固本增骨胶囊HPLC指纹图谱构建及多指标成分定量测定

打开文本图片集

关键词：固本增骨胶囊；指纹图谱；多指标成分测定；化学计量学；质量控制中图分类号：R284.1文献标志码：A文章编号：1003-9783（2025）10-1748-09doi： 10.19378/j.issn.1003-9783.2025.10.013

HPLC Fingerprint Construction and Multi-Component Quantitative Analysis of Guben Zenggu Capsules

YANG Xiujuan1，LI Quanmei，GUO Jingjing1，HAI Yunxiang¹，DONG Wantao²， SONG Min1（1.Gansu Universityof Chinese Medicine，Lanzhou 73Oooo Gansu，China；2.Affiliated HospitalofGansu Universityof Chinese Medicine，Lanzhou Gansu，China）

Abstract：Objective To establish an HPLC fingerprint and a multi-component quantitative method for Guben Zenggu Capsules. Methods HPLC was performed using an Extend- C18 column （ 250mm×4.6mm ， 5μm ）with a mobile phase of 0.1% formic acid aqueous solution-acetonitrile under gradient elution.The detection wavelength was set at 280nm ， column temperature at 30∘C ， and flow rate at 1.0mL⋅min-1 . The HPLC fingerprint of Guben Zenggu Capsules was established，and five marker components—echinacoside，calycosin-7-O- β ⋅D -glucoside，ferulic acid，verbascoside， and lobetyolin—were quantitatively analyzed. Quality evaluation of Guben Zenggu Capsules was conducted using clustering analysis，principal component analysis，and orthogonal partial least squares-discriminant analysis.Results The similarity of fingerprints among 15 batches of Guben Zenggu Capsules was >0.991 .The contents of the five marker components were as follows：：echinacoside 0.7845-0.8378mg∙g-1） ，calycosin-7-0-β- D -glucoside （0.714 5- 0.826 1mg⋅g-1 ），ferulic acid （0.3418-0.3692mg⋅g-1） ），verbascoside 0.1113-0.1233mg⋅g-1 ），and lobetyolin （1.9453-2.2407mg⋅g-1） ）. Chemometric analysis classified the 15 batches into two categories，with peaks 15，11，14， 13，12，10，6（calycosin-7-0- β ∇⋅D -glucoside），3，and 4 identified as quality marker peaks for distinguishing between batches.Conclusion The established method is accurate，feasible，and highly stable，providing a reliable reference for the quality control of Guben Zenggu Capsules.

KeyWords： Guben Zenggu Capsules； fingerprint；multi-component quantitative analysis；chemometrics；quality control

固本增骨胶囊是根据省名中医宋敏教授治疗骨质疏松症的临床经验方开发的医院制剂，由炙黄芪、党参、当归、熟地黄、肉苡蓉等药组成，具有益气健脾、补肾壮骨、活血止痛的功效。（剩余9216字）