頁籤選單縮合
| 題 名 | 102年度市售奈米藥品品質監測及奈米檢驗技術之研究=Investigating the Quality of Marketed Nano Drugs and Analytical Techniques in Research |
|---|---|
| 作 者 | 范孟棋; 王博譽; 陳玉盆; 周秀冠; 施養志; 陳惠芳; | 書刊名 | 食品藥物研究年報 |
| 卷 期 | 5 2014.12[民103.12] |
| 頁 次 | 頁132-138 |
| 分類號 | 412.36 |
| 關鍵詞 | 奈米科技藥品; 鐵劑; 動態光散射奈米粒徑分析儀; 穿透式電子顯微鏡; Nano drug; Iron supplement; Dynamic light scattering; Transmission electron microscopy; |
| 語 文 | 中文(Chinese) |
| 中文摘要 | 本研究蒐集市售奈米鐵劑之相關資料並進行檢測,以期建立奈米科技藥品之檢 驗技術。目前市售奈米鐵劑包括滴劑及咀嚼錠兩種劑型,其主成分為iron hydroxide polymaltose complex,本研究共取得7件市售奈米鐵劑進行檢驗,探討的檢測項目選 取ISO/TR 13014:2012技術報告所列舉奈米材料八大物化特性中粒徑(particle size)、 形狀(shape)、組成成分(composition)及表面電荷(surface charge)等4項。7件檢體分 別以動態光散射奈米粒徑分析儀檢測,平均粒徑分別為12.1、424.6、84.4、75.4、 66.9、60.4及78.2 nm;以穿透式電子顯微鏡觀察奈米粒子形狀,呈現圓形或長條狀; 以能量分散光譜分析檢測確認有鐵元素;並以介面電位分析儀執行奈米粒子表面電 位測定,其電位介於-15.8 mV與-31.0 mV之間。關於奈米科技藥品粒徑檢驗規範,目 前國際上尚未有一致之要求,亦未見於藥典各品項之規格中,本研究先就已有奈米化之產品建立粒徑檢驗技術,待日後奈米產品納入粒徑規範時,可據以檢驗並確認品質狀況。 |
| 英文摘要 | In order to investigate the analytical techniques of nano drugs, relevant scientific data were collected based upon testing marketed oral nano-iron supplements. The current routes for marketed oral nanoiron supplements are oral drops and chewable tablets with iron hydroxide polymaltose complex as an active pharmaceutical ingredient. A total of 7 samples of marketed products were collected to test for nano characteristics. The test items included particle size, shape, composition and surface charge, which were based on the ISO/TR 13014:2012 technical report. Each average particle size of the tested samples, which were determined by dynamic light scattering, were 12.1, 424.6, 84.4, 75.4, 66.9, 60.4 and 78.2 nm. Through the transmission electron microscope, the particle shapes were observed to be round or elongated rod-like. From the surface charge analysis, all of the 7 samples were found to be between -15.8 mV and -31.0 mV. Moreover, energy dispersive spectroscopy indicated iron composition in the samples. Currently, there are no international guidelines for nano drug analysis. Similarly, the pharmacopoeias do not mention regulations for tested items related to nano drug characteristics. This study was intended to establish the analytical techniques of nano drugs. We believe that in the near future, the laboratory would be able to verify and monitor the quality of nano drugs. |
本系統中英文摘要資訊取自各篇刊載內容。