頁籤選單縮合
題名 | 九十八年度抗生素製劑之品質監測=Quality Survey of Antibiotic Preparations in Taiwan |
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作者 | 連淑華; 曾思諭; 許鳳麟; 許家銓; 葉美伶; 林憶薰; 顏弼群; 陳瑜絢; 陳惠芳; | 書刊名 | 食品藥物研究年報 |
卷期 | 1 2010.11[民99.11] |
頁次 | 頁155-162 |
分類號 | 412.36 |
關鍵詞 | 頭孢福辛; 氯噻青黴素; 克拉黴素; Cefuroxime; Cloxacillin; Clarithromycin; |
語文 | 中文(Chinese) |
中文摘要 | 摘 要 本計畫目的係為瞭解台灣地區抗生素之品質,保障民眾使用藥物之安全,進行頭孢福 辛(Cefuroxime)錠劑、懸液劑及注射劑,氯噻青黴素(Cloxacillin)膠囊及注射劑,克拉黴素 (Clarithromycin)錠劑及懸液劑之品質調查。本計畫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98年1月至7月間,逕赴轄區內藥局、醫療院所、製造廠及 進口商處抽驗市售檢體共計137件。檢測方法依據中華藥典第六版(Ch. P. VI)、美國藥典第 32版(USP 32)及製造廠之檢驗方法進行檢測。檢驗項目包括外觀檢查、單位劑量均一度(重 量差異試驗)、水分測定、溶離度試驗、含量測定(力價試驗)及細菌內毒素試驗。總計完成 頭孢福辛錠劑、懸液劑及注射劑59件,氯噻青黴素膠囊及注射劑38件,克拉黴素錠劑及懸 液劑40件,共計137件之檢體。結果顯示134件符合規定,2件不符合規定,1件氯噻青黴素 膠囊則已過保存期限。2件不符合規定檢體分別為氯噻青黴素膠囊與克拉黴素錠劑,皆為水 分測定不符合藥典規定,不合格率為1.5% 。不合格之產品均函請轄區衛生局進行相關之行 政處理,並由本局派員查廠和輔導。 |
英文摘要 | ABSTRACT In order to ensure the safety for the patients using antibiotic pharmaceuticals, this study was aimed to investigate the qualities of cefuroxime tablets, oral suspension and injections, cloxacillin capsules and injections, and clarithromycin tablets and oral suspension in Taiwan area. All samples were collected by the local health authorities from hospitals, clinics, manufacturers and importers in various counties from January to July, 2009. One hundred and thirty-seven samples were tested by analytical methods described in the US Pharmacopeia XXXII, the Chinese Pharmacopoeia VI and the test methods originated from manufactures. The results showed that 2 samples (1.5%) didn’t meet the requirements of pharmacopeia and regulations. One cloxacillin and one clarithromycin sample failed to meet the water content test requirements. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。