八十八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 1999

本報告係本局於八十七年七月至八十八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503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13.1%。涵蓋衛生行政機關抽查案件則檢出率為8.0%。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0～7.0%之間，檢體來源為藥房者檢出率為7.0%，中醫診所檢出率為3.2%。屬第二類依法不得販售、提供藥品者其檢出率介於0~45.0%之間，以國術館檢出率最高。分析四十件不合格檢體中，每件檢體檢出西藥個數以檢出五種西藥成分占最多，達25.0%，其次檢出六種西藥成分占20.0%，檢出四種及七種西藥成分均占17.5%。檢出西藥之40件檢體依劑型別，以丸劑檢出率占13.9%，膠囊劑檢出率占9.5%，散劑檢出率占5.2%。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、類固醇類及氣喘類，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，acetaminophen，indomethacin，diazepam，chlorzoxazone，chlorpheniramine，ethoxybenzamide，phenylbutazone，theophylline，dicyclomine及diclofenac sodium。

In this study, we present the result on the synthetic chemicals contained, as adulterants, in 503 samples of Chinese herbal medicine, which we collected and analyzed during the fiscal year 1999. The result indicates that 13.1% of the samples obtained from the consumer centers of the local health bureaus are adulterated. However, if we include the samples that are randomly taken from local markets by the health bureau officers, the adulteration rate decreases to 8.0%.In the first category, which the supply sources include legal manufacturers of Chinese herbal medicine and medical units (hospitals and clinics of traditional Chinese medicine), approximately 0~7.0% of the samples are adulterated. In the second category, which include Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the adulterations rate ranges from 0 to 45%. Among them, the Kung-fu stores have the highest rate of adulteration.While the average number of adulterants in each sample is 4.8, there are as high as 25.0% of the samples contain five types of adulterants, and about 20% contain six types. In terms of categories and forms of dosage, the common found adulterants are antirheumatic-analegesics, steroids, antiasthmatics; the forms of dosage include pill (13.9%), capsule (9.5%), and powder (5.2%). In terms of regions, the rates of adulterations found are: in towns (13.6%), in special municipalities (5.9%), in provincial cities (3.3%), and in counties (2.6%).Adulterants found in the Chinese herbal medicine are not only associated with the required categories as indicated above. Other adulterants found are, as ranked by the frequency of use: caffeine, hydrochlorothiazide, thiamine, acetaminophen, indomethacin, diazepam, chlorzoxazone, chlorpheniramine, ethoxybenzamide, phenylbutazone, theophylline, dicyclomine, and diclofenac sodium.