ABSTRACT
Objective: A fingerprint similarity evaluation method was optimized, and combined with multivariable statistical analysis technology to evaluate the quality consistency of Xiaoyao Tablets comprehensively, systematically, and scientifically. Methods: UPLC fingerprint data of multiple batches of Xiaoyao Tablets were collected, and its similarities were performed by correlation coefficients, angle cosine, euclidean distance, macro qualitative and quantitative similarity, and equivalent coefficient. A similarity evaluation method was selected for product quality evaluation, according to the characteristics of various calculation methods. At the same time, pattern recognition technologies such as principal component analysis (PCA) was used to analyze and evaluate the overall quality of Xiaoyao Tables. Hotelling's T2 and DModX statistics were used to monitor the quality of different batches of products. The similarity calculation and multivariate statistical analysis were combined to evaluate the consistency of the quality of different batches of samples. Results: By analyzing the fingerprint data of 22 common peaks of 14 batches of Xiaoyao Tablets, the quality of products had high consistency evaluated by traditional similarity calculation method. The weighted equivalent coefficient evaluation method was more suitable for product quality evaluation comparing with the traditional similarity evaluation method, as different weight coefficients were set for different indicators according to the peak area information and pharmacological effect and the information reflected was more comprehensive and reasonable. There were no abnormal batches in the 14 batches of samples in the PCA analysis, indicating the quality of products were relatively stable. The upper control limits of Hotelling's T2 and DModX were 25.145 3 and 1.75, respectively. The equivalent coefficient method evaluates the quality of different batches of samples from a macro perspective, and the multivariate statistical analysis analyzes the contribution of each chromatographic peak based on evaluation results. The combination of the two methods can comprehensively evaluate the quality consistency of samples. Conclusion: The similarity evaluation and multivariate statistical analysis method based on fingerprints established in this study can evaluate the quality consistency of samples comprehensively and systematically. The study also provides a reference for the research on quality control of traditional Chinese medicine.
