八十七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 1998

本報告係本局於八十六年七月至八十七年六月間受理衛生行政機關、司法檢警情治機關送驗調製劑中藥摻加西藥案件，計538件之統計分析。結果如次，受理之調製劑中藥摻加西藥屬消費者申訴及司法檢警情治機關之服務案件者，其檢出率為10.8%。涵蓋衛生行政機關抽查案件則檢出率為7.3%。檢體來源屬第一類之合法廠商、醫療機構之調製劑中藥摻加西藥之檢出率介於0~10.2%之間，檢體來源為藥房者檢出率為10.2%，中醫診所檢出率為2,9%。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39件不合格檢體中，每件檢體檢出西藥個數以檢出4種西藥成分占最多，達33.3%，其次檢出1種及5種西藥成分均占18.0%，檢出7種西藥成分占7.7%，另檢出8種以上西藥成分占12.8%。檢出西藥之39件檢體依劑型別，以丸劑檢出率占16.1%，散劑檢出率占6.8%。檢出西藥檢體依送驗指定主治效能排名，前三名依序為感冒鎮咳類、類固醇類及風濕鎮痛類，然檢出之西藥成分常與指定效能或指定之檢驗成分無關。西藥成分之檢出頻率依序為caffeine, hydrochlorothiazide, thiamine, indomethacin, diazepam, acetaminophen, chlorzoxazone, ethoxybenzamide, piroxicam, bromhexine及dicyclomine。"

In this study, we present the results of our data on the synthetic chemicals contained as adulterants in 538 samples of Chinese herbal medicine which we collected and analyzed during the fiscal year 1998. The results indicate that 10.8% of samples obtained from the consumer centers of the local health bureaus were adulterated. However, if the samples included those randomly sampled from local markets by the health bureaus officers, the adulteration rate decreased to 7.3%.In the first category of supply sources including legal manufacturers of Chinese herbal medicines and medical care units (hospitals and clinics of traditional Chinese medicine), approximately 0~10.2% of the samples were found to be adulterated. In the second category including Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the adulteration rates ranged from 0 to 31.6%. The Kung-fu stores had the highest rate.While the average number of adulterants in each sample was 4.4, as high as 33.3% was revealed among the samples containing four kinds of adulterants. About 18% of the samples contained one or five adulterants. One sample was found to contain ten adulterants. In terms of categories and dosages, the common adulterants were presented as anticold-antitussives, steroids, antirheumatic-analgesics, and dosage forms included both pills (16.1%) and powders (6.8%).The adulterants found in the Chinese herbal medicines were not necessarily associated with the labeled category as indicated. The rank order of frequency for these adulterants was caffeine, hydrochlorothiazide, thiamine, indomethacin, diazepam, acetaminophen, chlorzoxazone, ethoxybenzamide, piroxicam, bromhexine and dicyclomine.