基于标准汤剂的秦皮(白蜡树)配方颗粒质量标准分析  

Analysis on Quality Standard of Fraxini Cortex(Fraxinus chinensis)Dispensing Granules Based on Standard Decoction

作　　者：曹桂云 宁波 秦金淼 庄雪松 王岱杰 林永强 董晓弟 罗毅 孟兆青 CAO Guiyun;NING Bo;QIN Jinmiao;ZHUANG Xuesong;WANG Daijie;LIN Yongqiang;DONG Xiaodi;LUO Yi;MENG Zhaoqing(Shandong Province Technical Innovation Center of Traditional Chinese Medicine Treatment of Respiratory Diseases,Shandong Hongjitang Pharmaceutical Group Co.Ltd.,Jinan 250103,China;Shandong Analysis and Test Center,Qilu University of Technology(Shandong Academy of Sciences),Jinan 250014,China;Shandong 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]齐鲁工业大学(山东省科学院)山东省分析测试中心,济南250014 [3]山东省食品药品检验研究院,济南250101

出　　处：《中国实验方剂学杂志》2023年第13期122-129,共8页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：山东省重点研发计划重大科技创新工程项目(2021CXGC010511);科技部中央引导地方科技发展项目(YDZX20203700003457);泰山产业领军人才项目(tscy20200410);泉城产业领军人才计划项目(2020年);泉城“5150”引才倍增计划项目(2021年)。

摘　　要：目的:建立基于标准汤剂的秦皮(白蜡树)配方颗粒质量标准,为该配方颗粒的质量控制提供依据。方法:利用15批秦皮(白蜡树)标准汤剂和3批秦皮(白蜡树)配方颗粒建立了高效液相色谱法(HPLC)特征图谱,流动相0.1%磷酸水溶液(A)-乙腈(B)梯度洗脱(0~10 min,12%~15%B;10~30 min,15%~32%B),检测波长220 nm,并进行相似度评价、聚类分析及主成分分析(PCA)。针对特征图谱中的共有峰建立HPLC一测多评法(QAMS),测定秦皮(白蜡树)标准汤剂与配方颗粒中主要成分的含量。测定秦皮(白蜡树)饮片中相应成分的含量,计算从饮片到标准汤剂及配方颗粒的转移率。结果:3批秦皮(白蜡树)配方颗粒特征图谱与标准汤剂对照特征图谱的相似度均>0.9,共确定了7个共有峰。聚类分析及PCA结果表明,不同批次标准汤剂成分存在一定差异性,未表现出产地聚集性。15批秦皮(白蜡树)标准汤剂出膏率6.18%~11.62%,秦皮甲素、紫丁香苷、秦皮苷、秦皮乙素、秦皮素、木通苯乙醇苷B质量分数分别为44.92~103.51、1.36~11.87、33.26~90.73、4.63~29.75、2.40~16.86、2.49~17.35 mg·g-1,其从饮片到标准汤剂的转移率分别为25.21%~42.54%、52.57%~88.84%、43.43%~79.45%、49.15%~88.27%、49.22%~72.69%、27.66%~47.67%。秦皮(白蜡树)配方颗粒出膏率10.4%~10.7%,上述6个成分从饮片到配方颗粒的转移率分别为42.76%~43.17%、80.01%~80.90%、59.59%~59.88%、51.35%~52.67%、60.50%~60.93%、37.98%~38.37%,与饮片到标准汤剂的转移率基本一致。结论:建立基于标准汤剂的秦皮(白蜡树)配方颗粒的质量控制标准,以出膏率、特征图谱的一致性、秦皮甲素等6种指标成分的含量及转移率为指标,衡量秦皮(白蜡树)配方颗粒与标准汤剂的一致性,结果合理可靠,可为该配方颗粒的质量控制及工艺研究提供参考。Objective:To establish the quality standard for Fraxini Cortex(Fraxinus chinensis)dispensing granules based on standard decoction,and to provide a basis for the quality control of this dispensing granules.Method:High performance liquid chromatography(HPLC)specific chromatograms of 15 batches of Fraxini Cortex(F.chinensis)standard decoctions and 3 batches of Fraxini Cortex(F.chinensis)dispensing granules were established with the mobile phase of 0.1%phosphoric acid aqueous solution(A)-acetonitrile(B)for gradient elution(0-10 min,12%-15%B;10-30 min,15%-32%B)and the detection wavelength of 220 nm.And similarity evaluation,cluster analysis and principal component analysis(PCA)were also carried out.HPLC quantitative analysis of multi-components by single marker(QAMS)was established to determine the contents of the main components in the standard decoctions and dispensing granules.The contents of the corresponding components in Fraxini Cortex(F.chinensis)decoction pieces were also detected,and the transfer rates from decoction pieces to standard decoctions and dispensing granules were calculated.Result:The similarities between specific chromatograms of 15 batches of Fraxini Cortex(F.chinensis)standard decoctions and 3 batches of Fraxini Cortex(F.chinensis)dispensing granules were all>0.9,and 7 common peaks were identified.The results of cluster analysis and PCA showed that there was some differences in the composition of different batches of standard decoctions,but did not show aggregation of origin.As the standard decoctions,the extract rate was 6.18%-11.62%,the contents of esculin,syringin,fraxin,esculetin,fraxetin,calceolarioside B were 44.92-103.51,1.36-11.87,33.26-90.73,4.63-29.75,2.40-16.86,2.49-17.35 mg·g-1,and the transfer rates from decoction pieces to standard decoction were 25.21%-42.54%,52.57%-88.84%,43.43%-79.45%,49.15%-88.27%,49.22%-72.69%,27.66%-47.67%,respectively.The extract rates of Fraxini Cortex(F.chinensis)dispensing granules were 10.4%-10.7%,the transfer rates of the above six components from dec

关 键 词：秦皮 标准汤剂 配方颗粒 一测多评法(QAMS) 特征图谱 质量控制 高效液相色谱法(HPLC) 

分 类 号：R22[医药卫生—中医基础理论] R28[医药卫生—中医学] R931[理学—分析化学] O657[理学—化学]