| 摘要: | 液-液分散系統在近年來的應用越來越廣泛，尤其是乳劑、微膠粒和微乳劑。在同個製劑上，液-液分散系統可同時使用親水或是親油性的藥物，但在製程時，有可能處方或製備上的疏失而改變相的結構甚至相分離而造成藥效不佳、降低藥物溶解度和身體可用率。為了避免在製程時發生製劑上相結構等物性改變，本實驗使用礦物油、Span 80、Tween 80和水製備乳劑、微膠粒和微乳劑之劑型，並以染色與顯微鏡測定、導電度測定和稀釋法來分辨相之結構，針對微膠粒與微乳劑，利用了測定凝固點的方式來分辨；之後以不同的比例處方繪製出三相圖來區分三者之範圍。而在製程方面，設計出六種不同的製法，包含了配方加入順序與攪拌速度的不同，並針對各個處方作進一步之黏稠度與黏性之物性探討。此外，經過二個月的安定性試驗，以評估製程之乳劑、微膠粒和微乳劑之後的有效性與穩定性。三者劑型在經過安定性試驗後，在乳劑方面，黏稠度在12.351、黏性在 - 4.626克為最安定之物性範圍；在微膠粒方面，黏稠度0.286至0.293克、黏性 - 0.5至 - 0.474 克之間為最安定之物性範圍；而在微乳劑方面，黏稠度0.275至0.297克、黏性 - 0.539至 - 0.424 克之間為最安定之物性範圍。
Liquid-liquid dispersion has been increasingly applied in recent years, especially emulsion, micelle and micromulsion. In the same preparation, liquid-liquid dispersion can both used in hydrophilic and lipophilic drugs. But on process, different formulation or process might change the result which are structure of phase or physical property of liquid-liquid dispersion, even phase stratification. It might cause decrease efficacy, solubility and bioavailability of drug.On process, to avoid occurs change the structure of phase, in this study we use mineral oil, span 80, tween 80 and water to prepare emulsion, micelle and microemulsion. And using microscope with dye, conductivity and dilution test to observe the structure of phase, also survey the freezing point to distinguish micelle and microemulsion. Then we are using different ratio of formulation to make the ternary plot to differentiate range of emulsion, micelle and microemulsion. By process, we plan six different method of process include the sequence adding of material and different stirring intensity of emulsification, then for further physical characterization of viscosity and stickiness. Furthermore, through two mouths of stability test to evaluate of emulsion, micelle and microemulsion.Through the stability test, most stable emulsion range of viscosity is 12.351g and the stickiness is - 4.626g also micelle range of viscosity between 0.286 g to 0.293 g and the stickiness is between - 0.5 g to - 0.474 g then stable microemulsion range of viscosity between 0.275 g to 0.297g and stickiness is between - 0.539 g to - 0.424g. |
