市售参苓白术散和参苓白术丸指纹图谱研究  

Study on fingerprints of commercial Shenling Baizhu Powder and Shenling Baizhu Pills

作　　者：贾谭蓉 于萍[1] 王佳佳[1] 胡一凡 柴润芃 董铖泽 巴寅颖[1] Jia Tanrong;Yu Ping;Wang Jiajia;Hu Yifan;Chai Runpeng;Dong Chengze;Ba Yinying(School of Traditional Chinese Medicine,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学中医药学院,北京100069

出　　处：《国际中医中药杂志》2024年第10期1338-1342,共5页International Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金(82104765);北京市中医药薪火传承“新3+3”工程--冯建春“三名”传承工作室(2023年)。

摘　　要：目的建立参苓白术散、参苓白术丸HPLC指纹图谱,评价市售参苓白术散和参苓白术丸的质量一致性。方法采用HPLC法,色谱柱为Agilent TC-C18(250 mm×4.6 mm,5μm),流动相为0.05%磷酸-乙腈,梯度洗脱,流速1.0 ml/min,检测波长203 nm,柱温25℃,建立不同厂家不同批次参苓白术散和参苓白术丸样品HPLC指纹图谱,采用中药色谱指纹图谱相似度评价系统(2012版)进行相似度评价,并对主要色谱峰进行指认。结果建立了参苓白术散和参苓白术丸对照指纹图谱,分别确定了73个和79个共有峰,样品与对照指纹图谱相对比,相似度均在0.92以上,不同生产企业的不同批次药品质量一致性较好。共指认了10个成分,分别是甘草苷、人参皂苷Rg1、人参皂苷Rb1、甘草素、异甘草苷、人参皂苷Rd、甘草酸、白术内酯Ⅰ、白术内酯Ⅱ、白术内酯Ⅲ。结论所建立的HPLC指纹图谱可快速评价参苓白术散、参苓白术丸制剂质量,为其质量控制提供依据。Objective To establish an HPLC fingerprint of Shenling Baizhu Powder and Shenling Baizhu Pills;To evaluate the quality consistency of commercial Shenling Baizhu Powder and Shenling Baizhu Pills.Methods HPLC method was adopted with Agilent TC-C18 column(250 mm×4.6 mm,5μm).The mobile phase was 0.05%phosphoric acid-acetonitrile with gradient elution;the flow rate was 1.0 ml/min;the detection wavelength was 203 nm;the column temperature was 25℃.The HPLC fingerprints of Shenling Baizhu Powder and Shenling Baizhu Pills from different manufacturing enterprises were established and analyzed by using the Similarity Evaluation System of Chromatographic Fingerprint of TCM(Version 2012)software for similarity evaluation,and the main chromatographic peaks were identified.Results The control fingerprints of Shenling Baizhu Powder and Shenling Baizhu Pills were obtained.73 common peaks and 79 common peaks were identified respectively.The similar degrees of all samples were over 0.92.The quality consistency of drugs different batches of different production enterprises was good.A total of 10 components were identified,including Liquiritin,Ginsenoside Rg1,Ginsenoside Rb1,Glycyrrhizin,Isoliquiritin,Ginsenoside Rd,Glycyrrhizic acid,AtractylenolideⅠ,AtractylenolideⅡand AtractylenolideⅢ.Conclusions The established HPLC fingerprints can quickly evaluate the formulation quality of Shenling Baizhu Powder and Shenling Baizhu Pills,providing basis the quality control.

关 键 词：参苓白术散 参苓白术丸 高效液相指纹图谱 相似度 质量控制 

分 类 号：R286.0[医药卫生—中药学]