Quality evaluation system for slice decoction of Ziziphi Spinosae Semen / 中草药

ABSTRACT

Objective To establish a quality evaluation system for slice decoction of Ziziphi Spinosae Semen (SZR). Methods Ten batches of SZR slice were collected and prepared into decoction, and then the decoctions of SZR were prepared as freeze-dried powders. The extraction rate and the content of the index components were used as indicators to optimize the extraction process. Multi-dimensional chemical fingerprints were established by HPLC coupled with UV detector and ELSD detector. The similarity, RSD of relative retention time, and RSD of relative peak area were analyzed to comprehensively evaluate the quality of ten batches of SZR slice decoction. A sensitive method based on ultra-HPLC coupled with triple quadrupole mass spectrometry (UPLC-MS/MS) was established and validated for quantitative analysis of the nine compounds in SZR slice decoction, including coclaurine, magnoflorine, vicenin II, spinosin, swertisin, kaempferol-3-O-rutinoside, 6'''-feruloylspinosin, jujuboside A, and jujuboside B. Consequently, the developed methods were successfully applied to the quality assessment of SZR slice decoction. Results The average dry extraction rate of ten batches of SZR slice decoction was 20.77%. Three, four, and two common peaks were identified in the HPLC-UV 227 nm, 335 nm, and HPLC-ELSD fingerprints. The similarity of the fingerprints at different detection wavelengths was in the range of 0.942-0.988, relative retention time and relative peak area RSD% were less than 3%. The method validation results indicated that the methods were simple, specific and reliable. All the compounds showed good linearity (r > 0.999 0) with a relatively wide concentration range, acceptable recovery at 87.40%-110.42%, and RSD% less than 4.12%. The content of nine chemical compounds in ten batches of SZR slice decoction were as follows 0.25-0.27 mg/g of coclaurine, 3.2-3.6 mg/g of magnoflorine, 0.077-0.084 mg/g of vicenin II, 0.82-0.89 mg/g of spinosin, 0.007 6-0.008 5 mg/g of swertisin, 0.057-0.060 mg/g of kaempferol-3-O-rutinoside, 0.32-0.35 mg/g of 6'''-feruloylspinosin, 0.83-0.91 mg/g of jujuboside A, and 0.095-0.110 mg/g of jujuboside B. Conclusion A stable and reliable quality evaluation method of SZR slice decoction was established, which provides a stable material basis for the follow-up pharmacokinetic and pharmacodynamic experiments and provides a reference for the quality control of the prescription containing SZR at the same time.