特征图谱、一测多评与模式识别相结合的茵陈【茵陈蒿(绵茵陈)】配方颗粒质量评价分析  

Quality evaluation of Artemisiae Scopariae Herba[Artemisia capillaris Thunb.(Mianyinchen)]dispensing granules by combination of characteristic chromatogram,quantitative analysis of multi-components by single marker and chemical pattern recognition analysis

作　　者：曹桂云 庄雪松 宁波 刘羽康 王全军 刘兴村 林永强 崔伟亮 张风超 刘子夜 孟兆青 CAO Gui-yun;ZHUANG Xue-song;NING Bo;LIU Yu-kang;WANG Quan-jun;LIU Xing-cun;LIN Yong-qiang;CUI Wei-liang;ZHANG Feng-chao;LIU Zi-ye;MENG Zhao-qing(Shandong Hongjitang Pharmaceutical Group Co.,Ltd.,Shandong Province Technical Innovation Center of Traditional Chinese Medicine Treatment of Respiratory Diseases,Jinan 250103,China;Shandong Provincial Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东宏济堂制药集团股份有限公司、山东省中医药治疗呼吸系统疾病技术创新中心,济南250103 [2]山东省食品药品检验研究院,济南250101

出　　处：《药物分析杂志》2024年第4期689-704,共16页Chinese Journal of Pharmaceutical Analysis

基　　金：山东省重点研发计划重大科技创新工程项目(2021CXGC010511);泉城“5150”引才倍增计划项目(2021年)。

摘　　要：目的:建立特征图谱、一测多评和化学模式识别分析相结合的茵陈【茵陈蒿(绵茵陈)】配方颗粒质量评价方法。方法:利用制备的15批茵陈【茵陈蒿(绵茵陈)】标准汤剂和3批配方颗粒建立了HPLC特征图谱,并对其中6个主要成分建立一测多评法进行含量测定。采用AcclaimTMRSLC 120 C18(100 mm×2.1 mm,2.2μm)色谱柱,以乙腈-0.05%磷酸水溶液为流动相,梯度洗脱,流速0.4 mL·min^(-1),检测波长327 nm。进行相似度评价、聚类分析(HCA)及主成分分析(PCA)。计算指标成分从饮片到标准汤剂及配方颗粒的转移率。结果:15批茵陈【茵陈蒿(绵茵陈)】标准汤剂和3批配方颗粒特征图谱相似度>0.85,共确定了8个共有峰。HCA、PCA的分析结果显示茵陈【茵陈蒿(绵茵陈)】配方颗粒与标准汤剂成分一致性较好。15批茵陈【茵陈蒿(绵茵陈)】标准汤剂中新绿原酸、绿原酸、隐绿原酸、异绿原酸B、异绿原酸A、异绿原酸C含量分别为1.87~5.23、7.44~15.26、2.85~8.18、3.05~6.14、0.99~3.93、3.23~10.38 mg·g^(-1),饮片到标准汤剂的转移率分别为23.85%~37.28%、19.57%~31.93%、28.15%~45.88%、22.34%~36.59%、16.64%~28.36%、21.81%~39.19%。茵陈【茵陈蒿(绵茵陈)】配方颗粒指标成分含量、转移率与标准汤剂接近。结论:所建立所建指纹图谱及一测多评分析方法可用于茵陈【茵陈蒿(绵茵陈)】配方颗粒的质量评价及工艺研究。Objective:To establish a method for quality evaluation of Artemisiae Scopariae Herba[Artemisia capillaris Thunb.(Mianyinchen)]dispensing granules by combining characteristic chromatogram,quantitative a⁃nalysis of multi-components by single marker(QAMS)and chemical pattern recognition analysis.Methods:The high performance liquid chromatography(HPLC)characteristic chromatogram was established by 15 batches of Artemisiae Scopariae Herba[Artemisia capillaris Thunb.(Mianyinchen)]standard decoctions and 3 batches of dispensing granules.The contents of 6 components were determined by QAMS.The chromatographic separation was achieved on a Acclaim TM RSLC 120 C18 column(100 mm×2.1 mm,2.2μm),with the mobile phase compri⁃sing of acetonitrile-0.05%phosphoric acid flowing at 0.4 mL·min^(-1)in a gradient elution manner.And the de⁃tection wavelength was set at 327 nm.The similarity evaluation system of fingerprint of traditional Chinese medi⁃cine was used to determine the common peak for similarity evaluation.Hierarchical cluster analysis(HCA)and principal component analysis(PCA)were applied for chemical pattern recognition.The transfer rates of the 6 components from decoction pieces to standard decoctions and dispensing granules were calculated.Results:The similarities of characteristic chromatograms of 15 batches of Artemisiae Scopariae Herba[Artemisia capillaris Thunb.(Mianyinchen)]standard decoctions and 3 batches of dispensing granules were all above 0.85.And 8 common characteristic peaks were identified.The results of HCA and PCA indicated the similarity of ingredients in formula granules to those in standard decoctions.The contents of neochlorogenic acid,chlorogenic acid,crypto⁃chlorogenic,isochlorogenic acid B,isochlorogenic acid A,isochlorogenic acid C in standard decoctions were 1.87-5.23,7.44-15.26,2.85-8.18,3.05-6.14,0.99-3.93 and 3.23-10.38 mg·g^(-1)and the trans⁃fer rates of these components from decoction pieces to standard decoction were 23.85%-37.28%,19.57%-31.93%,28.15%-45.88%,22.34%-36.59%,16.6

关 键 词：茵陈【茵陈蒿(绵茵陈)】 标准汤剂 配方颗粒 特征图谱 一测多评(QAMS) 聚类分析(HCA) 主成分分析(PCA) 

分 类 号：R917[医药卫生—药物分析学]