臺灣博碩士論文加值系統

本研究利用超臨界溶液快速膨脹法進行藥物依普黃酮之微粒化研究。利用2^K因子實驗設計法探討超臨界快速膨脹法中，萃取溫度(A)、萃取壓力(B)、膨脹前溫度(C)與膨脹後溫度(D)四個操作參數效應。經過異變數分析結果可得到，各參數中以膨脹前溫度(C)的效應最為顯著，且高膨脹溫度有利於較小的微粒生成。此外，亦發現二交互作用效應，即萃取溫度與膨脹後溫度(AD)以及萃取壓力與膨脹後溫度(BD)兩者。本研究可成功將依普黃酮的平均粒徑從原本的15.9微米，微粒化至3微米，由掃描式電子顯微鏡分析其外觀則由塊狀轉為較小的片狀，且其晶形與化學性質經傅立葉紅外線光譜儀、微分掃描式熱卡計、熱重分析儀、X光繞射儀分析皆保持一致沒有改變。可驗證RESS技術在藥物微粒化之可行性。

This study investigated the micronization of ipriflavone using rapid expansion of supercritical solution (RESS) process. A two-level factorial experimental design, is used to study the effect of operating parameters including extraction temperature (A), extraction pressure (B), pre-expansion temperature (C), and post-expansion temperature. According to the ANOVA results, pre-expansion temperature (C) is the most significant parameter, and a high pre-expansion temperature is favorable to generate the small ipriflavone particles. In additions, we also found two cross-interaction effects including the extraction temperature and post-temperature (AD) and the extraction pressure and post-temperature (BD). In this study, ipriflavone were successfully micronized by RESS process from original 15.9 μm to 3 μm Furthermore, the solid-state properties analyzed by Fourier transform infrared spectrometer (FTIR), differential canning calorimeter (DSC), and powder X-ray diffraction (PXRD) show consistent with original sample.

摘要 i
ABSTRACT ii
誌謝 iv
表目錄 vi
圖目錄 vii
第一章緒論 1
1-1超臨界流體 1
1-2藥物微粒化的重要性 2
1-3超臨界流體微粒化技術 3
1-4 RESS實驗設計法回顧 5
1-5 研究規劃與動機 6
第二章研究方法 13
2-1 實驗藥品 13
2-2藥物於超臨界溶液快速膨脹法之微粒化 13
2-2-1 實驗裝置 13
2-2-2 實驗步驟 15
2-2-3 分析方法 17
第三章結果與討論 21
3-1依普黃酮之RESS微粒化結果 21
3-1-1 參數效應 21
3-1-2 物性分析 26
第四章結論 44
參考文獻 45
附錄 49

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