Abstract:To study the characteristics of Xiaoqinglong Granules by HPLC and to observe whether the formula has the characteristics of predicting the quality level of Xiaoqinglong Granules.Methods:First,prepare Xiaoqinglong Granules,and four kinds of medicinal materials for test solution and optimize chromatographic conditions.The injection volume was 2 uL.In the study,a C18 column of 250×4.6 mm was used,and the column temperature was 35 degrees Celsius,and the mobile phase A was 0.1% phosphoric acid water+0.02% sodium heptane sulfonate; the mobile phase B was 82 acetonitrile:10 Anhydrous ethanol:8 (water+0.24% phosphoric acid),and detection wavelength was 220 nm.Then,from the 5 dimensions of precision,repeatability,stability,specificity and sample recovery rate,we studied the rigor of HPLC.Finally,we established the fingerprints of Xiaoqinglong Granules and combined with the prescription mode to predict the quality level of Xiaoqinglong Granules.Results:1) The results of the precision study showed that the RSD of the shared peak relative retention time was 0.08%.The reproducibility study showed that the shared peak relative retention time RSD was 0.3%.The stability results showed that the shared peak relative retention time RSD was 0.4%,indicating HPLC has good precision,repeatability and stability.2) The results of specificity showed that there were no impurity peaks between the peaks of Xiaoqinglong Granules in the relative retention time,which indicated good specificity of Xiaoqinglong Granules.3) The results of sample recovery showed that the average recovery rate was 96.52%~104.73%,and the range of RSD was 0.67%~2.14%,indicating that the HPLC method had good accuracy.4) there were 40 common peaks in the 22 batches of Xiaoqinglong Granules,including 4 common batches of S13,S14,S19 and S21.5) The total additive pattern of group composition was lower than that of group maximization mode; the total additive mode in unit mass chromatography was lower than that in maximization mode; the prediction ability of the column chromatography and the quality of the unit chromatography were comparable,and there was no significantly statistical difference (P>0.05); and then from the comparison of the average value of CMF and PMF with 2 RFP,the difference between the two groups was very small (P>0.05).Conclusion:The quality level of Xiaoqinglong Granules preparation can be predicted by high performance liquid chromatography (HPLC).