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通过平衡法测定了283.15~328.15 K温度下普瑞巴林晶型I在水、甲醇、乙醇、丙酮、四氢呋喃、N,N-二甲基甲酰胺、乙酸乙酯及丙酮-水混合溶剂中的溶解度,实验结果表明:普瑞巴林晶型I在所测定的所有纯溶剂及丙酮-水混合溶剂中的溶解度均随温度的升高而增大;在丙酮-水混合溶剂中,溶解度随着丙酮的摩尔分数的增加而降低,在丙酮的摩尔分数达到0.83附近时溶解度最小,接近0。采用修订的Apelblat经验方程和(CNIBS)/Redlich-Kister方程对溶解度数据进行关联,结果令人满意。所得实验数据和拟合模型为普瑞巴林在工业结晶及药物多晶型等方面的研究提供了重要的依据。
The solubility of pregabalin Form I in water, methanol, ethanol, acetone, tetrahydrofuran, N, N-dimethylformamide, ethyl acetate and acetone-water was measured by the equilibrium method at a temperature of 283.15 ~ 328.15 K The experimental results show that the solubility of pregabalin crystal I in all the pure solvents and acetone-water mixed solvents tested increases with the increase of temperature; in acetone-water mixed solvents, When the molar fraction of acetone reaches the vicinity of 0.83, the solubility is the smallest, which is close to zero. Correlation of solubility data using the revised Apelblat empirical equation and the (CNIBS) / Redlich-Kister equation gave satisfactory results. The obtained experimental data and fitting models provide an important basis for the study of pregabalin in industrial crystallization and drug polymorphism.