OBJECTIVE To identify and classify the chemical components and components absorbed into blood of Sishen Pills using ultra-high performance liquid chromatography-quadrupole-orbitrap high resolution mass spectrometry.

METHODS SD rats were divided into blank group and drug administration group. The rats in drug administration group were given water extract of Sishen Pills formula intragastrically, and blank and drug-containing plasma were collected respectively. A Hypersil GOLD VANQUISH column (2.1 mm×100 mm, 1.9 μm) was used, with 0.1% formic acid water acetonitrile as the mobile phase, gradient elution, volume flow rate of 0.3 mL·min^-1, and column temperature of 35 ℃. Electrospray ion source (ESI) with positive and negative ion scanning mode was used for chromatographic separation and mass spectrometry data acquisition. The chemical components of Sishen Pills were identified by comparing the exact molecular mass, fragment ion information and relative retention time with the map of reference substance, matching with the self-established database and combining with literature reports. On this basis, the components absorbed into blood of Sishen Pills were analyzed by comparing the blank plasma and drug-containing plasma.

RESULTS A total of 181 chemical components were identified from Sishen Pills, mainly including flavonoids, alkaloids, lignans and other components. A total of 49 prototype blood components were identified from the plasma samples, mainly including flavonoids, alkaloids and other components.

CONCLUSION A variety of chemical components in Sishen Pills and drug-containing plasma are comprehensively, accurately and quickly identified, and all of them are assigned to the various medicinal materials in the prescription. This study provides reference for the quality control, basic research on medicinal effect materials and clinical application of Sishen Pills.