Shenqi Fuzheng injection fingerprint atlas establishing method

A technology of Shenqi Fuzheng and fingerprints, which is applied in the field of establishment of fingerprints of Shenqi Fuzheng Injection, can solve the problems of long analysis time, complex processing, and inability to monitor

Active Publication Date: 2014-05-21
LI MIN PHARM FAB OF LIVZON PHARM GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Among its quality standards, the [fingerprint] item is detected by high performance liquid chromatography-ultraviolet detector, which has certain limitations. For example, the saponins that account for the main content have no absorption in ultraviolet light. Detector detection can monitor the components of saponins, but the sample pretreatment is complicated and the analysis time is also very long, so it cannot monitor the main components comprehensively and quickly, which needs to be improved

Method used

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  • Shenqi Fuzheng injection fingerprint atlas establishing method
  • Shenqi Fuzheng injection fingerprint atlas establishing method
  • Shenqi Fuzheng injection fingerprint atlas establishing method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] 1 Instruments and reagents

[0088] 1.1 Instrument: Agilent liquid mass spectrometer (1290UHPLC binary gradient pump, built-in vacuum degasser, 100-position autosampler, intelligent column oven, G6520B high-precision quadrupole tandem time-of-flight mass spectrometer system); Chromatographic column: Agilent Zorbax Eclipse Plus C18 (2.1×100 mm, 1.8 μm).

[0089] 1.2 Test drug: Shenqi Fuzheng Injection, provided by Limin Pharmaceutical Factory of Livzon Group. The reagents acetonitrile and formic acid used in the experiment were chromatographically pure, and the water was ultrapure water.

[0090] 2 Methods and Results

[0091] 2.1 Preparation of the test solution: Take Shenqi Fuzheng Injection and filter it with a 0.22um microporous membrane to obtain the solution.

[0092] 2.2 Preparation of mixed reference substance solution: Take appropriate amount of calycocoside glucoside reference substance and astragaloside IV reference substance, weigh them accurately, add met...

Embodiment 2

[0117] Example 2 Identification of Shenqi Fuzheng Injection

[0118] In recent years, with the increasing clinical use of Shenqi Fuzheng Injection, some criminals, driven by economic interests, use other varieties of counterfeit Shenqi Fuzheng Injection to sell and make huge profits, which has caused great harm to the brand of Shenqi Fuzheng Injection. Big negative impact brings very big economic loss to the enterprise of regular production and sales of Shenqi Fuzheng Injection. These counterfeit Shenqi Fuzheng injections are almost exactly the same as the genuine ones in appearance, and it is difficult to distinguish the authenticity from the fake.

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Abstract

The invention provides a Shenqi Fuzheng injection fingerprint atlas establishing method. The method comprises the steps that an ultra high pressure liquid phase chromatography-mass spectrometer is used to detect Shenqi Fuzheng injection, wherein the chromatography conditions comprise an Agilent Zorbax Eclipse Plus C18 chromatography column of 2.1mm*100mm and 1.8 microns, a mobile phase A which is 0.1% aqueous formic acid and a mobile phase B which is 0.1% formic acid acetonitrile; and gradient elution is used. The elution procedure is as follows: 0 to 0.5min, 95% of mobile phase A, and 5% of mobile phase B; 0.5 to 10min, 95% to 75% of mobile phase A, and 5% to 25% mobile phase B; 10 to 15min, 75% to 45% of mobile phase A, and 25% to 55% of mobile phase B; 15 to 18min, 45% to 0% of mobile phase A, and 55% to 100% of mobile phase B; and 18 to 20min, 0% of mobile phase A, and 100% of mobile phase B.

Description

technical field [0001] The invention belongs to the technical field of drug detection, and in particular relates to a method for establishing the fingerprint of Shenqi Fuzheng Injection. Background technique [0002] The quality control of compound Chinese medicine is one of the key issues restricting the modernization of Chinese medicine. The theory of traditional Chinese medicine emphasizes the overall effect of traditional Chinese medicine and attaches great importance to the synergistic effect on drug efficacy. Using one or two active ingredients in traditional Chinese medicine as qualitative and quantitative indicators is far from being able to effectively control and evaluate the quality of Chinese medicine, and it is even more difficult to reflect its safety and effectiveness. sex. Traditional Chinese medicine compound is a compound preparation that combines two or more traditional Chinese medicines for disease treatment, and its quality control is more difficult tha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N2030/8813G01N30/7233G01N30/8686G01N33/15
Inventor 宋艳刚刘学华黄文华刘东来
Owner LI MIN PHARM FAB OF LIVZON PHARM GRP
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