A rapid evaluation method for the quality consistency assessment and spectrum–effect relationship study of Xiaohuoluo Pills developed based on combined spectral and chromatography technology†

Abstract

To ensure the effectiveness of traditional Chinese medicine (TCM) and drive the advancement of high-quality Chinese medicine, the establishment of a scientifically sound quality evaluation system is particularly important. The objective of this study was to develop a straightforward and practical comprehensive evaluation method for quality control of Xiaohuoluo Pills (XHLP) by employing diverse fingerprint technologies. Firstly, Fourier transform infrared spectroscopy fingerprint (FT-IRFP), ultraviolet spectral fingerprint (UVFP) and fusion fingerprints based on five-wavelength matched average fusion fingerprint (FWFFP) were established for 21 samples. Secondly, the Comprehensive Quantified Ratio Fingerprinting Method (CQRFM) was used to conduct a comprehensive evaluation of the fingerprint profiles of 21 batches of samples and the results showed that all samples met the quality requirements. Then to further evaluate the samples, the External Standard Method (ESM) was employed to measure the content of three indicator components in XHLP, and this was done with the intention of enhancing the quality control system of the samples. Furthermore, antioxidant activity was also measured, and a model for analyzing the relationship between antioxidant data and fingerprint information from the three spectra was established using Orthogonal Projection to Latent Structures (OPLS), resulting in an accurate spectral efficacy relationship diagram. In conclusion, this study utilized spectral and chromatography techniques to comprehensively assess the quality of XHLP, incorporating qualitative and quantitative aspects. Additionally, a correlation between spectral profiles and efficacy was established by evaluating the antioxidant capacity of the samples. This method offers valuable insights for quality control not only of XHLP but also for other TCM.