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作 者:肖春霞 黄晓婧 许莉 李婷婷 李及 赵小勤 XIAO Chun-xia;HUANG Xiao-jing;XU Li;LI Ting-ting;LI Ji;ZHAO Xiao-qin(State Administration for Drug Administration Key Laboratory for Quality Monitoring and Evaluation of Traditional Chinese Medicine,Chengdu Municipal Institute for Drug Control and Research,Chengdu 610045,China)
机构地区:[1]成都市药品检验研究院,国家药品监督管理局中药材质量监测评价重点实验室,四川成都610045
出 处:《中成药》2024年第2期365-370,共6页Chinese Traditional Patent Medicine
基 金:2021年国家药品抽检计划[国药监药管(2021)1号];中央补助地方经费项目(2021)。
摘 要:目的 同时测定肤痒颗粒中新绿原酸、咖啡酸、绿原酸、隐绿原酸、羟基红花黄色素A、阿魏酸、洋川芎内酯I、洋川芎内酯H、洋川芎内酯A的含量,并进行化学模式识别。方法 UHPLC分析采用Waters Acquity UPLC?BEH C_(18)色谱柱(150 mm×2.1 mm, 1.7μm);流动相乙腈-0.01%磷酸,梯度洗脱;体积流量0.4 mL/min;柱温35℃;检测波长278、322、325、390 nm。再进行热图聚类分析、主成分分析。结果 9种成分在各自范围内线性关系良好(r>0.999 0),平均加样回收率93.89%~102.25%,RSD 0.85%~2.88%。同一企业不同批次样品整体质量一致,而不同企业样品之间整体质量差异较大。2个主成分累积贡献率大于64%。结论 该方法简便准确,可为肤痒颗粒质量评价提供参考。AIM To simultaneously determine the contents of neochlorogenic acid,caffeic acid,chlorogenic acid,cryptochlorogenic acid,hydroxysafflor yellow A,ferulic acid,senkyunolide I,senkyunolide H and senkyunolide A in Fuyang Granules,and to make chemical pattern recognition.METHODS The UHPLC was performed on a 35℃thermostatic Waters Acquity UPLC BEH C_(18) column(150 mm×2.1 mm,1.7μm),with the mobile phase comprising of acetonitrile-0.01%phosphoric acid flowing at 0.4 mL/min in a gradient elution manner,and the detection wavelengths were set at 278,322,325,390 nm.Then heatmap clustering analysis and principal component analysis were adopted.RESULTS Nine constituents showed good linear relationships within their own ranges(r>0.9990),whose average recoveries were 93.89%-102.25%with the RSDs of 0.85%-2.88%.Different batches of samples from the same enterprises demonstrated consistent overall qualities,while the overall qualities of samples from different enterprises exhibited obvious differences.CONCLUSION This simple and accurate method can be used for the quality control of Fuyang Granules.
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