본 연구는 경기도내 유통되고 있는 한약 및 한약제제에 대한 안전성을 평가하고자 한약 165종 366건에 대한 중금속 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 초과 하여 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 표시 된 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, 과립 제 28건, 환제 17건) 중 액제에서 benzoic acid 3건, dehydroacetic acid 1건이 검출되었으며, 과립제 11건과 환 제 7건에서 benzoic acid가 검출되었다.

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 (SO2), 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.

ABSTRACT
 재료 및 방법
  시험재료
  표준품 및 시약
  시험방법
  한약의 잔류이산화황 분석
  한약제제의 보존제 분석
 결과 및 고찰
  한약의 중금속 농도
  한약의 잔류이산화황 농도
  한약제제의 보존제 농도
 요 약
 참고문헌

• 정일형(경기도보건환경연구원 약품화학팀)
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• 박신희(경기도보건환경연구원 약품화학팀) | Shin-Hee Park (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment)
• 조현례(경기도보건환경연구원 약품화학팀) | Hyun-Ye Jo (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment)
• 김영숙(경기도보건환경연구원 약품화학팀) | Young-Sug Kim (Pharmaceutical Chemistry Team, Gyeonggi-do Institute of Health and Environment) Correspondence to