Objective  To establish a method for simultaneous determination of 12 components in Shezhi Shenhuang ointment, and to evaluate its comprehensive quality by combining chemometrics and grey relational analysis (GRA).

Methods  With sophoridine as the internal reference substance, HPLC-QAMS method was used to simultaneously determine the contents of sophocarpine, matrine, oxysophocarpine, sophoridine, oxymatrine, magnoflorine, phellodendrine hydrochloride, berberine hydrochloride, aloeresin D, aloin B, aloin A and pseudolaric acid B in Shezhi Shenhuang ointment. Chemometrics was used to excavate differential markers affecting the product quality of Shezhi Shenhuang ointment. The compositional data of each index of different batches of Shezhi Shenhuang ointment was analyzed based on GRA method, the relative correlation degree was used as measure and the comprehensive quality of Shezhi Shenhuang ointment was evaluated.

Results  The linear ranges of sophocarpine, matrine, oxysophocarpine, sophoridine, oxymatrine, magnoflorine, phellodendrine hydrochloride, berberine hydrochloride, aloeresin D, aloin B, aloin A and pseudolaric acid B were 0.47-23.50 µg·mL^-1, 7.05-352.50 µg·mL^-1, 4.28-214.00 µg·mL^-1, 1.36-68.00 µg·mL^-1, 13.65-682.50 µg·mL^-1, 0.24-12.00 µg·mL^-1, 0.36-18.00 µg·mL^-1, 2.68-134.00 µg·mL^-1, 2.85-142.50 µg·mL^-1, 1.24-62.00 µg·mL^-1, 1.96-98.00 µg·mL^-1 and 3.67-183.50 µg·mL^-1, respectively (r>0.999 0). The average recovery was between 96.75% and 100.26% (RSD<2.0%, n=9). There were no significant differences between the calculated values and the measured values (P>0.05). The main components that distinguish the quality of Shezhi Shenhuang ointment were oxymatrine, matrine, berberine hydrochloride and aloin A. The relative correlation degree of 12 components were 0.310 8-0.637 8, and there were some differences in the quality of Shezhi Shenhuang ointment.

Conclusion  The established HPLC-QAMS multi-component quantitative method combined with chemometrics and GRA is convenient and accurate, which provides a basis for the quality control and quality evaluation of Shezhi Shenhuang ointment.

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