基于“质-量”双标的枳壳质量分析方法研究  

Research on quality analysis method of Aurantii Fructus based on“quality-quantity”double standard

作　　者：罗曦 包永睿[1,2,3] 李天娇 王帅[1,2,3] 韩凌 韩晓妮[4] 孟宪生 LUO Xi;BAO Yong-rui;LI Tian-jiao;WANG Shuai;HAN Ling;HAN Xiao-ni;MENG Xian-sheng(College of Pharmacy,Liaoning University of Traditional Chinese Medicine,Dalian 116600,China;Liaoning Multi-dimensional Analysis of Traditional Chinese Medicine Technical Innovation Center,Dalian 116600,China;Liaoning Modern Traditional Chinese Medicine Research and Engineering Laboratory,Dalian 116600,China;China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.,Shenzhen 518110,China)

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]华润三九医药股份有限公司,广东深圳518110

出　　处：《中草药》2023年第22期7293-7299,共7页Chinese Traditional and Herbal Drugs

基　　金：辽宁省科技创新领军人才(XLYC1902116):气滞胃痛颗粒产品力提升研究。

摘　　要：目的建立以对照药材为基准物质的定性和不依赖多种对照品定量的枳壳Aurantii Fructus药材“质-量”双标控制方法。方法采用HPLC技术,以对照药材为基准物质建立枳壳特征图谱,通过Q-TOF-MS技术,鉴定共有峰的化学成分,以对照药材和供试药材特征峰的相似度,明确药材真伪,即“质”;对内标成分“柚皮苷”进行准确定量,以内标成分计,计算不同批次供试品中各特征峰的相对含量,取“平均数-标准差”作为特征峰化学成分相对于内标物质化学成分的相对含量下限,依据特征峰相对含量下限明确枳壳药材优劣,即“量”。结果建立的特征图谱及含量测定方法符合方法学考察要求;确定了11个共有色谱峰,鉴定出了7个化学成分,分别为圣草次苷、芸香柚皮苷、柚皮苷、橙皮苷、新橙皮苷、川陈皮素、橘皮素,各枳壳供试药材与枳壳对照药材的相似度均大于0.90;规定了枳壳药材特征峰化学成分相对含量下限。结论该方法不依赖多种对照品,能清晰、快速地判断药材的真伪优劣,为枳壳的质量控制方法提供参考。Objective To establish a“quality-quantity”double standard control method for Zhiqiao(Aurantii Fructus),which is qualitative based on the reference traditional Chinese medicinal materials(TCMM)as standard substances and quantitative without relying on multiple reference substances.Methods HPLC technology was used to establish the characteristic atlas of Aurantii Fructus based on the reference TCMM as standard substances.The chemical constituents of common peaks were identified by Q-TOF-MS technology,and the authenticity of Aurantii Fructus was determined by the similarity of characteristic peaks of the reference TCMM and the tested TCMM.The above statement is“quality”.The relative content of each characteristic peak in different batches of the tested TCMM was calculated by accurate quantition of internal standard component naringin.The“average value-standard deviation”was taken as the lower limit of the relative content of characteristic peak chemical components relative to chemical composition of internal standard substance,and the quality of Aurantii Fructus was determined according to the lower limit of the relative content of characteristic peak.The above statement is“quantity”.Results The characteristic atlas and content determination method met the requirements of methodology investigation.A total of 11 common chromatographic peaks were determined,and seven chemical components were identified,which were eriocitrin,narirutin,naringin,hesperidin,neohesperidin,nobiletin,tangeretin.The similarity between the tested TCMM and reference TCMM was greater than 0.90.The lower limit of relative content of chemical components of Aurantii Fructus characteristic peak was defined.Conclusion The method can judge the authenticity of medicinal materials clearly and quickly without many reference substances,and provide reference for quality control of Aurantii Fructus.

关 键 词：枳壳 对照药材 质量控制 特征图谱 圣草次苷 芸香柚皮苷 柚皮苷 橙皮苷 新橙皮苷 川陈皮素 橘皮素 

分 类 号：R286.2[医药卫生—中药学]