基于HPLC指纹图谱、化学计量学和含量测定评价苗药热淋清颗粒质量OA
Quality evaluation of Miao medicine Relinqing Granules based on HPLC fingerprints,chemometrics and content determination
目的 评价苗药热淋清颗粒质量.方法 建立 HPLC 指纹图谱,分析采用 ShimNex CS C18色谱柱(4.6 mm×250 mm,5 μm);流动相 0.2%磷酸-甲醇,梯度洗脱;体积流量 1.0 mL/min;柱温 30℃;检测波长 254 nm.再进行聚类分析、主成分分析、正交偏最小二乘-判别分析,并测定没食子酸、鞣花酸、槲皮苷含量.结果 47 批样品指纹图谱中有 13 个共有峰,相似度均大于 0.871.各批样品聚为 2 类,3 个主成分累积方差贡献率为 96.632%,筛选出 8 种差异性成分.3 种成分在各自范围内线性关系良好(R2≥0.999 7),平均加样回收率 96.57%~101.85%,RSD 0.70%~1.12%.结论 该方法简便可靠,重复性好,可为热淋清颗粒质量控制和标准提升提供科学依据.
AIM To evaluate the quality of Miao medicine Relinqing Granules.METHODS The HPLC fingerprints were established,the analysis was performed on a 30℃thermostatic ShimNex CS C18 column(4.6 mm×250 mm,5 μm),with the mobile phase comprising of 0.2%phosphoric acid-methanol flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 254 nm.Subsequently,cluster analysis,principal component analysis and orthogonal partial least squares-discriminant analysis were performed,after which the contents of gallic acid,ellagic acid and quercitrin were determined.RESULTS There were 13 common peaks in the fingerprints for 47 batches of samples with the similarities of more than 0.871.Various batches of samples were clustered into two categories,three principal components demonstrated the accumulative variance contribution rate of 96.632%,and eight differential components were screened.Three constituents showed good linear relationships within their own ranges(R2≥0.999 7),whose average recoveries were 96.57%-101.85%with the RSDs of 0.70%-1.12%.CONCLUSION This simple,reliable and reproducible method can provide a scientific basis for the quality control and standard enhancement of Relinqing Granules.
陈莲;何雨其;赵鑫艳;唐靖雯;潘婷;杨伟鹏;唐策;张静;张艺
成都中医药大学西南特色中药资源国家重点实验室,中药种质资源创新与高效利用实验室,四川 成都 611137成都中医药大学西南特色中药资源国家重点实验室,中药种质资源创新与高效利用实验室,四川 成都 611137成都中医药大学西南特色中药资源国家重点实验室,中药种质资源创新与高效利用实验室,四川 成都 611137贵州威门药业股份有限公司,贵州 贵阳 550000贵州威门药业股份有限公司,贵州 贵阳 550000中国中医科学院中药研究所,北京 100700成都中医药大学西南特色中药资源国家重点实验室,中药种质资源创新与高效利用实验室,四川 成都 611137成都中医药大学西南特色中药资源国家重点实验室,中药种质资源创新与高效利用实验室,四川 成都 611137成都中医药大学西南特色中药资源国家重点实验室,中药种质资源创新与高效利用实验室,四川 成都 611137
医药卫生
热淋清颗粒质量评价HPLC指纹图谱聚类分析主成分分析正交偏最小二乘法-判别分析含量测定
Relinqing Granulesquality evaluationHPLC fingerprintscluster analysisprincipal component analysisorthogonal partial least squares discriminant analysiscontent determination
《中成药》 2026 (4)
1079-1086,8
国家重点研发计划"中医药现代化"重点专项(2023YFC3504402,2023YFC3504404,2023YFC3504405)
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