口服可崩型的圓粒之製備與性質研究

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Title:	口服可崩型的圓粒之製備與性質研究 Preparation and characterization of oral disintegrable pellets
Authors:	李俊賢
Contributors:	藥學系林恆弘
Keywords:	滴丸 pellets
Date:	2015
Issue Date:	2015-10-21 17:04:12 (UTC+8)
Abstract:	在生產口服投予的圓粒，我們可以調整處方來實現我們希望的溶出曲線。這項研究是期望所製備出的小球，在口服時可溶解，而不會在製備過程中溶解。相較於其他製備方法，因藻酸鈉不容易崩解，加入崩解劑時可以使藻酸鈉構成的圓粒更容易溶解。本實驗中使用的崩散劑，有Primogel，kollidone,微晶纖維素。為了避免在製作過程中造成崩散劑崩散，我們以適合的混合物比例，結合藻酸鈉和崩散劑。酒精在這製造過程中扮演重要的角色，然後將混合物緩慢滴入氯化鈣溶液以製備圓粒。將圓粒在烘箱裡面乾燥並研究圓粒的尺寸改變，藉由質地分析儀和溶解度的研究以得到物理 - 化學性質。分別比較十組實驗狀態，我們就剛做好的滴丸圓粒尺吋與乾燥後的滴丸做比較，再把乾燥後的滴丸圓粒尺吋分別與浸水後五分鐘、浸水後24小時的圓粒尺吋做比較，並做成曲線圖觀察其尺吋變化差異與所需時間。我們最後可以發現,以組別N02的配方所製成的滴丸圓粒，在乾燥後再覆水的觀察，其狀況顯示在短時間內，滴丸的呎吋變化較大，符合滴丸崩散所需時間短，變化快速的原則。實驗結果表明，經過乾燥過程，這顆粒的尺寸是結合崩散劑的圓粒大於沒有加崩散劑的圓粒。吸水後的乾燥顆粒，水對球團產生顯著溶脹作用，上述結果將有助於其他顆粒崩散控制傳送系統可能的發展。 During the production of orally ingested pellets, we can adjust the formula to achieve the dissolution profile we desire. The study is to create pellets that will dissolve when taken orally but will not dissolve during the preparing process. In comparison to previous pellets prepared by other methods, as sodium alginate does not easily break down, the addition of disintegrating agents may be allowed the pellet to dissolve more easily. The following disintegration agents such as Primogel, kollidone, Avicel will be used in the research. In our preparing process, we combine sodium alginate and the disintegrating agents in the proper mixture ratio. The addition of alcohol also plays an important role in the mixture. And then the mixture would be slowly dropped into a calcium chloride solution to prepare pellets. The pellet was dried in oven and was investigated the particle size changed and physical-chemical properties by texture analyzer and dissolution study. Compare the experimental statuses of ten groups respectively, we compare the dimension of freshly prepared drop pills and rounded grains with drop pills after drying, and compare the dimension of drop pills and rounded grains after drying with rounded grains after soaking for 5 minutes and for 24 hours respectively and make curve diagram to observe its dimension change, difference and required time.Finally, we can find that drop pills and rounded grains made by the formula for group N02, observed after drying and overlaying water, their situations show that the dimension change of drop pills in a short time is larger and meet the principles of required time of disintegration of drop pills is short and rapid variation.The results show that the particle size of the pellet which was combined with disintegrants was larger than that without disintegrants through dry process. To reconstitute dry pellets by water, has significant swelling effect on pellets. The above results will be helpful to possible development of the other disintegrable pellet controlled delivery systems
Relation:	校外公開：2020-12-31,校內公開：2015-09-07，學年度：103，73頁
Appears in Collections:	[Dept. of Pharmacy] Dissertations and Theses

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