心悦滴丸的质量标准研究

Study on the Quality Standards of Xinyue Pills

目的 建立心悦滴丸的质量标准.方法 采用TLC对心悦滴丸中西洋参茎叶总皂苷进行定性鉴别;采用HPLC测定人参皂苷Rb2、Rb3、Rd的含量,色谱条件为Agilent ODS C18色谱柱（4.6mm＆#215;250mm,5 m）,乙腈-0.05％磷酸水溶液为流动相梯度洗脱,流速1.0mL/min,检测波长203nm,柱温40℃.结果 心悦滴丸中西洋参茎叶总皂苷的薄层色谱斑点清晰.人参皂苷Rb2在0.748-4.704μg范围内呈良好线性关系（r=0.9999）,平均回收率为96.2％（RSD1.9％）;人参皂苷Rb3在1.632～9.792μg范围内呈良好线性关系（r=0.9999）,平均回率为97.5％（RSD1.7％）;人参皂苷Rd在0.96～5.76μg范围内呈良好线性关系（r=0.9999）,平均回收率为96.6％（RSD2.1％）.结论 建立的方法操作简便、专属性强、灵敏度高、重复性好,可作为心悦滴丸的质量控制标准.

Objective To establish quality standards of Xinyue pills. Method Panax quinquefolius Saponin（PQS） in Xinyue pills were identified by TLC;The content of ginsenoside-Rb2,Rb3,Rd were determined by RP-HPLC,chromatographic conditions were as follows The Agilent ODS column （5 m, 4.6mm× 250mm） was used, and eluted with acetonitrile-0.05% phosphoric acid water in gradient mode. The UV detection wavelength was 203 nm,and the flow rate was 1.0mL/min ,with the tempture of column at 40℃. Results Spots of PQS in Xinyue pills on TLC could be well separated. Ginsenoside-Rb2 showed a good linear relationship at the range of 0.748-4.704μg （r=0.9999）, the average recovery was 96.2% with RSD1.9%. Ginsenoside-Rb3 showed a good linear relationship at the range of 1.632 -9.792μg （r =0.9999）,the average recovery was 97.5% with RSDI.7%. Ginsenoside-Rd showed a good linear relationship at the range of 0.96-5.76μg （r=0.9999）,the average recovery was 96.6% with RSD2.1%. Conclusion： This established method was simple, specifc, sensitive and reproducible,it was suitable for quality control of Xinyue pills.