摘要
研究四季草颗粒的高效液相色谱(HPLC)指纹图谱,并对其4种成分进行含量测定,为四季草颗粒的质量控制与质量标准提升奠定基础。以10批四季草颗粒为研究样本,参照《四季草颗粒标准:WS-10413(ZD-0413)-2002-2012Z》及2020版《中国药典》,采用HPLC法,色谱柱为Agela Promosil C_(18)(250 mm×4.6 mm,5μm),流动相为0.2%磷酸水~色谱乙腈(梯度洗脱),检测波长为270 nm,建立四季草颗粒的指纹图谱并开展相似度评价,并以没食子酸、鞣花酸、槲皮苷、槲皮素为指标性成分建立含量分析方法。建立了四季草颗粒的HPLC指纹图谱,四季草颗粒指纹图谱中有10个共有峰,其中,峰3、峰6、峰9、峰10分别为没食子酸、鞣花酸、槲皮苷、槲皮素,10批不同批号的四叶草颗粒中成药的相似度为0.996~1.000。没食子酸、鞣花酸、槲皮苷、槲皮素分别在10.1~202.5μg.mL^(-1)、1.6~32.7μg.mL^(-1)、5.1~102.3μg.mL^(-1),0.9~17.2μg.mL^(-1)质量范围内呈良好的线性关系,R值分别为0.999 9、0.999 8、0.999 2、0.999 8,其精密度、重复性、稳定性及加样回收率均良好。建立的四季草颗粒化学指纹图谱方法与四种指标性化学成分含量测定方法稳定、可靠,可用于四季草颗粒的质量控制。
The HPLC fingerprint of Sijicao Granules was studied,and the contents of four components were determined,which laid a foundation for the quality control and quality standard improvement of Sijicao Granules.Ten batches of Sijicao granules were used as research samples.According to the standard of"Sijicao granules:WS-10413(ZD-0413)-2002-2012Z"and the 2020 edition of"Chinese Pharmacopoeia",the HPLC method was used.The chromatographic column was Agela Promosil C_(18)(250 mm×4.6 mm,5μm),the mobile phase was 0.2% phosphoric acid water~chromatographic acetonitrile(gradient elution),and the detection wavelength was 270 nm.The fingerprint of Sijicao granules was established and the similarity evaluation was carried out.At the same time,the content analysis method was established with gallic acid,ellagic acid,quercitrin and quercetin as index components.The HPLC fingerprint of Sijicao granules was established.There were 10 common peaks in the fingerprint of Sijicao granules.Among them,peak 3,peak 6,peak 9 and peak 10 were identified as gallic acid,ellagic acid,quercitrin and quercetin,respectively.The similarity of 10 batches of Sijicao Granules with different batch numbers was 0.996~1.000.Gallic acid,ellagic acid,quercitrin and quercetin showed good linear relationship in the mass range of 10.1~202.5μg.mL^(-1)、1.6~32.7μg.mL^(-1)、5.1~102.3μg.mL^(-1) and 0.9~17.2μg.mL^(-1),respectively.The R values were 0.9999,0.9998,0.9992,0.998 and the precision,repeatability,stability and recovery were good.The chemical fingerprint method of Sijicao granules and the content determination method of four index chemical components were stable and reliable,which could be used for the quality control of Sijicao granules.
作者
韩忠耀
张德庆
滕乐
唐军相
刘方方
王杉杉
袁开伦
李燕
张林甦
HAN Zhong-yao;ZHANG De-qing;TENG le;TANG Jun-xiang;LIU Fang-fang;WANG Shan-shan;YUAN Kai-lun;LI Yan;ZHANG Lin-su(Qiannan Medical College for Nationalities,Duyun 558000,China;Kaili University,Kaili 556011,China;Guizhou Runsheng Pharmaceutical Co.,Ltd.,Longli 551200,China)
出处
《化学研究与应用》
北大核心
2025年第10期2991-3000,共10页
Chemical Research and Application
基金
贵州省自然科学技术基金项目(黔科合基础[2020]1Y390号)资助
贵州省中医药管理局中医药、民族医药科学技术研究课题(QZYY-2025-085)资助
黔南州科技计划项目(黔南科合社字[2024]5号)资助
黔南民族医学高等专科学校科研基金项目(Qnyz2024002,Qnyz2023004)资助。
