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目的测定盐酸氨溴索在多个pH值介质中的平衡溶解度及表观油水分配系数,为其制剂研究与处方筛选提供依据。方法采用紫外分光光度法测定盐酸氨溴索在水及10种有机溶剂中的平衡溶解度,通过盐酸氨溴索分配平衡后在油相和水相中的浓度比,计算其油水分配系数。结果盐酸氨溴索在各pH值介质中的平衡溶解度均较高,尤其是在蒸馏水以及pH值为2.0、5.8的缓冲液中,平衡溶解度分别为26.04、27.91、28.24 mg/m L;油水分配系数在pH7.4时最高,lgP为1.78。结论盐酸氨溴索的平衡溶解度及表观油水分配系数与各介质的pH值有关,且可推测其在人体内的胃肠吸收良好,有较好的应用价值。
OBJECTIVE To determine the equilibrium solubility and apparent oil-water partition coefficient of ambroxol hydrochloride in several pH media, and to provide the basis for its formulation research and prescription screening. Methods The equilibrium solubility of ambroxol hydrochloride in water and 10 organic solvents was determined by ultraviolet spectrophotometry. The oil-water partition coefficient was calculated by the concentration ratio of ambroxol hydrochloride in oil phase and aqueous phase. Results The equilibrium solubility of ambroxol hydrochloride in each pH medium was high, especially in distilled water and buffer solutions of pH 2.0 and 5.8. The equilibrium solubility of ambroxol hydrochloride was 26.04, 27.91 and 28.24 mg / m L respectively. The distribution of oil and water The coefficient is highest at pH 7.4, lgP is 1.78. Conclusion The equilibrium solubility and apparent oil-water partition coefficient of ambroxol hydrochloride are related to the pH of each medium, and it can be inferred that gastrointestinal absorption of ambroxol hydrochloride is good and has good application value.