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首页> 外文期刊>Journal of Pharmaceutical and Biomedical Analysis: An International Journal on All Drug-Related Topics in Pharmaceutical, Biomedical and Clinical Analysis >Combinative method using HPLC fingerprint and quantitative analyses for quality consistency evaluation of an herbal medicinal preparation produced by different manufacturers.
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Combinative method using HPLC fingerprint and quantitative analyses for quality consistency evaluation of an herbal medicinal preparation produced by different manufacturers.

机译:使用HPLC指纹图谱和定量分析的组合方法,对不同制造商生产的草药制剂的质量一致性进行评估。

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摘要

A combinative method using HPLC-DAD fingerprint and quantitative analysis was developed and validated for manufacturer-to-manufacturer quality consistency evaluation of Yiqing preparations. For fingerprint analysis, 22 peaks were selected as the characteristic peaks to evaluate the similarities of different samples collected from different manufacturers. The similarities of 12 Yiqing samples were beyond 0.90, indicating that samples from different manufacturers were, to some extent, consistent. Additionally, simultaneous quantification of nine markers including berberine, aloe-emodin, rhein, emodin, chrysophanol, baicalin, baicalein, wogonoside, and wogonin in Yiqing was performed to interpret the quality consistency. The results from the quantitative data showed that the contents of these nine marker compounds were quite consistent for batches produced within one manufacturer and significantly different from manufacturer-to-manufacturer. This study demonstrated that a combination of the chromatographic fingerprint and quantitative analysis offers an efficient way to quality consistency evaluation of herbal preparation.
机译:建立了使用HPLC-DAD指纹图谱和定量分析的组合方法,并验证了该方法可用于宜清制剂的制造商到制造商质量一致性评估。对于指纹分析,选择22个峰作为特征峰,以评估从不同制造商收集的不同样品的相似性。 12个宜清样品的相似度超过0.90,表明不同制造商的样品在一定程度上是一致的。此外,对宜清市的小碱,芦荟大黄素,大黄素,大黄素,香豆酚,黄ical苷,黄ical素、,草苷和w草苷等九种标记物进行了同时定量,以解释质量一致性。定量数据的结果表明,这九种标记化合物的含量对于一个制造商内部生产的批次而言是非常一致的,并且与制造商之间存在显着差异。这项研究表明,色谱指纹图谱和定量分析相结合提供了一种有效的方法来评估草药制品的质量一致性。

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