Quality Control of Zhenqi Fuzheng Granule Based on Multi-component Determination
10.13422/j.cnki.syfjx.20190919
- VernacularTitle: 基于多成分测定的贞芪扶正颗粒质量控制
- Author:
Cheng-tao REN
1
;
Lian-chao TIAN
2
;
Yun LI
2
;
Chun LI
2
;
Hong YI
2
;
Dong ZHANG
2
;
Xia-xia FENG
2
;
Wen-wen ZHANG
2
;
Xiao-qian LIU
2
;
Zhi-min WANG
2
Author Information
1. School of Pharmacy, Henan University of Chinese Medicine, Zhengzhou 450046, China
2. Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China
- Publication Type:Research Article
- Keywords:
Zhenqi Fuzheng granules;
quantitative determination;
HPLC-ELSD;
one-way ANOVA
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2019;25(9):150-158
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To estimate the overall quality characteristics of Zhenqi Fuzheng granules (ZQFZ),which were composed of Ligustri Lucidi Fructus and Astragali Radix and collected from different manufacturers (their final preparations included two types,contained sugar and sugar free) by established HPLC methods,in order to propose an appropriate quality-control strategy for promoting the quality control specification of ZQFZ.Method: The quantification of the 6 components (rhodioloside,calycosin-7-O-β-D-glucoside,specnuezhenide,ononin,calycosin and astragaloside IV) were performed on a C18 column with two chromatographic systems.Chromatographic system Ⅰ:methanol and water were adopted as mobile phase with gradient elution,the flow rate was 1.0 mL·min-1,and optimum detection waves were at 224,250 and 275 nm respectively.Chromatographic system Ⅱ:methanol and water (80:20) were adopted as mobile phase with gradient elution at the flow rate of 1.0 mL·min-1,and the detector parameters were set as follows:the drift tube temperature was 75℃,and the carrier gas flow rate was 1.5 L·min-1.Both column temperatures were at 30℃.All of the 80 batches of ZQFZ from different manufacturers were determined and analyzed.Result: All of the six markers could be detected in 80 batches of ZQFZ,but their contents were quite different.The results of the one-way ANOVA showed significant differences between manufacturer 4 and other three manufacturers in sugar-containing preparations (P <0.05).And for sugar-free preparations,manufacturer 3 was significant different from other manufacturers (P<0.05).The differences were concentrated in components of rhodioloside and specnuezhenide derived from crude maternal of Ligustri Lucidi Fructus.Conclusion: It is of great significance to increase relevant quality control markers of Ligustri Lucidi Fructus in ZQFZ,such as rhodioloside and specnuezhenide,for standardizing production and improving quality level.
