幾丁聚醣對藥物之影響 易延陵、王三郎 ; ? ; 耀國
E-mail: [email protected]
摘 要
本研究主要係以幾丁聚醣探討對於藥物釋放的影響,比較不同的比例,不同造粒製程,不同幾丁聚醣加入方式,進行比較 錠劑的溶離試驗(Dissolution Profile)的差異進而可推知於人體內藥物釋放的情形。並了解當有幾丁聚醣存在時,其打錠製程 所得參數ex:硬度、厚度、崩散試驗等是否有顯著差異,實驗主題選擇2種藥物分別就其藥物本身訴求進行處方設計,研究 在控釋劑型幾丁聚醣能扮演的角色,基於文獻上對於幾丁聚醣能促進藥物吸收的特性,故選擇一般習知的普拿
疼(Acetaminophen)止痛藥,期使幾丁聚醣能使其藥物迅速發揮,進而推知在人體內時其會快速解決疼痛病人的苦痛,於體 外評估實驗結果(測試Dissolution Profile)其與一般市售的樣品比較,可知不同比例的幾丁聚醣會影響溶出的速率。其實驗處 方設計原理是利用幾丁聚醣所佔濃度及Acetaminophen在酸性環境下會使溶解度增加且其幾丁聚醣本身有如崩散劑的性質
,因而可得一個預期加速溶出的結果。另選擇一個抗暈車藥(Meclizine HCl),因一般長途旅遊的旅者,若服用一般止暈藥 僅能維持3~4小時,於途中需再服藥,否則旅遊將受暈車影響因其引起身體不適、嘔吐、頭暈等痛苦,故基於幾丁聚醣能有 吸水形成膠體的特性,故進行比較不同比例的幾丁聚醣實驗,由其體外溶解試驗結果可知其可使抗暈車藥控制釋放延長,
進而可達到存在體內作用的時間。故基於以上結果可知,幾丁聚醣對於不同藥物的訴求及特性時,可經由處方設計將幾丁 聚醣的功能發揮適得其所。
關鍵詞 : 幾丁聚醣 ; 溶離曲線 ; 控制釋放 ; 快速釋放 ; 延遲釋放 ; 乙醯胺酚 ; 鹽酸氯苯& ; #21537 目錄
目錄 封面內頁 簽名頁 授權書………iii 中文摘要………
……….v 英文摘要………...vii 誌謝………
………....ix 目錄……….x 圖目錄………
………..xiii 表目錄………..xiv 緒論………
……….1 第一章 研究目的……….2 第二章 文獻回顧………
……….3 2.1 幾丁質之開發及分佈……….3 2.2 幾丁質之簡介……….
……….4 2.2.1幾丁質及幾丁聚醣………….………...4 2.2.2 幾丁質及幾丁聚醣之結構….………..5 2.2.3幾丁質 及幾丁聚醣之物化特性….………...7 2.2.4 幾丁質物質在生醫材料上的應用….……..9 2.3 藥物型式………
………..…...12 2.3.1 以幾丁聚醣製成之藥品型式…………..…13 2.3.2 幾丁聚醣的應用………..…20 2.4 藥物釋 放控制………22 2.4.1 藥物釋放模式……….23 2.4.2 幾丁聚醣於藥物釋放控制應 用………….24 第三章、Chitosan於Acetaminophen控制釋放之應用……….29 3.1 研究目的………
…….29 3.2 Acetaminophen(乙醯胺酚)物理化學物質………..29 3.3 實驗使用的儀器……….31 3.4 實驗 材料明細……….32 3.5 實驗內容……….32 3.5.1 製備方法…………
………..32 3.5.2 操作步驟………..33 3.6 實驗配方………
….35 3.7 打錠結果……….35 3.8 成品檢驗方法……….35 3.9 檢驗項 目……….36 3.10 結果與討論………...51 第四章、Chitosan
於Meclizine Hydrochloride控制釋放之 應用………52 4.1 研究目的………
……….52 4.2 Meclizine Hydrochloride物理化學性質………….52 4.3 實驗儀器………
….54 4.4實驗材料………..55 4.5 操作步驟……….56 4.6 實驗配 方……….57 4.7 打錠結果………58 4.8 成品檢驗方法…………
………58 4.9 檢驗項目………58 4.10 結果與討論………
……..69 第五章、結論………...70 參考文獻………
………...71 圖目錄 圖2.1 幾丁質、幾丁聚醣以及纖維素之化學結構……….6 圖2.2 幾丁質生物體內的排列方式…………
……….7 圖3.1 自動溶離試驗器(basket)………..37 圖3.2 自動溶離試驗器(paddle)………
………..38 圖3.5自動溶離試驗器(UV)………....41 圖3.6 重量比較表………
………...44 圖3.7 硬度比較表………...45 圖3.8 厚度比較表………
………...46 圖3.9 崩散比較表………...47 圖3.10 Acetaminophen在0.1HCl時之溶出比 較圖…………..48 圖3.11 Acetaminophen在pH4.5時之溶出比較圖…………....49 圖3.12 Acetaminophen在pH6.8時之溶出比較
圖…………....50 圖4.1重量比較表………62 圖4.2 硬度比較表………
………...63 圖4.3厚度比較表………64 圖4.4崩散比較表………
………65 圖4.5 Meclizine在0.1HCl時之溶出比較圖……….66 圖4.6 Meclizine在pH4.5時之溶出比較圖………
…………...67 圖4.7 Meclizine在pH6.8時之溶出比較圖………...68 表目錄 表2.1 來源昆蟲甲殼類真菌軟體動物……
………8 表2.2 全世界每年所能回收的幾丁質潛在量………8 表3.1 處方比較表………
………..42 表3.2 重量厚度硬度崩散比較表………..43 表4.1 處方比較表………
………..60 表4.2 重量厚度硬度崩散比較表………..61 參考文獻
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