Study on the Fingerprint of Crude/vinegar-processed Corydalis yanhusuo Decoction Pieces and Their Dispen- sing Granules and Content Determination of Five Alkaloids / 中国药房

ABSTRACT

OBJECTIVE：To establish the fingerprint of crude/vinegar-processed Corydalis yanhusuo decoction pieces and their dispensing granules，and to determine the contents of five alkaloids （protopine，tetrahydropalmatine，corydaline，berberine hydrochloride，palmatine hydrochloride ）. METHODS ：HPLC method was adopted. The determination was performed on Agilent TC-C18 column with mobile phase consisted of 0.1％ phosphoric acid solution-methanol （gradient elution ）at the flow rate of 1.0 mL/min. The detection wavelength was set at 280 nm，and the column temperature was 30 ℃. The sample size was 10 μL. Using palmatine hydrochloride as reference ， Similarity Evaluation System of TCM Chromatographic Fingerprint （2012 edition） was used to establish the fingerprint of 11 059） batches of C. yanhusuo decoction pieces ，7 batches of crude . yanhusuo dispensing granules ， 12 batches of vinegar- processed C. yanhusuo decoction pieces and 11 batches of vinegar-processed C. yanhusuo dispensing granules. The same HPLC method was adopted to determine the contents of protopine， tetrahydropalmatine， corydaline， berberine hydrochloride and palmatine hydrochloride in 41 batches of crude/ vinegar-processed C. yanhusuo decoction pieces and their dispensing granules. RESULTS ：There were 12 and 20 common peaks for crude C. yanhusuo decoction pieces and its dispensing granules ，and 14 and 16 common peaks for vinegar-processed C. yanhusuo decoction pieces and its dispensing granules. The similarity of each batch of same type were 0.529-0.981，0.342-0.985， 0.711-0.999，0.437-0.998，respectively. The linear range of protopine ，tetrahydropalmatine，corydaline，berberine hydrochloride and palmatine hydrochloride were 1.9-38.0，2.0-40.0，2.2-44.0，2.6-52.0，2.3-46.0 μg/mL（R2＞0.999 0）. The recoveries were 100.12％-100.98％（RSD＝1.05％-1.90％，n＝9）. RSDs of precision ，reproducibility，stability（24 h）and durability tests were all lower than 2.0％. The average contents of five alkaloids in different batches of crude/vinegar-processed C. yanhusuo decoction pieces and its dispensing granules were 0.24-0.46，0.37-0.82，0.24-0.58，0.07-0.75，0.24-0.76 mg/g. RSDs were 12.27％-147.48％. CONCLUSIONS：The fingerprint of crude/vinegar-processed C. yanhusuo decoction pieces and its dispensing granules is established successfully. The similarities of fingerprint are different before and after processing with vinegar ，and the contents of five alkaloids in C. yanhusuo decoction pieces and its dispensing granules are greatly different.