指纹图谱结合一测多评模式在贞蓉丹合剂质量评价中的应用

Application of Fingerprint Combined with QAMS in Quality Evaluation of Zhenrongdan Mixture

关键词:  指纹图谱  一测多评  贞蓉丹合剂  质量控制  校正因子

Key words:  fingerprint  quantitative analysis of multi-components by single marker (QAMS)  Zhenrongdan mixture  quality control  correction factor

摘要:

目的 采用指纹图谱与一测多评（QAMS）结合的方法对贞蓉丹合剂进行质量评价。方法 以松果菊苷为参照物建立贞蓉丹合剂HPLC指纹图谱，计算该成分与阿魏酸、丹酚酸B、淫羊藿苷的相对校正因子，并计算其含量。同时对QAMS的计算值与外标法实测值进行比较，以确证QAMS法的可行性和科学性。结果 研究建立了贞蓉丹合剂HPLC特征指纹图谱共有模式，标定了13个共有峰，占总体峰面积的91%，指认了其中4个共有峰，5批次贞蓉丹合剂的相似度均>0.99。5批次贞蓉丹合剂中4个主要成分QAMS法和外标法测定结果间无显著差异。结论 QAMS结合指纹图谱可为贞蓉丹合剂的定量测定和质量控制提供参考。

Abstract:

OBJECTIVE To evaluate the quality of Zhenrongdan mixture by fingerprint combined with QAMS. METHODS The quality evaluation method was established and validated with echinacoside as internal reference to determine the contents of other components (ferulic acid, salvianolic acid B, and icariin) according to the relative correction factor. The accuracy and feasibility of QAMS was evaluated by comparison on the results between the measured value and calculation value by external standard method and QAMS. RESULTS A common pattern of characteristic fingerprint of zhenrong dan mixture by HPLC was established. Thirteen common peaks were identified, they accounted for 91% of the total peak area and four components were verified in five batches of Zhenrongdan mixture, good similarities with correlation coefficients >0.99 were found in the fingerprints. There was no significant difference between the quantitative results of the four ingredients in the five batches by external standard method and QAMS. CONCLUSION The method of fingerprint combined with QAMS can be used for the quality control of multiple components determination and fingerprint chromatography for Zhenrongdan mixture.