九十三年度調製劑中藥檢出西藥成分之分析

Survey on Adulterants in Chinese Medicinal Preparations during the Fiscal Year of 2004

賴國誌(Kuo-Chih Lai) ； 劉宜祝(Yi-Chu Liu) ； 林哲輝(Jer-Huei Lin) ； 孫慈悌(Erick Tsi-Tee Suen)

《藥物食品檢驗局調查研究年報》 23號 (2005/09) Pp. 64-79

https://doi.org/10.6946/ASRNL.200509.0064

摘要

本報告係本局於九十三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，送驗調製劑中藥摻加西藥案件之統計分析結果，計316件檢體，共43件不合格，其檢出率為13.6%。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8.8%(21/239)，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7.9%(17/216)，由司法檢警單位等送驗案件檢出率為17.4%(4/23)；屬衛生行政機關之抽查案件者，其檢出率為28.6%(22/77)。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6.8%(13/189)；屬依法不得販售及提供藥品者，檢出率為23.6%(30/127)。每件檢體檢出西藥成分個數以一種最多，佔51.2%(22/43)；其次為檢出三種及四種西藥成分，均佔9.3%(4/43)。檢出西藥之檢體依送驗指定主治效能排名，檢出率最高為風濕鎮痛類，其次為外用春藥類及止痛類，再次為類固醇類、補腎滋養類及感冒鎮咳類。西藥成分檢出頻率前五名依序為Caffeine，Thiamine，Indomethacin，Hydrochlorothiazide及Acetaminophen。

關鍵字

調製劑中藥摻加西藥 ； 風濕鎮痛類 ； 外用春藥類 ； 止痛類 ； 類固醇類 ； 補腎滋養類 ； 感冒鎮咳類

並列摘要

In this study, we present the results on the synthetic chemical compounds adulterated in 316 samples of Chinese medicinal preparations (CMP), which we collected and analyzed during 2004. The result indicates that 8.8% (21/239) 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 increases to 13.6% (43/316).
The sources of samples are classified into two different categories. The first one consists of legal institutes, including manufacturers of CMP and medical units such as hospitals, clinics and dealers of traditional Chinese medicine, in which the sample adulterated rate ranges from 0 to 6.8%.The second category is the illegal suppliers, including Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the adulterated rate ranges from 0 to 23.6%.
There are 43 samples that contain adulterants. 56.4% of them contain one adulterant, and 10.3% of them contain three and four adulterants. The average number of adulterants in each sample is 2.21. In terms of therapeutic categories, most adulterants are found as antirheumatic-analgesics, external use aphrodisiac, analgesics, steroids, kidney-supplement and anticold-antitussives.
Most adulterants are irrelevant to the claimed therapeutic effect of CMP, and CNS stimulant caffeine is themost commonly used, the following are thiamine, indomethacin, hydrochlorothiazide and acetaminophen.

並列關鍵字

adulterants, Chinese medicinal preparations ； antirheumatic-analgesics ； external use aphrodisiac ； analgesics ； steroids ； kidney-supplement ； anticold-antitussives