九十二年度中藥製劑檢出西藥成分之分析

Survey on Adulterants in Chinese Herbal Preparations during the Fiscal Year of 2003

賴國誌(Kuo-Chih Lai) ； 劉宜祝(Yi-Chu Liu) ； 林哲輝(Jer-Huei Lin) ； 陳樹功(Shu-Kong Chen)

《藥物食品檢驗局調查研究年報》 22號 (2004/09) Pp. 50-68

https://doi.org/10.6946/ASRNL.200409.0050

摘要

本報告係本局於九十二年一月至十二月間受理衛生行政機關、司法檢警情治機關等，送驗中藥製劑摻加西藥案件之統計分析結果，計476件檢體，共64件不合格，其檢出率為13.4%。受理案件依送驗機關別統計，屬消費者及司法檢警情治機關申辦之服務案件者，其檢出率為16.0%(52/325)，其中各縣市衛生局消費者服務中心，轉送消費者申請案件檢出率為13.5%(40/296)，由司法檢警單位等送驗案件檢出率為41.4%(12/29)；屬衛生行政機關之抽查案件者，其檢出率為7.9%(12/151)。依檢體來源合法性統計，屬合法廠商及醫療機構者，檢出率為11.2%(37/329)；屬依法不得販售及提供藥品者，檢出率為18.4%(27/147)。每件檢體檢出西藥成分個數以一種最多，占39.1%(25/64)；其次為檢出五種西藥成分，占12.5%(8/64)；再次為檢出四種西藥成分，占10.9%(7/64)。檢出西藥之檢體依送驗指定主治效能排名，檢出率最高為抗過敏類，其次依序為春藥麻醉藥類、感冒鎮咳類、類固醇類及風濕鎮痛類等四類。西藥成分檢出頻率前五名依序為Thiamine, Caffeine, Acetaminophen, Hydrochlorothiazide, Sildenafil及Bromhexine。

關鍵字

中藥製劑摻加西藥 ； 抗過敏類 ； 春藥麻醉藥類 ； 感冒鎮咳類 ； 類固醇類 ； 風濕鎮痛類

並列摘要

In this study, we present the results on the synthetic chemical compounds adulterated in 476 samples of Chinese herbal preparations, which we collected and analyzed during 2003. The result indicates that 16.0%(52/325) of the samples obtained from the consumer service 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 13.4%(64/476).
The sources of samples are classified into two different categories. For the first category, the supply sources include legal manufacturers of Chinese herbal preparations and medical units (hospitals and clinics of traditional Chinese medicine), the adulterated rate ranges from 0 to 11.2%. The second category includes Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the adulterated rate ranges from 0 to 18.4%.
There are 64 samples that contain adulterants. The average number of adulterants in each sample is 3.39. 39.1% of the samples contain one kind of adulterant, and 12.5% of the samples contain five kinds. In terms of therapeutic categories, most adulterants are found as antiallergic, aphrodisiac-anesthetics, anticold-antitussives, steroids and antirheumatic-analgesics.
Not only the adulterants that are associated with the required categories are found in the Chinese herbal preparations, other adulterants that are irrelevant to the claimed effects are found as well. As ranked by the frequency of use, thiamine is the most commonly used adulterant, followed by caffeine, acetaminophen, hydrochlorothiazide, sildenafil and bromhexine.

並列關鍵字

Adulterants in Chinese Herbal Preparations ； antiallergic ； aphrodisiac-anesthetics ； anticold-antitussives ； steroids ； antirheumatic-analgesics