散结镇痛胶囊中皂苷类成分的指纹图谱研究和多指标成分定量测定

Fingerprint and Multi-components Determination of Saponins in Sanjie-zhentong Capsule

目的:建立散结镇痛胶囊中皂苷类成分的指纹图谱,为评价散结镇痛胶囊质量提供依据。方法:采用Waters Symmetry ShieldTMRP18柱(4.6 mm×250 mm,5μm),以乙腈-水梯度洗脱,流速1.2 mL·min-1,柱温30℃,检测波长203 nm。结果:各批次样品相似度在0.95以上,标示出9个共有峰;通过对照品比对,确定了5个成分,分别为三七皂苷R1和人参皂苷Rg1、Re、Rb1、Rd,并对其进行定量分析。结论:该方法快速、简便、准确,可作为评价该制剂质量的有效方法之一。

This study was aimed to establish a HPLC fingerprint of saponins in Sanjie-zhentong Capsule in order to make a quantitative analysis of the quality of Sanjie-zhentong Capsule. The Waters Symmetry ShieldTM RP18 （4.6 mm ×250 mm, 5 μm） column was used with a mobile phase of acetonitrile-water gradient elution. The flow rate was 1.2 mL/min. The column temperature was 30℃. The detection wavelength was 203 nm. The results showed that the fingerprint chromatography included 9 mutual peaks. The similarity among batches was more than 0.95. Compared with reference substance, five characteristic components were recognized. The five components are notoginsenoside R1, ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1 and ginsenoside Rd. It was concluded that this method was rapid, simple and accurate and can be used as one of the effective methods for the quality control of Sanjie-zhen- tong Capsule.