半固態劑型製品物理安定性與製程適宜化研究

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標題:	半固態劑型製品物理安定性與製程適宜化研究 The physical stability study of preparation and processoptimization of semi solid dosage forms
作者:	李宗德
貢獻者:	藥學系林恆弘
關鍵字:	安定性 stability
日期:	2016
上傳時間:	2016-12-21 15:30:17 (UTC+8)
摘要:	皮膚傳遞方法比注射或口服給藥有更多優勢，因為它可以避免肝臟首渡代謝效應，而且可以提供病患簡單而方便的給藥途徑。半固態劑型包含一種或多種有效成分溶解或分散在一個適當的基劑和任何適當的賦形劑。主要的安定性問題，是基劑在貯存過程中物性產生變化。本研究是探討半固態劑型在最佳化的製備過程中的物理安定性，利用凡士林、凡士林油及界面活性劑依照不同比例、轉速進行半固態劑型製品製造，再探討物理安定性與製程適宜化之影響因素。結果顯示，在密度方面:凡士林組會隨著攪拌轉速增加進而造成密度增加，而加入界面活性劑後密度改變差異較不顯著。塗抹性方面:凡士林組以轉速9000rpm及21000rpm以及凡士林比凡士林油9:1組別產生最佳塗抹性，而添加了界面活性劑後隨著油相比例的降低塗抹性是越高且呈現穩定上升的現象。在黏性方面:各組結果有黏性偏低的現象，以Span 80組有相對較好的黏性，利用黏度計進行的黏度測定亦呈現相同趨勢。在黏彈性方面: 隨著油相比例的降低則基劑黏彈性會呈現增加的現象，而加入界面活性劑Span 80後有最佳的黏彈性。綜合上述結果，添加界面活性劑Span 80組不論在密度、塗抹性、黏度、黏彈性可得到比凡士林組與Tween 80組的較好的處方物性。 A skin delivery method has many advantages over injection or oral administration because it can avoid first-pass hepatic metabolism and provides patients with an easier and more convenient route for drug administration. Topical semi-solid dosage forms contain one or more active ingredients dissolved or uniformly dispersed in a suitable base and any suitable excipients. The main stability problems observed in base are bleeding and change in consistency due to aging. The study was to investigate the physical stability in preparation and process optimization of the base of semi-solid dosage forms. The physical stability study of preparation and process optimization of semi-solid dosage forms which according to different ratios, speed of vaseline, vaseline oil and surfactants. The result shows that the density of vaseline group was related to the stirring speed of the preparation. The physical properties of base was more stable by adding a surfactant in particular Span 80 group. The group of Vaseline / vaseline oil (9:1) has the most consistency which rotating speed is 9000 rpm and 21000 rpm, respectively. However, the oil phase ratio is reduced and consistency is higher and showed stable with adding surfactants. In cohesiveness, there are lower cohesive phenomenon in each group, however the Span 80 group has more cohesive which the same of shear stress data. In viscosity, the base shows that the swelling phenomenon will appear and added surfactant Span 80 has the best viscoelastic. The base which was added Span 80 surfactants, the property of base such as density, cohesiveness resistance, viscosity and viscoelasticity which was obtained in Vaseline group or Tween 80 group has more advantages. With compared to vaseline group, the group of Tween 80 and Span 80, which can be a more stable base to provide and selective in future research opportunities.
關聯:	校外公開：2021-08-24,校內公開：2021-08-23，學年度：104，89頁
顯示於類別:	[藥學系(所)] 博碩士論文

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