一個天然材質的黏膜黏附性與緩釋賦形劑之體外試驗評估

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Title:	一個天然材質的黏膜黏附性與緩釋賦形劑之體外試驗評估 An in-vitro evaluation of a novel natural material as a mucoadhesive and sustained release excipient
Authors:	楊崇暉 Chong-hui Yang
Contributors:	陳俊仁嘉南藥理科技大學：生物科技研究所
Keywords:	口頰錠延遲釋放黏膜黏性 sustained release buccal tablet mucoadhesive
Date:	2007
Issue Date:	2008-12-03 11:16:21 (UTC+8)
Abstract:	本實驗室一直以來均致力於發展藥物賦型劑之開發，經過去的實驗發現並證實一植物之萃取物為天然賦型劑，可利用於藥物的控制釋放。且由於對人體係屬無毒性、生物可降解性、高生物相容性之材質，因此大幅地提升了其可利用的價值。由先前實驗室已開發並建立了萃取方法，且實驗證明了此植物萃取之天然賦型劑對於藥物具有延遲釋放的能力，而本研究則著於開發其他可應用的空間。本研究目的係為植物萃取物經熬煮萃取後，再由噴霧乾燥製造出來的粉末顆粒，此植物粉末為基質的錠劑，先以豬胃模擬體內的黏膜給藥系統，探討其基質型錠劑經水合後，與體內腸胃道的黏膜產生的黏性交互作用進行觀察，並且紀錄其黏著力。另外，也與市面上常見的合成聚合物【Methocel K100M；Methocel K15CR；Sod CMC …】等進行試驗比較，並觀察其黏性以等物化特性，以確立發展此植物天然萃取物之緩釋機制可應用的層面。此外，藉由模擬口腔黏膜的藥物釋放系統的舌下頰部給藥系統，利用豬的口腔黏膜，使此天然材質的黏著力與他種合成賦型劑進行比較實驗包括時間(10、30秒，1、3分鐘)、力量(0.05、0.1、0.5、1 N)以及探針的回程速度等物理性質之影響，證明此植物萃取物具有相當穩定的黏著力，對於設計成口腔黏給藥系統的口腔貼片而言，有很好的發展空間。 The purpose of this study is to evaluate a novel natural material as the mucoadhesive and sustained release excipient used in buccal adhesion tablet. The extract from a plant is obtained and dried by spray drying and other technologies. The mucoadhesion between tablets made from dried plant extract and buccal mucosa of pig was thoroughly evaluated. Effect of contact time, pretest speed, post test speed, and contact force on the mucoadhesion were studied and compared with K15M CR. The mucoadhesion strength is close to K15M CR, but is lower than Sod CMC. The difference of contact time (such as 10 sec, 30 sec, 60 sec, and 180 sec) and applied force (such as 0.05 N, 0.1 N, 0.5 N, and 1.0 N) have effect on the mucoadhesion strength. The mucoadhesion between tablets made from dried plant extract and gastric mucosa of pig was also evaluated and compared with various polymers. The release rate of the buccal tablet was also studied. It was found that the material has a sustained release effect. In conclusion, this material could be applied as a buccal tablet excipient with sustained release effect.
Relation:	校內校外均不公開
Appears in Collections:	[Dept. of Biotechnology (including master's program)] Dissertations and Theses

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