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Method for identifying finger print atlas of injecta

A fingerprint and comparison fingerprint technology is applied in the field of quality control of traditional Chinese medicine compositions, which can solve the problems of irregular and perfect quality standards of traditional Chinese medicines, inability to accurately reflect the quality status of traditional Chinese medicines, and backward quality analysis and evaluation methods.

Active Publication Date: 2006-08-09
JIANGSU KANION PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0002] At present, the quality standards of traditional Chinese medicine are not standardized and perfect, and the means of quality analysis and evaluation are still very backward, which cannot accurately reflect the quality status of existing traditional Chinese medicine, which has become an obstacle for Chinese medicine to go abroad and go to the world

Method used

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  • Method for identifying finger print atlas of injecta
  • Method for identifying finger print atlas of injecta
  • Method for identifying finger print atlas of injecta

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Embodiment 1: Reduning Injection Liquid Phase Fingerprint Determination Method

[0068] time (minutes)

Methanol (%)

0.1% phosphoric acid (%)

0

50

60

20

60

60

80

40

40

[0069] The flow rate is 0.8ml / min; the detection wavelength is 225nm. The number of theoretical plates is calculated according to the peak of the reference substance (geniposide), and should not be less than 6000.

[0070] Preparation of reference substance solution: Take an appropriate amount of geniposide reference substance, weigh it accurately, add methanol to make a solution containing 50 μg per 1 ml, and obtain it.

[0071] Preparation of the test solution: Take 1ml of this product, put it in a 25ml measuring bottle, add 50% methanol solution to dilute to the mark, shake well, and you get it.

[0072] Determination method: Precisely draw 10 μl of the reference substance solution and the test solution, inject them into the liquid...

Embodiment 2

[0075]Embodiment 2: Determination method of reduning injection gas phase fingerprint

[0076] Chromatographic conditions and system adaptability test Agilent 6890 gas chromatograph, gas chromatographic headspace sampling method determination, headspace oven temperature 95 ° C, transfer tube temperature 110 ° C, sampling loop temperature 125 ° C, equilibration time: 60 min; with 5 % diphenyl-95% dimethylsilane copolymer as the stationary phase capillary chromatographic column (HP-5: 30m×0.32mm×0.25μm); inlet temperature: 240°C; detector temperature (FID): 240 ℃; headspace sampling measurement, split ratio: 1:1; temperature program: initial temperature 50 ℃, keep 5 minutes, rise to 80 ℃ at 10 ℃ per minute, keep 10 minutes, rise to 130 ℃ at 10 ℃ per minute , kept for 6 minutes, then raised to 240°C at 5°C per minute, held for 9 minutes, and measured; carrier gas flow rate: 2.0ml / min; the number of theoretical plates was calculated according to the peak of the reference substance ...

Embodiment 3

[0082] Embodiment 3: Reduning Injection Biphasic Fingerprint Determination Method

[0083] time (minutes)

Methanol (%)

0.1% phosphoric acid (%)

0

50

60

20

60

60

80

40

40

[0084] The flow rate is 0.8ml / min; the detection wavelength is 225nm. The number of theoretical plates is calculated according to the peak of the reference substance (geniposide), and should not be less than 6000.

[0085] Preparation of reference substance solution: Take an appropriate amount of geniposide reference substance, weigh it accurately, add methanol to make a solution containing 50 μg per 1 ml, and obtain it. Preparation of the test solution: Take 1ml of this product, put it in a 25ml measuring bottle, add 50% methanol solution to dilute to the mark, shake well, and you get it. Determination method: Precisely draw 10 μl of the reference substance solution and the test solution, inject them into the liquid chromatograph respect...

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Abstract

The present invention discloses a fingerprint chromatogram determination method of Chinese medicine injection preparation made up by using (by weight portion) 1000-1400 portions of sweet wormwood, 600-900 portions of lonicera flower and 500-700 portions of gardenia fruit. Said determination method adopts liquid-phase chromatography and gas-phase chromatography to make determination so as to raise the quality control of Reduning injection.

Description

field of invention [0001] The invention relates to a quality control method of a Chinese medicine composition, in particular to a fingerprint identification method of an injection of the Chinese medicine composition. Background technique [0002] At present, the quality standards of traditional Chinese medicine are not standardized and perfect, and the means of quality analysis and evaluation are still very backward, which cannot accurately reflect the quality status of existing traditional Chinese medicine, which has become an obstacle for Chinese medicine to go abroad and go to the world. Chinese patent medicine fingerprints refer to the concept of fingerprint identification in forensic medicine, and use certain analytical methods to obtain a common peak spectrum that can reflect the characteristics of the medicinal materials or drugs after proper processing. Identify and identify the quality of medicinal materials or medicines through the analysis of common peak spectra t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/744A61P29/00G01N30/02G01N33/15
Inventor 肖伟戴翔翎凌娅王振中毕宇安刘涛梁慧
Owner JIANGSU KANION PHARMA CO LTD
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