Study on quality control of Dalitong Granule Extract based on one test multiple evaluation method combined with chemical recognition pattern
10.3760/cma.j.cn115398-20240702-00016
- VernacularTitle:基于一测多评法结合化学识别模式的达立通浸膏质量控制研究
- Author:
Xianzhao XIONG
1
;
Yaolu ZHU
;
Xinli WANG
;
Yuyun LI
Author Information
1. 江西省医疗器械检测中心（江西省药物研究所）研发中心，南昌 330046
- Keywords:
Quality control;
Assay (TCD);
Dalitong granule extract;
Intermediate;
fingerprint;
QAMS method;
Chemical recognition pattern;
Relative correction factor
- From:
International Journal of Traditional Chinese Medicine
2025;47(4):515-521
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the fingerprint of the intermediate of Dalitong Granules; To control its quality with QAMS method.Methods:Gradient elution was performed by HPLC on Wondasil C18 superb column (4.6 mm × 250 mm, 5 μm). The mobile phase was 0.02% acetonitrile - acetic acid aqueous solution, gradient elution. The detection wavelength was 325 nm and the injection volume was 10 μl. The column temperature was 30 ℃, and the flow rate was 1.0 ml/min. Chemical recognition patterns were combined for analysis, and QAMS method was used for content determination.Results:Through methodological investigation, the fingerprint of Dalitong Granule Extract had good repeatability. The 10 batches of Dalitong Granule Extract could be divided into 3 categories through clustering analysis and principal component analysis. The relative correction factors of four components in Dalitong Granule Extract were established. Compared with external standard method, the established QAMS method has higher reliability.Conclusion:The established fingerprint and QAMS method can be used for the quality control of Dalitong Granule Extract.
