Study on Quality Evaluation of Aurantii Fructus Standard Decoction

OBJECTIVE To establish the quality control methods of Aurantii Fructus standard decoction and to provide reference for quality evaluation of Aurantii Fructus formula granules and other Aurantii Fructus products. METHODS According to the standard decoction preparation requirements, 13 batches of Aurantii Fructus standard decoctions were prepared and HPLC fingerprint was established. The main chromatographic peaks were identified under the positive and negative ion mode by high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry(HPLC-Q-TOF-MS) and electrospray ionization source. The four chemical components(narirutin, naringin, hesperidin and neohesperidin) in the standard decoction were determined by HPLC. The extract rate, the transfer rate of the four flavonoid glycosides, and the pH of the standard decoction were calculated. RESULTS Six common peaks in the fingerprint were assigned by qualitative analysis of mass spectrometry and standard comparison, namely neoeriocitrin, narirutin, naringin, hesperidin, neohesperidin and poncirin. The fingerprint similarities of the 13 batches of standard decoctions were >0.98. The content ranges of narirutin, naringin, hesperidin and neohesperidin in the standard decoction were 0.07%-0.26%, 1.30%-3.40%, 0.14%-0.34%, 0.85%-3.64%, respectively. The transfer rates of the four components were 31.4%-50.6%, 31.3%-48.9%, 22.9%-48.2%, 25.3%-50.9%, respectively. The dry extract rates were 19.3%-30.71% and pH values were 3.45-4.64. CONCLUSION The established systematic evaluation method of the quality of the Aurantii Fructus standard decoction is stable and feasible and can provide a scientific basis for the quality evaluation of Aurantii Fructus standard decoction and related preparations.