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目的:建立一测多评法,同时测定楤木总皂苷中多种成分的平衡溶解度及表观油水分配系数,为楤木总皂苷的剂型设计奠定基础。方法:以楤木皂苷A为内标物,计算楤木皂苷A与竹节参皂苷Ⅳa、齐墩果酸的相对校正因子,将校正因子计算值与外标法测定值进行对比,检验有无显著性差异,实现一测多评法测定楤木总皂苷中多种成分的平衡溶解度趋势和表观油水分配系数。结果:运用相对校正因子所得的计算值与外标法实测值相比没有显著性差异(P>0.05);楤木皂苷A、竹节参皂苷Ⅳa及楤木总皂苷中其他成分的平衡溶解度受p H的影响,在p H7.0的磷酸盐中最大,碱性条件优于酸性条件;在不同p H条件下,楤木皂苷A、竹节参皂苷Ⅳa、齐墩果酸及楤木总皂苷中其他成分的log P均小于0。结论:楤木总皂苷提取物脂溶性弱,水溶性强,在生物膜不易透过,在肠道中极不易被吸收,其平衡溶解度在中性条件下最佳。
OBJECTIVE: To establish a multi-assessment method for simultaneous determination of the equilibrium solubility and apparent oil-water partition coefficient of various components in Alnus sativa saponins, which laid the foundation for formulation design of Alder saponins. Methods: Alnus japonicus saponin A was used as internal standard to calculate the relative correction factor between alnus saponin A and bamboo ginsenoside Ⅳa and oleanolic acid, and the calculated value of correction factor was compared with that of external standard method Significant differences, to achieve a multi-test method for determination of alnum saponins balance of various components of the trend and the apparent solubility of oil-water partition coefficient. Results: There was no significant difference between the calculated values and those of the external standard method (P> 0.05). The equilibrium solubility of the other components in the saponins A, Stro-saponins Ⅳa and saponins p H, the maximum in p H7.0 phosphate, alkaline conditions than acidic conditions; under different p H conditions, saponins A, bamboo ginseng saponin Ⅳ a, oleanolic acid and alder total The log P of other components in saponins were less than zero. Conclusion: The extract of Alnus japonicum total saponin has low liposolubility, strong water solubility, is not easily permeable in the biofilm, is very difficult to be absorbed in the intestine, and its equilibrium solubility is optimal under neutral conditions.