含中草藥之滴丸的製備技術和物理化學性質研究

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Title:	含中草藥之滴丸的製備技術和物理化學性質研究 Study on preparation technology, physico-chemical characterization of dripping pills with herb extract
Authors:	李建鈞
Contributors:	林恆弘嘉南藥理科技大學：藥物科技研究所
Keywords:	維他命B2 大黃滴丸劑氯化鈣藻酸鈉 riboflavin Sodium Alginate CaCl2 dripping pills Da-Huag
Date:	2009
Issue Date:	2010-06-09 09:33:46 (UTC+8)
Abstract:	藻酸鈉為天然的高分子材料，依製作方法不同常被應用在各式各樣的劑型，如錠劑，微膠囊劑，或是滴丸劑等等。本研究的主要目的是發展一個簡單的製程製作滴丸劑，首先以riboflavin為水溶性包埋藥物，接著再替換成Acetaminophen和大黃萃取物做為包埋之藥物，另一個研究目的是找尋一組最適宜的處方，不僅在凍乾後可以維持滴丸之丸型和平滑的外觀，同時也可以維持高的藥物包埋率。藉由處方中添加阿拉伯膠的含量，探討滴丸之外觀、粒徑大小、膨脹度，以及在0.1N HCl 和 pH6.8 緩衝溶液之藥物累積釋離率。利用熱卡式分析儀（DSC）進行物理化學性質分析。未含有阿拉伯膠之凍乾後滴丸，其粒徑範圍為0.39~0.48cm；含有阿拉伯膠之凍乾後滴丸，其粒徑範圍為0.46~0.54cm。滴丸之包埋率範圍為87~96%。在0.1N HCl 溶液中之滴丸膨脹度皆會在三小時內增加。從DSC中判斷藻酸鈣與藥物無化學交互作用。在0.1N HCl 溶液中，滴丸的藥物釋離率為60~80%；在pH6.8 緩衝溶液中，滴丸之藥物釋離率皆會在第四小時達百分之百釋出。由Korsmeyer-Peppas model藥物動力模式顯示，在0.1N HCl 溶液中，滴丸之n值介於0.61~0.81，在 pH6.8 緩衝溶液中，滴丸之n值介於1.08~1.40 。 Nature polymer such as alginate has been applied on various dosage like tablets, microcapsules or pills which were prepared by different technology. The aim of this study is to develop an easy preparation technology by dropping a floating alginate -drug formulation in dripping pills with riboflavin first, then other model drugs such as acetaminophen and Da-Hwang extracts are instead of riboflavin. The other purpose of this study is to develop the optimize formulation of dripping pills could not only maintain sphere shape and smooth surface morphology after freeze-dry, but also increase the encapsulation efficiency of model drug in calcium - alginate pills. The pills with or without arabic gum powder of physico-chemicalcharacterizations such as appearance of pills, pills size, swelling ratio, and drug release in 0.1N HCl and pH6.8 phosphate buffer were examined. The chemical interaction among the components in pills is detected by differential scanning calorimetry (DSC).The formulation without arabic gum yielded pills size ranging from 0.39~0.48cm. The formulation with arabic gum yielded pills size from 0.46~0.54cm. The mean of percent entrapment of riboflavin pills ranged from 87~96%. The swelling ratio of test dripping pill is increased during 3 hours in 0.1N HCl media. The results of DSC measurement reveal that no chemical interaction among the component. At pH 0.1N HCl media, the riboflavin release from dripping pills is approximately 60~80%. At pH 6.8 phosphate buffer, the riboflavin almost release 100% at 4 hours from the dripping pills. The value of exponent (n) of release kinetics is 0.56~0.81 in 0.1N HCl media and 1.08~1.40 in pH 6.8 phosphate buffer which is fitted by the Korsmeyer-Peppas model.
Relation:	校內外均一年後公開，學年度：97， 102 頁
Appears in Collections:	[Dept. of Pharmacy] Dissertations and Theses

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