Fingerprint Establishment and Content Determination of 3 Components in Fritillaria thunbergii Formula Granules / 中国药房

ABSTRACT

OBJECTIVE：To establish the fingerprint of Fritillariae thunbergii formula granules and determine the contents of 3 components. METHODS ：HPLC method was used. Using peiminine as reference ，HPLC fingerprints of 13 batches of F. thunbergii formula granules were drawn with Similarity Evaluation System of TCM Chromatogram Fingerprint （2012 edition）. Similarity evaluation and common peak identification were conducted. The contents of peimisine ，peimine and peiminine in F. thunbergii formula granules were determined by the same HPLC method. The quality difference of samples were compared among different manufacturers. RESULTS ：There were 5 common peaks in 13 batches of F. thunbergii formula granules ，and the similarity was 0.669-0.971. Three common peaks of peimisine ，peimine and peiminine were identified. The linear ranges of peimisine ，peimine and peiminine were 30.00-180.00 μg/mL（r＝0.999 9），79.58-477.50 μg/mL（r＝0.999 6）and 97.33-584.00 μg/mL（r＝0.999 4）， respectively. RSDs of precision ，stability（24 h）and reproducibility tests were all lower than 3％. The average recoveries were 95.82％（RSD＝1.17％，n＝6），99.00％（RSD＝1.96％，n＝6）and 95.39％（RSD＝2.00％，n＝6），respectively. In the 13 batches of samples ，the content of peimisine ，peimine and peiminine were 0.17-1.02 mg/g，0.52-2.26 mg/g，and 0.70-3.50 mg/g， respectively. Their average total content was 3.62 mg/g. The average total content of manufacturer C and A was higher （5.02 mg/g and 4.61 mg/g），followed by manufacturer E and B （3.48 mg/g and 3.02 mg/g）；the lowest was manufacturer D（only 1.87 mg/g）. CONCLUSIONS：Established fingerpri nt and content determination method is simple ，feasible and reproducible ，which can be used for the quality evaluation of F. thunbergii formula granules. There are some differences in content among different manufacturers.