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藥物食品檢驗局調查研究年報

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篇名 九十四年度調製劑中藥檢出西藥成分之分析
卷期 24
並列篇名 Survey on Adulterants in Chinese Medicinal Preparations during 2005
作者 賴國誌曾木全林美智楊禮安蔡麗瑤劉宜祝林哲輝陳樹功
頁次 121-136
關鍵字 調製劑中藥摻加西藥風濕鎮痛類類固醇類減肥類adulterantsChinese medicinal preparationsantirheumatic-analgesicssteroidsanorecticsTSCI
出刊日期 200609

中文摘要

 本報告係本局於九十四年一月至十二月間受理衛生行政機關、司法檢警情治機關等,送驗調製劑中藥摻加西藥案件之統計分析結果,計456件檢體,共51件不合格,其檢出率為11.2%。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者,其檢出率為9.9% (35/354);屬衛生行政機關之抽查案件者,其檢出率為15.7% (16/102)。依檢體來源合法性統計,屬合法廠商及醫療機構者,檢出率為10.9% (30/275);屬依法不得販售及提供藥品者,檢出率為11.6% (21/181)。每件檢體檢出西藥成分個數以一種最多,佔35.3% (18/51);其次為檢出五種西藥成分,佔15.7% (8/51)。檢出西藥之檢體依送驗指定主治效能排名,檢出率最高為風濕鎮痛類及類固醇類,其次為減肥類。西藥成分檢出頻率前五名依序為Caffeine,Thiamine,Acetaminophen,Hydrochlorothiazide及Indomethacin。

英文摘要

In this study, we examined the synthetic chemical compounds adulterated in 456 samples of Chinese medicinal preparations (CMP), which we collected and analyzed during 2005. The result indicates that 9.9%(35/354) of the samples obtained from the consumer service centers of the local health bureaus were adulterated.However, if we include the samples that were randomly taken from local markets by the health bureau officers,the adulteration rate increased to 11.2% (51/456).The sources of samples were classified into two different categories. The first one consisted of samples collected by legal institutes, including manufacturers of CMP and medical units such as hospitals, clinics and dealers of traditional Chinese medicine, in which the sample adulterated rate ranged from 0 to 10.9%. In the second category by the illegal suppliers, including Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the adulterated rate ranged from 0 to 11.6%.Among the 51 samples contained adulterants, 35.3% had one adulterant, and 15.7% had five adulterants.The average number of adulterants in each sample was 3.47. In terms of therapeutic categories, most adulterants were antirheumatic-analgesics, steroids and anorectics.The therapeutic effect of most adulterants was irrelevant to the claimed activity of CMP. Caffeine, a CNS stimulant, was the adulterant most commonly used, followed by thiamine, acetaminophen, hydrochlorothiazide and indomethacin.

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