Quality Evaluation of Polyporus Formula Granules Based on Fingerprint and Multi-component Determination

OBJECTIVE To establish the quality evaluation method of Polyporus formula granules, and to comprehensive evaluate the quality uniformity and stability of products from different manufacturers. METHODS The fingerprint of Polyporus formula granules was determined by HPLC. Shim-pack GIST C₁₈-AQ(4.6 mm×150 mm, 3 μm) was used, mobile phase was acetonitrile-water with gradient elution, volume flow rate was 1.0 mL·min^-1, detection wavelength was 350 nm (0-3 min) and 250 nm(3-35 min), column temperature was 30℃. HPLC fingerprints of Polyporus formula granules from different manufacturers were established, common peaks were identified, similarities were evaluated and cluster analysis were performed. HPLC was used to determine the contents of 4 active ingredients, and the quality of 16 batches of samples was analyzed and evaluated. RESULTS The established HPLC fingerprint of Polyporus formula granules defined 14 common peaks and identified 6 common components. They were peak 2(uridine), peak 4(guanosine), peak 6(adenosine), peak 12(polyporusteron B), peak 13(polyporusteron A), peak 14(polyporusteron C). The similarity of 16 batches of samples were 0.609-0.982, and could be clustered into 2 categories by cluster analysis. Guanosine, adenosine, polyporusteron B and polyporusteron A all showed good linear relationships(r ≥ 0.999 7), RSDs of instrument precision, stability and reproducibility tests were <3%. The average recoveries were 98.22%, 99.32%, 99.56%, 99.15%, RSD<3%(n=6). The contents of guanosine, adenosine, polyporusteron B, polyporusteron A in 16 batches of samples were 6.326-28.006, 13.392-44.058, 10.324-30.335, 9.270-26.964 μg·g^-1.CONCLUSION There is considerable quality difference among different manufacturers. The established fingerprint combine with the compound determination can comprehensively and accurately evaluate the internal quality of Polyporus formula granules, and provide a basis for the overall improvement of the quality.