关键词: font-size:medium, "> , 脾氨肽口服冻干粉；特征图谱；化学模式识别；质量评价

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， orthogonal 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 cluster analysis and principal component analysis. Orthogonal partial least squares discriminant analysis further screened seven quality-differentiating marker components， including thymosin β4. Conclusion： The characteristic chromatogram of spleen aminopeptide oral lyophilized powder established in this study is accurate， stable， and reliable， providing a reference for controlling and evaluating its quality.

Key words: font-size:medium, ">Spleen aminopeptide oral lyophilized powder； Characteristic chromatogram； Chemical pattern recognition； Quality evaluation