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目的对醋酸甲羟孕酮(MPA)在不同溶剂中的平衡溶解度及其在正辛醇-缓冲液体系中的油水分配系数进行测定。方法采用HPLC法测定MPA的质量浓度,测定MPA在水、有机溶剂、缓冲溶液和加十二烷基硫酸钠的缓冲溶液中的平衡溶解度,采用摇瓶法结合HPLC法测定MPA在正辛醇-缓冲液体系中的质量浓度,从而计算油水分配系数。结果 37℃时,MPA在蒸馏水和丙酮中的平衡溶解度分别为0.52±0.04和238.70±0.47μg·mL~(-1);在体积分数为90%的乙醇溶液中的平衡溶解度最大;在加十二烷基硫酸钠的缓冲溶液中的平衡溶解度增大;在水中的表观油水分配系数为1.99(lgP=0.30),脂溶性较强;在pH值为1.2~6.8的缓冲溶液中,平衡溶解度随pH值的升高而减小,油水分配系数随pH值的升高而增大。结论该实验建立的测定方法可准确测定MPA的平衡溶解度和油水分配系数。
OBJECTIVE To determine the equilibrium solubility of medroxyprogesterone acetate (MPA) in different solvents and its oil-water partition coefficient in n-octanol-buffer system. Methods The mass concentration of MPA was determined by HPLC. The equilibrium solubility of MPA in water, organic solvent, buffer solution and sodium dodecyl sulfate buffer solution was determined. The equilibrium solubility of MPA in buffered saline solution was determined by shake flask method and HPLC. Buffer mass concentration in the system to calculate the oil-water partition coefficient. Results The equilibrium solubility of MPA in distilled water and acetone at 37 ℃ was 0.52 ± 0.04 and 238.70 ± 0.47μg · mL -1, respectively. The equilibrium solubility of MPA in ethanol solution with 90% The equilibrium solubility in the buffer solution of sodium dialkylsulfate increases; the apparent water-oil partition coefficient in water is 1.99 (lgP = 0.30) and the liposolubility is strong; in the buffer solution with pH value of 1.2-6.8, the equilibrium solubility With the increase of pH value decreases, the oil-water partition coefficient increases with the increase of pH value. Conclusion The experimental method established by this experiment can accurately determine the equilibrium solubility and oil-water partition coefficient of MPA.