三七二醇皂苷含量测定方法建立及其固有稳定性研究

Study on the content determination method and the inherent stability of Panaxadiolsaponins

目的:采用HPLC建立同时测定三七二醇皂苷提取物(PDS)中人参皂苷Rb_1和Rd两种主要药效成分的含量测定方法,并对影响PDS固有稳定性的因素进行初步探索。方法:以乙腈-水系统作为流动相,采用梯度洗脱法,同时测定PDS主要成分的含量,并进行方法学考察;考察PDS主要药效成分在不同pH值溶液中以及在高温、高湿和强光照射条件下的固有稳定性。结果:方法学考察结果显示,人参皂苷Rb_1和Rd分别在0.1502~1.5020mg·mL^(-1)、0.0202~0.2022 mg·mL^(-1)范围内呈良好线性;平均回收率分别为99.35%、98.94%。稳定性研究结果显示,PDS主要药效成分人参皂Rb_1和Rd在pH 1.2的溶液中均迅速降解,24h内含量降低了90%以上;在高温、高湿和强光条件下含量降低幅度不大。结论:建立的含量测定方法准确可靠,可用于PDS含量测定及过程质量控制;溶液pH值会影响PDS的稳定性。高温、高湿和强光对PDS的稳定性有一定影响。该研究可为三七二醇皂苷新制剂的辅料与剂型的选择、处方设计及工艺优化等提供科学依据。

Objective:To establish a HPLC method for simultaneous determination of two major components in Panaxadiolsaponins CPDS and investigate the factors influencing their stability.Method:Gradient mobile phase system consisting of water and acetonitrile was used to detect the main components in PDS, and the method was totally validated. The stability of the major components in PDS was measured in different pH solutions and in high temperature, high humidity and strong light conditions. Result:The results of methodological verification showed that ginsenoside Rb1 and Rd had a goodlinear correlation in the ranges of 0.15021.5020 mg·mL^-1 and 0.02020.2022 mg·mL^-1 respectively, with the average recoveries of 99.35% and 98.94% respectively. The stability results showed that ginsenoside Rb1 and Rd were rapidly degraded more than 90% in 24 h in pH 1.2 solution and little degraded in the other test mediums. The contents of saponins decreased not obviously under the high temperature, high humidityand strong light conditions. Conclusion:This method can be used as a quantitative analysis for Panaxadiolsaponins content determination. Stability of the saponinsis is closely related to the pH value of solution, while the conditions of high temperature, high humidity and strong light play a certain role in influencing the stability. This study can provide the basis for the formulation design and the process optimization of Panaxadiolsaponins.