基于HPLC指纹图谱结合多元统计分析经典名方调胃承气汤基准样品的质量评价研究OA

Objective The quality research system of the classic formula Tiaowei Chengqi Decoction(TCD,调胃承气汤)was constructed by establishing HPLC fingerprinting and index component content determination methods,and the quantity value transfer law of its reference samples were explored.Methods Prepare TCD reference samples from 15 batches of herbal materials sourced from different regions using traditional methods.Establish fingerprint profiles via HPLC and evaluate batch-to-batch consistency using chemometric methods such as hierarchical cluster analysis(HCA)orthogonal partial least squares-discriminant analysis(OPLS-DA)and principal component analysis(PCA)to identify the batch-to-batch consistency and differential markers.Simultaneously,Hotelling's T2 and DMod X were calculated based on the PCA model,with 95%and 99%confidence limits serving as the warning and control limits[T2Crit(95%)=31.49,T2Crit(99%)=54.15,DCrit=1.97]for batch consistency evaluation.A method was established to simultaneously determine the content of six target components gallic acid,glycyrrhizin,aloe-emodin,emodin,glycyrrhetic acid,and rhein in 15 batches of samples and their corresponding crude drug slices.The transfer rate of these components from crude drug slices to samples was calculated.Results A robust HPLC fingerprint profile of TCD was successfully established,allowing for the identification of 16 common peaks.Chemometric analysis confirmed effective batch-to-batch differentiation,with gallic acid and glycyrrhizic acid identified as key chemical markers contributing to the discrimination of batch variations.Quantitative analysis of six marker components across 15 batches revealed mass fractions ranging from 0.521 to 1.581 mg/g for gallic acid,0.143 to 0.711 mg/g for glycyrrhizin,0.025 to 0.071 mg/g for aloe-emodin,0.016 to 0.182 mg/g for emodin,0.487 to 2.740 mg/g for glycyrrhizic acid,and 0.007 to 0.039 mg/g for rhein.Furthermore,component tracking from crude drug to final sample demonstrated average transfer rates of 17.625%,2.878%,5.929%,5.159%,1.689%and 1.088%for these compounds,respectively.Conclusion Combined with multi-component quantitative analysis with chemometric methods to develop an HPLC fingerprint profile for TCD,systematically investigating the compositional variation patterns from herbal materials to reference samples.The findings provide a scientific foundation for quality evaluation research on TCD.