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  • 學位論文

氧雜蔥酮染料之劑型設計

Dosage Form Design of a Xanthene Dye

指導教授 : 蔡翠敏

摘要


光動力作用為光感物質經由可見光照射後形成激發態的光感物質,在經過一連串光化學反應,形成單態氧以破壞病原體,現今為了尋求更安全且具有方便性的治療方法,使得光動力逐漸成為替代治療癌症以及皮膚疾病的治療方法。孟加拉玫瑰紅(Rose Bengal)為長期被應用於肝功能及乾眼症之診斷,具有相當高的安全性,在臨床試驗中已有將Rose Bengal製成的凝膠治療慢性皮膚疾病。此藥劑在專利的保護之下,本實驗室若要發展孟加拉玫瑰紅用以治療局部皮膚的劑型,薄膜是比較可行的方法。製備結果發現,孟加拉玫瑰紅分別可使用羥丙基甲基纖維素以及羧甲基纖維素作為成膜的賦形劑並搭配丙二醇作為塑化劑,可做出製程簡單且孟加拉玫瑰紅釋放效果較好的薄膜,而當孟加拉玫瑰紅溶於Carbopol或檸檬酸緩衝液時會導致孟加拉玫瑰紅的顏色變淡,降低溶液中孟加拉玫瑰紅吸收可見光的能力,實驗結果顯示孟加拉玫瑰紅在酸性的環境下呈現無色,因此在後續製備薄膜時可採用酸性環境來保存,以避免照光後產生光漂白現象,使用前將薄膜酸鹼值提升至中性即可恢復孟加拉玫瑰紅產生光動力效應的能力。

並列摘要


Photodynamic therapy (PDT) involves the photosensitizers which are activated through the visible light in the presence of oxygen to produce toxic oxygen species that results in oxidative damages to a variety of targets. Rose bengal has been applied to the diagnose of liver function and dry eye syndrome for a long period of time, and thus proven its safety to clinical applications. Consequently, the pharmaceutical gel formulation of rose bengal has been developed for the treatment of chronic skin diseases through PDT. In this study, we developed a feasible formulation of rose bengal for clinical skin treatment based on a specific combinations of pharmaceutical excipients. Prelimilary experimental results revealed the mixture of rose bengal, hydroxypropyl methyl cellulose, carboxy methyl cellulose, and propylene glycol could be easily manufactured into films with desired performances. In the presence of carbopol or citrate buffer, the color of rose bengal solution faded which is probably related to the acidic environment. When rose bengal solution is kept in low pH condition, the photobleaching effect was significantly reduced, and such finding may be used for photoprotection of rose bengal preparation in ths future drug development.

參考文獻


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