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Please use this identifier to cite or link to this item: http://ntour.ntou.edu.tw:8080/ir/handle/987654321/48941

Title: 麻醉藥利多卡因 (Lidocaine)導入口腔溶解薄膜之開發及應用
Development and Application of Oral Dissolving Film Incorporated with Lidocaine
Authors: Lin, Fang-Chu
林芳竹
Contributors: NTOU:Department of Food Science
國立臺灣海洋大學:食品科學系
Keywords: 利多卡因;口腔溶解薄膜;局部麻醉藥;體外評估試驗
Lidocaine;Oral dissolving film;Local anesthetic;In vitro evaluation test
Date: 2015
Issue Date: 2018-08-22T06:39:32Z
Abstract: 牙醫師進行拔牙手術時可施打局部麻醉劑,不但可以減輕患者不適的心理壓力,增加手術過程中舒適度,更可以使醫生進行手術較快速、順利。本研究目的為將傳統麻醉劑利多卡因 (lidocaine)針劑進行新劑型改良為口腔溶解薄膜 (Oral Dissolving Films, ODF)劑型,簡稱為口溶膜;期能在無痛的狀態下進行手術,且可克服其他劑型起效時間較長的問題。首先本研究以lidocaine配合不同膠體、填充劑、可塑劑、著色劑及矯味劑形成口溶膜製品。在評估 lidocaine口溶膜製品是否合適作為口腔局部麻醉劑,透過之平順性、通透性、延展性、黏附性來選擇最佳製品。其次利用自動溶離試驗儀設備將口溶膜樣品分別放入在0.1 N HCl、pH 4.5磷酸鹽溶液、pH 6.8磷酸鹽溶液和水中,在3、6、9、12、15、30、45及60 min採取溶液,檢測 lidocaine溶出量,觀察口溶膜與市售品錠劑在相同的pH溶液中進行藥物釋放的溶離試驗中變化。並使用另一種儀器裝置為Transdermal Franz Diffusion Cell,實驗設計將藥品放置人工皮上利用pH模擬口腔的狀態,整個儀器裝置溫度37.0 ± 0.5℃,採樣點為5、10、15、20、30及60 min共6點三重複。實驗結果顯示口溶膜在不同pH溶液的藥物溶出,均能在6 min內釋放出90%以上,而市售品-錠劑在不同的pH的溶離曲線釋放皆需要30 min才達到釋放90%以上。而藥品滲透分析結果顯示試驗中藥物滲透人工皮的藥物濃度,在30 min內明顯觀察到口溶膜與市售品凝膠的差異性,藥品滲透過人工皮釋放的藥物濃度口溶膜與凝膠釋放速度比為2:1以上。因此在體外溶離試驗評估,呈現口溶膜可以在短時間內快速達到完全藥物釋放之效用。在臨床應用上能夠更快和有效的麻醉該部位以進行下一步的診治,顯示本研究所製得 lidocaine口溶膜具有取代傳統針劑作為口腔局部麻醉藥之潛力。
In dental therapy, local anesthetic administration not only can improve therapeutic outcome, but also relieves psychological tension from patients, consequently enhancing comfort during the procedure. This study aims to reformulate the traditional injection form into oral dissolving film (ODF), which allows painless surgical procedure and can overcome the problem of slow onset from that of other dosage forms. In this study, a combination of lidocaine and different polymers, fillers, plasticizers, coloring agents and flavoring agents is used to formulate ODF. Then, the product of lidocaine ODF is formulated and evaluated in aspects of smoothness, permeation, tensility and adhesiveness. On the other hand, to compare the dissolution rate of lidocaine under same pH, ODF and commercial products are separately placed in the vessels of dissolution apparatus with different solvents, including 0.1 N HCl, pH 4.5 phosphoric acid, pH 6.8 phosphoric acid and water. Dissolved samples are collected to analyze lidocaine at 3, 6, 9, 12, 15, 30, 45, and 60 min. In addition to the dissolution test, another apparatus used in this study is the Transdermal Franz Diffusion Cell, in which ODF and commercial products are placed on the artificial skin of the receptor with donor filled with 37.0 ± 0.5℃ of solvents to simulate the physiological environment of the oral cavity. The diffused lidocaine from each cell is collected at 5, 10, 15, 20, 30, and 60 min and determined. The results show that ODF can release 90% of lidocaine within 6 min, while the commercial product requires 30 min to release 90% of the pharmaceutical ingredient lidocaine. On the other hand, the permeation test show a significant different between the permeation rate of the ODF and commercial product. The ratio of the permeation rate of ODF and commercial product is 2:1 within 30 min. Therefore, the ODF releases the pharmaceutical ingredient lidocaine in a short time to exert pharmacological action. The ODF formulated in this study shows the potential of being applied clinically and to serve as an alternative to the traditional injection form of local anesthetic.
URI: http://ethesys.lib.ntou.edu.tw/cgi-bin/gs32/gsweb.cgi?o=dstdcdr&s=G0040242017.id
http://ntour.ntou.edu.tw:8080/ir/handle/987654321/48941
Appears in Collections:[食品科學系] 博碩士論文

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