生产设备对苦参膜指纹图谱及指标成分的影响

目的筛选苦参膜主要指标活性成分,建立高效液相色谱(HPLC)指纹图谱分析方法,并进行多元分析,探讨生产设备变更对苦参膜主要有效物质含量的影响。方法建立生产设备变更前后30批样品指纹图谱,输入指纹图谱相似度评价软件对指纹图谱数据进行处理,运用SPSS 22.0版软件进行系统聚类分析和主成分因子分析,根据主成分因子分析结果再进行聚类分析,筛选出苦参膜质量差异的指标性成分。测定30批设备变更前后样品指标性成分含量,运用SPSS 22.0版软件进行独立样本T检验,讨论设备变更对苦参膜指标成分含量的影响。结果指纹图谱共标记8个共有峰,根据聚类分析结果,可将样品聚为2类,导致差异的原因可能与生产年份远近以及是否过期有一定关系,与生产设备变更无关。由主成分因子分析结果筛选出5个苦参膜差异成分,以差异成分为变量再进行聚类分析发现与之前结果基本一致,初步确定苦参膜的指标性成分为槐果碱、苦参碱、槐定碱与氧化苦参碱。30批苦参膜4个已知指标成分含量结果显示,设备变更后批次的苦参膜含量更高,差异有统计学意义(P<0.05)。结论所建HPLC指纹图谱及聚类分析和主成分因子分析结果可为苦参膜的质量控制提供参考,设备变更并未对苦参膜造成质量改变,并提高其有效物质含量与稳定性。

Effect of Production Equipment on Main Components of Kushen Mo and the Fingerprint

Objective To screen the main active component indexes of Kushen mo and establish HPLC fingerprint analysis method,and to investigate the influence of production equipment changes on the main active components of Kushen mo.Methods Fingerprints of 30 batches of samples before and after the change of production equipment were established.Fingerprint map similarity evaluation software was used to process fingerprint map data.SPSS 22.0 was used for system cluster analysis and principal component factor analysis,and then re-cluster analysis according to the results of principal component factor analysis.Based on the class analysis,the difference of the index components in the quality of the Kushen mo was screened out.The content of index components of the samples before and after the 30 batches of equipment were measured.The independent sample T test was performed using SPSS 22.0 to discuss the influence of equipment changes on the content of the components of Kushen mo.Results There were 8 common peaks in the fingerprint.According to the results of cluster analysis,the samples could be clustered into two groups.The reason for the difference might be related to the production year and whether the samples were overdued or not.Five different components of Kushen mo were screened out from the results of principal component factor analysis.Cluster analysis based on the different components was consistent with the previous results.Sophocarpine,matrine,sophoridine,and oxymatrine were initially identified as the indicators of Kushen mo.The contents of four known components in 30 batches of Kushen mo were determined.The results showed that the content of Kushen mo was higher in batches after the equipment was changed,and the difference was significant(P<0.05).Conclusion The fingerprints,cluster analysis,and principal component analysis of the established HPLC fingerprints can provide references for the quality control of Kushen mo.