Objective: To establish a quality control method for the main active components of Xiao’er Chaihu Tuire suppository based on gas chromatography-mass spectrometry (GC-MS). Methods: The contents of N-hexanal and N-heptanal in the main active components of Xiao’er Chaihu Tuire suppository were determined by GC-MS

and the unknown components were compared and analyzed combined with the mass spectrometry database. The samples were separated on a SH-Rtx-Wax (30 m×0.25 mm×0.25 μm) capillary column under the initial programmed temperature of 60 ℃ for 2 min

the temperature was increased to 140 ℃ at the rate of 20 ℃ /min for 3 min

to 180 ℃ at the rate of 15 ℃/min for 4 min

and finally to 230 ℃ at a rate of 10 ℃/min for 4 min. GC-MS carrier gas was helium

with a flow rate of 1 mL/min and a split ratio of 10∶1. The inlet temperature was 230 ℃

and the injection volume was 1.0 μL. Mass spectrometry conditions were as follows: the EI source

positive ion mode

bombardment voltage at 70 eV

ion source temperature at 230 ℃

the quality scan range from 45 to 300

and data acquisition mode of Q3 Scan. Results: N-hexanal and N-heptanal had good linear relationship with the peak areas in the selected concentration range. The correlation coefficients were 0.998 and 0.999

the recovery rates were 99.7% and 100.4%

and RSD were 1.46% and 2.89%

respectively. The repeatability

stability and precision were all good. The average contents of N-hexanal and N-heptanal in Xiao’er Chaihu Tuire suppository were respectively 73.3 μg/piece and 110.3 μg/piece

and 26 compounds were identified

including β-Eudesmol and terpinen-4-ol. Conclusion: The quality control method of the main pharmacodynamic components of Xiao’er Chaihu Tuire suppository based on GC-MS has strong specificity

high sensitivity and good repeatability

and can be used as quality control method to provide theoretical basis for further research on the material basis of the pharmacological action of Xiao’er Chaihu Tuire suppository.