- 期刊
鎮咳袪痰劑之品質監測
Survey on the Quality of Oral Preparations of Antitussives and Expectorants in Taiwan
摘要
為瞭解臺灣地區現階段市售鎮咳袪痰劑(Ambroxol hydrochloride、Bromhexine hydrochloride、Eprazinone hydrochloride)口服固型製劑之品質狀況，經函請北、高兩市及各縣市衛生局，於民國95年1月至6月間，赴轄區內醫院診所、藥局、藥廠及代理商抽驗市售檢體，抽驗檢體中Ambroxol hydrochloride計32件、Bromhexine hydrochloride計25件、Eprazinone hydrochloride計21件，共計78件，其中國產品76件，輸入品2件。參照中華藥典第五版之檢驗規格、方法及本局常用藥物化粧品檢驗方法專輯進行一般檢查、鑑別及含量測定等重點項目檢驗及依原廠規格判定，結果1件（含Eprazinone hydrochloride成分）品質檢驗不合格，不合格率1.28%，3件不判定（外觀與原申請之規格不一致），其他74件均合格，以上不符規定之產品，均已函送各地方衛生單位，依違反藥事法予以處理。本調查計畫之結果將提供作為藥政管理之參考。
並列摘要
To investigate the quality of oral solid dosage forms of antitussive and expectorant in current Taiwan market, a total of 78 samples of ambroxol hydrochloride (32), bromhexine hydrochloride (25) and eprazinone hydrochloride (21) drug products were collected from manufacturer, importer, hospital and pharmacy via county and/or city local health agencies during January to June 2006. Seventy-six products were local and 2 were imported. Analytical tests were performed on these products and conclusions were drawn based on the testing methods of Chinese Pharmacopeia V (Ch. P. V) and Bureau of Food and Drug and Analysis (BFDA) Analytical Methods for Drugs and Cosmetics. One (1.28%) antitussive failed to meet the requirement (eprazinone hydrochloride content), 3 antitussives and expectorants failed to conform to the specification of appearances. Local health agencies were noticed of the test results for administrative sanctions of Phramaceutical Affairs Law (PAL) violation.