Quality Control Research of Qishen Yiqi Dripping Pills Based on UPLC Fingerprint Combined with Chemical Pattern Recognition

OBJECTIVE To establish the UPLC fingerprint of Qishen Yiqi Dripping pills and conduct a systemic, comprehensive quality evaluation of the drug using a chemical pattern recognition method. METHODS Ultra-high performance liquid chromatography instrument and ACQUITY UPLC® HSS T3 chromatographic column was employed, the separation was performed with the mobile phase consisting of acetonitrile and 0.1% formic acid aqueous solution, and the detection wavelength was set at 256 nm to establish the UPLC fingerprint of Qishen Yiqi Dripping pills. Then, the further quality assessment of the drug was carried out by similarity evaluation, cluster analysis(CA), principal component analysis(PCA) and orthogonal partial least squares discriminant analysis(OPLS-DA). RESULTS Fifty-three peaks were recognised as common peaks in the fingerprint, 14 peaks were identified using standard references. The similarity value of the drugs were all >0.94, indicating a relatively stable quality of the quality. Little difference was then discovered between the batches of the drug by CA and PCA. Finally, 3 peaks were recognised as the quality makers using a OPLS-DA method. CONCLUSION The analysis method established in this study is scientific, accurate, reliable and simple; the drug quality of Qishen Yiqi Dripping pills can be evaluated systematically and comprehensively using a fingerprint combined with chemical pattern recognition technique; what's more, it will also lay a solid theoretical basis for the further quality control of traditional Chinese medicine and its preparations at the same time.