摘要
目的:建立寒喘祖帕颗粒的高效液相色谱法(HPLC)指纹图谱,结合统计学分析综合评估其质量。方法:采用Kromasil C_(18)色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,柱温为35℃,流速为1.0 mL·min^(-1),在紫外吸收波长为220 nm处进行检测。采用相似度软件、SPSS 23.0统计软件和SIMCA-P 14软件对12批寒喘祖帕颗粒的色谱数据进行化学计量学分析。结果:确定了15个共有峰,相似度较好。12批样品通过化学模型识别聚为3类;所有共有峰中2个主成分的累积方差贡献率达80.675%。结合偏最小二乘法-判别分析得到可能鉴别寒喘祖帕颗粒最关键的4个色谱峰分别为13号峰(甘草酸铵)、6号峰、1号峰(没食子酸)、7号峰(甘草苷)。结论:建立的方法简捷、准确、稳定,结合统计学分析可为寒喘祖帕颗粒的质量控制与评价提供参考。
Objective:To establish the high performance liquid chromatography (HPLC) fingerprint of Hanchuan Zupa Granules and comprehensively evaluate its quality by statistical analysis.Methods:This study adopted Kromasil C(250 mm×4.6 mm,5μm) column with the acetonitrile-0.1%phosphoric acid aqueous solution (volume fraction) as mobile phase for gradient elution.The column temperature was 35℃,and the flow rate was 1.0 mL·min.Detection was performed at 220nm of UV absorption wavelength.Similarity software,SPSS 23.0 statistical software,and SIMCA-P 14 software were used to conduct stoichiometric analysis of the chromatographic data of 12 batches of Hanchuan Zupa granules.Results:There were common 15 peaks with good similarity.The 12 batches of samples were identified by a chemical model and were clustered into three categories.The cumulative variance contribution rate of the two principal components in all common peaks reached 80.675%.Combined with partial least squares regression analysis,four critical chromatographic peaks that were possible to identify Hanchuan Zupa Granuleswere obtained,which were No.13 (ammonium glycyrrhetate),No.6,No.1(gallic acid),and No.7 (liquiritin).Conclusion:The established HPLC fingerprint method of Hanchuan Zupa Granulesis simple,accurate,and stable,which provides references for the quality control and evaluation of Hanchuan Zupa Granulesin the combination of statistical analysis.
作者
李柯翱
米尔扎提·麦麦提
张明惠
刘婷
苏海娣
马璇
LI Ke-ao;MIERZHATI Mai-mai-ti;ZHANG Ming-hui;LIU Ting;SU Hai-di;MA Xuan(Xinjiang Cimu Pharmaceutical Research Institute(Co.,Ltd.),Urumqi 830011,China;Xinjiang Medical University,Urumqi 830011,China;Xinjiang Drug Evaluation and Inspection Center,Urumqi 830011,China)
出处
《中国现代中药》
CAS
2022年第8期1555-1560,共6页
Modern Chinese Medicine
基金
科技助力经济2020重点专项(SQ2020YFF0425027)
新疆维吾尔自治区重大科技专项(2021A03002)。
作者简介
通信作者:马璇,高级工程师,研究方向:新药开发,E-mail:mx646@163.com。
