目的 建立HPLC法,模拟人体皮肤环境,测定维A酸在水、正辛醇中的平衡溶解度,以及在正辛醇-缓冲液体系中的表观油水分配系数.方法 采用HPLC法测定维A酸的浓度,采用摇瓶法测定维A酸的表观油水分配系数.结果 在32℃下,pH为5.8时,测得维A酸在正辛醇中的溶解度为6.25 mg/mL,在水中的溶解度小于0.1 mg/mL,维A酸的表观油水分配系数为36 079.8(lgP=4.55).结论 本文建立的HPLC法,可用于维A酸溶解度及油水分配系数的测定,该方法简便、准确.%Objective To determine the equilibrium solubility of tretinoin in water and n-octyl alcohol, as well as to determine its apparent oil/water partition coefficient in the n-octane-water/buffer solution for establishing a high performance liquid chromatographic method by simulating the environment of human skin. Methods The concentration of tretinoin was determined by HPLC, apparent oil/water partition coefficient was measured by shaking flask method. Results The equilibrium solubility of tretinoin in n-octyl alcohol was 6.25 mg/mL and the equilibrium solubility of that in water was below 0.1 mg/mL, at 32℃, pH 5.8, and the apparent oil/water partition coefficient was 36 079.8 (lgP=4.55). Conclusion The method is accurate and reliable, which can be used in the determination the equilibrium solubility of tretinoin as well as its apparent oil/water partition coefficient.
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