中国药物评价2025，Vol.42Issue(3)：172-176,5.
基于特征图谱结合化学模式识别的脾氨肽口服冻干粉质量评价
Quality Evaluation of Spleen Aminopeptide Oral Lyophilized Powder Based on Characteristic Chromatogram Combined with Chemical Pattern Recognition
摘要
Abstract
Objective:To establish an analytical method for the characteristic chromatogram of spleen aminopeptide oral lyophilized powder and evaluate its quality using chemical pattern recognition,providing a basis for its scientific identification and quality control.Methods:The characteristic chromatogram was developed using liquid chromatography(HPLC),and 22 batches of samples(S1-S22)were classified using cluster analysis and principal component analysis from chemical pattern recognition methods.Additionally,orthogo-nal partial least squares-discriminant analysis was employed to identify key components distinguishing spleen aminopeptide oral lyophilized powder.Results:The characteristic chromatogram was established based on 22 batches of samples,identifying 14 common peaks and confirming four components:inosine,tyrosine,tryptophan,and thymosin β4.The samples were divided into two categories based on clus-ter analysis and principal component analysis.Orthogonal partial least squares discriminant analysis further screened seven quality-differ-entiating marker components,including thymosin β4.Conclusion:The characteristic chromatogram of spleen aminopeptide oral lyophi-lized powder established in this study is accurate,stable,and reliable,providing a reference for controlling and evaluating its quality.关键词
脾氨肽口服冻干粉/特征图谱/化学模式识别/质量评价Key words
Spleen aminopeptide oral lyophilized powder/Characteristic chromatogram/Chemical pattern recognition/Quality evaluation分类
医药卫生引用本文复制引用
刘雨浓,李悦忱,崔韶婧,田洁,邹翩..基于特征图谱结合化学模式识别的脾氨肽口服冻干粉质量评价[J].中国药物评价,2025,42(3):172-176,5.基金项目
大连市科技人才创新支持项目-青年科技之星(2023RQ024) （2023RQ024）
