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Parecoxib sodium for injection and preparation method thereof

A technology of parecoxib sodium and parecoxib, which is applied in the directions of inactive medical preparations, pharmaceutical formulations, inorganic inactive ingredients, etc., can solve the problems of low concentration, collapse, affecting product quality, etc., to avoid Hypocalcemia, good pore structure, good appearance effect

Active Publication Date: 2021-10-01
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In addition, the appearance formability, resolubility and high water content of parecoxib sodium are the difficulties in the production of preparations
In addition, due to the small dose and low concentration of the main ingredient, the freeze-drying process affects the quality of the product. If the drying temperature is too high, the rigidity of the solid matrix is ​​not enough to maintain the honeycomb structure, and the solid matrix wall of the cavity will collapse; Low, high water content, affecting product stability and resolubility

Method used

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  • Parecoxib sodium for injection and preparation method thereof
  • Parecoxib sodium for injection and preparation method thereof
  • Parecoxib sodium for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Embodiment 1: Parecoxib sodium for injection

[0073]

[0074] Preparation:

[0075] a) Add 19Kg of water for injection into the dissolving tank, start stirring and cooling, and lower the temperature to 25°C;

[0076] b) Add the prescribed amount of anhydrous disodium hydrogen phosphate, and continue to stir for 10 minutes until the anhydrous disodium hydrogen phosphate is completely dissolved;

[0077] c) Add 0.1mol / L phosphoric acid in the prescribed amount, and continue to stir for 10 minutes;

[0078] d) Add the prescribed amount of parecoxib sodium into the dissolving tank, and continue to stir for 15 minutes until the parecoxib sodium is completely dissolved; at this time, the pH of the solution is 8;

[0079] e) Slowly add water for injection until the total weight of the solution is 20Kg, and continue to stir for 10 minutes to make the mixture uniform;

[0080] f) Turn on the filter, pass the liquid medicine from the dissolution tank through filters of 1.0...

Embodiment 2

[0084] Embodiment 2: Parecoxib sodium for injection

[0085]

[0086] Preparation:

[0087] a) Add 180Kg of water for injection to the dissolving tank, start stirring and cooling, and lower the temperature to 25°C;

[0088] b) Add the prescribed amount of anhydrous disodium hydrogen phosphate, and continue to stir for 10 minutes until the anhydrous disodium hydrogen phosphate is completely dissolved;

[0089] c) Add 0.1mol / L phosphoric acid in the prescribed amount, and continue to stir for 10 minutes;

[0090] d) Add the prescribed amount of parecoxib sodium into the dissolving tank, and continue to stir for 15 minutes until the parecoxib sodium is completely dissolved; at this time, the pH of the solution is 8;

[0091] e) Slowly add water for injection until the total weight of the solution is 190Kg, and continue to stir for 10 minutes to make the mixture uniform;

[0092] f) Turn on the filter, pass the liquid medicine from the dissolution tank through filters of 1.0...

Embodiment 3

[0096] Embodiment 3: parecoxib sodium for injection

[0097]

[0098] Preparation:

[0099] a) Add 19Kg of water for injection into the dissolving tank, start stirring and cooling, and lower the temperature to 25°C;

[0100] b) Add the prescribed amount of anhydrous disodium hydrogen phosphate, and continue to stir for 10 minutes until the anhydrous disodium hydrogen phosphate is completely dissolved;

[0101] c) Add 0.1mol / L phosphoric acid in the prescribed amount, and continue to stir for 10 minutes;

[0102] d) Add the prescribed amount of parecoxib sodium into the dissolving tank, and continue to stir for 15 minutes until the parecoxib sodium is completely dissolved; at this time, the pH of the solution is 8;

[0103] e) Slowly add water for injection until the total weight of the solution is 20Kg, and continue to stir for 10 minutes to make the mixture uniform;

[0104] f) Turn on the filter, pass the liquid medicine from the dissolution tank through filters of 1.0...

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Abstract

The invention provides a parecoxib sodium for injection and a preparation process thereof. The special freeze-drying process is adopted, so that a freeze-dried product maintains a relatively good pore structure, a very uniform particle size is formed, sufficient sublimation of water is facilitated, and good appearance, stable quality and quick dissolution of the product are ensured; When the parecoxib sodium for injection prepared by the method is placed for 0-24 months under the conditions that the temperature is 25 + / -2 DEG C and the humidity is 60 + / -5% or placed for 0-6 months under the conditions that the temperature is 40 + / -2 DEG C and the humidity is 75 + / -5%, the moisture of the parecoxib sodium is not higher than 2%; the total impurity content of the parecoxib sodium for injection prepared by the method is not higher than 0.5%, the impurity F content of the parecoxib sodium is not higher than 0.1%, the impurity A content of the parecoxib sodium is not higher than 0.4%, the impurity B content of the parecoxib sodium is not higher than 0.15%, and the impurity D content of the parecoxib sodium is not higher than 0.15%.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to parecoxib sodium for injection and a preparation method thereof. Background technique [0002] Parecoxib Sodium (Parecoxib Sodium), the trade name is special Nai ®, Dynastat ®, the chemical name is N-[[4-(5-methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonate Acyl]propionamide sodium salt is the first selective cyclooxygenase-2 inhibitor for injection developed by Pfizer. It is an inactive prodrug of valdecoxib, which is metabolized into valdecoxib in the body after injection. Coxib works. Athanasakis confirmed that intravenous injection of 40 mg parecoxib sodium can be used as an effective supplementary opioid therapy, improve postoperative analgesic management, reduce opioid-related adverse events, and reduce the average treatment cost. In March 2002, it was approved for marketing in the European Union, and in May 2008, it was approved for marketing in my country, and it is used for ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/42A61K47/04A61P29/00
CPCA61K9/19A61K9/0019A61K31/42A61K47/02A61P29/00
Inventor 焦魁良冯晨龙刘颖张亚非赵楠郑现龙
Owner CSPC OUYI PHARM CO LTD
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