Study on quality control of Jinbei oral liquid based on fingerprint，chemical pattern recognition and multi-index content determination
- VernacularTitle:基于指纹图谱、化学模式识别和多指标含量测定的金贝口服液质量控制研究
- Author:
Jing TIAN
1
;
Weiliang CUI
2
;
Yuanfang ZANG
3
;
Bing WANG
3
;
Huifen LI
4
;
Aijun ZHANG
5
;
Fei XUE
3
;
Yingying XIE
3
;
Yongqiang LIN
6
Author Information
1. Institute of Materia Medica，Shandong University of Traditional Chinese Medicine，Jinan 250355，China;Dept. of Traditional Chinese Medicine，Shandong Institute for Food and Drug Control/Shandong Engineering Research Center for Common Technology of Traditional Chinese Medicine Formula Granules/Public Service Platform for Industrial Technology Infrastructure/Shandong Key Laboratory of Effective Components and Innovative Transformation of Traditional Chinese Medicine，Jinan 250101，China
2. Dept. of Traditional Chinese Medicine，Shandong Institute for Food and Drug Control/Shandong Engineering Research Center for Common Technology of Traditional Chinese Medicine Formula Granules/Public Service Platform for Industrial Technology Infrastructure/Shandong Key Laboratory of Effective Components and Innovative Transformation of Traditional Chinese Medicine，Jinan 250101，China;School of Pharmacy，Shandong University of Traditional Chinese Medicine，Jinan 250355，China
3. Dept. of Traditional Chinese Medicine，Shandong Institute for Food and Drug Control/Shandong Engineering Research Center for Common Technology of Traditional Chinese Medicine Formula Granules/Public Service Platform for Industrial Technology Infrastructure/Shandong Key Laboratory of Effective Components and Innovative Transformation of Traditional Chinese Medicine，Jinan 250101，China
4. School of Pharmacy，Shandong University of Traditional Chinese Medicine，Jinan 250355，China
5. Shandong Hongjitang Pharmaceutical Group Co.，Ltd.，Jinan 250103，China
6. Institute of Materia Medica，Shandong University of Traditional Chinese Medicine，Jinan 250355，China
- Publication Type:Journal Article
- Keywords:
Jinbei oral liquid;
multi-wavelength switching;
fingerprint;
content determination;
chemical pattern recognition;
quality standard
- From:
China Pharmacy
2026;37(13):1704-1709
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To establish a quality control method for Jinbei oral liquid based on multi-wavelength switching high performance liquid chromatography （HPLC） fingerprint， chemical pattern recognition and multi-index content determination. METHODS A total of 15 batches of Jinbei oral liquid were used as test samples. The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine （ Version 2012 ） was adopted to establish multi-wavelength switching HPLC fingerprints， followed by chromatographic peak identification and similarity evaluation. Cluster analysis， principal component analysis and orthogonal partial least squares-discriminant analysis were applied to conduct chemical pattern recognition on the 15 batches of samples. The multi-wavelength switching HPLC method was used to simultaneously determine the contents of neochlorogenic acid， chlorogenic acid， cryptochlorogenic acid， forsythoside A， baicalin， salvianoli c acid B and wogonoside in samples. RESULTS A total of 25 common peaks were calibrated in the fingerprints of 15 batches of Jinbei oral liquid， among which 7 common peaks were unambiguously identified. The similarity of all samples was higher than 0.960. Chemical pattern recognition results showed that samples S1-S8 were clustered into group 1， and samples S9-S15 were clustered into group 2. Baicalin， wogonoside， neochlorogenic acid， chlorogenic acid and salvianolic acid B were identified as the differential quality markers. The average contents of neochlorogenic acid， chlorogenic acid， cryptochlorogenic acid， forsythoside A， baicalin， salvianolic acid B and wogonoside in 15 batches of Jinbei oral liquid were 0.213 7， 0.085 3， 0.104 9， 0.287 3， 0.420 1， 0.062 1， 0.176 0 mg/mL， respectively. CONCLUSIONS The established quality control method for Jinbei oral liquid combining multi-wavelength switching HPLC fingerprint， chemical pattern recognition and multi-index content determination is stable and reliable， which can provide a reference for the formulation of quality standards of this preparation.
