Quality Evaluation of Chuanxiong Rhizoma Dispensing Granules Based on HPLC Specific Chromatogram and Two Reference Substances for Determination of Multiple Components
10.13422/j.cnki.syfjx.20250868
- VernacularTitle:基于HPLC特征图谱及双标多测法的川芎配方颗粒质量评价
- Author:
Jinxin LI
1
;
Xue DONG
1
;
Shuai DUAN
1
;
Guiyun CAO
1
;
Jinghua ZHANG
1
;
Yongfu LUAN
2
;
Yongqiang LIN
2
;
Xiaodi DONG
1
;
Zhaoqing MENG
1
Author Information
1. Shandong Province Technical Innovation Center of Traditional Chinese Medicine Treatment of Respiratory Diseases，Shandong Hongjitang Pharmaceutical Group Co. Ltd.，Jinan 250103，China
2. Shandong Institute for Food and Drug Control，Jinan 250101，China
- Publication Type:Journal Article
- Keywords:
Chuanxiong Rhizoma dispensing granules;
specific chromatogram;
chemometrics;
partial least squares-discriminant analysis（PLS-DA）;
linear calibration using two reference substances（LCTRS）;
relative correction factor method（RCFM）;
high performance liquid chromatography（HPLC）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(11):246-253
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish the specific chromatogram of Chuanxiong Rhizoma dispensing granules（CRdg）， and to evaluate its quality by chemometrics and two reference substances for determination of multiple components（TRSDMC）. MethodsHigh performance liquid chromatography（HPLC） specific chromatograms were established using 13 batches of CRdg from 7 manufacturers， and preliminary quality evaluation was performed by similarity evaluation and chemometrics analysis. Eight characteristic peaks in the specific chromatogram of CRdg were measured on 22 different types of C18 columns， and the actual retention times were recorded. Taking chlorogenic acid（peak 1） and senkyunolide A（peak 8） as double standard compounds， the retention times of the eight characteristic peaks were predicted by linear calibration using two reference substances（LCTRS）， and the method was validated on three other columns of different brands. Taking chlorogenic acid as reference peak， the relative correction factor method（RCFM） was used to quantify cryptochlorogenic acid， caffeic acid， ferulic acid， senkyunolide I and senkyunolide A， and the results were compared with the external standard method（ESM）. ResultsThe similarities of specific chromatograms of 13 batches of CRdg were all >0.90， and a total of 8 characteristic peaks were calibrated， and six of them were identified， including chlorogenic acid（peak 1）， cryptochlorogenic acid（peak 2）， caffeic acid（peak 3）， ferulic acid（peak 5）， senkyunolide I（peak 6） and senkyunolide A（peak 8）. Through chemometric analysis， it was found that ferulic acid， chlorogenic acid， senkyunolide I and cryptochlorogenic acid were the main components causing quality difference in CRdg， and the accuracy of LCTRS in predicting the retention time of 8 characteristic peaks was superior to that of the relative retention time method（RRT）. Further comparison of the results obtained from RCFM and ESM showed that there was no statistically significant difference between the two methods. ConclusionA quality evaluation method for CRdg based on HPLC specific chromatogram and TRSDMC is established， its qualitative accuracy is better than that of RRT， the quantitative accuracy is similar to that of ESM， and 4 quality-differentiated components among different manufacturers are found. This method is stable and reliable， and has reference value for the quality evaluation of other dispensing granules.
