107－108年度中藥摻加西藥檢驗案件分析   全文下載

Survey on Pharmaceutical Adulterants in Chinese Medicinal Preparations from 2018 to 2019

食品藥物管理署於107及108年度受理中藥摻加西藥檢驗案件共計219件檢體，其中88件檢出西藥成分，檢出率為40.2％。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海關等機關送驗之服務案件有151件，檢出72件（47.7％）；屬衛生行政機關送驗之抽查案件有68件，檢出16件（23.5％）。依檢體來源統計，屬合法廠商及醫療機構者62件，檢出4件（6.5％）；屬依法不得販售及提供藥品者157件，檢出84件（53.5％）。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）（69件）。西藥成分檢出頻率前3名依序為sildenafil、sibutramine及phenolphthalein。相關檢驗結果及趨勢分析將供制定政策之參考。

This report summarized the results of 219 samples of Chinese medicinal preparations (CMP) analyzed for the presence of pharmaceutical adulterants from 2018 to 2019. In total, 40.2% (88/219) of the samples were adulterated. Among them, 151 samples were from consumer service centers of local health authorities and other governmental institutions, and the adulteration rate was 47.7% (72/151). A lower rate of 23.5% (16/68) of the inspected samples from local health authorities were found adulterated. Samples from lawful manufacturers and medical units such as hospitals, clinics and dealers of traditional Chinese medicine showed 6.5% (4/62) adulteration rate. Samples from unlicensed retailers showed 53.5% (84/157) adulteration rate. Sildenafil, was the most common adulterant found, followed by sibutramine and phenolphthalein. The report would be forwarded to relevant administration authorities as references for policy making.