Method for determining chemical compositions in Shenqi Fuzheng injection and application thereof
A technology for Shenqi Fuzheng and chemical components, which is applied in the field of evaluating the chemical components of traditional Chinese medicines, and can solve the problems of difficulty in evaluating the active components of Shenqi Fuzheng injection, unfavorable product safety and effectiveness, and the like.
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Embodiment 1
[0085] Embodiment 1: the screening of HSCCC separation condition
[0086] 1. Experimental method
[0087] Screening of HSCCC solvent system: Take Shenqi Fuzheng Injection SFI and filter it through a 0.45 μm filter membrane, then inject 75 μl directly with HPLC-DAD-ELSD, and measure the common peak area A1; Proportions of ethyl acetate-ethanol-water and ethyl acetate-n-butanol-water) were fully shaken, and after standing still, take the water phase (lower layer solution) and rotary evaporate to recover the solvent to dryness, ultrasonically dissolve with water and set the volume to 5ml, After filtering through a 0.45 μm filter membrane, inject 75 μl directly, measure the common peak area A2, and calculate the partition coefficient K value.
[0088] Screening of HSCCC collection time: Prepare a screened solvent system, separate by sample injection, and analyze each part of the separated sample by HPLC-DAD-ELSD sample injection, and finally determine the HSCCC separation metho...
Embodiment 2
[0105] Embodiment 2: the preparation of difference sample
[0106] 1. Experimental method:
[0107] (1) Repeatability investigation of the HSCCC method: adopt the separation conditions of HSCCC screened in Example 1 (conditions are as follows a) to collect four parts of the liquid, repeat the operation seven times, and perform HPLC-DAD-ELSD fingerprint analysis ( The conditions are as follows b), and the repeatability of the HSCCC method was investigated with the Chinese medicine chromatographic fingerprint similarity evaluation system (version 2009).
[0108] A. Solvent system: ethyl acetate-n-butanol-water 4:1:5, after standing still, take the upper phase as the stationary phase, and the lower phase as the mobile phase; sample volume: 250ml SFI concentrated to 20ml, rotary evaporated to dryness Dissolve in 5ml solvent system for later use; flow rate: 2ml / min; six-way valve connection: forward to forward rotation; rotational speed: 900rpm; detection wavelength: 254nm; sam...
Embodiment 3
[0160] The mensuration of the fingerprint spectrum of embodiment 3 difference samples
[0161] According to the same conditions and operations as the HPLC-DAD-ELSD spectrum measurement in embodiment 2, the difference samples 1 to 9 prepared in embodiment 2 are respectively subjected to fingerprint spectrum measurement, and the obtained fingerprint spectrum and peak area are shown in Figure 8 and Table 16.
[0162] Table 16 Fingerprint characteristics of difference samples 1-9
[0163]
[0164] Continuation of Table 16:
[0165]
[0166] The inventor also performed a cluster analysis on the above-mentioned differential samples: according to the above-mentioned HPLC-DAD-ELSD fingerprints, the peak areas of the 23 common peaks of the differential samples 1-9 were obtained respectively, and were imported into SPSS16.0 for clustering For analysis, the clustering method uses Nearest neighbor, and the distance calculation method uses Euclidean distance. The results show t...
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