Journal of Food Hygiene and Safety (한국식품위생안전성학회지)

The Korean Society of Food Hygiene and Safety (한국식품위생안전성학회)
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Monitoring of Fake Anti-impotence Drugs

불법유통 발기부전치료제 유사제품 조사 연구

  • Kim, Beom-Ho (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Jeon, Jong-Sup (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Lee, Myung-Jin (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Park, Eun-Mi (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Cho, Sang-Hun (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Kwon, Hye-Jung (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Yoon, Mi-Hye (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment) ;
  • Lee, Jong-Bok (Pharmaceutical chemistry Team, Gyeonggi-do Institute of Health and Environment)
  • 김범호 (경기도보건환경연구원 약품화학팀) ;
  • 전종섭 (경기도보건환경연구원 약품화학팀) ;
  • 이명진 (경기도보건환경연구원 약품화학팀) ;
  • 박은미 (경기도보건환경연구원 약품화학팀) ;
  • 조상훈 (경기도보건환경연구원 약품화학팀) ;
  • 권혜정 (경기도보건환경연구원 약품화학팀) ;
  • 윤미혜 (경기도보건환경연구원 약품화학팀) ;
  • 이정복 (경기도보건환경연구원 약품화학팀)
  • Received : 2014.02.06
  • Accepted : 2014.04.01
  • Published : 2014.06.30
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Abstract

The safety of fake anti-impotence drugs (fake Viagra : 26 samples, fake Cialis : 25 samples) distributed in Gyeonggi province was studied by monitoring the concentrations of anti-impotence pharmaceutical ingredient and their analogues. The concentrations of anti-impotence pharmaceutical ingredient 4 specis and their analogues 17 specis were estimated using by HPLC/PDA, LC-MS/MS. The range of concentration of sildenafil in fake viagra was 40~199 mg/tablet, among them the portion of the concentrations of sildenafil over 150 mg/tablet exceeded 65%. 3 cases in tested samples contained sildenafil and tadalafil. The range of concentration of sildenafil in fake cialis was 102~249 mg/tablet, among them the portion of the concentrations of sildenafil over 150 mg/tablet exceeded 88%. One case in tested samples contained demethylhongdenafil (90 mg/tablet). These results indicate that there were many fake anti-impotence drug contained high level of anti-impotence pharmaceutical ingredients, a sustainable monitoring and the blocked distribution of fake anti-impotence drugs recommended.

경기도내 유통되고 있는 발기부전치료제 유사제품 51건(유사비아그라 26품목, 유사시알리스 25품목)에 대하여 발기부전치료제성분 및 그 유사물질을 조사하여 안전성을 평가하였다. 발기부전치료제성분 4종과 그 유사물질 17종에 대하여 HPLC/PDA, LC-MS/MS를 이용하여 정량 및 정성시험을 실시하였다. 유사비아그라의 경우에는 sildenafil 성분이 40~199 mg/정의 범위를 나타냈으며, 함량이 150 mg/정 넘는 제품이 65% 이상 이었다. Tadalafil과 sildenafil을 동시에 사용한 경우는 3개 제품에서 나타났다. 유사시알리스의 경우에는 주성분인 tadalafil이 모두 검출되지 않았고 비아그라의 주성분인 sildenafil만 102 mg/정~249 mg/정 검출되었다. 이 중 sildenafil 함량이 150 mg/정 넘는 제품이 88% 이상 이었으며, 1개 제품에서 발기부전치료제유사물질인 demethylhongdenafil이 90 mg/정 검출되었다. 이러한 발기부전치료제 유사제품은 권장 복용량보다 3배가 넘는 고 함량 제품이 대부분이었으며, 지속적인 감시와 유통차단이 요구된다고 본다.

Keywords

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