Method for resolving and determining flurbiprofen axetil and S-flurbiprofen axetil

A technology of flurbiprofen axetil and degree of separation, applied in the field of medicine, can solve the problems of lack of cyclooxygenase inhibitory activity, increased gastrointestinal side effects and the like

Active Publication Date: 2019-04-05
SHANGHAI WHITTLONG PHARMA INST +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the racemate is used clinically. It is found that the active source of flurbiprofen axetil is mainly its S-(+)-enantiomer, while the R-(-) enantiomer lacks significant cyclooxygenase Inhibiting activity, the gastrointestinal toxicity of this racemate is increased due to the presence of the R-(-) enantiomer

Method used

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  • Method for resolving and determining flurbiprofen axetil and S-flurbiprofen axetil
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  • Method for resolving and determining flurbiprofen axetil and S-flurbiprofen axetil

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preparation example Construction

[0054] The present invention will be further illustrated by specific preparation examples and test examples below, but it should be understood that these examples are only used for more detailed description and should not be construed as limiting the present invention in any form.

[0055] The present invention provides general and / or specific descriptions of the materials and test methods used in the tests. While many of the materials and methods of manipulation which are employed for the purposes of the invention are well known in the art, the invention has been described here in as much detail as possible. It will be clear to those skilled in the art that in the following, unless otherwise specified, the materials and operation methods used in the present invention are well known in the art.

[0056] 1. Supply of flurbiprofen axetil and S-flurbiprofen axetil

[0057] Flurbiprofen axetil is a commercially available bulk drug (the product approved by the State Food and Dru...

Embodiment 1

[0061] The HPLC resolution and determination of embodiment 1, flurbiprofen axetil and S-flurbiprofen axetil

[0062] (1) Dosing:

[0063] Accurately weigh flurbiprofen axetil or S-flurbiprofen axetil need testing 10mg, put in 10ml measuring bottle, add mixed solvent to dissolve and dilute to scale, shake up, as need testing solution;

[0064] Draw need testing solution 1ml and put in 100ml measuring bottle, add mixed solvent and dilute to scale, shake up, as contrast solution (its concentration is equivalent to 1% of need testing solution);

[0065] In addition, accurately weigh 10mg of flurbiprofen axetil racemate reference substance, put it in a 100ml measuring bottle, add a mixed solvent to dissolve and dilute to the mark, shake well, and make a solution containing 0.1mg per 1ml, as a system suitability test solution ;

[0066] (2) Chromatographic conditions and system suitability test:

[0067] A chromatographic column using starch-tris(3,5-dimethylphenylcarbamate) as...

Embodiment 2

[0074] The HPLC resolution and determination of embodiment 2, flurbiprofen axetil and S-flurbiprofen axetil

[0075] (1) Dosing:

[0076] Accurately take flurbiprofen axetil need testing sample or S-flurbiprofen axetil need testing sample amount, put in 10ml measuring bottle, add mixed solvent to dissolve and dilute to scale, shake up, as need testing solution (0.01mg / ml);

[0077] Draw 0.2ml of the test solution, put it in a 100ml measuring bottle, add a mixed solvent to dilute to the mark, shake well, and use it as a control solution;

[0078] In addition, accurately weigh an appropriate amount of flurbiprofen axetil racemate reference substance, put it in a 10ml measuring bottle, add mixed solvent to dissolve and dilute to the mark, shake well, and make a solution with the same concentration as the test solution, as the system suitability test solution;

[0079] (2) Chromatographic conditions and system suitability test:

[0080] A chromatographic column using starch...

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Abstract

The invention relates to a method for resolving and determining flurbiprofen axetil and S-flurbiprofen axetil, in particular to a method for resolving and determining flurbiprofen axetil and S-flurbiprofen axetil by using an HPLC method. The method adopts a starch column to perform resolution separation analysis for various products of the flurbiprofen axetil and S-flurbiprofen axetil, and the excellent chromatography effect in the description of the invention can be presented.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a method for splitting and measuring flurbiprofen axetil and S-flurbiprofen axetil, in particular to a method for splitting and measuring flurbiprofen axetil and S-flurbiprofen axetil by using an HPLC method. - method of flurbiprofen axetil. Background technique [0002] Flurbiprofen axetil is a prodrug of flurbiprofen. Pain relief after surgery and various cancers. Flurbiprofen axetil injection is a non-steroidal targeted analgesic, which reduces the synthesis of prostaglandins by inhibiting cyclooxygenase (COX) in the spinal cord and the periphery, and reduces the hyperalgesia state caused by surgical trauma. [0003] The original flurbiprofen axetil was developed by Japan Research & Development Co., Ltd. in 1992. It is a colorless to light yellow transparent oily substance with a slight odor and a bitter taste. It is miscible with methanol, ethanol, acetonitrile or acetone, b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 温光辉宛六一王浩军刘宏伟张明珠孙超张帅赵明明
Owner SHANGHAI WHITTLONG PHARMA INST
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