利用實驗設計法開發一抗組織胺藥物之最佳化處方

CNU IR > Pharmacy and Science > Dept. of Pharmacy > Dissertations and Theses > Item 310902800/22931

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Title:	利用實驗設計法開發一抗組織胺藥物之最佳化處方 Development of optimum formulation for an antihistamine using experimental design
Authors:	郭崑福
Contributors:	宋國峻嘉南藥理科技大學：藥物科技研究所
Keywords:	實驗設計法 Desloratadine 溶離田口方法 Experimental design Desloratadine Dissolution Taguchi method
Date:	2009
Issue Date:	2010-06-09 09:34:28 (UTC+8)
Abstract:	實驗設計方法可以讓實驗者用最少的實驗次數就能達到實驗的目的，以節省時間與成本，並找出具有影響力的因子與水準。它與傳統的實驗設計最大的差別在於傳統的實驗設計是一次一因子慢慢的試驗與修改參數條件，而實驗設計方法可以一次多因子的探討影響實驗的變因，因此它可以用最少的實驗次數來達到實驗的目的。本篇論文研究的目的為利用一常用之抗組織胺(desloratadine)作為模型藥物，並由預試驗找出在錠劑處方中影響溶離的因子，其次為開發一個實驗設計的方法，最後並利用這個實驗設計的方法來得到可能之最佳化處方。本研究是以3因子3水準(L9(34))之田口方法之直交表實驗設計法來設計。錠劑的製備是以直接打錠法來製備。藥物的溶離是依據USP裝置法Ⅱ(槳子式)來進行試驗。藥物分析乃採用高效能液相層析(HPLC)法之逆相層析管柱來分析。統計分析是以定時內溶出百分率(%Ptime)以及溶離相似係數(f2)作為研究標的來從事分析，並運用反應曲面法來設計可能之最佳化處方。 Experimental design can be used to reduce experiment frequency and cost as well as, discover influence factor and level in the experiment. Experimental design may probe several factors into experimental variables, which use the least experimental frequency to procure experimental purpose. Therefore, it can reduce time and the cost. In this study, desloratadine is used as a model drug to explore the effects of formulation variables on drug dissolution from tablets. The experimental design is Taguchi method for three factors by three levels (L9(34)) of Taguchi orthogonal array. The aims of this study are to identity formulation factors on drug release from desloratadine tablets, to develop of an experimental design method and to optimize formulation utilizing experimental design method . The tablet sample were prepared by direct compression. The dissolution test were performed using the USP apparatus Ⅱ(paddle) method under 37±0.5℃ and 50 rpm in medium for 2 hours. HPLC analysis method was used by using RP-C18 column. Statistical analysis were performed on percent released at certain time point (% Ptime) and similarity factor (f2). Response surface methodology was used to simulate to obtain the possible optimum formulation.
Relation:	校內一年後公開，校外永不公開，學年度：97， 69 頁
Appears in Collections:	[Dept. of Pharmacy] Dissertations and Theses

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