九十一年度調製劑中藥檢出西藥情形之分析

Survey on Adulterants in Prescriptive Chinese Herbal Medicines in Fiscal Year 2002

林美智(Mei-Chih Lin) ； 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》 21號 (2003/09) Pp. 122-136

https://doi.org/10.6946/ASRNL.200309.0122

摘要

本報告係本局於九十一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，檢驗是否摻加西藥案件共計551件之統計分析結果。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24.3%。涵蓋衛生行政機關抽查案件者則檢出率為20.3%。檢體來源屬合法廠商、醫療機構之調製劑中藥摻加西藥之平均檢出率10.9%，屬依法不得販售及提供藥品者其平均檢出率27.5%，其中以其它未述明來源者檢出率最高，達32.1%，顯示民眾用藥不依專業之情形嚴重。分析112件不合格檢體，每件檢體檢出西藥個數以檢出四種西藥成分最多，占30.4%，其次檢出一種西藥成分占24.1%，檢出五種西藥成分占15.2%，檢出六種西藥成分占12.5%。檢出西藥之112 件檢體依劑型別，散劑檢出率最高，占47.3%。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、類固醇類及感冒鎮咳類，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前十名依序為hydrochlorothiazide, thiamine, caffeine, piroxicam, dicyclomine, indomethacin, acetaminophen, ethoxybenzamide, diazepam, dexamethasone及ibuprofen。

關鍵字

中藥摻加西藥 ； 風濕鎮痛類 ； 感冒鎮咳類 ； 類固醇類

並列摘要

In this study, we present the results on the synthetic chemical compounds adulterated in 511 samples of Chinese herbal medicines, which we collected and analyzed during 2002. The result indicates that 24.3% (96/395) 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 20.3% (112/551).
The sources of samples are classified into two different categories. For the first category, the supply sources include legal manufacturers of Chinese herbal medicines and medical units (hospitals and clinics of traditional Chinese medicine), the adulterated rate ranges from 0 to 27.3%. The second category includes Chinese Kung-fu stores, folk medicine stores, unlicensed practitioners and others, the adulterated rate ranges from 0 to 32.1%.
There are 112 samples that contain adulterants. The average number of adulterants in each sample is 3.73. 30.4% of the samples contain four kinds of adulterants, and 24.1% of the samples contain one kind. In terms of therapeutic categories, most adulterants are found as antirheumatic-analgesics, steroids and anticold-antitussives. In terms of dosage forms, the rate of adulteration in capsule is 39.1%, in external preparation is 30.8%, and in tablet is 28.6%. In terms of regions, the rates of adulterations in provincial cities, in towns, in counties and in special municipalities are 41.9%, 21.3%, 15.9% and 10.6%, respectively.
Not only the adulterants that are associated with the required categories are found in the Chinese herbal medicine, other adulterants that are irrelevant to the claimed effects are found as well. As ranked by the frequency of use, hydrochlorothiazide is the most commonly used adulterant, followed by thiamine, caffeine, piroxicam, dicyclomine, indomethacin, acetaminophen, ethoxybenzamide, diazepam, dexamethasone and ibuprofen.

並列關鍵字

Adulterants in Prescriptive Chinese Herbal Medicines ； antirheumatic-analgesics ； steroids ； anticold-antitussives