Quality consistency evaluation of Tongmai preparations
10.3969/j.issn.1001-1528.2025.03.001
- VernacularTitle:通脉制剂质量一致性评价
- Author:
Jia-hui XU
1
;
Yu-hong LIU
;
Zhi-fang HUANG
;
Yun-hua LIU
;
Yan CHEN
;
Ting-ting XU
;
Jin-hai YI
Author Information
1. 成都中医药大学药学院,四川成都 611130;四川省中医药科学院,中药新药创制川渝共建重点实验室,中药材品质及创新中药研究四川省重点实验室,四川成都 610041
- Publication Type:Journal Article
- Keywords:
Tongmai Granules;
Tongmai Tablets;
Tongmai Capsules;
Tongmai Oral Liquid;
HPLC fingerprints;
content determination;
cluster analysis;
principal component analysis
- From:
Chinese Traditional Patent Medicine
2025;47(3):709-716
- CountryChina
- Language:Chinese
-
Abstract:
AIM To evaluate the quality consistency of Tongmai Granules,Tongmai Tablets,Tongmai Capsules and Tongmai Oral Liquid.METHODS The HPLC fingerprints were established,after which the contents of danshensu,protocatechuic aldehyde,3'-hydroxy puerarin,puerarin,puerarin apioside,daidzin,ferulic acid,salvianolic acid B and salvianolic acid A were determined,and cluster analysis and principal component analysis were adopted in the quality analysis from the perspective of daily intake.RESULTS There were 21 common peaks in the fingerprints for 39 batches of samples with the similarities of 0.765-0.997.Various batches of samples were clustered into 5 categories,2 principal components demonstrated the accumulative variance contribution rate of 83.53％ .The daily intakes of various constituents in different dosage forms exhibited obvious differences,especially for that of salvianolic acid B,which were low in tablets and capsules,and their heterogeneities existed among the same dosage forms.CONCLUSION This simple and accurate method can provide a reference for the quality evaluation of Tongmai preparations from different manufacturers.
