103及104年度中藥摻加西藥檢驗案件分析

Survey on Chemical Drug Adulteration in Chinese Medicinal Preparations during the Fiscal Year 2014/15

食品藥物管理署於103及104年度受理中藥摻加西藥檢驗案件共計1,095件檢體，其中289件檢出西藥成分，檢出率為26.4%。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機關送驗之服務案件有441件，檢出212件（48.1%）；屬衛生行政機關送驗之稽查案件有654件，檢出77件（11.8%）。依檢體來源統計，屬合法廠商及醫療機構者572件，檢出39件（6.8%）；屬依法不得販售及提供藥品者523件，檢出250件（47.8%）。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），佔總檢出件數之66.8%。西藥成分檢出頻率前三名依序為Sildenafil、Acetaminophen及Caffeine。相關檢驗結果及趨勢分析將提供行政管理單位制定政策之參考。

To investigate the chemical drug adulteration in Chinese medicinal preparations (CMP), 1095 samples were collected between 2014 and 2015. The statistic results showed that 26.4% (289/1095) samples were adulterated. Samples submitted by the consumer service centers of local health authorities and judicial organizations showed 48.1% (212/441) adulteration rate. Samples submitted by local health bureaus confiscated from local markets showed 11.8% (77/654) adulteration rate. The data also processed by the legality of drug selling place. Samples from legal manufacturers and medical units such as hospitals, clinics and dealers of traditional Chinese medicine showed 6.8% (39/572) adulteration rate. Samples from unlicensed retailers such as Chinese kung-fu institutes, herbal stores, personals and others showed 47.8% (250/523) adulteration rate. Sildenafil, an erectile dysfunction treatment, was the top adulterant found in this study, followed by acetaminophen and caffeine. The report has provided to related administration authorities for to reference of policy making.