A kind of parecoxib sodium pharmaceutical composition for injection and preparation method thereof

Abstract

The invention provides a pharmaceutical composition of parecoxib sodium for injection and a preparation method thereof. The pharmaceutical composition of parecoxib sodium for injection provided by the invention has the advantages of simple prescription, and the dosage of disodium hydrogen phosphate is greatly reduced compared with the prior art, which is more in line with the requirements of injection drug safety; Quickly, shorten the liquid preparation time, ensure stable quality, and improve production efficiency; the method of rapid freezing and cooling is adopted in the preparation process, so that the freeze-dried product maintains a good pore structure and forms a very uniform particle size, which is conducive to moisture It is fully sublimated; the nitrogen filling operation is omitted, the production process is simplified, the cost is reduced, and it is more conducive to socialized large-scale production.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of parecoxib sodium for injection and a preparation method thereof. Background technique

[0002] Parecoxib sodium, chemical name: N-[[4-(5-methyl-3-phenyl-4-isoxazolyl)phenyl]sulfonyl]propionamide sodium salt, chemical structural formula:

[0003]

[0004] Parecoxib sodium is a highly selective COX-2 inhibitor, which belongs to the coxib analgesics in anti-arthritis drugs, and can be used for short-term treatment of pain after surgery. Parecoxib sodium is easily hydrolyzed into valdecoxib, and valdecoxib has poor solubility in water, which makes it difficult to make injections. As the prodrug of valdecoxib, parecoxib sodium has high solubility. In order to avoid its rapid transformation into valdecoxib in aqueous solution, parecoxib sodium is mainly made into lyophilized preparations.

[0005] Although parecoxib is rapidly converted in...

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