에 대한 보존제 사용 실태를 조사하였다. 한약 중 중금속 검사결과는 13종 17건(4.6%)이 기준을 초과하였고 기준 초과 검출 농도는 Pb 6.1~19.2 mg/kg, Cd 0.4~0.7 mg/kg, As 6.9 mg/kg, Hg 0.7 mg/kg 이었으며, 국산 한약은 110건 중 2건(1.8%), 수입산 한약은 256건 중 15건(5.9%)이 기준을 초과하여 국산보다 수입산이 3.3배나 많았다. 잔류이산화황 검사결과는 10종 13건(3.6%)이 기준을 초과하였고 그 중 국산 한약은 4건에서 105~428 mg/kg이 검출되어 평균 338 mg/kg이었으며, 수입산 한약은 9건에서 114~2,468 mg/kg이 검출되어 평균 804 mg/kg으로 수입산이 국산 한약 보다 2.4배 높았다. 한약제제에 대한 보존제 검사결과 보존제가 표시된 17건(액제 14건, 환제 3건) 중 액제 3건에서 dehydroacetic acid가 표시량의 48.9~64.1% 검출되어 표시량 미만이었으며, 환제 1건에서는 benzoic acid가 139.9% 검출되어 표시량을 초과하였다. 보존제가 미표시된 51건(액제 6건, 과립제 28건, 환제 17건) 중 액제에서 benzoic acid 3건, dehydroacetic acid 1건이 검출되었으며, 과립제 11건과 환제 7건에서 benzoic acid가 검출되었다.

Keywords

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