Abstract:
OBJECTIVE To establish HPLC fingerprint of compound Chuipencao decreasing enzyme granules, and to determine the contents of four active ingredients and conduct a systemic, scientific quality evaluation of the drug by chemical pattern recognition technology.
METHODS Using acetonitrile-0.1% phosphoric acid aqueous solution as mobile phase for gradient elution, the detection wavelength was set at 254 nm, to establish the HPLC fingerprint of 10 batches of compound Chuipencao decreasing enzyme granules and the contents of the active ingredients of albiflorin, paeoniflorin, liquiritigenin and ammonium glycyrrhizinate were determined. Then, the further quality assessment of the drug was carried out by similarity evaluation combined with cluster analysis(CA), principal component analysis(PCA) and orthogonal partial least squares discriminant analysis(OPLS-DA).
RESULTS Twenty-two common peaks were found in the fingerprint of the samples, 4 peaks were identified using standard references. The similarity of 10 batches of samples was >0.9, and the quantitative results of the four active ingredients showed little difference, indicating that the overall quality of the drug was stable. However, little difference was then discovered between the batches of the drug by CA and PCA, and they were mainly divided into two categories. Finally, OPLS-DA was used to screen out four main components that caused the quality differences in the batches, namely peak 9, peak 19(ammonium glycyrrhizinate), peak 7(paeoniflorin) and peak 4.
CONCLUSION The method of fingerprint combined with chemical pattern recognition of active ingredients is simple, accurate, scientific and reliable, and can be used to evaluate the quality of compound Chuipencao decreasing enzyme granules more systematically and comprehensively.