100年度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 2011

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) ； 施養志(Daniel Yang-Chih Shih) ； 羅吉方(Chi-Fang Lo)

《食品藥物研究年報》 3期 (2012/12) Pp. 358-365

https://doi.org/10.6945/ARFDR.201212.0358

摘要

本局100年度受理調製劑中藥摻加西藥案件計1224件檢體，其中258件檢出西藥成分，檢出率為21.1%。屬各縣市衛生局消費者服務中心轉送及司法檢警情治機關送驗之服務案件有647件，檢出189件（29.2%）；屬衛生行政機關送驗之抽查案件577件，檢出69件（12.0%）。依檢體來源統計，屬合法廠商及醫療機構者490件，檢出16件（3.3%）；屬依法不得販售及提供藥品者367件，檢出99件（27.0%）。檢出西藥之檢體，檢出率最高為補腎滋養類，佔59.2%。西藥成分檢出頻率前3名依序為Sildenafil、Acetaminophen及Caffeine。本報告另分析本局於91至100年度執行該項業務之統計結果，檢出西藥之比率在8.8-24.9% 之間，並依檢體來源、檢出之西藥成分及檢驗類別等，進行趨勢分析，提供作為行政管理單位制定政策之參考。

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), 1224 samples were collected and analyzed during the fiscal year 2011. The result showed that 29.2% (189/647) of the samples acquired from the consumer service centers of local health bureaus and judicial organizations were adulterated. However, if the samples collected by local health bureau from local markets were included, the adulteration rate decreased to 21.1% (258/1224).The sources of samples were classified into two categories. The first one was from legal institutions, including manufacturers of CMP and medical units such as hospitals, clinics and dealers of traditional Chinese medicine, with an average adulteration rate of 3.3%. The second one was illegal suppliers, such as Chinese kungfu stores, folk medicine stores, unlicensed practitioners and others, with an average adulterated rate of 27.0%.In terms of therapeutic activity, most adulterants 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 among the top adulterant followed by acetaminophen and caffeine.In this study, the data on synthetic drugs added as adulterants in Chinese herbal medicines, which we tested during the fiscal years 2002-2011, were collected and analyzed. The results showed that the adulteration rate were 8.8-24.9%. Besides, the source of samples, adulterant numbers and therapeutic activity were also used for trend analysis, which will be provided as the reference in formulating policies for the administrative unit.

並列關鍵字

adulterants ； Chinese medicinal preparations