三七总皂苷中代表性皂苷含量测定方法学的建立及稳定性研究

目的 建立同时测定三七总皂苷中三七皂苷R1、人参皂苷Rg1 和人参皂苷Rb1 三种成分的含量测定方法,并对其各种状态下的稳定性进行研究.方法：以乙腈-水系统作为流动相,采用高效液相-梯度洗脱法,同时测定三七总皂苷中三种成分的含量,并考察方法的专属性、线性、精密度和回收率;测定四种pH值溶液中三种皂苷成分的稳定性以及在高温、高湿和强光照射条件下,三七总皂苷粉末中三种皂苷成分的稳定性.结果：方法学验证结果显示,在选定的梯度洗脱条件下,方法专属性良好,三种皂苷可有效分离和定量;在各自的线性范围内线性良好;精密度RSD 值均小于2%;三种皂苷的平均回收率分别为（98.98 ± 0.60）%、（98.86 ± 0.34）%和（100.19 ± 0.64）%,方法准确性良好.稳定性研究结果显示,在溶液状态下,三种皂苷的稳定性趋势基本-致,稳定性与pH值密切相关,在pH 1.2 溶液中药物迅速降解,24 h 含量即降低了约80%;而在pH 4.5 溶液、pH 6.8 溶液以及水中,三种成分的稳定性均良好,24 h 内含量未发生明显变化;而在三七总皂苷粉末中,三种代表性皂苷对湿、热和光照均不敏感,10 d 内含量基本保持稳定;但是在高湿条件下,粉末有-定的吸湿性.结论：所建立的液相方法准确、可靠,溶液状态下三七皂苷R1、人参皂苷Rg1 和人参皂苷Rb1 的稳定性与pH密切相关,随pH的降低稳定性变差,而在固体状态下则稳定性良好.

Study on the methodology establishment of content determination and stability of representativesaponins in Panax notoginseng saponins

Objective： The HPLC method for simultaneous determination of notoginsenoside R1, ginsenoside Rg1 andginsenoside Rb1 in Panax notoginseng saponins （PNS） was established to study the stability of the saponins under different states.Methods： Acetonitrile-water system was used as the mobile phase, and the method specificity, linearity, precision, recovery werestudied. The stability of the three saponins in different pH solutions and solid state was evaluated. Results： The results of methodvalidation showed good specificity, effective separation and quantification, as well as good linearity of the three saponins in theirlinear range. The precision RSD values were less than 2%, average recovery rates were （98.98 ± 0.60）%, （98.86 ± 0.34）% and （100.19 ±0.64）% for the three saponins respectively. The stability results showed that the stability of the three saponins was closely related tothe pH value under the solution state, with rapid degradation about 80% in 24 h in pH 1.2 solutions and little degradation in the othertest medium. In the solid powder state, the stability of saponins was good under the experimental high temperature, high humidity andhighlight conditions, while a little moisture absorption was found in the high humidity conditions. Conclusion： The HPLC methodwas reliable. Stability of three saponins was closely related to the pH value of solution, while they were stable under solid state.