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    題名: Venlafaxine HCl 延長釋放性圓粒配方之研究;Formulation Studies of Extended Release Venlafaxine HCl Pellets
    作者: 張碧純;Bi-Chung Chang
    貢獻者: 中國醫藥大學:藥學系碩士班
    關鍵詞: 乙基纖維素;圓粒;延遲釋放;Ethylcellulose;Pellet;Extended release
    日期: 2007-06-02
    上傳時間: 2009-08-13 10:54:04 (UTC+8)
    摘要: 隨著控釋劑型之藥物發展及應用技術,可利用各種劑型的特殊設計來控制藥物釋放,嘗試著將主成分Venlafaxine HCl以流動床機器之底噴方式(Wurster)黏附於糖球圓粒上,藉由不同結合劑PVP K-30、HPMC(615)、HPC-SL之黏附條件進行處方設計,進而探討載藥量的含量及物理特性如顆粒密度、粒徑之分佈、POM偏光顯微鏡測試圓粒之增長情形及SEM掃描式電子顯微鏡分析表面性質。

    而膜衣層之控釋處方則利用乙基纖維Aquacote ECD-30含不同百分比的濃度,進行體外溶離試驗,並從最適的百分比濃度加以探討於不同之媒液:pH1.2、pH4.5、pH6.8條件下,所測得之溶離曲線與對照標準品是否皆能達到近似之相似因子(Similarity Factor) f2參數。

    結果顯示以於載藥處方層中含有結合劑HPMC(615)之處方為最適當,而最終溶離曲線研究中,緩釋層藥物以含20%之Aquacote ECD-30的溶離曲線呈現出有緩釋之效果,進一步於pH1.2、pH4.5、pH6.8溶離媒液進行溶離試驗與對照品之相似度較理想。

    Make use of special designs of different dosage form and controlled the dug release. Try the active ingredient Venlafaxine HCl by way of the bottom spray of the fluid bed machine and stick it on round one of sugar sphere. Different binders viz. PVP K-30, HPMC, HPC-SL were studied on the formulation design. The formulation was evaluated for different parameters such as drug loaded content and physical characteristic of the particle density, particle size distribution, moisture content. The surface of pellets was examined by scanning electron microscopy (SEM) and polarizing optical microscopy (POM) test.

    Then core pellets were subsequently film-coated with ethylcellulose (Aquacote ECD-30) as controlled release polymer. The effect of drug to poly-
    mer ratio on in vitro release was studied. In the medium of pH1.2, pH4.5,
    pH6.8 of release profile were compared with marketed one of similar factor (F2) parameter.

    The result shows with HPMC as binder was drug loaded the best formul-
    lation. Dissolution test showed coating with 20% of ethylcellulose also get the desired extended-release.
    顯示於類別:[藥學系暨碩博士班] 博碩士論文

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