아연피리치온을 유효성분으로 표기한 화장품류에서 미표기 성분인 베타메타손 유도체의 검출

Detection of Undeclared Betamethasone Derivatives in Cosmetic Products Labeled to Contain Zinc Pyrithione as the Active Ingredient

  • 이정표 (식품의약품안전청 의약외품과) ;
  • 박성환 (식품의약품안전청 화장품평가팀) ;
  • 양성준 (식품의약품안전청 화장품평가팀) ;
  • 김선미 (식품의약품안전청 화장품평가팀) ;
  • 손경훈 (식품의약품안전청 화장품평가팀) ;
  • 윤미옥 (식품의약품안전청 마약신경계의약품과) ;
  • 최상숙 (식품의약품안전청 의약외품과)
  • Lee, Jeong-Pyo (Quasi-drug Division, Korea Food and Drug Administration) ;
  • Park, Sung-Hwan (Cosmetics Evaluation Team, Korea Food and Drug Administration) ;
  • Yang, Seong-Jun (Cosmetics Evaluation Team, Korea Food and Drug Administration) ;
  • Kim, Sun-Mi (Cosmetics Evaluation Team, Korea Food and Drug Administration) ;
  • Son, Kyung-Hun (Cosmetics Evaluation Team, Korea Food and Drug Administration) ;
  • Yun, Mi-Ok (Narcotic & Neuropharmacological Division, Korea Food and Drug Administration) ;
  • Choi, Sang-Sook (Quasi-drug Division, Korea Food and Drug Administration)
  • 발행 : 2009.03.30

초록

스테로이드 함유 표시가 없는 화장품에서 항염증 효과가 있는 글루코코티코스테로이드인 베타메타손프로피오네이트 성분이 검출되었다. 이 화장품은 외용스프레이 및 샴푸로서 주성분으로 아연피리치온을 함유하는 것으로 표기되어 있었다. 화장품에서 스테로이드 구조와 활성을 갖는 물질의 존재를 확인하기 위하여 실리카겔 박층판을 이용한 박층크로마토그래프를 사용하였으며 이 성분을 분리하기 위해 high-performance liquid chromatography (HPLC)를 이용하여 확인 및 정량을 수행하였다. 분취용 HPLC를 이용하여 스테로이드를 함유한 것으로 판단되는 분획을 모은 다음 nuclear magnetic resonance (NMR) 및 mass spectrometry (MS)를 이용하여 스테로이드 성분을 확인하였다. 스테로이드 표준물질로 베타메타손 17-프로피오네이트 및 베타메타손 21-프로피오네이트를 합성하여 사용하였고 이 표준물질과 HPLC 크로마토그램을 비교하여 스테로이드 성분의 함량을 분석하였다. 이 방법으로 아연피리치온 제제와 같은 일부 시판 화장품에서 스테로이드 성분을 확인하였고 reversed-phase high-performance liquid chromatography (RP HPLC) 상의 유지시간 비교를 통하여 스테로이드 성분을 정량한 결과 시험한 총 8종의 화장품 시료 중 2개 제품에서 0.005 ${\sim}$ 0.02%의 베타메타손프로피오네이트가 검출되었다.

Betamethasone propionate, an anti-inflammatory glucocorticosteroid, was detected in cosmetics with no indication on the label of this compound as an ingredient. The product was formulated as a topical spray or shampoo and labeled to contain zinc pyrithione as the active ingredient. A thin-layer chromatographic analysis was carried out on silica gel plates to provide a first indication about the presence of a compound with steroid structure and reactivity; then high-performance liquid chromatography (HPLC) separation allowed the identification of the corticosteroid agent and its quantification. To identify the corticosteroid agent from these commercial samples we collected the fractions suspected to have ketol steroids by prep HPLC and identified the compound as betamethasone propionate by NMR and MS spectrometry. Then we synthesized the standard for the betamethasone 17-propionate and 21-propionate and quantitate the corticosteroids from the sample by HPLC with that standards. By this method we identified the corticosteroid compounds from some commercial cosmetics such as zinc pyrithione sprays. The finding of betamethasone propionate in the products was shown by comparison to an authenticated standard of betamethasone propionate by retention time on reverse-phase HPLC. Two of the tested products contained betamethasone propionate at the levels of 0.005 ${\sim}$ 0.02% and the others were free of betamethasone propionate.

키워드

참고문헌

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