摘要
本研究旨在建立强心康颗粒HPLC指纹图谱检测方法,分析评价不同批制剂质量。采用高效液相色谱法,Shim-packVP-ODS(4.6 mm 250 mm, 5 m)色谱柱,乙腈-0.1%磷酸水系统流动相,梯度洗脱,流速1.0 mL/min,柱温25℃,检测波长203 nm。通过中药色谱指纹图谱相似度评价系统,对10批强心康颗粒指纹图谱进行相似度评价。同时,使用SPSS 26.0和SIMCA 14.1进行化学模式识别分析,旨在筛选出影响不同批次制剂质量的标志性成分。建立了强心康颗粒HPLC指纹图谱,标定出26个共有峰,并鉴定出9个成分,结合主成分分析(PCA)和正交偏最小二乘法-判别分析(OPLS-DA),筛选出影响10批样品质量的主要标志性成分6个,分别为人参皂苷Ro、京尼平苷酸、丹酚酸B、人参皂苷Re、人参皂苷Rf、人参皂苷Rg_(3)。本研究建立强心康颗粒HPLC指纹图谱测定方法的重复性、稳定性、精密度良好。建立的化学模式识别方法能高效的分析出影响制剂各批间质量的标志成分,为强心康颗粒质量评价提供依据。
The HPLC fingerprint method of Qiangxinkang granules was established to analyze and evaluate the quality of different batches of preparations.High performance liquid chromatography was performed on Shim-pack VP-ODS(4.6 mm 250 mm,5 m)column with mobile phase of acetonitrile-0.1%phosphoric acid water system and gradient elution at the flow rate of 1.0 mL/min.The column temperature was 25℃ and the detection wavelength was 203 nm.The similarity of fingerprint of 10 batches of Qiangxinkang granules was evaluated by"similarity evaluation system of TCM chromatographic Fingerprint".At the same time,SPSS 26.0 and SIMCA14.1 were used for chemical pattern recognition analysis to screen out the signature components that affect the quality of different batches of preparations.HPLC fingerprint of Qiangxinkang granules was established,26 common peaks were identified,and 9 components were identified.Combined with PCA and OPLS-DA,6 main landmark components affecting the quality of 10 batches of samples were screened,including ginsenoside Ro,geniposide,salvianolic acid B,ginsenoside Re,ginsenoside Rf,and ginsenoside Rg_(3).This study established HPLC fingerprint determination method for Qiangxinkang granules has good repeatability,stability,and precision.The established chemical pattern recognition method can efficiently analyze the marker components that affect the quality of each batch of the preparation,providing a basis for the quality evaluation of Qiangxinkang granules.
作者
陈冬梅
张洪铭
王茜颖
刘淑荣
张晓华
徐雅娟
解生旭
朴光春
CHEN Dongmei;ZHANG Hongming;WANG Qianying;LIU Shurong;ZHANG Xiaohua;XU Yajuan;XIE Shengxu;PIAO Guangchun(School of Pharmacy,Yanbian University,Yanji 133002,China;Key Laboratory of MateriaMedica Pharmacodynamics of Traditional Chinese Medicine,Changchun 130012,China)
出处
《特产研究》
2026年第1期153-160,共8页
Special Wild Economic Animal and Plant Research
基金
中央财政转移支付地方项目。
