保健食品中違法摻雜sildenafil類緣物之鑑別   全文下載

Identification of a Sildenafil Analogue Adulterated in Two Herbal Food Supplements

隨著保健食品使用量日益增加，在維護民眾健康前提下，加強此類產品之監控是極為必要。本報告係檢驗上市之兩種保健食品，檢出摻雜一種首次發現新成分為sildenafil（商品名為威而鋼）類緣物。該新成分係屬未知成分，經由核磁共振光譜、質譜、紅外線光譜及X射線繞射分析，才得以確認結構。其結構與sildenafil之主要基本結構相同，僅有一些些不同。即其側鍵之取代基由N-methylpiperazine改為N-hydroxyethylpiperazine。其名稱為hydroxyhomosildenafil。經由文獻搜尋，此成分目前並未核准上市作為藥品。此類成分之檢出更值得吾人提高警覺，顯示保健食品中除可能違法摻雜已上市之藥品外，更有不肖業者，以已上市藥品之相關類緣物質摻雜其中，以規避檢驗及行政管理。而此種類緣物新成分的檢出，是檢驗工作上頗具挑戰性的一環。

Consumption of herbal supplements becomes more and more popular in the world. For the sake of public health, enhanced supervision on those products is needed. A novel sildenafil analogue is detected from two herbal dietary supplements in our laboratory. Its structure has been identified by various NMR techniques, mass spectrum, IR and X-ray diffraction. This compound is slightly different from sildenafil (Viagra) in the piperazine moiety, where N-methyl group in sildenafil is replaced by N-hydroxyethyl group. Thereby this compound is named as hydroxyhomosildenafil. Noticeably, this compound has not been approved as medication. Therefore, it is necessary to monitor diverse analogues besides the commercial chemical compounds.