机构地区:[1]武汉理工大学化学化工与生命科学学院,430070 [2]湖北太子药业有限公司 [3]湖北省药品监督管理局检查中心
出 处:《环球中医药》2024年第8期1515-1522,共8页Global Traditional Chinese Medicine
基 金:湖北省科技服务人才专项(2023DJC132)。
摘 要:目的采集不同基原的45批藁本药材,通过建立高效液相指纹图谱,结合指纹图谱相似度评价、聚类分析、主成分分析、偏最小二乘判别分析进行不同基原的藁本药材的质量评价,以期达到更全面的药材质量控制。方法按照《中国药典》2020年版藁本项下,采用水分、总灰分测定法、酸不溶性灰分测定法、醇溶性浸出物测定法、含量测定法对45批不同基原藁本药材进行质量评价。同时运用高效液相建立不同基原藁本药材的指纹图谱,并运用中药指纹图谱相似度评价系统对其进行相似度评价,用SPSS软件对其进行显著性差异分析、聚类分析、主成分分析,用SIMCA进行偏最小二乘判别分析。结果不同基原藁本药材水分、灰分、酸不溶性灰分测定结果均符合药典要求。藁本浸出物平均含量为37.59%,辽藁本浸出物平均含量为19.59%,新疆藁本浸出物平均含量为14.75%。藁本中阿魏酸平均含量为0.07%,辽藁本中阿魏酸平均含量为0.09%,新疆藁本中阿魏酸平均含量为0.13%。指纹图谱相似度评价结果为相同基原藁本指纹图谱相似度在0.973~0.999,而辽藁本与藁本之间的相似度为0.612~0.780,新疆藁本与藁本之间的相似度为0.108~0.212。通过聚类分析,藁本与辽藁本较为相似,而新疆藁本差异较大。通过主成分分析进行综合评价,新疆藁本综合得分较高。通过偏最小二乘判别分析,预测香草醛、阿魏酸、藁本内酯可能是不同基原藁本质量产生差异的主要原因。结论不同基原藁本药材在浸出物含量、阿魏酸含量、指纹图谱均存在一定的差异,可为藁本临床用药选择、新药开发、药材质量控制等方面提供依据。Objective 45 batches of Ligusticum Sinense from different origins were collected to establish high performance liquid chromatography fingerprint,and combine fingerprint similarity evaluation,cluster analysis,principal component analysis,and partial least squares discriminant analysis to evaluate the quality of Ligusticum Sinense from different origins,in order to achieve more comprehensive drug quality control.Methods According to the 2020 edition of the Chinese Pharmacopoeia,the quality evaluation of 45 batches of different raw materials of Ligusticum Sinense was conducted using methods such as moisture and total ash determination,acid insoluble ash determination,alcohol soluble extract determination,and content determination.At the same time,high performance liquid chromatography was used to establish fingerprint spectra of different original Ligusticum Sinense,and the similarity evaluation system of traditional Chinese medicine fingerprint spectra was used to evaluate their similarity.SPSS software was used for significance difference analysis,cluster analysis,principal component analysis,and SIMCA was used for partial least squares discriminant analysis.Results The determination results of water content,ash content,and acid insoluble ash content of different types of Ligusticum Sinense meet the requirements of the pharmacopoeia.The average content of Ligusticum Sinense extract is 37.59%,that of Ligusticum Jeholense Nakai et Kitag.extract is 19.59%,and that of Conioselinum Vaginatum(Spreng.)is 14.75%.The average content of ferulic acid in Ligusticum Sinense is 0.07%;the average content of ferulic acid in Ligusticum Jeholense Nakai et Kitag.is 0.09%;the average content of ferulic acid in Conioselinum Vaginatum(Spreng.)was 0.13%.The similarity evaluation results of the fingerprint spectra showed that the similarity of the fingerprint spectra of the same original Ligusticum Sinense is between 0.973 and 0.999,while the similarity between Ligusticum Sinense and Ligusticum Jeholense Nakai et Kitag.was between 0.612
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