二值三谱法评价红曲整体质量一致性研究OA

Objective To establish a digitized control method for the quality standard of red yeast rice,for which serves as a novel evaluating criteria for its quality standard.Methods The overall quality uniformity of red yeast rice and batch-to-batch consistency were comprehensively evaluated using Bi-value and Tri-spectrum method(BVTSM)and estimating purity Bi-value method(EP-BVM).Separation was performed on a C18 column(4.6 mm×250 mum,5 μm)using a gradient elution of acetonitrile and 0.05％phosphoric acid.Detection wavelengths were set at 237 nm and 256 nm,with a flow rate of 1.0 mL·min-1,injection volume of 20 μL,and column temperature of 30 ℃.Results Using genistein as the reference peak,the 10 common fingerprint peaks were analyzed.Methodology validation showed that the Relative standard deviation(RSD)values for precision,repeatability,and sample solution stability tests within 12 hours were all less than 3.0％,for which meet the technical requirements for traditional Chinese medicine(TCM)fingerprint.The 256 nm-HPLC fingerprint of red yeast rice was established.Using BVTSM,the macro-qualitative similarity Sm of 31 batches of red yeast rice samples were all＞0.97,while the macro-quantitative similarity Pm fluctuated from 76.7％to 124.7％.Samples were classified into five grades,with all batches qualifying except those in grade 5(S2,S6,S8,S9,S16,S30).The contents from the standard curve method and the ratio fingerprint quantitation(R-SFP)Method for three indicators were compared,showing high consistency.BVTSM can serve as a concise approach for the overall quality control and evaluation of complex TCMs.The dual-wavelength absorbance ratio spectrum was established,and the overall purity of all 10 fingerprint peaks of red yeast rice was identified and analyzed using the EP-BVM,confirming that all the fingerprint peaks met purity standards.Conclusion BVTSM can effectively evaluates and determines the total pharmacologically active substance content in red yeast rice,while the EP-BVM can comprehensively identify the purity of all fingerprint peaks at one time.Digitized HPLC fingerprint is an accurate and feasible approach for controlling TCM quality standard.