頁籤選單縮合
題名 | 100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; 李珮玲; 王德原; 施養志; | 書刊名 | 食品藥物研究年報 |
卷期 | 3 2012.11[民101.11] |
頁次 | 頁312-321 |
分類號 | 412.36 |
關鍵詞 | 頭孢泰新鈉; 氯絲菌素; 諾弗洒欣; Cefotaxime sodium; Chloramphenicol; Norfloxacin; |
語文 | 中文(Chinese) |
中文摘要 | 抗生素可經由特定的作用,達到抑制或殺死細菌的效果,為目前用於抗感染治療之最佳藥物,其製劑品質之優劣攸關治療感染症的效力。本計畫為監測台灣地區市售抗生素製劑之品質狀況,並依據風險評估結果,選定頭孢泰新鈉(Cefotaxime sodium)、氯絲菌素(Chloramphenicol)及諾弗洒欣(Norfloxacin)相關製劑,作為100年監測之品項。檢體係委託各地方衛生局逕至轄區醫療院所、藥廠及代理商進行抽樣,並依據中華藥典第六版(Ch. P.VI)、美國藥典第32版(USP 32)及原廠之檢驗規格,進行外觀檢查、單位劑量均一度(重量差異試驗)、含水量(水分)、pH值、溶離度、含量測定(力價試驗)及細菌內毒素等試驗項目之檢驗。本計畫於100年1至10月間,抽樣頭孢泰新鈉37件、氯絲菌素58件及諾弗洒欣38件,共計133件檢體。檢驗結果有129件符合規定,4件不合格,不合格率為3.0%。不合格檢體中,2件為溶離度試驗不符合規定,分別是氯絲菌素膠囊與諾弗洒欣膠囊;另2件為氯絲菌素眼藥水,其pH值與藥典所載不符,均已函請轄區衛生局進行相關行政處理,並由本局派員查廠,實地找出問題所在並輔導改善。 |
英文摘要 | The aim of this study was to investigate the quality of antibiotics used in Taiwan, including Cefotaxime sodium, Chloramphenicol and Norfloxacin to ensure the drug safety and efficacy. All these samples were collected from hospitals, clinics, manufacturers and importers in various counties from January to October, 2011 by the local health authorities. Totally, 133 samples were evaluated by the analytical methods described in the Chinese Pharmacopoeia VI, the US Pharmacopoeia 32 and the original manufactures specification. The results showed 4 samples (3.0%) were unqualified, among which the chloramphenicol capsule and norfloxacin capsule did not meet the requirements of dissolution test in pharmacopeia and original regulation. pH test of 2 chloramphenicol ophthalimc solution did not meet the requirements of pharmacopeia. The unqualified products will be followed up and continuously tracked by the local health authorities. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。