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Parecoxib sodium anhydrous compound

A technology of parecoxib sodium and hydrate, which is applied in the field of parecoxib sodium anhydrous compound and its preparation, and medicine, and can solve the problem that the crystalline structure of parecoxib sodium has not been characterized.

Active Publication Date: 2015-03-18
TIANJIN HANRUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] Patent US5932598 discloses the method of synthesizing parecoxib sodium, but the patent only discloses that its melting point is 271.5-272.7°C, and the crystal structure of parecoxib sodium is not characterized

Method used

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  • Parecoxib sodium anhydrous compound
  • Parecoxib sodium anhydrous compound
  • Parecoxib sodium anhydrous compound

Examples

Experimental program
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Effect test

Embodiment 1

[0045] In a 500ml reaction flask equipped with a stirrer, a thermometer and a condenser, 60g of parecoxib sodium and 300ml of heptane were added, and the obtained suspension was heated to reflux for 6 hours with vigorous magnetic stirring. The crystals were collected by vacuum filtration. Vacuum drying overnight at 40°C to obtain parecoxib sodium anhydrous compound with a chemical purity of 99.9% and an optical purity of 99.96%.

[0046] Elemental analysis results:

[0047] Actual measured value (calculated value), C: 58.04 (58.10), H: 4.25 (4.33), N: 7.12 (7.14),

[0048] S: 8.21 (8.15), Na: 5.98 (5.86)

[0049] X-ray powder diffraction characteristic absorption peak (2θ) and D value are as follows:

[0050] Clef number 2θ angle (°) measured value d (?) measured value I / I0 14.5020.6175 27.2811.1381 39.139.7242 412.629.5322 512.718.32100 613.507.798 714.557.6213 814.926.8214 915.126.249 1016.445.588 1116.505.174 1217.154.831 1318.344.5726 1419.874.341 1520.104.314 1620.343.683 1720...

Embodiment 2

[0054] Injection containing parecoxib sodium anhydrate

[0055] Prescription: Parecoxib sodium anhydrate (20g based on parecoxib), 3g disodium hydrogen phosphate, 0.5g sodium dihydrogen phosphate, appropriate amount of phosphoric acid / sodium hydroxide, 2L water for injection, made into 1000 bottles.

[0056] Process: Take 90% of the prescription amount of water for injection, first add the prescription amount of disodium hydrogen phosphate and sodium dihydrogen phosphate and stir to dissolve, add 0.1 mol / L phosphoric acid or sodium hydroxide aqueous solution, adjust the pH, and then add the prescription amount to the solution Sodium parecoxib, stir to dissolve completely; add 0.1% of the solution amount of charcoal for needles, leave it for 15 minutes, filter, add water for injection to the full amount; add 0.1mol / L phosphoric acid or sodium hydroxide aqueous solution to adjust the pH , Fine filtration, quality control of intermediates, filling, semi-press stopper, put the aliquote...

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Abstract

The invention belongs to the technical field of medicines and in particular relates to a parecoxib sodium anhydrous compound and a preparation method thereof. The parecoxib sodium anhydrous compound is basically anhydrous and not solvated and has the advantages that the chemical purity is 99.9 percent, the maximum impurity is smaller than one thousandth, the optical purity reaches up to 99.96 percent ee, and the stability is good. The invention also relates to application of a composition of parecoxib sodium in preparing a medicament for treating cyclooxygenase-2(COX-2) mediated diseases.

Description

Technical field [0001] The present invention belongs to the technical field of medicine, and specifically relates to parecoxib sodium anhydrous compound and a preparation method thereof. The present invention also relates to the use of a composition of this compound to produce a compound for treating cyclooxygenase-2 (COX-2) mediated diseases Application in medicine. Background technique [0002] Pain is a complex physical and psychological activity and one of the most common symptoms in clinical practice. It includes the pain sensation caused by noxious stimuli acting on the body, and the body's pain response to noxious stimuli. Pain can be used as a warning for the body to be injured, causing a series of defensive protective reactions in the body, and a symbol of danger signals, prompting people to act urgently to avoid danger and avoid harm. Pain after surgery refers to the acute pain that occurs after surgery, usually nociceptive pain, generally lasting within 7 days, and i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D261/08A61K31/42A61P29/00
CPCC07D261/08
Inventor 严洁李轩
Owner TIANJIN HANRUI PHARMA
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