三七药材、三七三醇皂苷及其制剂的特征图谱质量控制研究

目的: 建立三七药材、三七三醇皂苷(PTS)及其制剂三七通舒胶囊(肠溶微丸)的HPLC特征图谱,为三七药材、提取液、PTS和制剂的质量控制以及工艺评价提供有效的方法。 方法: 采用Waters Symetry Shield C₁₈(4.6 mm×250 mm,5 μm)色谱柱,以乙腈-水为流动相,梯度洗脱,流速1.0 mL·min^-1,检测波长203 nm,柱温40 ℃;对多批三七药材、PTS、中间体及其制剂进行HPLC测定和方法学考察,采用"中药色谱指纹图谱相似度评价系统2004A版"对其进行相似度分析。 结果: 所建立的HPLC特征图谱能分离三七药材、PTS、中间体及制剂的各组分,具有较好的精密度、重复性和稳定性;经相似度评价,确定各组分平均相似度大于0.9。 结论: 采用HPLC建立的特征图谱方法简单,重复性良好,能充分展示三七药材、PTS、中间体及其制剂的物质组成以及有效物质群的变化,可用于三七药材、PTS及其制剂的质量控制和工艺评价。

Objective: To provide an effective way for quality control and process evaluation of Radix Notoginseng,panaxatriol saponins(PTS),intermediate products,and its preparation by establishing the specific chromatogram of Radix Notoginseng,PTS and Sanqi Tongshu capsules(intestinal solution pellets). Methods: Waters Symetry Shield C₁₈(4.6 mm×250 mm,5 μm) column was adopted under the temperature of 40 ℃.The proportion of mobile phase consisting of acetonitrile and water was set in gradient mode,and the total flow rate was 1.0 mL·min^-1.The detection wavelength was set at 203 nm.The methodology examination was studied,and several batches of Radix Notoginseng,PTS,intermediate products and the preparation were determined by HPLC.The similar degree was analyzed with "Similarity Evaluation System for Chromatographic Fingerprint of TCM(Version 2004 A)". Results: The components of Radix Notoginseng,PTS,intermediate parts of the key production processes,and its preparation could be separated well using HPLC method.The developed method was precise, reproducible and stable.By similar degree calculating,the similarity degree of the samples was more than 0.9. Conclusion: The method can be used for the quality control and process evaluation Radix Notoginseng,PTS and its preparation,because it is simple,reproducible,and can fully demonstrate the components of Radix Notoginseng,PTS,intermediate parts of the key production processes,Sanqi Tongshu capsules and change of active materials.