頁籤選單縮合
題 名 | 安莫西林口服製劑之品質監測=Quality Survey of Amoxicillin Oral Preparations in Taiwan Area |
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作 者 | 葉美伶; 王姿惠; 蔡美麗; 許鳳麟; 許家銓; 連淑華; 邱怡寧; 楊瑋銘; 陳瑜絢; 林嘉伯; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 26 2008.10[民97.10] |
頁 次 | 頁56-62 |
分類號 | 412.36 |
關鍵詞 | 安莫西林膠囊; 安莫西林錠劑; 安莫西林懸浮糖漿乾粉劑; Amoxicillin capsules; Amoxicillin tablets; Amoxicillin particles for suspension; |
語 文 | 中文(Chinese) |
中文摘要 | 為瞭解台灣地區抗生素之品質狀況,保障民眾使用藥物之安全,96年度進行安莫西林(Amoxicillin)3種口服製劑(膠囊、錠劑及懸浮糖漿乾粉劑)品質調查。由台北市政府衛生局、高雄市政府衛生局及各縣市政府衛生局,於民國96年1月至7月間,赴轄區內醫療院所、製造廠及輸入代理商抽驗市售檢體共計72件,參照中華藥典第六版、美國藥典第29版及原製造廠之檢驗規格、方法進行檢驗,檢驗項目包括外觀、含水量、單位劑量均一度(重量差異)、溶離度及抗生素力價試驗,結果顯示有6件檢體之溶離度不符合規定,符合規定者64件,合格比率為91.4 %。不合格之產品已由衛生局進行相關之行政處理,另由本局派員查廠和輔導,本調查結果並提供衛生主管機關作為藥政管理之參考。 |
英文摘要 | The purpose of this study was to survey the quality of antibiotic drugs in Taiwan area to ensure the medication safety. Seventy-two amoxicillin oral preparations were sampled from hospitals, clinics, manufacturers and importers in different counties by local health authorities from January to July, 2007. Excluding the repeated lots, 70 samples, including amoxicillin capsules, amoxicillin tablets, and amoxicillin particles for suspension, were tested by analytical methods described in Ch. P. VI, USP 29 and the original manufacture analytical method to evaluate their qualities. The results showed that 64 samples (91.4%) met the requirements of pharmacopeia and government regulations. Six amoxicillin samples failed to meet the dissolution test requirements, and the local health authorities were notified for penalty according to Pharmaceutical Affairs Act. |
本系統中英文摘要資訊取自各篇刊載內容。