| 中文摘要 |
食品藥物管理署於105及106年度受理中藥摻加西藥檢驗案件共計551件檢體，其中273件檢出西藥成分，檢出率為49.5％。依受理案件類別統計，屬縣市衛生局轉送消費者申請案件及司法檢警調海關等機關送驗之服務案件有375件，檢出251件（66.9％）；屬衛生行政機關送驗之抽查案件有176件，檢出22件（12.5％）。依檢體來源統計，屬合法廠商及醫療機構者141件，檢出7件（5.0％）；屬依法不得販售及提供藥品者410件，檢出266件（64.9％）。檢出西藥成分之檢體依檢驗類別排序，檢出率最高為補腎滋養類（壯陽類）（230件）。西藥成分檢出頻率前3名依序為sildenafil、phenolphthalein及sibutramine。相關檢驗結果及趨勢分析將供制定政策之參考。
In this report, 551 samples of Chinese medicinal preparations (CMP) were analyzed for the presence of pharmaceutical adulterants between 2016 and 2017. The results showed that 49.5% (273/551) of the samples were adulterated. Among them, 375 samples were from consumer service centers of the local health authorities and other governmental institutions, and the adulterant rate was 66.9% (251/375). Twelve point five percent (22/176) of the inspected samples from local health authorities were found adulterated. Samples from legal manufacturers and medical units such as hospitals, clinics and dealers of traditional Chinese medicine showed 5.0% (7/141) adulteration rate. Samples from unlicensed retailers such as customs administration, Chinese kung-fu institutes, personals and others showed 64.9% (266/410) adulteration rate. Sildenafil, an erectile dysfunction treatment, was the most common adulterated preparations found in this study, followed by phenolphthalein and sibutramine. The report would be forwarded to relevant administration authorities as references for policy making. |
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