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藥物食品檢驗局調查研究年報

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篇名 調製劑中藥檢出西藥成分之分析
卷期 26
並列篇名 Survey on Adulterants in Chinese Medicinal Preparations during the Fiscal Year 2007
作者 賴國誌王依婷曾木全林美智顧祐瑞楊禮安蔡麗瑤范振一劉宜祝林哲輝
頁次 74-85
關鍵字 調製劑中藥摻加西藥風濕鎮痛類感冒鎮咳類AdulterantsChinese medicinal preparationsAntirheumatic-analgesicsAnticold-antitussivesTSCI
出刊日期 200810

中文摘要

96年度受理衛生行政機關、司法檢警情治機關等送驗調製劑中藥摻加西藥案件計532件檢體,其中73件不合格,檢出率為13.7%。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435件者,檢出55件(12.6%);衛生行政機關抽查案件97件,檢出18件(18.6%)。依檢體來源合法性統計,屬合法廠商及醫療機構者254件,檢出20件(7.9%);屬依法不得販售及提供藥品者278件,檢出53件(19.1%)。73件不合格檢體中檢出西藥成分數以一種27件最多(37.0%);其次為檢出4及6種西藥成分12件(16.4%)。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感冒鎮咳類。西藥成分檢出頻率前五名依序為Caffeine,Thiamine,Acetaminophen,Chlorpheniramine,Hydrochlorothiazide。本檢驗結果將提供行政管理參考。

英文摘要

In this study, we examined the chemical compounds adulterated in 532 samples of Chinese Medicinal Preparations (CMP), which were collected and analyzed during the fiscal year of 2007. The result indicated that 12.6% (55/435) of the samples acquired from the consumer service centers of the local health bureaus and judicial organizations were adulterated.However, if the samples randomly collected from local markets were included, the adulteration rate increased to 13.7% (73/532).
The sources of samples were classified into two categories. The first one consisted of samples collected from legal institutions, including manufacturers of CMP and medical units such as hospitals, clinics and dealers of traditional Chinese medicine, where the adulterated average rate was 7.9%. The second category consists of samples from illegal suppliers, such as Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, where the adulterated average rate was 19.1%.
73 samples contained adulterants, among them, 37.0% with one adulterant and 16.4% with four or six adulterants. In terms of therapeutic activity, most adulterants were claimed to be antirheumatic-analgesics and
anticold-antitussives.
The therapeutic activity of most adulterants was irrelevant to the claimed use of CMP. Caffeine was the most commonly used in adulterants, followed by thiamine, acetaminophen, chlorpheniramine and hydrochlorothiazide.

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