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咽痒咳合剂质量评价

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目的 评价咽痒咳合剂质量.方法 建立HPLC指纹图谱,进行聚类分析、主成分分析和偏最小二乘判别分析.测定甘草苷、射干苷、迷迭香酸、异甘草苷、野鸢尾黄素、甘草酸单铵盐、次野鸢尾黄素、和厚朴酚、厚朴酚的含量,分析采用Agilent ZORBAX SB-C18色谱柱(5 µm,250 mmx4.6 mm);流动相0.1％磷酸-乙腈,梯度洗脱;体积流量1 mL/min;柱温35 ℃;多波长检测.结果 12批样品指纹图谱中有10个共有峰,相似度均大于0.9.各批样品聚为3类,3种主成分累积方差贡献率达87.448％,峰5、14(和厚朴酚)、3(甘草苷)、11(甘草酸单铵盐)、15(细辛脂素)为质量标志物.9种成分在各自范围内线性关系良好(r=0.999 9),平均加样回收率98.23％～101.63％,RSD 1.05％～2.92％.结论 该方法稳定可靠,可为咽痒咳合剂质量控制提供依据.
Quality evaluation of Yanyangke Mixture
AIM To evaluate the quality of Yanyangke Mixture.METHODS The HPLC fingerprints were established,after which cluster analysis,principal component analysis and partial least squares discriminant analysis were performed.The contents of liquiritin,rosmarinic acid,sheganoside,irisgenin,honokiol,monoammonium glycyrrhizinate,irisflorentin,isoliquiritin and magnolol were determined,the analysis was performed on a 35 ℃ thermostatic Agilent ZORBAX SB-C18 column(5 μm,250 mmx4.6 mm),with the mobile phase comprising of 0.1％phosphoric acid-acetonitrile flowing at 1 mL/min in a gradient elution manner,and multi-wavelength detection was adopted.RESULTS There were ten common peaks in the fingerprints for twelve batches of samples with the similarities of more than 0.9.Various batches of samples were clustered into three types,three principal components displayed the acumulative variance contribution rate of 87.448％,peaks 5、14(honokiol),3(liquiritin),11(monoammonium glycyrrhizinate)and 15(asarinin)were quality markers.Nine constituents showed good linear relationships within their own ranges(r＞0.999 0),whose average recoveries were 98.5％-103.6％with the RSDs of 0.92％-1.7％.CONCLUSION This stable and reliable method can provide a basis for the quality control of Yanyangke Mixture.

Yanyangke Mixturequality evaluationHPLC fingerprintscluster analysisprincipal component analysispartial least squares discriminant analysiscontent determination

梁晓莲、桂雄斌、陈勇、杨正腾、马家宝、赵凤仙、宋海梅、冯家茹

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广西中医药大学,广西南宁 530200

梧州市中医医院,广西梧州 543000

广西中医药大学第一附属医院,广西南宁 530200

咽痒咳合剂 质量评价 HPLC指纹图谱 聚类分析 主成分分析 偏最小二乘判别分析 含量测定

广西科技基地和人才专项广西重点研发计划项目2022年广西壮瑶药重点实验室项目

桂科AD23023011桂科AB20297010GXZYKF2022-12

2024

10.3969/j.issn.1001-1528.2024.06.002

中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子：1.217
ISSN：1001-1528
年,卷(期)：2024.46(6)
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