運用液相／液相萃取法及中和法製備gliclazide-β-環糊精複合物以探討兩者的溶解度與溶離速率   全文下載

Comparison of the Solubility and Dissolution Rate of Gliclazide-β-cyclodextrin Inclusion Complexes Prepared by Liquid/liquid Extraction and Neutralization

本實驗運用液相/液相萃取法及中和法製備Gliclazide固體複合物。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-環糊精的固體複合物是依照1:1莫耳比來製備。Gliclazide與β-環糊精之間的交互影響是運用傅利葉紅外線光譜儀及示差掃描熱分析儀來進行研究。使用液相/液相萃取法製備的Gliclazide複合物，其溶離速率快於中和法、物理混合物及純藥品。二種固體複合物的粒子大小皆比物理混合物及β-環糊精較小且集中。實驗結果指出，液相/液相萃取法與中和法一樣，都可以改善Gliclazide的溶解度與溶離速率。

The solid complexes of gliclazide and β-cyclodextrin were prepared by 2 methods, liquid/liquid extraction and neutralization. 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. The interaction between gliclazide and β-cyclodextrin was analyzed by Fourier-transform infrared spectroscopy and differential scanning calorimetry. The dissolution rate of gliclazide from the complex made by liquid/liquid extraction was faster than those from neutralization method, physical mixtures and pure drug. The mean particle size of two complexes was smaller with a narrower size distribution than those of physical mixtures and β-cyclodextrin. The results indicate that liquid/liquid extraction method, as well as neutralization method, provides some signs of improvement in the solubility and dissolution rate of gliclazide.