松香酸钠理化性质及油水分配系数的测定

Determination of the oil-water distribution coefficient and the physicochemical properties of sodium rosin acid

目的测定松香酸钠理化性质及油水分配系数。方法采用饱和法-HPLC法测定其在水、生理盐水、甲醇、乙醇、无水乙醇、乙腈、乙酸乙酯、正辛醇、氯仿中的溶解度,HPLC法测定其在强光、高温、强酸、强碱、强氧化剂作用下的稳定性,摇瓶-HPLC法测定松香酸钠在不同pH值磷酸盐缓冲溶液中平衡溶解度和正辛醇-水/磷酸盐缓冲溶液中的油水分配系数。结果松香酸钠在有机相中的溶解度由大到小:甲醇>乙醇>正丁醇>丙酮>乙酸乙酯>氯仿;在水相中:0.9%生理盐水>水>pH值6.8>pH值7.0>pH值7.4>pH值1.2>pH值5.0>pH值2.0缓冲液;影响其稳定性的因素由大到小:强碱>氧化剂>高温>光照>强酸;在水与不同pH值下的油水分配系数(lgP值)分别为2.2、2.47、3.70、3.57、2.59、2.14、1.92、1.32。结论松香酸钠甲醇中溶解度最大;稳定性结果提示保存时,应密闭、避光、低温、避强酸强碱及氧化剂;平衡溶解度及油水分配系数明示松香酸钠为亲脂性成分,可用于皮肤及口服胃肠道药物吸收,为其制剂前剂型设计提供参考。

OBJECTIVE Determination of rosin acid sodium physical and chemical properties and oil-water partition coefficient.METHODS By using the method-HPLC method for determination of saturated water,saline,methanol,ethanol,anhydrous ethanol,acetonitrile,ethyl acetate,the solubility of octyl alcohol,chloroform,HPLC method for determination of its strong light,high temperature,strong acid,strong alkali,strong oxidizing agents under the action of the stability of shaker-HPLC method for determination of rosin acid sodium in different pH value equilibrium solubility in phosphate buffer solution and octyl alcohol-water/oil/water distribution coefficient of phosphate buffer solution.RESULTS Rosin acid sodium in the solubility in organic solvents from big to small:methanol>ethanol>n-buoh alcohol>ethyl acetate>acetone chloroform;Drainage in 0.9%saline water>H2O>pH value 6.8>pH value 7.0>pH value 7.4>pH value 1.2>pH value 5.0>pH value 2.0 buffer.From big to small:the factors which influence the stability of strong base>oxidant>the high temperature>light>strong acid.Oil-water partition coefficient under different pH values(lgP)were 2.2,2.47,3.70,3.57,2.59,2.14,1.92,1.32.CONCLUSION Rosin acid sodium methanol solubility in most;Stability results suggested,when saving should be sealed,avoid light,low temperature,acid alkali and oxidant;Equilibrium solubility and oil/water partition coefficient express rosin acid sodium as fatty ingredients,can be used for the skin and oral drug absorption of gastrointestinal tract,provide reference for the preparation before the dosage form design.