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藥物食品檢驗局調查研究年報
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中文摘要
為瞭解台灣地區抗生素製劑之品質狀況，保障民眾使用藥物之安全，96年度進行安比西林（Ampicillin）膠囊之品質調查。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70件，因部分檢體重複批號未進行檢驗，實際進行檢驗件數為60件。參照中華藥典、美國藥典及原製造廠之檢驗規格方法進行檢測，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1件檢體之溶離度不符合規定，符合規定者59件，合格比率為98.3%。不合格之產品已由衛生局進行相關之行政處理，本局並派員查廠和輔導，本調查結果提供衛生主管機關作為藥政管理之參考。
英文摘要
This study was aimed to surrey the quality of antibiotic drugs in Taiwan area to ensure the medication safety. Seventy Ampicillin were sampled from hospitals, clinics, manufacturers and importers by local health
authorities in different counties from January to July, 2007. Excluding the repeated lots, 60 samples 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 59 samples (98.3%) met the requirements of pharmacopeia and government regulations. One Ampicillin sample failed to fulfill the dissolution test requirements and was penalized by local health authority according to Pharmaceutical Affairs Act.