Combinative method using HPLC fingerprint and quantitative analyses for quality consistency evaluation of an herbal medicinal preparation produced by different manufacturers
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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DOI：
10.1016/j.jpba.2010.01.018
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发表时间：
2010-08-01
影响因子：
3.4
通讯作者：
Guo, Cheng
中科院分区：
文献类型：
--
作者：
Li, Yan;Wu, Tao;Guo, Cheng
开发并验证了一种使用 HPLC-DAD 指纹图谱和定量分析的组合方法，用于对一清制剂进行制造商之间的质量一致性评价。指纹图谱分析中，选取22个峰作为特征峰，评价不同厂家采集的不同样品的相似性。 12个一清样品的相似度均在0.90以上，说明不同厂家的样品具有一定的一致性。此外，还对益清中的小檗碱、芦荟大黄素、大黄酸、大黄素、大黄酚、黄芩苷、黄芩素、汉黄芩苷、汉黄芩素等9个标志物进行同步定量，以解释其质量一致性。定量数据结果表明，同一制造商生产的批次中这九种标记化合物的含量相当一致，而不同制造商之间的含量差异显着。这项研究表明，色谱指纹图谱和定量分析的结合为草药制剂的质量一致性评价提供了一种有效的方法。 (C) 2010 Elsevier B.V. 保留所有权利。
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. (C) 2010 Elsevier B.V. All rights reserved.