Quality Uniformity Analysis of 7 Commercially Available Yangyin Qingfei Preparations
10.13422/j.cnki.syfjx.20240963
- VernacularTitle:市售7种养阴清肺制剂质量均一性分析
- Author:
Jiangmin SU
1
;
Yongzhen LAO
2
;
Sha CHEN
1
;
Jun ZHANG
1
;
Cong GUO
1
;
Anyi ZHAO
1
;
Jipeng DI
1
;
An LIU
1
;
Yan LIU
1
Author Information
1. Institute of Chinese Materia Medica，China Academy of Chinese Medical Sciences，Beijing 100700，China
2. National Engineering Technology Research Center for Gelatin-based Traditional Chinese Medicine，Dong'e Ejiao Co. Ltd.，Liaocheng 252200，China
- Publication Type:Journal Article
- Keywords:
Yangyin Qingfei preparations;
daily intake;
dosage form difference;
multivariate statistical analysis;
quality uniformity;
high performance liquid chromatography（HPLC）;
fingerprint
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2024;30(18):164-170
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish the fingerprint of seven commercially available Yangyin Qingfei preparations， to quantitatively analyze the index components， to evaluate their quality uniformity with multivariate statistical analysis， and to explore the quality differences among different dosage forms. MethodA total of 33 batches of commercially available 7 kinds of Yangyin Qingfei preparations were analyzed by high performance liquid chromatography（HPLC）， the fingerprints were established and the common peaks were identified. Paeoniflorin， verbascoside， harpagoside， glycyrrhizic acid and paeonol were selected as the indicators of quality attributes to quantitatively analyze 33 batches of preparations. Based on the administration methods of Yangyin Qingfei preparations， the daily intake was calculated and the radar charts were poltted， and cluster analysis and principal component analysis were used to explore the quality differences of 7 kinds of Yangyin Qingfei preparations and the quality uniformity among different batches of the same dosage form. ResultThe similarity of fingerprints of 7 dosage forms was 0.248-0.956， suggesting that there were significant differences among different dosage forms of Yangyin Qingfei preparations， and a total of 15 common peaks were calibrated， of which peak 7， peak 8， peak 11， peak 13 and peak 15 were paeoniflorin， verbascoside， harpagoside， glycyrrhizic acid and paeonol， respectively. The radar plots showed that the average total daily intake of large honeyed pills and water honeyed pills was the highest， and the uniformity of pill components was better. The quality of 33 batches of samples was divided into poor quality and high quality by cluster analysis. Principal component analysis showed that the uniformity and dosage form of different dosage forms were significantly different， the oral liquid had the best quality homogeneity with the minimum dispersion. And the content of paeonol in different dosage forms was significantly different， which was the key component of quality control of Yangyin Qingfei preparations. ConclusionYangyin Qingfei large honeyed pills and water honeyed pills show high content and good uniformity， which are relatively preferred dosage forms. Different preparation processes have a great influence on the content of paeonol， and its quality control should be emphasized during production. This study provides a scientific method for the comparison of product quality of different dosage forms of traditional Chinese medicine prescriptions， which is helpful for the development of preferred dosage forms of different prescriptions， and provides a reference for efficient use of medication in the clinical practice.
