ABSTRACT
OBJECTIVE： To establish the fingerprint of Maizao yishen granules， and to provide scientific basis for its further development. METHODS： HPLC method was adopted to establish the fingerprint by using 10 batches of Maizao yishen granules sa samples. The determination was performed on Venusil XBP C18（L） column with mobile phase consisted of acetonitrile-0.2％ phosphoric acid （gradient elution） at the flow rate of 1→0.7 mL/min at 7-10 min， 0.7→1 mL/min at 10-15 min and 1 mL/min at the rest of time. The detection wavelengths were set at 284 nm （0-7 min）， 330 nm （7-32 min） and 360 nm （32-45 min）. The column temperature was 25 ℃， and sample size was 10 μL. The fingerprint of Maizao yishen granules was established， and the similarity evaluation was performed by using “Similarity Evaluation System of TCM Chromatographic Fingerprints” （2004 A edition） software. Then， the common peaks were assigned and identified by comparing reference substance and control medicinal materials. RESULTS： The precision， stability （24 h） and repeatability of the methodological investigation were all good [RSD values of relative retention time and relative peak area of each chromatographic peak were less than 3％ （n＝6）]. The similarity of 10 batches of samples were all above 0.900. Seventeen common peaks were identified， of which common peak 1 and 6 came from Semen Raphani； common peak 7， 9， 14， 15 and 16 from Citrus reticulata； common peak 5， 10， 11， 12 and 13 came from Glycyrrhiza uralensis； common peak 2 came from C. reticulata， G. uralensis and Ziziphus jujuba； peak 3 came from G. uralensis and Semen Raphani； peak 8 came from Hordeum vulgare and Semen Raphani； peak 4 and 17 came from C. reticulata and G. uralensis. Peak 1 was identified as hesperidin and the peak 9 was identified as sinapine. CONCLUSIONS： Established fingerprint of Maizao yishen granules is accurate and reliable， and can be used for quality control of Maizao yishen granules.