八十六年度調製劑中藥檢出西藥情形之分析   全文下載

Survey on Adulterants in Prescriptive Chinese Herbal Medicines during the Fiscal Year 1997

本報告係本局於八十五年七月至八十六年六月間受理衛生行政機關、司法檢警情治機關送驗中藥製劑摻加西藥案件，計八六三件之統計分析。結果如次，受理之中藥製劑摻加西藥屬受理消費者申訴之服務案件者，其檢出率為12.3%。涵蓋上述機關抽查案件則檢出率為6.0%。檢體來源屬第一類之合法廠商、醫療機構之中藥製劑摻加西藥之檢出率介於0-3.9%之間，檢體來源為藥廠者檢出率為2.0%。屬第二類依法不得販售、提供藥品者其檢出率介於0-31.6%之間，以國術館檢出率最高。分析五十二件不合格檢體中，每件檢體檢出西藥個數以檢出二種及五種西藥成分占最多，達25.0%，檢出四種西藥成分占13.5%。檢出一種及六種西藥成分均占11.5%。檢出三種西藥成分占9.6%。另檢出七個成分者有2件，占3.9%。檢出西藥檢體依送驗指定主治效能排名，前三名依序為風濕鎮痛類、春藥類及類固醇類。然檢出之西藥成分常與指定效能或指定之檢驗成分無關。經常檢出之西藥成分依序為hydrochlorothiazide，caffeine，diazepam，thiamine，piroxicam，indomethacin，acetaminophen，chlorzoxazone，ethoxybenzamide及mefenamic acid。

During the fiscal year of 1997, eight-hundred-and-sixty-three samples of Chinese herbal medicines were accumulated and analysed for synthetic chemicals as adulterants. The results indicated that 12.3% of samples from consumer centers of local health bureaus were adulterated. However, if the samples included those randomly sampled from local markets by the health bureau officers, the adulteration rate decreased to 6.0%.The analysis of the first category of supply sources including samples of legal manufacturers of Chinese herbal medicines and medical care units (hospitals and clinics of traditional Chinese medicine) yielded the following results. Approximately 0-3.9% of the samples were found to be adulterants as were 2.0% of samples of legal manufacturers. The analysis of the second category including Chinese Kung-Fu stores, folk medicine stores, unlicensed practitioners and others yielded adulteration rates that ranged from 0 to 31.6%. The Kung-Fu stores had the highest rate.The average number of adulterants in each sample was 3.7. As high a 25.0% was revealed both in the samples containing two and five kinds of adulterants. About 13.5% of the samples contained four adulterants. Two samples were found to contain seven adulterants. In terms of categories, the common adulterants were antirheumatic-analgesics, aphrodisiacs and steroids.The adulterants found in Chinese herbal medicines were not necessarily associated with the labelled category as indicated. The rank order of occurrence of adulterants is the following; Hydrochlorothiazide, Caffeine, Diazepam, Thiamine, Piroxicam, Indomethacin, Acetaminophen, Chlorzoxazone, Ethoxybenzamide and Mefenamic acid.