基于全时段多波长融合特征定量指纹图谱的满药仙灵脾颗粒质量控制方法研究  

Quality control of Manchu medicine Xianlingpi granules by characteristic quantitative fingerprint based on full-time multi-wavelength fusion

作　　者：于洋 王帅[1,2,3] 李天娇 赵琳[1] 包永睿 张秀君[4] 孟宪生[1,2,3] YU Yang;WANG Shuai;LI Tian-jiao;ZHAO Lin;BAO Yong-rui;ZHANG Xiujun;MENG Xian-sheng(College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian Liaoning 116600;Liaoning Technical Innovation Center for Multi-Dimensional Analysis of Traditional Chinese Medicine,Dalian Liaoning 116600;Liaoning Modern Traditional Chinese Medicine Research Engineering Laboratory,Dalian Liaoning 116600;Dandong Pharmaceutical Group Co.,Ltd,Dandong Liaoning 118303)

机构地区：[1]辽宁中医药大学药学院,辽宁大连116600 [2]辽宁省中药多维分析专业技术创新中心,辽宁大连116600 [3]辽宁省现代中药研究工程实验室,辽宁大连116600 [4]丹东药业集团有限公司,辽宁丹东118303

出　　处：《中南药学》2023年第3期771-776,共6页Central South Pharmacy

基　　金：大连市民族药天然活性成分研究与开发重点实验室开放课题(No.20200707001,No.20200707002)。

摘　　要：目的建立全时段多波长融合特征定量指纹图谱,为仙灵脾颗粒质量控制提供科学依据。方法选取270 nm、327 nm、353 nm 3个波长,建立10批仙灵脾颗粒的高效液相(HPLC)指纹图谱,确定18个共有峰,通过对照品指认出8个成分;指纹图谱与多指标成分含量测定结合,建立全时段多波长融合特征定量指纹图谱,并将8个成分进行相对于内标物柚皮苷的含量测定;同时选取5个批次的仙灵脾颗粒,对其8个成分进行绝对定量,确定建立的含量测定方法的误差率。结果建立了全时段多波长融合特征定量指纹图谱,运用其对仙灵脾颗粒指认出的成分进行相对定量,其结果与绝对定量相比,误差率小于5%。结论所建立的方法准确可靠,可用于仙灵脾颗粒的质量控制,并为中药复方的质量评价提供参考。Objective To establish the characteristic quantitative fingerprints based on full-time multi-wavelength fusion,and provide scientific basis for the quality control of Xianlingpi granules.Methods Three wavelengths(270 nm,327 nm and 353 nm)were selected to establish HPLC fingerprints for 10 batches of Xianlingpi granules,18 common peaks were identified,and 8 components were identified by the reference substances.The fingerprints were combined with the content determination of multi-index component to establish the full-time multi-wavelength fusion characteristic quantitative fingerprints,and 8 components were determined with reference to the internal standard naringenin.At the same time,5 batches of Xianlingpi granules were selected and 8 components were absolutely quantified to determine the error rate of the established determination method.Results The full-time multi-wavelength fusion characteristic quantitative fingerprints were established to relatively quantify the identified components in Xianlingpi granules.The results showed an error rate of less than 5%compared with absolute quantification.Conclusion The method is accurate and reliable,which can be used for the quality control of Xianlingpi granules and provide reference for the quality evaluation of Chinese medicine compounds.

关 键 词：满药 仙灵脾颗粒 指纹图谱 多指标成分含量测定 全时段多波长融合特征定量指纹图谱 质量控制方法 

分 类 号：R917[医药卫生—药物分析学]