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Parecoxib sodium for injection and preparing method of parecoxib sodium for injection

A technology of parecoxib sodium and parecoxib, which is applied in the field of injection drugs and can solve problems such as turbidity, discoloration, and unstable drug storage process

Inactive Publication Date: 2015-12-09
SHANGHAI CHENPON PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, to provide a kind of parecoxib sodium for injection for clinic, in order to solve the problem that the drug often occurs in the prior art during the storage process is unstable, or the problem of discoloration, turbidity, precipitation, etc. occurs during the preparation process. urgently needed in the field

Method used

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  • Parecoxib sodium for injection and preparing method of parecoxib sodium for injection

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Embodiment Construction

[0024] The technical solution of the present invention, that is, a preparation method of parecoxib sodium for injection, is characterized in that it comprises:

[0025] (1) Add 2.84g of disodium hydrogen phosphate to 80% of the prescription water for injection, and stir until completely dissolved;

[0026] (2) Continue to add 40 g of parecoxib sodium based on parecoxib and stir until completely dissolved;

[0027] (3) Continue to add phosphoric acid or sodium hydroxide to adjust the pH of the solution to be 8.0-9.0;

[0028] (4) processing, testing and packaging to obtain intermediate products;

[0029] (5) Freeze-drying treatment: uniformly cool the intermediate product from room temperature to -20°C in 30 minutes, continue to uniformly cool to -30°C in 90-150 minutes, continue to uniformly cool to -45°C in 20 minutes and keep it for 120 minutes; then Raise the temperature to 0°C evenly in 120 minutes and keep it for 300-540 minutes while controlling the vacuum to 0.3-0.8mb...

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Abstract

The invention provides a preparing method of parecoxib sodium for injection. The method comprises the following steps of: (1) adding disodium hydrogen phosphate into water for injection; (2) adding parecoxib sodium; (3) adding phosphoric acid or sodium hydroxide to regulate the pH value of the solution to be 8.0 to 9.0; (4) performing processing, detection and split charging; (5) performing freeze-drying processing: uniformly lowering the temperature to -20 DEG C from the room temperature in 30min; uniformly lowering the temperature to -30 DEG C in 90 to 150min; uniformly lowering the temperature to -45 DEG C in 20min and maintaining the temperature for 120min; then, uniformly raising the temperature to 0 DEG C in 120min and maintaining the temperature for 300 to 540min; uniformly raising the temperature to 40 DEG C in 120min and maintaining the temperature for 180 to 300min; and meanwhile, controlling the vacuum degree to be 0.3 to 0.8mbar; and (6) performing plug pressing, box discharging and cover milling. Finally, the parecoxib sodium for injection with the advantages of high stability and few problems in the preparing process is obtained.

Description

technical field [0001] The invention relates to a medicine for injection, in particular to parecoxib sodium for injection and a preparation method thereof. Background technique [0002] Parecoxib sodium, as a cyclooxygenase-2 (COX-2) specific inhibitor, its chemical name is N-[[4-(5-methyl-3-phenyl-4-iso Oxazolyl)phenyl]sulfonyl]propionamide sodium salt can be used for short-term treatment of postoperative pain, and can be used clinically for the treatment of moderate or severe postoperative acute pain. [0003] After intravenous or intramuscular injection, parecoxib is hydrolyzed by liver enzymes and rapidly converted into a pharmacologically active substance, valdecoxib. After a single dose of parecoxib, within the clinical dose range, the exposure level of valdecoxib represented by the area under the plasma concentration-time curve (AUC) and the peak concentration (Cmax) is approximately linear. When parecoxib is administered twice a day, the intravenous dose does not e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/42A61K47/02A61P29/00
Inventor 宋晓丽沈莹陈霓祥杜狄峥
Owner SHANGHAI CHENPON PHARM TECH CO LTD
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