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目的:检测白头翁总皂苷提取物的表观溶解度、表观油水分配系数及其在体外胃肠液中的稳定性。方法:以白头翁皂苷类成分(B3,BD,B7)为指标,采用饱和法测定表观溶解度,摇瓶法测定油水分配系数,考察白头翁总皂苷提取物在体外胃肠液中的稳定性。采用ELSD-HPLC测定指标成分含量,流动相甲醇(A)-水(B)梯度洗脱(0~28 min,25%~10%B)。结果:3种白头翁皂苷类成分中B7的溶解能力最强。白头翁总皂苷提取物在不同pH缓冲液中油水分配系数均很小。指标成分在胃蛋白酶、胰蛋白酶环境较稳定,RSD均<5%。结论:白头翁总皂苷提取物在弱碱性环境中溶解能力最强。白头翁皂苷类成分的亲脂性较弱,较难通过肠壁的脂质膜与水性层吸收进入体内。白头翁总皂苷在体外胃肠液环境中较稳定。
Objective: To detect the apparent solubility of Pulsatilla saponin extract, the apparent oil-water partition coefficient and its stability in vitro gastrointestinal fluid. Methods: The apparent solubility of Pulsatilla saponin (B3, BD, B7) was determined by saturation method. The oil-water partition coefficient was determined by shake flask method. The stability of Pulsatilla saponin extract was studied in vitro. The content of indicator components was determined by ELSD-HPLC. The mobile phase was eluted with methanol (A) -water (B) gradient (0-28 min, 25% -10% B). Results: Among the three Pulsatilla saponins, B7 had the strongest lytic capacity. Pulsatilla total saponin extract in different pH buffer oil-water partition coefficients are small. The indicator components in the pepsin, trypsin environment more stable, RSD <5%. Conclusion: Pulsatilla saponin extract has the strongest ability to dissolve in weakly alkaline environment. Pulsatilla glycosides lipophilic ingredient is weak, more difficult to absorb through the intestinal wall of the lipid membrane and aqueous layer into the body. Pulsatilla total saponin in vitro gastrointestinal fluid environment more stable.