[关键词]
[摘要]
目的 建立血府逐瘀片HPLC指纹图谱及其6种成分苦杏仁苷、芍药苷、柚皮苷、橙皮苷、阿魏酸、新橙皮苷的一测多评法(QAMS),验证该方法在血府逐瘀片质量分析中应用的科学性与可行性。方法 采用中药指纹图谱软件(2012A版)软件对10批样品进行相似度分析。以苦杏仁苷为内参物,建立芍药苷、阿魏酸、柚皮苷、橙皮苷和新橙皮苷的相对校正因子(fs/i),并利用fs/i计算血府逐瘀片样品中该6种成分的含量,同时采用外标法计算各成分的含量,并比较2种方法差异。结果 10批样品指纹图谱中共有24个峰,相似度均大于0.990。以苦杏仁苷为内参物建立的芍药苷、柚皮苷、橙皮苷、阿魏酸、新橙皮苷的fs/i分别为1.169 6、0.172 0、0.363 3、0.141 3、0.259 2,QAMS与外标法得到的10批血府逐瘀片样品含量测定结果相对误差(RE)<3%,没有显著差异。结论 建立的指纹图谱和QAMS含量测定法稳定可控,简单易行,可用于血府逐瘀片的质量控制。
[Key word]
[Abstract]
Objective To establish HPLC fingerprint of Xuefu Zhuyu Tablets (血府逐瘀片, XZT) and a quantitative analysis of multi-components by single-marker (QAMS) method for the simultaneous determination of six components of amygdalin, paeoniflorin, naringin, hesperidin, ferulic acid and neohesperidin in XZT, so as to prove the scientificity and feasibility of the method in the quality analysis for XZT. Methods The similarity evaluation software (2012A) was used to analyze the similarity of 10 batches of samples. The relative factor (fs/i) of paeoniflorin, ferulic acid, naringin, hesperidin and neohesperidin were established by HPLC method with amygdalin as internal standard, which were used to calculate the content of five constituents in the samples of XZT. Meanwhile, external standard method (ESM) was used to calculate the content of six constituents. The difference between QAMS and ESM was analyzed to evaluate the accuracy of QAMS. Results There were 24 common peaks in the fingerprints of 10 batches of samples with the similarities of more than 0.990. The fs/i of paeoniflorin, naringin, hesperidin, ferulic acid and neohesperidin were 1.169 6, 0.172 0, 0.363 3, 0.141 3 and 0.259 2, respectively. There was no significant difference in the content determination results of 10 batches of XZT calculated by the methods of QAMS and ESM, with RE < 3.0%. Conclusion The fingerprints and QAMS method are stable and controllable, which can be used for the quality control of XZT.
[中图分类号]
R286.02
[基金项目]
陕西省中药大品种品牌价值提升示范研究(202190025);国家农业部现代农业产业技术体系建设专项资金(CARS-21)