頁籤選單縮合
題名 | 101年度市售奈米藥品品質調查=Investigation on the Quality of Marketed Nano-Drug Products |
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作者 | 范孟棋; 王博譽; 陳玉盆; 闕麗卿; 施養志; Fan, Meng-chi; Wang, Por-yuh; Chen, Yu-pen; Chiueh, Lih-ching; Shih, Yang-chih; |
期刊 | 食品藥物研究年報 |
出版日期 | 20131100 |
卷期 | 4 2013.11[民102.11] |
頁次 | 頁156-161 |
分類號 | 412.36 |
語文 | chi |
關鍵詞 | 奈米藥品; 微粒物質檢查; 平均粒徑; Nano-drug; Particulate matter; Particle size; |
中文摘要 | 為建立奈米粒子檢測技術及奈米化藥品之品質, TFDA委請台北市、桃園縣及新竹縣等衛生局進行市售奈米化藥品之抽驗。實際抽得檢體計 8件(含口服劑型 5件,注射劑型 3件),並進行注射液微粒物質檢查及平均粒徑等項目之檢驗,以建立奈米粒子檢測技術,同時依據原查驗登記核准之檢驗規格及方法進行鑑別、含量測定、單位劑量均一度及溶離度試驗,以瞭解品質狀況。檢驗結果 3件注射劑產品之微粒物質檢查均符合藥典規範,其中有 1件注射劑另訂有平均粒徑規格,該項目之檢驗結果符合原廠規格,其他一般藥品製劑檢驗項目之檢驗結果均符合藥典規範及原廠規格。 |
英文摘要 | In order to establish nanoparticle analytical technique, a total of 8 marketed nano-drug samples were collected by local health authorities from Taipei city, Taoyuan county and Hsinchu county for test of particulate matter and particle size. In addition, The test of identification, assay, content uniformity and dissolution were also conducted for surveying the quality of pharmaceutical products. All samples met the requirement as described in Pharmacopeia. Besides, the particle size test result of one of the injectable drug products showed compliance with in-house specification. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。