93-100年度抗生素製劑之品質監測結果分析

Quality Survey of Antibiotic Preparations in Taiwan between 2004 and 2011

連淑華(Shu-Hwa Lian) ； 陳怡臻(Yi-Chen Chen) ； 許家銓(Jia-Chuan Hsu) ； 王德原(Der-Yuan Wang) ； 施養志(Daniel Yang-Chih Shih)

《食品藥物研究年報》 3期 (2012/12) Pp. 322-335

https://doi.org/10.6945/ARFDR.201212.0322

摘要

為瞭解台灣地區抗生素之品質，及保障民眾使用藥物之安全及有效性，自93年起啟動「藥物品質監測計畫」（即現今產品後市場品質監測計畫），結合中央、地方衛生機關資源與民間檢驗能量共同執行產品品質調查與監控。本計畫委請台北市政府衛生局、新北市政府衛生局、台中市政府衛生局、台南市政府衛生局、高雄市政府衛生局及各縣市政府衛生局持續就轄區內醫療院所、製造廠協助抽取檢體。93至100年底，8年間共執行9個計畫，35種抗生素品項之調查，分屬青黴素類（Penicillins）等9種藥理分類、口服膠囊等9種劑型及力價/含量測定等9種試驗項目。監測項目之檢驗規格與方法，主要依據新版中華藥典、美國藥典或原廠規進行檢驗。8年間共檢測1,567件檢體，國產1,364件（87%）與輸入產品203件（13%），檢驗結果合格件數1,508件（96.2%）不合格件數59件（3.8%），不合格檢體以恩菎類（Quinolones）（10.2%）及口服錠劑劑型（11.0%）居多，檢驗不合格試驗項目，由以往不合格率較高之力價/含量測定項有逐漸下降趨勢（0.2%），惟93年起增加檢驗項目與輔助藥品安定（含水量測定）（0.9%）及吸收（溶離度試驗）（4.4%）有關之品質檢測，仍有部分製劑不符合規定，尚須製造廠持續有效矯正與嚴格控管。

關鍵字

抗生素 ； 藥物品質監測 ； 產品後市場品質監測

並列摘要

In order to investigate the quality of antibiotics used in Taiwan, series of post-marketing surveillance have been performed for eight years. All samples were collected from hospitals, clinics, manufacturers and importers in various counties from 2004-2011 by local health authorities. Totally, 35 different antibiotics with nine testing items have been examined during eight years. The 1,567 test samples, which contained 1,364 domestic samples (87%) and 203 (13%) imported samples, were evaluated according to the analytical methods described in the Chinese Pharmacopoeia, the US Pharmacopoeia and the original manufactures' documents. The results showed 59 samples (3.8%) did not meet the requirements. Among them, quinolones antibiotic (10.2%) and oral preparation (11.0%) were the highest proportions in nine categories of antibiotics and nine different preparations that we have investigated, respectively. In addition, we found the common uncertified items were the dissolution test (4.4%) and moisture (0.9%) which involved the drug absorption and stability. The follow-up treatments and improvement of antibiotic products and manufacturers have been continuously monitored and tracked by health authorities.

並列關鍵字

antibiotic ； quality control ； post marketing surveillance