Résumé
Objective To analyze the quality of 22 batches of Fritillariae thunbergii bulbus Formula Granules from 12 different manufacturers by using water-extraction reference substance of Fritillariae thunbergii bulbus(ZBM ERS ST)and water-extraction reference substance of Fritillariae hupehensis bulbus(HBBM ERS ST)as references.Methods Ethyl acetate-methanol-triethylamine-water(17∶1∶1∶0.5)was used as the developing solvent for high-performance thin-layer chromatography(HPTLC)fingerprint analysis.The high-performance liquid chromatography(HPLC)fingerprint analysis was performed on a Agilent Eclipse XDB-C18 column(4.6 mm×250 mm,5 μm)with the gradient mobile phase consisted of acetonitrile-0.03%diethylamine solution.The column temperature was set at 25℃and evaporative light-scattering detector was used.The determination was conducted according to standard test method for measurement of Fritillariae thunbergii bulbus Formula Granules(Guangdong PFKL00117).Results The results of HPTLC and HPLC analysis showed that there are significant differences among the 22 batches of Fritillariae thunbergii bulbus Formula Granules.There were 4 batches of Fritillariae thunbergii bulbus Formula Granules from 3 manufacturers among them showed fingerprint characteristics of Fritillariae hupehensis bulbus.The total amount of peimine and peiminine in the remaining 18 batches of Fritillariae thunbergii bulbus Formula Granules was 0.291-3.179 mg·g-1,which were quite different.Conclusion Currently,the quality of Fritillariae thunbergii bulbus Formula Granules on the market varies greatly.Standardized water-extract reference substance has better applicability for the analysis of the quality of Fritillariae thunbergii bulbus Formula Granules than the control medicinal materials.