Establishment of quantitative analysis of multi-components by single marker and quality evaluation of Gushen dingchuan pills

ZHANG Ying; LI Zhiping; GAO Yuqiu; WANG Jialiang; HOU Jiafu

doi:10.6039/j.issn.1001-0408.2022.18.11

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Establishment of quantitative analysis of multi-components by single marker and quality evaluation of Gushen dingchuan pills

更新时间：2025-09-28

- Establishment of quantitative analysis of multi-components by single marker and quality evaluation of Gushen dingchuan pills
- ZHONGGUO YAOFANG Vol. 33, Issue 18, Pages: 2230-2234(2022)
- 作者机构：
  
  1.牡丹江医学院附属红旗医院药学部，黑龙江牡丹江　157011
  2.牡丹江医学院药学院，黑龙江牡丹江　157011
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2022.18.11
  CLC： R917
- Received：17 March 2022，
  
  Revised：2022-07-22，
  
  Published：30 September 2022
- 稿件说明：
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张颖,李志平,高雨秋,等.固肾定喘丸多指标成分一测多评法的建立及质量评价[J].中国药房,2022,33(18):2230-2234.

ZHANG Ying,LI Zhiping,GAO Yuqiu,et al.Establishment of quantitative analysis of multi-components by single marker and quality evaluation of Gushen dingchuan pills[J].ZHONGGUO YAOFANG,2022,33(18):2230-2234.
张颖,李志平,高雨秋,等.固肾定喘丸多指标成分一测多评法的建立及质量评价[J].中国药房,2022,33(18):2230-2234. DOI： 10.6039/j.issn.1001-0408.2022.18.11.

ZHANG Ying,LI Zhiping,GAO Yuqiu,et al.Establishment of quantitative analysis of multi-components by single marker and quality evaluation of Gushen dingchuan pills[J].ZHONGGUO YAOFANG,2022,33(18):2230-2234. DOI： 10.6039/j.issn.1001-0408.2022.18.11.

摘要

目的

建立一测多评（QAMS）法检测固肾定喘丸中肉桂酸、桂皮醛、大车前苷、毛蕊花糖苷、异毛蕊花糖苷、木通苯乙醇苷B、补骨脂素、异补骨脂素、新补骨脂异黄酮、补骨脂二氢黄酮的含量，并结合化学模式识别分析对固肾定喘丸进行质量评价。

方法

采用高效液相色谱法进行测定。以补骨脂素为内参物，建立其他9个待测成分的相对校正因子，计算其含量，并与外标法测定结果进行比较；通过对QAMS法计算结果进行聚类分析、主成分分析和偏最小二乘法-判别分析，评价15批固肾定喘丸的质量。

结果

上述10个待测成分分别在各自检测质量浓度范围内线性关系良好（

＞0.999 0）；精密度、重复性、稳定性、加样回收率的RSD均小于2.00%；QAMS法测定结果与外标法测定结果差异无统计学意义（

＞0.05）；聚类分析和主成分分析结果显示，15批固肾定喘丸聚为3类；偏最小二乘法-判别分析结果显示，补骨脂素、毛蕊花糖苷、桂皮醛、异补骨脂素是影响固肾定喘丸产品质量的潜在标志性成分。

结论

所建立的QAMS法多指标成分定量控制及化学模式识别分析可用于固肾定喘丸的质量评价。

Abstract

OBJECTIVE

To establish quantitative analysis of multi-components by single marker（QAMS） method to simultaneously detect the contents of cinnamic acid，cinnamaldehyde，plantamajoside，verbascoside，isoacteoside，calceolarioside B，psoralen，isopsoralen，neobavaisoflavone and bavachin in Gushen dingchuan pill，and to perform quality evaluation of Gushen dingchuan pill by combining with chemical pattern recognition.

METHODS

High-performance liquid chromatography was adopted. Using psoralen as internal standard，the relative correction factors of the other 9 components were established，and the contents of each component were calculated and compared with those determined by external standard method.Cluster analysis，principal component analysis and partial least squares discrimination analysis were performed by the results of QAMS method， and the qualities of 15 batches of Gushen dingchuan pills were evaluated.

RESULTS

The above 10 components showed a good linear relationship in their respective ranges（

＞0.999 0）. RSDs of precision，repeatability，stability and recovery tests were all lower than 2.00%. There was no significant difference between QAMS method and external standard method （

＞0.05）. The results of cluster analysis and principal component analysi showed that 15 batches of Gushen dingchuan pills could be clustered into 3 categories. The results of partial least squares discrimination analysis showed that psoralen，verbascoside，cinnamaldehyde and isopsoralen were the main potential markers affecting the quality of Gushen dingchuan pills.

CONCLUSIONS

Established QAMS method for quantitative control of multi index components and chemical pattern recognition can be used for the quality evaluation of Gushen dingchuan pills.

关键词

Keywords

references

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