血府逐瘀汤不同剂型数字化指纹图谱的构建

The establishment of UPLC-Digitized fingerprinting of multiple dosage forms of Xuefu Zhuyu decoction

[目的]建立一种有效的超高效液相色谱(UPLC)数字化色谱指纹图谱,评价血府逐瘀汤不同剂型的质量,为血府逐瘀汤制剂(胶囊、口服液、片剂、软胶囊、汤剂)质量控制提供参考。[方法]采用超高效液相色谱仪,以色谱柱ACQUITY UPLC BEH C18(2.1 mm×100 mm,1.7μm),柱温50℃,体积流量0.3 m L/min,进样量2μL,检测波长为280 nm,0.1%甲酸水溶液(A)-乙腈(B)为流动相进行梯度洗脱(0~8 min,3%~8%B;8~24 min,8%~19%B;24~35 min,19%~45%B)。[结果]构建了血府逐瘀汤多种剂型的指纹图谱。以野漆树苷为参照峰,共标定了30个共有峰,通过标准品比对确定了血府逐瘀汤不同制剂指纹图谱中的16个共有峰。采用《中药色谱指纹图谱相似度评价系统》(2004A版)评价了血府逐瘀汤不同制剂指纹图谱相似度均大于0.81。以血府逐瘀汤不同剂型共有峰的相对峰面积为特征值进行主成分分析(PCA),不同剂型样品聚类在3个不同的区域,说明血府逐瘀汤不同剂型的质量存在明显差异。[结论]该方法构建的指纹图谱简便易行,为血府逐瘀汤不同剂型的质量控制研究提供依据。

[Objective] To establish a sensitive and specific UPLC-digitized fingerprinting of multiple dosage forms of Xuefu Zhuyu decoction(capsule, oral liquid, tablet, soft capsule and Decoction) with UPLC-DAD technology. [Methods] The UPLC method was established by employing an ACQUITY UPLC誖BEH C18(2.1×100 mm, 1.7 μm) with 0.1% formic acid aqueous solution(A)-acetonitrile(B) as mobile phase in a gradient elution(0 ~8 min, 3% ~8% B; 8 ~24 min, 8% ~19% B; 24 ~35 min, 19% ~45% B). The detection wavelength was 280 nm. The flow rate was 0.3 m L/min and the column temperature was 50 °C. [Results] The established method was employed to develop UPLC-digitized fingerprinting(UPLC-DFP) of multiple dosage forms of Xuefu Zhuyu decoction. By choosing rhoifolin as reference, 30 common peaks were obtained. 16 of 30 common peaks of Xuefu Zhuyu decoction were identified by comparing with standards. The similarity of the multiple dosage forms of Xuefu Zhuyu decoction is over 0.81, which was evaluated by Similarity Evaluation System for Chromatographic Fingerprint of TCM(Version 2004A). The relative peak area of common peaks as characteristic value was implemented to perform principal component analysis(PCA). The multiple dosage forms of Xuefu Zhuyu decoction were classified as three clusters based on different quality. [Conclusion] This method was simple, and provided the basis for the quality control of multiple dosage forms of Xuefu Zhuyu decoction.