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Quality control method of ginseng and astragalus injection for strengthening body

A technology of Shenqi Fuzheng and injection, which is applied in the field of fingerprint control of Shenqi Fuzheng injection, and can solve the problems of general practical limitations of the method, etc.

Inactive Publication Date: 2009-01-28
LI MIN PHARM FAB OF LIVZON PHARM GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the method described in the patent application publication has many advantages, there are still some points for improvement. For example, the preparation method of the test solution of the Shenqi Fuzheng injection sample is limited to one method, and the method involves the use of a specific model macroporous adsorbent resins, the general applicability of which method is limited

Method used

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  • Quality control method of ginseng and astragalus injection for strengthening body
  • Quality control method of ginseng and astragalus injection for strengthening body
  • Quality control method of ginseng and astragalus injection for strengthening body

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1, the establishment of the standard fingerprint of Shenqi Fuzheng Injection (A method)

[0041] 1. Preparation of standard test solution

[0042] ①Fingerprint of phenolic acids: Precisely measure 25ml of Shenqi Fuzheng injection sample, put it in a water bath to concentrate to about 5ml, and slowly pass it through the AB-8 macroporous adsorption resin column (the inner diameter of the column is 1.5cm, and the column length is 20cm). Elute with 70ml of water, discard the water eluate, continue to elute with 80ml of 70% ethanol, collect the 70% ethanol eluate, put it in a water bath and concentrate to dryness, add water to dissolve the residue and transfer it to a 10ml measuring bottle, add water to dilute to Scale, shake well, filter with 0.45μm microporous membrane, that is.

[0043] ②Fingerprint of saponins: Precisely measure 200ml of Shenqi Fuzheng injection sample, put it in a water bath and concentrate it to about 10ml, slowly pass it through the AB-8 m...

Embodiment 2

[0095] Embodiment 2. The establishment of the standard fingerprint of Shenqi Fuzheng Injection (B method)

[0096] 1. Preparation of standard test solution

[0097] (1) Test sample of phenolic acid fingerprints: Accurately measure 25ml of Shenqi Fuzheng injection sample, extract four times with water-saturated n-butanol, 20ml each time, combine n-butanol solution, let stand, and wait for complete clarification , discard the remaining water layer, put the n-butanol solution in a water bath and concentrate to dryness, add water to dissolve the residue, transfer it to a 10ml measuring bottle, add water to dilute to the mark, shake well, and use a microporous membrane filter (water phase, 0.45 μm ) filter, that is.

[0098](2) Test samples of saponins fingerprints: Accurately measure 200ml of Shenqi Fuzheng injection sample, put in a water bath and concentrate to about 20ml, extract with n-butanol saturated with water four times, 25ml each time, combine the n-butanol solution, W...

Embodiment 3

[0146] Embodiment 3, this method is applied to the quality control of Shenqi Fuzheng Injection

[0147] Select commercially available Astragalus Injection, Salvia Infusion, and Shenqi Fuzheng Injection, measure its fingerprints according to the A method of Example 1, and compare them with standard fingerprints. If the similarity is greater than 0.9, it is Shenqi Fuzheng Injection. The rest are all lower than 0.9, which can be used to distinguish the authenticity of Shenqi Fuzheng Injection.

[0148] Astragalus Injection:

[0149] The fingerprints of phenolic acids and saponins at 208nm and 266nm are as follows: Figure 7A one Figure 7C , and their similarities are 0.409, 0.315, and 0.611, respectively.

[0150] Salvia Infusion:

[0151] The fingerprints of phenolic acids and saponins at 208nm and 266nm are as follows: Figure 8A one Figure 8C , and their similarities are 0.292, 0.257, and 0.000, respectively.

[0152] Shenqi Fuzheng Injection:

[0153] The fingerprin...

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Abstract

The invention discloses an improved quality control method of a ginseng and astragalus body resistance strengthening injection, in particular to an improved fingerprint control method of a ginseng and astragalus body resistance strengthening injection. In the method of the invention, the preparation method of the test solution of the ginseng and astragalus body resistance strengthening injection sample is modified into an A method: a ginseng and astragalus body resistance strengthening injection sample is concentrated in accordance with legal rules and passes through a macroporous absorptive resin column, water is firstly used for eluting, then ethanol is adopted for eluting, ethanol eluent is collected and concentrated to be dried, and residue is added with water or ethanol for being dissolved so as to obtain the test solution of the ginseng and astragalus body resistance strengthening injection sample; or into a B method: the ginseng and astragalus body resistance strengthening injection sample is leached by saturated normal butanol, the normal butanol liquid is concentrated to be dried, residue is added with polar solvent for dissolving and diluting and is filtered by a microporous film so as to obtain the test solution of the ginseng and astragalus body resistance strengthening injection sample.

Description

technical field [0001] The invention relates to an improved quality control method of Shenqi Fuzheng injection, in particular to an improved fingerprint control method of Shenqi Fuzheng injection. Background technique [0002] Shenqi Fuzheng Injection is a pure Chinese medicine preparation made by extracting Codonopsis pilosula and Astragalus membranaceus. Codonopsis pilosula and Astragalus meridian have the same nature, flavor and meridian distribution, and their efficacy is basically the same. The addition of the two medicines has a synergistic effect of the monarch and his ministers assisting each other and envoys each other, which significantly enhances the clinical curative effect. However, quality control is always the most important issue for ensuring the stability and safety of TCM injections in clinical use. [0003] In the Chinese patent application No. 200610098953.1 published on January 24, 2007, the quality control method of Shenqi Fuzheng Injection was reporte...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/481G01N33/02G01N30/86A61P37/04
Inventor 谢海燕刘东来刘学华
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP
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