化粧品中Chlorhexidine等防腐劑成分檢驗方法之探討   全文下載

Method of test for Preservatives in Cosmetics

2020年新冠肺炎（COVID-19）爆發後，市面上宣稱抗菌的產品愈來愈多，包括以化粧品列管嬰兒濕巾、洗手乳及沐浴乳等與將於110年7月1日納入化粧品管理之漱口水產品。文獻指出高濃度的防腐劑可能具刺激、致敏之風險，為確保消費者使用化粧品之安全，本計畫利用液相層析串聯質譜儀（Liquid Chromatograph/Tandem Mass Spectrometer, LC-MS/MS）建立簡單、快速的方法可在15分鐘同時分析chlorhexidine等8種防腐劑成分。其中hexamidine diisethionate及chlorhexidine標準曲線之線性範圍為2-20 μg/mL，其餘6項成分為0.01-0.2 μg/mL，標準曲線相關係數（r）皆大於0.998。添加標準溶液於洗髮乳、漱口水及嬰兒用濕紙巾等3種不同空白基質中評估方法回收率與重複性，平均回收率為76.7-114.0%，變異係數均小於11.2%。方法之定量極限，hexamidine diisethionate為0.02%，chlorhexidine對於洗髮乳及沐浴乳類檢體為0.02%，對於漱口水及嬰兒專用濕巾類檢體為0.002%，其餘防腐劑為0.0001%。將本方法應用於檢測市售宣稱抗菌洗髮乳、沐浴乳、洗手乳、潔膚液、非藥用漱口水、嬰兒濕巾及化粧水等共40件檢體，結果顯示檢出率最高的成分為chlorhexidine。

After the outbreak of COVID-19, There were more and more products on the markets that claimed antibacterial functions, including mouthwashes, baby wipes, hand sanitizers and shower gel in which preservatives were added. High concentrations of preservatives may cause skin irritation and sensitization. In order to ensure the safety of consumers using cosmetics, a test method utilizing ultra performance liquid chromatography tandem mass spectrometry was established. This simple and rapid method enabled simultaneous analysis of 8 preservatives in 15 minutes on an ACQUITY BEH Shield RP18 column. Calibration curves were linear in the concentration range of 2 - 20 μg/mL for hexamidine diisethionate and chlorhexidine, and 0.01 - 0.2 μg/mL for the others. The correlation coefficients were all greater than 0.998. The recovery ranges were between 76.7 and 114.0%, and the coefficient of variation (CV) was all less than 11.2% tested in three types of blank matrix including shampoo, mouthwash and baby wipes. The limit of quantification was 0.02% for hexamidine diisethionate and chlorhexidine(shampoo/shower), and 0.002% for chlorhexidine (mouthwashes/baby wipes), and 0.0001% for the others. A surveillance consisted with 40 commercial samples including antibacterial shampoo, body wash, hand sanitizers, cleanser, mouthwash, baby wipes, and lotion showed that chlorhexidine was the top detected preservative.