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研究生:游淑華
研究生(外文):Shu-Hua Yu
論文名稱:褐藻膠、鹿角菜膠、幾丁聚醣和氯化鈣在間質型型控制釋放錠劑的開發
論文名稱(外文):Development of Sodium Alginate, Carrageenan, Chitosan and Calcium Chloride in the Matrix Control Release Tablet
指導教授:黃登福黃登福引用關係
指導教授(外文):Deng-Fwu Hwang
學位類別:碩士
校院名稱:國立臺灣海洋大學
系所名稱:食品科學系
學門:農業科學學門
學類:食品科學類
論文種類:學術論文
論文出版年:2012
畢業學年度:100
語文別:中文
論文頁數:82
中文關鍵詞:褐藻膠鹿角菜膠幾丁聚醣間質型控制釋放
外文關鍵詞:AlginateCarrageenanChitosanMatrix Control Release
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本研究目的利用親水性聚合物褐藻膠 (alginate) 和鹿角菜膠
(carrageenan) 與交聯劑( 氯化鈣和幾丁聚醣) 進行交聯反應
(cross-linking),使錠劑水合時形成膠層,進而達到藥物持續釋放
(sustained-release) 的效果。以示差掃描熱量分析儀 (differential
scanning calorimetry; DSC) 檢測賦型劑與主成份沒有交互作用。配方設計以單方膠體、兩種膠混合及膠體與交聯劑作用,進行配方試製配合
體外溶離試驗與紫外光分光光度計執行快速檢測,得聚合物褐藻膠和
鹿角菜膠與交聯劑 (氯化鈣和幾丁聚醣) 比例為1:1:1:1 最佳,藥
物持續釋放可達20 至24 小時。放大製程其粉體特性:安息角 (angle of
repose) 為42 度、總體密度 (bulk density) 與敲擊密度 (tapped density)分別為0.41 及0.46 g/cm3 、水份含量為3.59%和粉體含量為98.21 ±0.95%。以此粉體製錠成每顆重250 mg,含主成份120 mg 之錠劑。重量均一度為250.54 ± 0.59 mg,平均厚度為4.63 mm,硬度為80.5 N;以高效液相層析方法分析,得錠劑含量為99.07 ± 0.97%、含量均一度
為97.10 ± 0.97%,體外溶離試驗結果為0.1 N 鹽酸、pH 4.5 磷酸緩衝
溶液和pH 6.8 磷酸緩衝溶液分別在24 小時、22 小時及20 小時達到完
全釋出。
This study is to use hydrophilic polymers (sodium alginate and carrageenan) and crosslink agents (calcium chloride and chitosan) to crosslinking reaction. When the tablets were dissolved with water, surface gel was performed and showed drug sustained release. The differential scanning calorimetry analyzer proved no mutual effect between excipients and acetaminophen. To prepare hydrogel matrix sustained release, tablets containing acetaminophen with alginate, carrageenan and chitosan were as the matrix material. The optimal formulation was examined by using in
vitro dissolution test and UV spectrophotometer test. The result showed that the test ratio of drug sustained release sodium alginate, carrageenan and crosslink agents (calcium chloride and chitosan) 1:1:1:1 which had up to 20-24 hr. After amplification of process, the powder characteristics were as follows: angle of repose, 42 degrees; crude density, 0.41 g/cm3; tapped density, 0.46 g/cm3; the water content, 3.59%; and the powder content, 98.21 ± 0.95%. Each tablet was 250.54 ± 0.59 mg, containing main
components 120 mg, and the average thickness was 4.63 mm, and the hardness was 80.5 N. The content of tablets tested by high performance liquid chromatography method was 99.07 ± 0.97%, the content uniformity for each tablet was 97.10 ± 1.17%. In vitro dissolution in 0.1 N HCl, pH 4.5 phosphate buffer solution and pH 6.8 phosphate buffer solution, the complete release of content was 24 hr, 22 hr and 20 hr.
目錄
摘要 ···································································································1
英文摘要 ···························································································2
研究背景 ···························································································3
壹、文獻整理
一、錠劑的分類 ······································································· 5
二、錠劑製造流程 ··································································· 6
三、藥物的吸收 ······································································· 7
四、間質型釋放原理 ······························································· 7
五、常見的間質型錠劑材料 ··················································· 8
六、Acetaminophen 的特性 ····················································· 9
七、膠體特性 ·············································································11
貳、研究內容
一、前言 ······················································································15
二、材料與方法
(一) 材料
1. 配方原料與賦形劑 ····················································16
2. 試劑 ···········································································16
3. 實驗儀器 ···································································17
3. 市售品 ·······································································18
(二) 方法
1. 實驗架構 ···································································19
2. 原料測試 ···································································20
3. 配方試製 ···································································20
II
4. 配方分析 ···································································20
5. 最佳配方製程管制試驗 ···········································22
6. HPLC 分析方法確校 ·················································25
7. 體外溶離試驗 ···························································29
參、結果與討論 ················································································32
肆、結論 ···························································································39
伍、圖表 ···························································································41
陸、參考文獻 ····················································································63
柒、附錄 ···························································································69
謝誌 ···································································································75
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