基于高效液相色谱指纹图谱及一测多评法的复方珍珠解毒口服液质量评价  

Quality evaluation of compound Zhenzhu Jiedu oral liquid by HPLC fingerprints and quantitative analysis of multi-components with single marker

作　　者：谢百波 苏加乐 里艳茹 臧新钰 李映 寻园 周骅 程林友 XIE Bai-bo;SU Jia-le;LI Yan-ru;ZANG Xin-yu;LI Ying;XUN Yuan;ZHOU Hua;CHENG Lin-you(Beijing Hebabiz Biotechnology Co.,Ltd.,Beijing 102206;Guangxi Hebabiz Pharmaceutical Co.,Ltd.,Qinzhou Guangxi 535008;National and Region Joint Engineering Center for Anticancer Drug Development,Qinzhou Guangxi 535008)

机构地区：[1]北京慧宝源生物技术股份有限公司,北京102206 [2]广西慧宝源医药科技有限公司,广西钦州535008 [3]抗肿瘤药物开发国家地方联合工程研究中心,广西钦州535008

出　　处：《中南药学》2022年第7期1639-1643,共5页Central South Pharmacy

基　　金：国家海洋局“十三五”北海市海洋经济创新发展示范项目(No.Bhsfs001-2)。

摘　　要：目的建立复方珍珠解毒口服液的高效液相色谱指纹图谱,并采用一测多评法(QAMS)测定样品中绿原酸、甘草苷、落新妇苷的含量,为完善该药品的质量标准提供依据。方法采用Agilent 5TC-C_(18)(2)(250 mm×4.6 mm,5μm)色谱柱,以乙腈-0.5%磷酸水溶液为流动相进行梯度洗脱,检测波长220 nm,体积流量0.8 mL·min^(-1),进样量10μL,柱温30℃。测定10批次样品,得到指纹图谱并进行相似度评价。采用QAMS,以绿原酸为参照物,计算甘草苷、落新妇苷的相对校正因子及含量,与外标法测定结果进行比较,验证QAMS的准确性。结果10批次样品的指纹图谱的相似度在0.990~0.999,共标定10个共有峰,并指认了3个成分。建立的QAMS重现性好,计算值和实测值之间无明显差异。结论本研究建立的检测方法准确可靠、简便快捷、重复性和稳定性良好,可应用于复方珍珠解毒口服液整体质量评价。Objective To establish an HPLC fingerprint for compound Zhenzhu Jiedu oral liquid(CPDOL)and determine the contents of chlorogenic acid,liquiritin and astilbin in the samples with quantitative analysis of multi-components with single marker(QAMS)to provide a scientific basis for quality standard improvment.Methods Agilent 5TC-C_(18)(2)(250 mm×4.6 mm,5μm)column was used.Acetonitrile-0.5%phosphoric acid aqueous solution was used as the mobile phase with gradient elution.The detection wavelength was 220 nm,the flow rate was 0.8 mL·min^(-1),the injection volume was 10μL,and the column temperature was 30℃.The HPLC fingerprints of 10 batches of samples were obtained and the similarity was evaluated.The relative correction factors of liquiritin and astilbin were determined with chlorogenic acid as the internal standard.The content of each component was calculated in CPDOL.At the same time,the accuracy of QAMS method was investigated by comparing the results with those of traditional external standard method.Results The similarity between the fingerprints of 10 batches of samples and the reference fingerprints ranged from 0.990 to 0.999.Ten mutual peaks were marked.Based on the identification of the common peaks,3 components[chlorogenic acid(peak 1),liquiritin(peak 4),and astilbin(peak 5)]were identified and quantified by QAMS.Conclusion The method is simple,rapid,accurate,reliable,reproducible and stable,which can be used to improve the quality standard of CPDOL.

关 键 词：复方珍珠解毒口服液 HPLC指纹图谱 一测多评法 绿原酸 甘草苷 落新妇苷 

分 类 号：R927.2[医药卫生—药学]