近红外光谱法结合聚类分析对云芝胞内糖肽胶囊不同生产工艺的分类研究

Study of different preparation processes of Coriolus versicolor intracellular glycopeptide capsules by Near-infrared spectroscopy combined with cluster analysis

目的利用近红外光谱技术对云芝胞内糖肽胶囊进行制剂工艺研究,采用聚类分析对不同工艺样品进行分类,评估制剂工艺的合规性。方法2023年5―8月采用无损检验方法,对46批样品进行近红外光谱检测,对平均光谱经二阶导数预处理后得到的导数光谱进行建模,对预处理后的谱图进行聚类分析。结果不同生产工艺的样品分别聚类,提示某生产企业的制剂工艺与批准工艺可能不符,经调研确认情况属实。结论近红外光谱结合聚类分析可运用于云芝胞内糖肽胶囊制剂工艺的分类研究,为工艺控制提供有益的技术借鉴。

Objective To study the preparation process of Coriolus versicolor intracellular glycopeptide capsules by near-infrared spectroscopy,to classify samples of different preparation process by cluster analysis,and to evaluate the compliance of the preparation process.Methods The non-destructive testing method was used to detect 46 batches of samples by near-infrared spectroscopy from May to August 2023,and the derivative spectra obtained by the second derivative pretreatment of the average spectrum were modeled,and the pretreated spectra were clustered and analyzed.Results The samples of different preparation processes were clustered separately,and the preparation process of a manufacturing enterprise was suspected to be inconsistent with the approved process,and was verified by investigation.Conclusion Near-infrared spectroscopy and cluster analysis can be applied to the classification of preparation processes,which can provide a useful technical reference for process control.