- 學位論文
Gliclazide快速溶解劑型之研究
A Study on Fast Dissolving Dosage Forms of Gliclazide
摘要
本實驗運用液相/液相萃取法來製備Gliclazide-?毧D鑲嵌複合物及沉澱溶劑蒸發法來製備Gliclazide奈米顆粒。利用相溶解度圖來計算Gliclazide與β-環糊精的複合物安定性常數。Gliclazide與β-環糊精的鑲嵌複合物是依照1:1莫耳比來製備。以傅利葉紅外線光譜儀及示差掃描熱分析儀來證明Gliclazide-?毧D鑲嵌複合物及Gliclazide奈米顆粒之形成是否成功。 奈米顆粒的形貌沒有出現Gliclazide的晶狀結構，而Gliclazide鑲嵌複合物也沒有任何不規則的Gliclazide片狀晶狀結構。測量粒子的大小也發現最小的粒子是Gliclazide奈米顆粒，這也證明達到了奈米範圍。Gliclazide奈米顆粒的溶離速率確實比鑲嵌複合物和純藥物快很多。經動物實驗證明Gliclazide奈米顆粒用於高血糖大鼠有最佳的降血糖效果。 複因子試驗設計法可以找到Gliclazide口腔溶解錠和口腔溶解片的最佳配方。這個實驗中，黏著劑的濃度在崩散時間上具有統計學的意義。Gliclazide奈米顆粒的口腔溶解錠具有最短的崩散時間。
並列摘要
The solid complex of Gliclazide and β-cyclodextrin was prepared by liquid/liquid extraction method; and the precipitation-solvent evaporation method was used to prepare Gliclazide nanospheres. The phase-solubility diagram was used to calculate the stability constant of Gliclazide and β-cyclodextrin. According to the molar stoichiometry, the complex of Gliclazide with β-cyclodextrin was prepared following the 1:1 ratio. Fourier-transform infrared spectroscopy and differential scanning calorimetry were used to examine whether Gliclazide solid complex and Gliclazide nanospheres were successfully formed in this study. The morphology of particles for nanospheres showed no crystal character of Gliclazide and the result of Gliclazide solid complex appeared without any irregular crystal flake characters of Gliclazide. The measurement of particle size also found that the smallest particle was Gliclazide nanospheres, which also attained the scale of nanosize. The dissolution rate of Gliclazide from its nanospheres was faster than its solid complex and pure drug. The animal experiments of hyperglycemia Wistar rats indicate the Gliclazide nanospheres have the best hypoglycemic effect. Full factorial experimental design method was employed for optimization study on Gliclazide orally dissolving tablets and oral dissolving strips formulations. It was found that the concentration of adhesive in the formulation had a significant effect on disintegration time of the dosage form. Orally dissolving tablets with Gliclazide nanospheres has the shortest disintegration time.