中国药房2025，Vol.36Issue(15)：1866-1870,5.DOI:10.6039/j.issn.1001-0408.2025.15.08
基于HPLC指纹图谱及一测多评法的心通颗粒质量评价
Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method
摘要
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.关键词
心通颗粒/指纹图谱/一测多评法/含量测定Key words
Xintong granules/fingerprint/quantitative analysis of multi-components by single-marker method/content determination分类
医药卫生引用本文复制引用
叶喜德,孟凡强,冯小龙,邵明国,万林春,胡振宇,陈春羽,吴宇,卜俊文,钱宇航..基于HPLC指纹图谱及一测多评法的心通颗粒质量评价[J].中国药房,2025,36(15):1866-1870,5.基金项目
国家科技重大专项课题(No.2023ZD0505605) （No.2023ZD0505605）
江西省重点研发计划项目(No.20232BBG70013) （No.20232BBG70013）
国家药品监督管理局中成药质量评价重点实验室开放课题(No.XW20231208) （No.XW20231208）
