Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method
- 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
1
;
Mingguo SHAO
1
,
2
;
Linchun WAN
3
;
Zhenyu HU
1
;
Chunyu CHEN
1
;
Yu WU
1
;
Junwen BU
1
;
Yuhang QIAN
1
;
Fanqiang MENG
2
Author Information
1. School of Pharmacy，Jiangxi University of Chinese Medicine，Nanchang 330004，China
2. Lunan Pharmaceutical Group Co.，Ltd.，Shandong Linyi 276006，China
3. Jiangxi Institute for Drug Control，Nanchang 330029，China
- Publication Type:Journal Article
- Keywords:
Xintong granules;
fingerprint;
quantitative
- 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.
