Study on the Quality Standard of Lixieling Tablets Based on Multicomponent Analysis
10.13748/j.cnki.issn1007-7693.20224001
- VernacularTitle:基于多组分分析的痢泻灵片质量标准研究
- Author:
YU Mimi
1
;
ZHANG Wenting
1
;
ZHANG Ran
1
;
LIU Xuan
1
;
CHEN Yougen
1
;
LI Zheng
1
;
FU Xintong
1
;
GUO Hongzhu
1
Author Information
1. Beijing Institute for Drug Control, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Patent Medicine), Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing 102206, China
- Publication Type:Journal Article
- Keywords:
Lixieling tablets;
quality standard;
analysis of multi-components by single marker;
quality control
- From:
Chinese Journal of Modern Applied Pharmacy
2023;40(19):2687-2693
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To establish the quality standard of Lixieling tablets. METHODS Thin layer chromatography was used to identify Bistortae Rhizoma, Andrographis Herba and Sophorae Flavescentis Radix in Lixieling tablets. The components of andrographolium and matrine were determined by HPLC. RESULTS The thin layer spots of Bistortae Rhizoma, Andrographis Herba and Sophorae Flavescentis Radix were clear, with good separation effect and repeatability. The linear relationship between andrographolide, neoandrographolide, 14-deoxygenated andrographolide, dehydrated andrographolide, sophorine, oxymatrine, sophorine and oxysophorine and their respective concentration ranges was good. The RSDs of instrument precision, repeatability, stability and recovery all met the requirements. CONCLUSION The method is simple and reproducible, and can be used for the quality control of Lixieling tablets.