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摘要


本計畫目的係為瞭解台灣地區抗生素眼藥水之品質,保障民眾使用藥物之安全。進行氯絲菌素(Chloramphenicol)眼藥水、紫菌素(Gentamicin)眼藥水、新絲菌素(Neomycin)眼藥水、諾弗洒欣(Norfloxacin)眼藥水及泰百黴素(Tobramycin)眼藥水之品質調查,經函請台北市政府衛生局、高雄市政府衛生局及各縣市政府衛生局,於民國95年1月至8月間,赴轄區內醫療院所、製造廠及輸入代理商抽驗市售檢驗檢體共計137件,包含國產121件及輸入16件。所進行之抗生素眼藥水各為氯絲菌素眼藥水30件、紫菌素眼藥水50件、新絲菌素眼藥水28件、諾弗洒欣眼藥水13件及泰百黴素眼藥水16件,參照中華藥典第五版(Ch. P. V)及美國藥典第29版(USP 29)之檢驗方法進行檢測,其外觀、酸鹼值、無菌試驗、抗生素鑑別及抗生素力價之檢測結果均符合規定。

並列摘要


In order to survey the quality of antibiotic eye drops in Taiwan, 137 samples were collected from various manufacturers and agents via local health personnel throughout Taiwan area from January to August, 2006. These samples, including chloramphenicol ophthalmic, gentamicin sulfate ophthalmic, neomycin sulfate ophthalmic, norfloxacin ophthalmic, and tobramycin ophthalmic solutions, were analyzed by methods described in Ch. P. V, USP 29, MRAP 2000, BP 2000 to evaluate their quality. The results showed that all samples met the requirements of pharmacopeia and government regulations.

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