九十九年調製劑中藥檢出西藥成分之分析

Survey on Adulterants in Chinese Medicinal Preparations during the Fiscal Year 2010

賴國誌(Kuo-Chih Lai) ； 廖永智(Yung-Chih Liao) ； 林美智(Mei-Chih Lin) ； 顧祐瑞(Yoe-Ray Ku) ； 徐雅慧(Ya-Hui Hsu) ； 蔡麗瑤(Li-Yao Tsai) ； 李蕙君(Hui-Chun Lee) ； 呂康祖(Kang-Tsu Lu) ； 劉宜祝(Yi-Chu Liu) ； 羅吉方(Chi-Fang Lo)

《食品藥物研究年報》 2期 (2011/12) Pp. 339-349

https://doi.org/10.6945/ARFDR.201112.0341

摘要

本局99年度受理衛生行政機關、司法檢警調查機關等送驗調製劑中藥摻加西藥案件計1436件檢體，其中357件檢出西藥成分不合格，檢出率為24.9%。受理案件依送驗機關別統計，屬各縣市衛生局消費者服務中心轉送消費者申請案件及司法檢警情治機關申辦之服務案件有963件，檢出248件（25.8%）；衛生行政機關抽查案件473件，檢出109件（23.0%）。依檢體來源合法性統計，屬合法廠商及醫療機構者361件，檢出35件（9.7%）；屬依法不得販售及提供藥品者1075件，檢出322件（30.0%）。357件不合格檢體中檢出1種西藥成分計243件（68.1%）最多；其次為檢出2種西藥成分共40件（11.2%）。檢出西藥之檢體依送驗單位指定檢驗類別排名，檢出率最高為補腎滋養類，佔54.3%。西藥成分檢出頻率前3名依序為Sildenafil、Hydrochlorothiazide及Caffeine。本報告並提出結論，作為行政管理參考，主要結論為檢出率近年來仍未有改善，建議應由源頭管理面把關為主，檢驗面為輔，加強民眾宣導，加重刑罰，以維護國人健康。

關鍵字

調製劑中藥 ； 摻加西藥

並列摘要

To investigate the chemical adulterants in Chinese medicinal preparations (CMP), 1436 samples were collected and analyzed during the year 2010. The result showed that 25.8% (248/963) of the samples acquired from the consumer service centers of local health bureaus and judicial organizations were adulterated. However, if the samples that collected by local health bureau from local markets were included, the adulteration rate decreased to 24.9% (357/1436).The sources of samples were classified into two categories. The first was legal institutions, including manufacturers of CMP and medical units such as hospitals, clinics and dealers of traditional Chinese medicine, in which the average adulteration rate was 9.7%. The second was illegal suppliers, such as Chinese kung-fu stores, folk medicine stores, unlicensed practitioners and others, where the average adulterated rate was 30.0%. Among the 357 samples contained adulterants, 68.3% contained 1 adulterant and 11.2% 2 adulterants. In terms of therapeutic activity, most adulterants found in the CMP were for treatment of erectile dysfunction. The therapeutic activity of most adulterants was irrelevant to the claimed use of CMP. The result also showed that sildenafil was the most found compound in adulterants, and the others were hydrochlorothiazide and caffeine.

並列關鍵字

adulterants ； Chinese medicinal preparations