Study on Fingerprints of Liposoluble Constituents from Danqi Soft Capsule by GC-MS / 中国药房

ABSTRACT

OBJECTIVE:To establish GC-MS fingerprints of liposoluble constituents from Danqi soft capsule. METHODS:GC-MS method was adopted. GC chromatogram column was DB-5 ms capillary column with high purity helium (99.999%)as carrier gas at the flow rate of 1.0 mL/min,with temperature programming. The injector temperature was 250 ℃. The sample size was 1 μL. The shunt ratio was 140,with distributary injection. Ionization mode was as follows as electron bombardment ion source,ion source temperature of 280 ℃,injector temperature of 300 ℃,electronic energy of 70 eV, solvent delay time of 3 min,mass charge ratio(m/z)of 50-550. Using ethyl palmitate as reference,MS spectrums of 11 batches of samples were determined. Similarity evaluation was conducted by using TCM Fingerprint Chromatogram Similarity Evaluation System(2004 A edition)to determine common peak. The common peaks were determined by LC Solution 2 workstation standard mass spectrometry Library(NIST05.LIB or NIST05s.LIB). RESULTS:The similarity of 11 batches of samples was higher than 0.90. After validation,GC-MS chromatograms of 11 batches of samples were in good agreement with control fingerprint. There were 49 common peaks in GC-MS chromatogram,and 38 chemical constituents were identified, accounting for 94.94% of total peak areas. CONCLUSIONS:Established fingerprint can provide evidence for quality evaluation of Danqi soft capsule.