Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method

YE Xide; FENG Xiaolong; SHAO Mingguo; WAN Linchun; HU Zhenyu; CHEN Chunyu; WU Yu; BU Junwen; QIAN Yuhang; MENG Fanqiang

doi:10.6039/j.issn.1001-0408.2025.15.08

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Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method

更新时间：2025-11-14

- Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method
- ZHONGGUO YAOFANG Vol. 36, Issue 15, Pages: 1866-1870(2025)
- 作者机构：
  
  1.江西中医药大学药学院，南昌　330004
  2.鲁南制药集团股份有限公司，山东临沂　276006
  3.江西省药品检测检验研究院，南昌　330029
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.15.08
  CLC： R917
- Received：24 February 2025，
  
  Revised：2025-06-18，
  
  Accepted：20 June 2025，
  
  Published：15 August 2025
- 稿件说明：
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叶喜德,冯小龙,邵明国,等.基于HPLC指纹图谱及一测多评法的心通颗粒质量评价[J].中国药房,2025,36(15):1866-1870.

YE Xide,FENG Xiaolong,SHAO Mingguo,et al.Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method[J].ZHONGGUO YAOFANG,2025,36(15):1866-1870.
叶喜德,冯小龙,邵明国,等.基于HPLC指纹图谱及一测多评法的心通颗粒质量评价[J].中国药房,2025,36(15):1866-1870. DOI： 10.6039/j.issn.1001-0408.2025.15.08.

YE Xide,FENG Xiaolong,SHAO Mingguo,et al.Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method[J].ZHONGGUO YAOFANG,2025,36(15):1866-1870. DOI： 10.6039/j.issn.1001-0408.2025.15.08.

摘要

目的

建立心通颗粒的高效液相色谱（HPLC）指纹图谱，并结合一测多评（QAMS）法测定其中7种成分含量，为其质量评价提供参考。

方法

利用HPLC法，建立10批（编号S1～S10）心通颗粒的指纹图谱，并进行相似度评价、聚类分析和偏最小二乘-判别分析。采用QAMS法测定10批心通颗粒中葛根素、大豆苷、毛蕊异黄酮葡萄糖苷、二苯乙烯苷、柚皮苷、淫羊藿苷、丹参酮ⅡA的含量，并与外标法测定结果比较。

结果

10批心通颗粒的HPLC指纹图谱共标记了18个共有峰，指认了7个峰，分别是葛根素（峰4）、大豆苷（峰7）、毛蕊异黄酮葡萄糖苷（峰9）、二苯乙烯苷（峰10）、柚皮苷（峰12）、淫羊藿苷（峰17）、丹参酮ⅡA（峰18）；相似度均大于0.990；聚类分析和偏最小二乘-判别分析结果均显示S4～S5样品聚为一类，S8～S10样品聚为一类，S1～S3、S6～S7样品聚为一类。以柚皮苷为内标物，采用QAMS法测得葛根素、大豆苷、毛蕊异黄酮葡萄糖苷、二苯乙烯苷、淫羊藿苷、丹参酮ⅡA的含量分别为7.868 1～10.181 2、1.709 2～2.374 1、0.285 2～0.326 3、1.024 1～1.523 9、0.140 2～0.290 4、0.077 1～0.219 4 mg/g，与外标法含量测定结果无明显差异。

结论

本研究建立的HPLC指纹图谱和QAMS法便捷、稳定、准确，可为心通颗粒质量评价提供依据。

Abstract

OBJECTIVE

To establish the HPLC fingerprint of Xintong granules and the quantitative analysis of multi-components by single-marker method （QAMS） to determine the contents of 7 components， so as to provide a scientific basis for their quality control.

METHODS

HPLC method was used to establish the fingerprints for 10 batches of Xintong granules （No. S1-S10）， and similarity evaluation， cluster analysis （CA） and partial least squares-discriminant analysis （PLS-DA） were performed. At the same time， the contents of seven components， including puerarin， daidzin， calycosin-7-

-D-glucoside， stilbene glycoside， naringin， icariin and tanshinone ⅡA， were determined by QAMS method， and were compared with the results of external standard method.

RESULTS

A total of 18 common peaks were marked and 7 peaks were identified in the HPLC fingerprints for 10 batches of Xintong granules， namely puerarin （peak 4）， daidzin （peak 7）， calycosin-7-

-D-glucoside （peak 9）， stilbene glycoside （peak 10）， naringin （peak 12）， icariin （peak 17）， and tanshinone ⅡA （peak 18）； the similarities among them were more than 0.990， and CA and PLS-DA results showed that S4-S5，S8-S10，S1-S3 and S6-S7 were clustered into three categories， respectively. Using naringin as the internal standard， the contents of puerarin， daidzin， calycosin-7-

-D-glucoside， stilbene glycoside， icariin and tanshinone ⅡA were determined to be 7.868 1-10.181 2， 1.709 2-2.374 1， 0.285 2-0.326 3， 1.024 1-1.523 9， 0.140 2-0.290 4， and 0.077 1-0.219 4 mg/g， respectively， by the QAMS. These results showed no significant differences compared to those obtained by the external standard method.

CONCLUSIONS

Established HPLC fingerprint and QAMS method are convenient， stable and accurate， which can provide a basis for the quality evaluation of Xintong granules.

关键词

Keywords

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