Integrated quality assessment of Tieshuang Anshen Prescription by multiple fingerprint profiles combined with quantitative analysis and chemometric methods

Chinese herbal medicine compound prescription (CHM-CP) contains more complex active compounds than single herbal medicine owing to its compatibility. Hence, finding an effective, rapid, and comprehensive quality control method for evaluating the safety and efficacy of CHM-CP in the process of development and preparation is of great importance. Tieshuang Anshen Prescription (TSASP) is a newly optimized prescription developed from Zhusha Anshen Pill. In the present research, a rapid and efficient HPLC-DAD method was applied to collect fingerprints at five wavelengths and establish quantitative determination of four major components of TSASP. Then, their intrinsic characteristics with different source compatibility were determined by chemometric methods (principal component analysis). The chromatographic fingerprints at five wavelengths were fused into a synthesized fingerprint to avoid bias of a single wavelength. In addition, a comprehensive strategy based on multi-wavelength fusion HPLC fingerprints and Fourier transform infrared spectroscopy was proposed and all samples were classified into six quality grades by the systematic quantified fingerprint method. Furthermore, the integrative evaluation proved to be more reasonable and comprehensive when it was applied to monitor the quality consistency of TSASP by evaluating the results of hierarchical clustering analysis. In conclusion, our study indicated that there was a significant correlation between the ingredient content and quality consistency of TSASP and the source compatibility, which provides a novel and scientific quality evaluation idea and strategy for the selection of raw material sources and formula development of TSASP. More importantly, our research strongly verified the accuracy and sensitivity of the fingerprint approach in the quality control and evaluation of TSASP (CHM-CP) to a certain extent.