基于化学计量学的三七伤药片质量控制方法研究  

The Research of Quality Control for Sanqishangyao Tablets Based on Chemometrics

作　　者：赵振霞 雷蓉 耿莲 朱靖 刘永利 ZHAO Zhenxia;LEI Rong;GENG Lian;ZHUJing;LIU Yongli(Hebei Institute for Drug and Medical Device Control,HEBEI Key Laboratory of Traditional Chinese Medicine Quality Evaluation And Standard Research,Shijiazhuang 050227,China;Hebei Medical University,Shijiazhuang 050017,China)

机构地区：[1]河北省药品医疗器械检验研究院,河北省中药质量评价与标准研究重点实验室,河北石家庄050227 [2]河北医科大学,河北石家庄050017

出　　处：《中国民族民间医药》2023年第19期30-37,共8页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：国家药典委员会2018年度药品标准提高工作(中药)(2018Z019);河北省“三三三人才工程”人才培养资助项目(A202005016)。

摘　　要：目的:建立三七伤药片的TLC鉴别方法和HPLC含量测定方法,并结合化学计量学构建其质量控制体系。方法:采用TLC法对冰片、骨碎补和赤芍进行鉴别,采用HPLC法对三七中5种皂苷类成分进行含量测定。结合化学计量学方法进行分析,以挖掘不同生产企业样品间对质量控制具有显著贡献的主要成分。结果:薄层色谱鉴别斑点清晰,分离度好,阴性无干扰;方法线性关系良好,r=0.9999,平均加样回收率(n=9)分别为100.0%、99.9%、100.6%、99.0%和99.6%。通过化学计量学分析,寻找到2个对模型贡献较大的成分,包括三七皂苷R_(1)(VIP=1.2131)和人参皂苷Rd(VIP=1.1260),可进一步深化三七伤药片质量控制研究。结论:所建立的方法专属性强、准确度高、重复性好,化学计量学分析为三七伤药片质量控制的进一步研究提供了重要参考。Objective To establish TLC identification method and HPLC determination method for Sanqishangyao Tablets and build its quality control system combined with chemometrics.Methods Borneolumsyntheticum,Drynariae Rhizoma and Paeoniae Radix Rubra were identified by TLC.The contents of five saponins in Notoginseng Radix et Rhizoma were determined by HPLC.Combined with the chemometrics methods,the main components of samples from different production enterprise which had significant contribution to the quality control were analyzed.Results The spots on the TLC plate were clear,the resolution was well and without interference for negative control sample.The linear relationships of calibration curves were favorable,r=0.9999.The recoveries(n=9)of notoginsenoside R_1,ginsenoside Rg_1,ginsenoside Re,ginsenoside Rb_1,ginsenoside Rd were 100.0%、99.9%、100.6%、99.0%和99.6%.Through chemometrics analysis,it was found that 2 component scontributed significantly to the model,including notoginsenoside R_(1)(VIP=1.2131) and ginsenoside Rd(VIP=1.1260),which can further deepen the quality control research of SanqishangyaoTablets.Conclusion The methods of established were specificity,accuracy and well repeatability.Further through the chemometrics,which provided an important reference for the quality control research of Sanqishangyao Tablets.

关 键 词：三七伤药片 质量控制 薄层色谱 高效液相色谱 化学计量学 

分 类 号：R284.1[医药卫生—中药学]