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Parecoxib sodium long-acting preparation and preparation method thereof

A parecoxib sodium, long-acting technology, applied in the field of parecoxib sodium long-acting preparations and its preparation, can solve the problems of excessive appearance, shrinkage, unqualified products and the like

Pending Publication Date: 2018-12-11
湖南赛隆药业(长沙)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The freeze-dried powder disclosed in the prior art often has many problems such as collapse, shrinkage, and more ice crystals appearing on the appearance. At the same time, the structure of the drug may also change due to physical and chemical effects during the freeze-drying process, resulting in unnecessary impurities. Product failure, etc.

Method used

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  • Parecoxib sodium long-acting preparation and preparation method thereof
  • Parecoxib sodium long-acting preparation and preparation method thereof
  • Parecoxib sodium long-acting preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029]

Embodiment 2

[0031]

[0032] The parecoxib sodium is in an invisible state, and the X-ray diffraction pattern is as follows: figure 1 shown.

[0033] The preparation method of the amorphous state is as follows: add 1g of parecoxib sodium to 15mL of methanol and heat at 70°C, add 5mL of ethyl acetate under temperature control at 70°C, stir for 10min, slowly cool to 5°C, and crystallize to obtain the amorphous state state of parecoxib sodium.

[0034] The preparation method is as follows:

[0035] Mix parecoxib sodium, croscarmellose sodium, karaya gum and polyvinyl butyral with surfactants and freeze-drying excipients evenly, and freeze-dry to obtain the ready-made preparation.

Embodiment 3

[0037]

[0038]

[0039] The parecoxib sodium, cross-linked carboxymethyl cellulose sodium, karaya gum and polyvinyl butyral form microspheres, and the microspheres are prepared by the following method: cross-linked carboxymethyl fiber Sodium sodium is dispersed in twice the amount of water, and stirred evenly to obtain a dispersed phase; put karaya gum in a mortar and grind at 3000rpm, add parecoxib sodium while grinding, and continue grinding for 10 minutes to form a grinding phase. Mix the polyvinyl butyral and the grind, add 0.5 times the weight of ethanol after mixing to form an oil phase, add the dispersed phase to the oil phase, and emulsify with a shearing machine to form an emulsion, at a speed of 2500rpm Stir and spray dry to prepare microspheres; the specific method of emulsification is as follows: the first emulsification speed is 1500 rpm, and the time is 2 minutes; the second emulsification speed is 4500 rpm, and the time is 3 minutes; the third emulsificati...

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Abstract

The invention provides a parecoxib sodium long-acting preparation and a preparation method thereof. The long-acting preparation is prepared from parecoxib sodium, croscarmellose sodium, karaya gum, butyral resin, surfactants and freeze drying shaping agents. The long-acting preparation has the advantages that high stability is realized; the long-time storage can be realized; in addition, the phenomena of collapse, atrophy and the like do not occur in the storage process.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a long-acting parecoxib sodium preparation and a preparation method thereof. Background technique [0002] Parecoxib (Parecoxib) is a new type of non-steroidal anti-inflammatory analgesic drug (NSAID) listed by Pfizer, a highly selective cyclooxygenase-2 inhibitor, which can be rapidly absorbed by the liver after intravenous injection. Carboxylesterase is hydrolyzed into valdecoxib, which exerts anti-inflammatory and analgesic effects by specifically inhibiting cyclooxygenase-2 (COX-2) and blocking the synthesis of prostaglandins from arachidonic acid. It inhibits COX-2 28,000-fold more than cyclooxygenase-1 (COX-1). Because of its selective inhibition of COX-2, it greatly reduces gastrointestinal adverse reactions and has no adverse reactions of respiratory depression, so it has been widely used in postoperative analgesia in recent years. [0003] The structural form...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/38A61K47/22A61K47/32A61K47/26A61K31/42A61P29/00
CPCA61K47/22A61K47/26A61K47/32A61K47/38A61P29/00A61K9/0019A61K9/19A61K31/42
Inventor 李剑峰周文
Owner 湖南赛隆药业(长沙)有限公司
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