97年度抗生素製劑之品質監測

Quality Survey of Antibiotics Preparations in Taiwan

97年度抗生素製劑品質監測計畫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，進行萘利啶酸(Nalidixic acid)膠囊及錠劑、歐弗洒欣(Ofloxacin)錠劑、鹽酸羥四環素(Oxytetracycline Hydrochloride)膠囊及注射劑之品質調查。本計畫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97年1月至7月間，逕赴轄區內醫療院所及製造廠抽驗市售檢體共計114件。依據中華藥典第六版(Ch. P. VI)、美國藥典第30版(USP 30)及原廠之檢驗方法進行檢測，結果顯示其中有26件檢體不符合規定，2件檢體不予判定，不合格率為22.8%，不合格之產品已函請轄區衛生局進行相關之行政處理。

In order to ensure the safety of the patients using antibiotic pharmaceuticals, this study was aimed to investigate the quality of nalidixic acid capsules and tablets, ofloxacin tablets, oxytetracycline hydrochloride capsules and injections in Taiwan area. All samples were collected by the local health authorities from hospitals, clinics, manufacturers and importers in different counties from January to July, 2008. One hundred forteen samples were tested by analytical methods described in the USP 30, the Ch. P. Ⅵ and the original manufactures to evaluate their qualities. The results showed that 26 samples (22.8%) didn't meet the requirements of pharmacopeia and government regulations. One oxytetracycline hydrochloride and 24 nalidixic acid samples failed to meet the dissolution test requirements. One nalidixic acid sample failed to meet the assay and dissolution test requirements.