目的 測定鹽酸氨溴索在多個(gè)pH值介質(zhì)中的平衡溶解度及表觀油水分配系數(shù)，為其制劑研究與處方篩選提供依據(jù)。方法 采用紫外分光光度法測定鹽酸氨溴索在水及10種有機(jī)溶劑中的平衡溶解度，通過鹽酸氨溴索分配平衡后在油相和水相中的濃度比，計(jì)算其油水分配系數(shù)。結(jié)果 鹽酸氨溴索在各pH值介質(zhì)中的平衡溶解度均較高，尤其是在蒸餾水以及pH值為2.0、5.8的緩沖液中，平衡溶解度分別為26.04、27.91、28.24 mg/mL；油水分配系數(shù)在pH7.4時(shí)最高，lgP為1.78。結(jié)論 鹽酸氨溴索的平衡溶解度及表觀油水分配系數(shù)與各介質(zhì)的pH值有關(guān)，且可推測其在人體內(nèi)的胃腸吸收良好，有較好的應(yīng)用價(jià)值。

Objective To determine the equilibrium solubility of ambroxol hydrochloride and its apparent oil/ water partition coeffioients at different pH for the study of the preparations and formulation selection. Methods UV method was used to detect concentration of ambroxol hydrochloride in water and ten organic solvent, and K_O/W was calculated with concentration ratio of ambroxol hydrochloride in n-octanol and water phase after partition equilibrium. Results The equilibrium solubility of ambroxol hydrochloride is high in various solvents, especially at distilled water, pH 2.0 and pH 5.8, the equilibrium solubility are 26.04, 27.71, 28.24 mg/mL; And the maximum of apparent partition coefficient is 60.80 at pH 7.4. Conclusion The equilibrium solubility and apparent partition coefficient of ambroxol hydrochloride are correlated to pH of the medium. And it can be inferred that ambroxol hydrochloride can be absorbed by the gastrointestinal and has better using value.