Analysis on Quality Standard of Sennae Folium（Cassia angustifolia） Dispensing Granules Based on Standard Decoctions
10.13422/j.cnki.syfjx.20250167
- VernacularTitle:基于标准汤剂的番泻叶（狭叶番泻）配方颗粒质量标准分析
- 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 Technical Innovation Center for 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:
Sennae Folium;
standard decoction;
dispensing granules;
linear calibration with two reference substances（LCTRS）;
quantitative analysis of multi-components by single-marker（QAMS）;
specific chromatograms;
quality control;
high performance liquid chromatography（HPLC）
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2025;31(9):192-200
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish the quality standards for Sennae Folium（Cassia angustifolia） dispensing granules based on standard decoctions. MethodsHigh performance liquid chromatography（HPLC） specific chromatograms were established for 15 batches of Sennae Folium（C. angustifolia） standard decoctions and 10 of Sennae Folium（C. angustifolia） dispensing granules from different manufacturers， and the similarity evaluation， hierarchical cluster analysis（HCA） and principal component analysis（PCA） were performed. Linear calibration with two reference substances（LCTRS） and quantitative analysis of multi-components by single-marker（QAMS） were established for the common peaks in the specific chromatograms to determine the contents of main components in the decoction pieces， standard decoctions and dispensing granules， and to calculate their transfer rates from decoction pieces to standard decoctions and dispensing granules. ResultsThe similarities of specific chromatograms of 15 batches of Sennae Folium（C. angustifolia） standard decoctions and 10 batches of Sennae Folium（C. angustifolia） dispensing granules were all greater than 0.95， and a total of 8 characteristic peaks were calibrated， and five of them were identified， including kaempferol-3，7-O-diglucoside， apigenin-6，8-di-C-glucoside， quercetin-3-O-gentianoside， sennoside B and sennoside A. HCA and PCA results showed that there were certain differences in the composition of different batches of standard decoctions， but no clustering was observed in the production area. As the standard decoctions， the extract rate of 15 batches of samples was 26.54%-45.38%， the contents of kaempferol-3，7-O-diglucoside， apigenin-6，8-di-C-glucoside， quercetin-3-O-gentianoside， sennoside B and sennoside A were 12.16-19.26， 2.57-4.94， 3.27-5.11， 6.75-11.39， 4.69-7.79 mg·g-1， and their transfer rates from decoction pieces to standard decoctions were 45.41%-79.02%， 29.12%-55.07%， 40.52%-67.90%， 24.72%-49.12%， 27.54%-49.34%， respectively. The extract rates of Sennae Folium（C. angustifolia） dispensing granules（C8-C10） were 38.10%-39.50%， the transfer rates of the above five components from decoction pieces to dispensing granules were 72.85%-73.58%， 53.43%-53.94%， 40.19%-40.74%， 24.62%-25.00%， 28.65%-29.11%， respectively， which were generally consistent with the transfer rates from decoction pieces to standard decoctions. ConclusionCompared with the relative retention time method， LCTRS has higher prediction accuracy and is more suitable for chromatographic columns. The established quality control standard of Sennae Folium（C. angustifolia） dispensing granules based on standard decoction is reasonable and reliable， and all indicators of samples from different manufacturers are within the range specified based on the standard decoction， which can provide reference for the quality control and process research of this dispensing granules.
