缽式包覆阿斯匹靈藥物與控制釋放之研究

Studies on the Pan Coating and Controlled Release of Aspirin

賴秀英(Shiou-Ying Lai)

指導教授 ： 蔡德華

國立臺北科技大學/工程學院/化學工程研究所/碩士(2010年)

https://doi.org/10.6841/NTUT.2010.00619

摘要

藥新劑型之藥物控制釋放技術是指利用各種劑型的特殊設計，來控制藥物釋放的地點或時間，進而改變藥物在人體內的分布情形，以達到降低藥物的副作用或延長藥物在人體內的作用時間，同時也可以減少投藥次數。
本實驗是使用Coatig pan作為包覆的機器，將混合藥物且具有控釋作用的高分子材質包覆溶液包覆於圓粒表面，最後再將乾燥後所製成的圓粒控釋劑型準備好，等待溶離測試；實驗主要分為兩個階段進行：第一階段為「缽式膜衣包覆藥物之設計」，此部分以不同的膜衣比例製備圓粒劑型控釋藥物，並交叉分析，已獲得最適化的膜衣比例；第二階段則為「藥物控制釋放之研究」，將前述所製備的緩釋劑型控釋藥物以體外溶離試驗做為評估的方法，並對照不同pH值的溶離緩衝液來模擬腸胃道的酸鹼情形。
最後由實驗結果可知：
一、影響膜衣包覆的因素
1. 包覆缽的設計
2. 膜衣溶液的組成
3. 包覆過程等
二、包覆有高分子材質之圓粒控釋劑型，對於溶離會有明顯的緩釋效果，另外可藉由包覆不同厚度(或質量)的膜衣來修飾藥物溶離情形
三、利用不同製程方法或材料所製備出的圓粒控釋劑型有其不同的應用特性，因此深具發展空間。

關鍵字

缽式包覆法 ； 阿斯匹靈 ； 控制釋放劑型 ； 膜衣材質 ； 控制釋放系統

並列摘要

The medicine controlled release technology in old medicines with new formulation uses the special design to control the releasing place or time of the medicines. Furthermore, it can change the distributed situations of the medicines in human bodies that achieves the decrease in side effects or the extension of action time of the medicines. At the same time, the frequency of dosing can be reduced.
This experiment use Coating pan as a covered machine. The medicines mix with the coating solution containing the polymer material of controlled release effect and coat the pellet surface. Finally, the produced granulous does controlled release medicine after being dried is well-prepared and waits for the dissolution test. The experiment is divided into two stages to conduct. The first stage is design of pan-type membrane for coating medicine. This part uses different ratios of membrane to produce the granulous does controlled release medicine and then does the cross analysis in order to obtain the most suitable ratio of membrane. The second stage is the research on controlled release medicine. The produced controlled release medicine mentioned before uses in vitro dissolution test as a method of assessment and contrasts with the different pH values of buffer solution to simulate gastrointestinal pH conditions.
From the experiment, the results are as following:
At first, factors affecting membrane coating are
1. the design of coating pan,
2. the composition of membrane solution,
3. and the process of coating and so on
Secondly, the granulous does controlled release medicine covered by polymer materials has the obvious sustained-release effect. In addition, by coating the different thickness or quality and quantity of the membrane, the situation of medicine dissolution can be modified.
Thirdly, by different process approaches or materials, the granulous does controlled release medicine having various applied features is produced. Therefore, there’s still spacious room for development.

並列關鍵字

Pan coating ； Aspirin ； Controlled release dosage form ； Film-forming materials ； Controlled release system

參考文獻

[5] W. A. Ritschel, Biopharmaceutic and pharmakinetic aspects in the design of controlled release peroral drug delivery systems, Drug Dev. Ind. Pharm., 15(6&7), 1073-1103 (1989).

[6] 劉正雄，口服間質性控釋錠片之研發，台北醫學院藥學研究所博士論文，4-7 (1992)。

[7] 楊國明，藥物釋放之親疏水性乙基纖維素/羥丙基纖維素摻合微粒的製備與其藥物釋放之研究，成功大學化學工程學系博士論文，5-12 (2006)。

[9] S. P. Li, R. G. Felt, L. C. Paolo, M. Y. Huang, and Williams III, R. Q., Development and in vitro-in vivo evaluation of a multiparticulate sustained release formulation of diltiazem, Phram. Res., 12, 1338-1342 (1995).

[10] J. Varshosaz, R. A. Kennedy, and E. M. Gipps, Use of enteric polymers for production of microspheres by ertrusion-spheronization, Pharm. Acta. Helvetiae., 72, 145-152 (1997).