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Method for evaluating chemical components of Shenqi Fuzheng Injection and its application

A technology of Shenqi Fuzheng and chemical composition, which is applied in the field of evaluation of chemical composition of traditional Chinese medicine, and can solve problems such as difficult evaluation of active ingredients of Shenqi Fuzheng injection, unfavorable product safety and effectiveness, etc.

Active Publication Date: 2016-08-24
LI MIN PHARM FAB OF LIVZON PHARM GRP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, in the current quality standard of Shenqi Fuzheng Injection, the original quality standard fingerprint only focused on the S peak (verbacosin) and the more polar water-soluble components, as well as the Astragalus A under the content determination item. glycoside content, it is difficult to evaluate the active ingredients in Shenqi Fuzheng Injection, and its negatively related ingredients, which is not conducive to the standard control of product safety and effectiveness

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  • Method for evaluating chemical components of Shenqi Fuzheng Injection and its application
  • Method for evaluating chemical components of Shenqi Fuzheng Injection and its application
  • Method for evaluating chemical components of Shenqi Fuzheng Injection and its application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Embodiment 1: the screening of HSCCC separation condition

[0087] 1. Experimental method

[0088] 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; Fully oscillate in different proportions of ethyl acetate-ethanol-water and ethyl acetate-n-butanol-water), 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 being filtered by a 0.45 μm filter membrane, inject 75 μl of the sample directly, measure the common peak area A2, and calculate the partition coefficient K value.

[0089] 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 ...

Embodiment 2

[0106] Embodiment 2: the preparation of difference sample

[0107] 1. Experimental method:

[0108] (1) The repeatability investigation of HSCCC method: adopt the separation condition (condition as following a) of the HSCCC screened in embodiment 1 to collect the liquid of four parts, repeat operation seven times, carry out HPLC-DAD-ELSD fingerprint spectrum 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 (2009 edition).

[0109] 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 steamed to After drying, dissolve it in 5ml solvent system for later use; flow rate: 2ml / min; six-way valve connection: forward to forward rotation; speed: 900rpm; detection wavelength: 254nm; sam...

Embodiment 3

[0161] The mensuration of the fingerprint spectrum of embodiment 3 difference samples

[0162] According to the same conditions and operations as the HPLC-DAD-ELSD spectrum measurement in Example 2, the difference samples 1 to 9 prepared in Example 2 were respectively subjected to fingerprint spectrum measurement, and the obtained fingerprint spectrum and peak area are shown in Figure 8 and Table 16.

[0163] Table 16 Fingerprint characteristics of difference samples 1-9

[0164]

[0165] Continuation of Table 16:

[0166]

[0167] 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 to 9 were obtained respectively, and were imported into SPSS 16.0 for cluster analysis , the clustering method uses the nearest neighbor method, and the distance calculation method uses Euclidean distance. The results sh...

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Abstract

A provided method for determining chemical compositions in Shenqi Fuzheng injection comprises the following steps: (1) preparing a test sample of Shenqi Fuzheng injection; (2) preparing a differentiated sample; (3) determining a fingerprint of the differentiated sample; (4) determining the drug effect of the differentiated sample; and (5) performing spectrum-activity relationship analysis to evaluate the drug effect activity of common peaks. By employing the method disclosed by the invention, the inventor discovers that No. 9 peak, No. 11 peak, No. 12 peak, No. 15 peak and No. 20 peak in the fingerprint of Shenqi Fuzheng injection are active compositions, and No. 5 peak and / or No. 13 peak are negative correlated compositions, and the method is beneficial for controlling traditional Chinese medicine quality, safety and effectiveness.

Description

technical field [0001] The invention relates to a method for evaluating chemical components of traditional Chinese medicines, in particular to a method for evaluating chemical components of Shenqi Fuzheng Injection and the application of the method. Background technique [0002] Codonopsis (Radix Codonopsis) is mild in nature, widely used, and has various pharmacological activities. It not only has an effect on digestion and cardiovascular system, but also regulates the function of the immune system, enhances the body's resistance, and has little toxicity. Astragalus (Radix Astragalus) is the main drug for invigorating qi, which can significantly increase the phagocytic function of macrophages. When used in combination with Codonopsis pilosula, it can enhance the macrophages' ability to phagocytose harmful substances. [0003] Shenqi Fuzheng Injection is a pure Chinese medicine preparation made by extracting Codonopsis pilosula and Astragalus membranaceus. Codonopsis pilosu...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/06
Inventor 苏薇薇王锦旭童欣曹晖李沛波彭维王永刚
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP