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藥物食品檢驗局調查研究年報
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| 篇名 | 鎮咳祛痰劑之品質監測 |
|---|---|
| 卷期 | 25 |
| 並列篇名 | Survey on the Quality of Oral Preparations of antitussives and Expectorants in Taiwan |
| 作者 | 黃俐嘉 、 陳玉盆 、 黃明權 、 鄒玫君 |
| 頁次 | 11-15 |
| 關鍵字 | Antitussive 、 Expectorants 、 Ambroxol hydrochloride 、 Bromhexine hydrochloride 、 Eprazinone hydrochloride 、 Survey 、 TSCI |
| 出刊日期 | 200710 |
中文摘要
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。
英文摘要
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.