世界中医药

作者	单位
于密密，范妙璇，李铮，陈有根，傅欣彤，郭洪祝	北京市药品检验研究院/国家药品监督管理局中成药质量评价重点实验室/中药成分分析与生物评价北京市重点实验室，北京，102206

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中文摘要:

目的:建立小金制剂系列品种的高效液相色谱法（HPLC）指纹图谱，结合化学识别模式方法评价市售不同厂家小金制剂的质量一致性。方法：采用HPLC建立不同厂家47批小金制剂的指纹图谱，利用中药色谱指纹图谱相似度评价系统（2012）进行相似度评价，确定共有峰；运用主成分分析、聚类分析和正交偏最小二乘判别分析，筛选出不同批次小金制剂的质量差异性成分，对小金制剂进行整体评价。结果：建立了小金制剂的HPLC指纹图谱，共标定9个共有峰，不同厂家小金制剂的相似度差异较大，相似度在0.90以上的仅占63%。通过主成分分析、聚类分析、正交偏最小二乘判别分析，发现47批小金制剂可聚为3类，并从标定的9个共有峰中筛选出了小金制剂的4个质量标志物。结论：HPLC指纹图谱结合化学模式识别的方法可以快速、可靠地评价不同厂家、不同批次小金制剂的质量，为小金制剂的质量一致性评价提供了参考。

English Summary:

To establish HPLC fingerprint of Xiaojin preparations and evaluate their quality consistency combined with chemical pattern recognition.Methods:Fingerprints of 47 batches of Xiaojin preparations from different manufacturers were established by HPLC.The similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine(2012) was used to evaluate the similarity and determine the common peak.Principal component analysis，cluster analysis and orthogonal partial least squares discriminant analysis were conducted to screen out the quality markers of different batches of Xiaojin preparations and make an overall evaluation.Results:HPLC fingerprint was established，and nine common peaks were marked.The similarity of Xiaojin preparations from different manufacturers varied greatly，and only 63% of them were above 0.90.By principal component analysis，cluster analysis and orthogonal partial least squares discriminant analysis，47 batches of Xiaojin preparations were clustered into three types，and four quality markers were screened from the nine common peaks.Conclusion:HPLC fingerprint combined with chemical pattern recognition can accurately and reliably evaluate the quality of Xiaojin preparations from different manufacturers，providing reference for the overall quality control of Xiaojin preparation.

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