Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method
10.6039/j.issn.1001-0408.2025.15.08
- VernacularTitle:基于HPLC指纹图谱及一测多评法的心通颗粒质量评价
- Author:
Xide YE
1
;
Xiaolong FENG
;
Mingguo SHAO
;
Linchun WAN
;
Zhenyu HU
;
Chunyu CHEN
;
Yu WU
;
Junwen BU
;
Yuhang QIAN
;
Fanqiang MENG
Author Information
1. 江西中医药大学药学院,南昌 330004
- Publication Type:Journal Article
- Keywords:
Xintong granules;
fingerprint;
quantitative analysis of multi-components by single-marker method;
content determination
- From:
China Pharmacy
2025;36(15):1866-1870
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To establish the HPLC fingerprint of Xintong granules and the quantitative analysis of multi-components by single-marker method(QAMS)to determine the contents of 7 components,so as to provide a scientific basis for their quality control.METHODS HPLC method was used to establish the fingerprints for 10 batches of Xintong granules(No.S1-S10),and similarity evaluation,cluster analysis(CA)and partial least squares-discriminant analysis(PLS-DA)were performed.At the same time,the contents of seven components,including puerarin,daidzin,calycosin-7-O-β-D-glucoside,stilbene glycoside,naringin,icariin and tanshinone ⅡA,were determined by QAMS method,and were compared with the results of external standard method.RESULTS A total of 18 common peaks were marked and 7 peaks were identified in the HPLC fingerprints for 10 batches of Xintong granules,namely puerarin(peak 4),daidzin(peak 7),calycosin-7-O-β-D-glucoside(peak 9),stilbene glycoside(peak 10),naringin(peak 12),icariin(peak 17),and tanshinone ⅡA(peak 18);the similarities among them were more than 0.990,and CA and PLS-DA results showed that S4-S5,S8-S10,S1-S3 and S6-S7 were clustered into three categories,respectively.Using naringin as the internal standard,the contents of puerarin,daidzin,calycosin-7-O-β-D-glucoside,stilbene glycoside,icariin and tanshinone ⅡA were determined to be 7.868 1-10.181 2,1.709 2-2.374 1,0.285 2-0.326 3,1.024 1-1.523 9,0.140 2-0.290 4,and 0.077 1-0.219 4 mg/g,respectively,by the QAMS.These results showed no significant differences compared to those obtained by the external standard method.CONCLUSIONS Established HPLC fingerprint and QAMS method are convenient,stable and accurate,which can provide a basis for the quality evaluation of Xintong granules.