九十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 2001

林美智(Mei-Chih Lin) ； 劉宜祝(Yi-Chu Liu) ； 林哲輝(Jer-Huei Lin) ； 廖俊亨(Chun-Heng Liao)

《藥物食品檢驗局調查研究年報》 20號 (2002/09) Pp. 178-194

https://doi.org/10.6946/ASRNL.200209.0178

摘要

本報告係本局於九十年一月至十二月間受理衛生行政機關、司法檢警情治機關送驗調製劑中藥，檢驗是否摻加西藥案件計694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17.0%。涵蓋衛生行政機關抽查案件則檢出率為15.3%。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10.4%。屬依法不得販售及提供藥品者其平均檢出率20.4%，以國術館檢出率最高。分析106件不合格檢體中，每件檢體檢出西藥個數以檢出一種西藥成分最多，占36.8%，其次檢出六種西藥成分占12.3%，檢出二種及三種西藥成分均占9.4%。檢出西藥之106件檢體依劑型別，散劑檢出率最高，占49.1%。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，外用膏、粉類及類固醇類，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依序為caffeine, acetaminophen, thiamine, hydrochlorothiazide, indomethacin, diazepam, diphenhydramine, dicyclomine, chlorzoxazone, ethoxybenzamide及chlorpheniramine。

關鍵字

中藥摻加西藥 ； 風濕鎮痛類 ； 外用膏 ； 粉類 ； 類固醇類

並列摘要

In this study, we presented the survey result of 694 Chinese herbal preparations, which we collected and analyzed during 2001, that were adulterated with synthetical chemical drugs. The result indicated that 17.0% (83/488) of the samples obtained from the consumer service centers of the local health bureaus were adulterated. However, if we included the samples that were randomly taken from local markets by the health bureau officers, the adulteration rate decreased to 15.3% (106/694).
The sources of samples were classified into two different categories. The first one of which the supply sources included legal manufacturers of Chinese herbal medicines and medical units (hospitals and clinics of traditional Chinese medicine) in which the adulteration rate ranged from 0 to 57.1% of the samples. In the second category, which included Chinese Kung-fu Stores, folk medicine stores, unlicensed practitioners and others, the adulteration rate ranged from 11.1 to 50.0%.
Totally 106 samples were adulterated with chemical drugs. The average number of adulterants in each sample was 3.56. Among them, 36.8% of the samples contained one adulterant and 12.3% of the samples contained six adulterants. In terms of therapeutic categories, most adulterants were found in antirheumatic-analegesics preparations, external use preparations and steroids preparations. In terms of dosage forms, the rate in external preparations was 76.7%, 16.9% in capsule and 15.5% in powder. In terms of regions, the rates of adulterations found were: 21.4% in towns, 13.0% in provincial cities, 12.1% in special municipalities, and 9.2% in counties.
In addition to the adulterants as indicated above, some of the adulterants found in the Chinese herbal medicine were irrelevant to the intended treatment. As ranked by the frequency of use, caffeine was the top one item followed by acetaminophen, thiamine, hydrochlorothiazide, indomethacin, diazepam, diphenhydramine, dicyclomine, chlorzoxazone, ethoxybenzamide and chlorpheniramine.

並列關鍵字

adulterants in prescriptive Chinese herbal medicines