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A method for measuring the gas-phase fingerprint of Xingnaojing injection and its standard gas-phase fingerprint

A technology for Xingnaojing injection and fingerprints, which is applied in the field of Xingnaojing injection gas-phase fingerprints and Xingnaojing injection-made gas-phase fingerprints determination, can solve the problem of unclear mechanism of action, complex chemical components of traditional Chinese medicine, and difficult to ensure Problems such as the quality stability of traditional Chinese medicine products, to achieve the effect of perfect quality control technology

Active Publication Date: 2020-09-25
WUXI JIYU SHANHE PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to the complex chemical composition and unclear mechanism of action of traditional Chinese medicine, it is difficult to ensure the quality stability of traditional Chinese medicine products in the existing traditional Chinese medicine pharmaceutical technology.

Method used

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  • A method for measuring the gas-phase fingerprint of Xingnaojing injection and its standard gas-phase fingerprint
  • A method for measuring the gas-phase fingerprint of Xingnaojing injection and its standard gas-phase fingerprint
  • A method for measuring the gas-phase fingerprint of Xingnaojing injection and its standard gas-phase fingerprint

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0117] Embodiment 1 Xingnaojing Injection Gas-phase Fingerprint Determination

[0118] Take Xinnaojing Injection, batch number 180205

[0119] Step (1) The preparation method of the test solution is: get 8 finished products of Xingnaojing Injection, pour out the contents, mix evenly, each precisely draw 50ml, and pass through the C8 stationary phase extraction cartridge (100mg / l ml, C8 small The column was pre-washed with 20ml of absolute ethanol and 20ml of water), discarded, and eluted with 5ml of absolute ethanol respectively, and the eluate was collected, placed in a 5ml volumetric flask, added with absolute ethanol to the mark, and shaken to obtain .

[0120] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the curcumadione reference substance is 48.3 μg / ml.

[0121] Step (3) need testing solution, reference substance solution is injected into chromatograph, obtains chromatogram.

[0122] Gas chromatograph...

Embodiment 2

[0126] Example 2 Determination of Xingnaojing Injection Gas Phase Fingerprint

[0127] Take Xinnaojing Injection, the batch number is 180206

[0128] Step (1) The preparation method of the test solution is: get 8 finished products of Xingnaojing Injection, pour out the contents, mix evenly, each precisely draw 50ml, and pass through the C8 stationary phase extraction cartridge (100mg / l ml, C8 small The column was pre-washed with 20ml of absolute ethanol and 20ml of water), discarded, and eluted with 5ml of absolute ethanol respectively, and the eluate was collected, placed in a 5ml volumetric flask, added with absolute ethanol to the mark, and shaken to obtain .

[0129] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the curcumadione reference substance is 48.3 μg / ml.

[0130] Step (3) need testing solution, reference substance solution is injected into chromatograph, obtains chromatogram.

[0131] Gas chroma...

Embodiment 3

[0135] Embodiment 3 Xingnaojing Injection Gas-phase Fingerprint Spectrum Determination

[0136] Take Xinnaojing Injection, the batch number is 180207

[0137] Step (1) The preparation method of the test solution is: get 8 finished products of Xingnaojing Injection, pour out the contents, mix evenly, each precisely draw 50ml, and pass through the C8 stationary phase extraction cartridge (100mg / l ml, C8 small The column was pre-washed with 20ml of absolute ethanol and 20ml of water), discarded, and eluted with 5ml of absolute ethanol respectively, and the eluate was collected, placed in a 5ml volumetric flask, added with absolute ethanol to the mark, and shaken to obtain .

[0138] Step (2) The concentration of the reference substance solution preparation is respectively: the concentration of the curcumadione reference substance is 48.3 μg / ml.

[0139] Step (3) need testing solution, reference substance solution is injected into chromatograph, obtains chromatogram.

[0140] G...

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Abstract

The invention relates to a measurement method for a gas phase fingerprint of a Xingnaojing injection and a standard fingerprint thereof, wherein the measurement method comprises the following steps: (1) preparation of a test solution: taking a Xingnaojing injection, pouring out the content, mixing uniformly, absorbing an appropriate amount accurately, extracting a small column through a C8 stationary phase, discarding, adding absolute ethyl alcohol to elute, carrying out a constant volume to a scale, shaking well, serving as the test solution; (2) acquisition of a gas chromatogram: injecting the test solution into a gas chromatograph, measuring, and recording the chromatogram; (3) contrasting the acquired chromatogram with a standard fingerprint, being qualified when the similarity is greater than 0.75, wherein the evaluation of similarity is evaluated by the Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System 2004A Edition.

Description

technical field [0001] The invention relates to a method for analyzing gas-phase fingerprints of traditional Chinese medicine injections, in particular to a method for measuring gas-phase fingerprints of Xingnaojing injections, and the gas-phase fingerprints of Xingnaojing injections obtained therefrom. [0002] technical background [0003] Due to the complex chemical composition and unclear mechanism of action of traditional Chinese medicine, it is difficult for the existing traditional Chinese medicine pharmaceutical technology to ensure the quality stability of traditional Chinese medicine products. At present, most of the active ingredients of traditional Chinese medicine are not clear, and the method of fingerprinting of traditional Chinese medicine will effectively characterize the quality of traditional Chinese medicine. Fingerprints have been recognized by the international community, which is conducive to the entry of Chinese medicines and products into the internat...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/86
CPCG01N30/8686G01N30/88G01N2030/8809
Inventor 甘国峰张玉洁张小娜
Owner WUXI JIYU SHANHE PHARM CO LTD
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