Construction method for HPLC (high performance liquid chromatography) finger-print chromatogram of ginseng and astragalus strengthening injection and application of finger-print

Abstract

The invention discloses a construction method for an HPLC (high performance liquid chromatography) finger-print chromatogram of ginseng and astragalus strengthening injection, and application of the finger-print. The construction method includes the following steps: performing online automatic pretreatment for a sample through utilizing a double-pump double-gradient high performance liquid chromatograph; and then, performing detection in a manner of series connecting DAD-ELSD detectors and switching wavelengths of 266nm / 208nm ultraviolet detecting waves, and obtaining the HPLC finger-print chromatogram of the ginseng and astragalus strengthening injection. 21 common chromatographic peaks are detected in the HPLC finger-print chromatogram of the ginseng and astragalus strengthening injection, which is obtained through the method, 20 chemical components in the finger-print chromatogram are testified through adopting the UFLC-DAD-MS / MS technology, and the diagram of the finger-print chromatogram is shown in the figure 1 in the attached figures of the explanatory memorandum. The method disclosed by the invention can correctly reflect the overall quality characteristics of the ginseng and astragalus strengthening injection, can comprehensively monitor and control the quality of raw material drugs, semi-finished products and finished products, and can perform quality control and fake prevention through comparing similarity of chromatogram fingerprint characteristics.

Description

technical field [0001] The invention relates to a method for constructing the HPLC fingerprint of Shenqi Fuzheng injection and the HPLC standard fingerprint of Shenqi Fuzheng injection obtained by the method, belonging to the technical field of drug analysis. Background technique [0002] Shenqi Fuzheng Injection is a traditional Chinese medicine infusion made from Codonopsis pilosula and Astragalus membranaceus, which are traditional Chinese medicines for invigorating Qi and strengthening Qi. When it is used in combination with antitumor drugs, it has the effect of reducing toxicity and enhancing efficacy. At the same time, it is also an ideal therapeutic drug for patients with coronary heart disease, angina pectoris and stroke, and has broad clinical application prospects. [0003] In-depth research on the quality control methods of traditional Chinese medicine injections is always the most important issue to ensure its stability and safety in clinical use. In published ...

AI Technical Summary

Problems solved by technology

The disadvantages of the methods described in these two patent application publications are: (1) The test sample should be prepared through steps such as separation and purification of AB-8 macroporous resin column or extraction with saturated n-butanol for 4 times followed by concentration, which is complicated Complicated, high-temperature concentration steps are likely to cause composition changes, affecting the reproducibility of the method

The determination of phenolic acids with UV absorption and saponins without UV absorption requires the same cumbersome method to prepare the test solution respectively. The method has the disadvantages of long time consumption and the use of many organic solvents.

(2) Fingerprints are measured using up to 5 nonlinear gradients. The same conditions are used to measure phenolic acids with UV absorption and saponins without UV absorption. The time for one measurement is as long as 166 minutes. Complicated, time-consuming, high mobile phase consumption, difficult to reproduce

(3) The method of determination of fingerprint spectrum is UV 208nm, 266nm detection and ELSD detection respectively in the whole process, and 3 spectra are obtained, and the chromatographic peak information overlaps a lot, and repeated measurement brings inconvenience to the analysis

(4) The chemical information provided by the fingerprints is insufficient, and the chromatographic peaks provided are few. Only calycosin-7-O-β-D glucoside and astragaloside IV are identified as components of Astragalus , there is no chromatographic peak component assigned to Codonopsis pilosula

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