97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 2008

本報告係本局97年度受理衛生行政機關、司法檢警情治機關等送驗調製劑中藥摻加西藥案件計480件檢體，其中42件檢出西藥成分不合格，檢出率為8.8%。受理案件依送驗機關別統計，屬各縣市衛生局消費者服務中心轉送消費者申請案件及司法檢警情治機關申辦之服務案件有373件，檢出34件(9.1%)；衛生行政機關抽查案件107件，檢出8件(7.5%)。依檢體來源合法性統計，屬合法廠商及醫療機構者207件，檢出13件(6.3%)；屬依法不得販售及提供藥品者273件，檢出29件(10.6%)。42件不合格檢體中檢出西藥成分數以1及4種各10件(23.8%)最多；其次為檢出3種西藥成分8件(19.0%)。檢出西藥之檢體依檢驗類別排名，檢出率最高為外用膏粉類。西藥成分檢出頻率前3名依序為Caffeine，Acetaminophen，Hydrochlorothiazide及Indomethacin。本統計分析報告將提供作為行政管理參考。

In this study, we examined the chemical compounds adulterated in 480 samples of Chinese medicinal preparations (CMP), which were collected and analyzed during the fiscal year of 2008. The result indicated that 9.1% (34/373) of the samples acquired from the consumer service centers of the local health bureaus and judicial organizations were adulterated. However, if the samples randomly collected from local markets were included, the adulteration rate decreased to 8.8% (42/480).The sources of samples were classified into two categories. The first one consisted of samples collected from legal institutions, including manufacturers of CMP and medical units such as hospitals, clinics and dealers of traditional Chinese medicine, in which the average adulterated rate was 6.3%. The second category consisted of samples from illegal suppliers, such as Chinese kung-fu stores, folk medicine stores, unlicensed practitioners and others, in which the average adulterated rate was 10.6%.42 samples contained adulterants, among them, 23.8% with one or four adulterants, and 19.0% with three adulterants. In terms of therapeutic activity, most adulterants were found in external use preparations.
The therapeutic activity of most adulterants was irrelevant to the claimed use of CMP. The result showed that caffeine was the most commonly used adulterants, followed by acetaminophen, hydrochlorothiazide and indomethacin.