八十五年度調製劑中藥檢出西藥情形之分析

SURVEY ON ADULTERANTS IN PRESCRIPTIVE CHINESE HERBAL MEDICINES FROM THE FISCAL YEAR 1996

本報告係本局於八十四年七月至八十五年六月間受理衛生行政機關、司法檢警情治機關送驗中藥摻加西藥案件，計一千一百件之統計分析。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12.5%。涵蓋上述機關抽查案件則檢出率為6.9%。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約在0-5.4%之間，藥廠者未檢出。屬第二類依法不得販售、提供藥品者其檢出率在0-31.5%之間，國術館檢出率最高。分析七十六件不合格檢體中，每件檢體檢出西藥個數以檢出四個西藥成分占最多達36.8%，驗出二～五個西藥成分者占七成。另亦有檢出十一及十二個成分者分別為3件，1件。檢出西藥檢體依送驗指定主治效能排名，依序為風濕鎮痛類、感冒鎮咳、過敏性鼻炎類，精神安定類及類固醇類為主。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caffeine, hydroch1orothiazide, acetaminophen, indomethacin, diazepam, ethoxybenzamide, ch10rpheniramine ma1eate, pheny1butazone， thiamine disu1fide, mefenamic acid 及ch1orzoxazone。

In this study, the data on the synthetic chemicals as adulterants in 1100 samples of chinese herbal medicines that we tested during the fiscal year 1996 were collected and analyzed. The results indicate that 12.5% of samples obtained from the consumer centers of the local health bureaus had been adulterated. However, if the samples included those randomly sampled from local markets by health bureau's officers, the adulteration rate decreases to 6.9%. In the first category of supply sources including legal manufacturers of Chinese herbal medicines and medical care units (hospital and clinics of traditional Chinese medicine), approximately 0-5.4% of the samples were found to have been adulterated; however, adulteration in samples from the legal manufacturers was not found. In the second category including Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the detection rates ranged 0-31.5%. The Kung-fu stores have the highest detection rate. The mean number of adulterants in each sample was 4.1. As high as 36.8% of the samples contained four kinds of adulterants. About 70% of the samples contained two to five adulterants. Three samples were found to have contained even eleven adulterants. In one case, twelve adulterants was found in a single sample. In terms of categories, the common adulterants were antirheumatic-analgesics, anticold-antitussive, tranqulizers and steroids. The adulterants found in the Chinese herbal medicines were not necessarily associated with the labeled category. The order of frequency of adulterants were caffeine, hydrochlorothiazide, acetaminophen, indomethacin, diazepam, ethoxybenzamide, chlorpheniramine maleate, phenlbutazone, thiamine disulfide, mefenamic acid and chlorzoxazone, respectively.