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AIM To evaluate the quality of Beidougen Formula Granules.METHODS Fifteen batches of standard decoctions and three batches of formula granules were prepared,after which paste rate and contents,transfer rates of magnoflorine,daurisoline,dauricine were determined.HPLC specific chromatograms were established,and cluster analysis was adopted in chemical pattern recognition.RESULTS For three batches of formula granules,the paste rates were 15.1%-16.6%,the contents of magnoflorine,daurisoline,dauricine were 18.93-19.39,9.42-9.60,6.79-6.85 mg/g with the transfer rates of 34.42%-35.25%,43.81%-44.65%,27.27%-27.51%from decoction pieces to formula granules,respectively,and there were seven characteristic peaks in the specific chromatograms with the similarities of more than 0.95,which demonstrated good consistence with those of standard decoctions and accorded with related limit requirements.Fifteen batches of standard decoctions were clustered into two types,and the medicinal materials produced from Jilin,Hebei,Shangdong could be used for the preparation of formula granules.CONCLUSION This reasonable and reliable method can provide references for the quality control and clinical application of Beidougen Formula Granules.
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Objective: To establish the HPLC specific chromatograms of the ethyl acetate layer in ten batches of effective parts of Filifolium sibiricum and to determine the contents of five components. Methods: The analysis of effective parts of F. sibiricum was performed on a Thermo AcclaimTM120 C18 column (250 mm × 4.6 mm, 5 μm) with acetonitrile (B)-PBS (A) (0.1 mol/L sodium dihydrogen phosphate-2% glacial acetic acid, 1∶1) as the mobile phase in a gradient elution mode, the detection wavelength was set at 360 nm, the flow rate was 0.8 mL/min, and the column temperature was 35 ℃. Results: The specific chromatograms of F. sibiricum effective parts were established and ten common peaks were designated. Among them, five components including isorientin, isovitexin, isoquercitrin, luteoloside and isorhamnetin-3-O-β-D-glucose all showed good linear relationship within the ranges of 0.018—0.108, 0.066 8—0.400 8, 0.088—0.528, 0.118 4—0.710 4 and 0.017 6—0.105 6 μg, respectively. The average recovery was 98.67%, 97.93%, 98.95%, 99.81%, and 97.33% with the RSD value at 1.10%, 0.93%, 1.10%, 0.62%, and 1.48%, respectively. Moreover, the similarity of the eight batches of samples was above 0.9 in the ten batches of medicinal herbs, the similarity of the two batches of which was 0.688 and 0.695, indicating that its content was lower and the difference was greater. In addition, there were significant differences in the content of five components in each harvest time. The content of flavonoids in medicinal herbs was higher with high flower percentage. It was suggested that the content of flavonoids in F. sibiricum was related to the flower percentage of harvest period. Conclusion: The HPLC specific chromatograms of the F. sibiricum effective parts were established and the common characteristic peaks were determined, which could be used for quality control of the F. sibiricum.