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Parecoxib sodium lyophilized preparation and preparation method thereof

A technology for parecoxib sodium and freeze-dried preparations is applied in the field of freeze-dried preparations of parecoxib sodium and its preparation, which can solve the problems of affecting product stability, low rigidity in the sublimation stage, and small dosage of the main drug, and achieve excellent Stability, stable product quality, easy storage effect

Active Publication Date: 2016-01-06
NANJING HERON PHARMA SCI & TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the small dose and low concentration of the main drug, the rigidity of the freeze-dried product in the sublimation stage is low. 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

Method used

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  • Parecoxib sodium lyophilized preparation and preparation method thereof
  • Parecoxib sodium lyophilized preparation and preparation method thereof
  • Parecoxib sodium lyophilized preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Example 1 Each frozen dry agent contains (20mg specifications)

[0048] The prescription is as follows:

[0049] Parimb sodium 0.43g,

[0050] Twelve water phosphate di sodium 0.072g,

[0051] 0.2g of glycine,

[0052] 0.1g of uncleol,

[0053] 0.3m phosphate regulation pH between 8.15 and 8.25,

[0054] Injecting water to the total volume of the liquid distribution is 20ml.

[0055] Preparation:

[0056] (1) First use 90%of injection of water to dissolve the glycine and uncopyl alcohol, and then add sodium di -sodium water phosphate, so that the pH is between 8.9 and 9.1, and then maintains the temperature of 35-40 ℃.The amount of Parimetu sodium is quickly dissolved. Use a 0.3m phosphate solution to adjust the pH to 8.15 to 8.25, and replenish the water to the full amount.

[0057] (2) Pre-frozen stage: Cool the above-mentioned Pariecabin sodium frozen dry preparation intermediate solution at 20 ° C / h to reduce the temperature of the sample to -40 ° C ~ -50 ° C, 4h therma...

Embodiment 2

[0062] Example 2 Each frozen drying agent contains (40mg specifications)

[0063] Parimobu sodium 0.85g,

[0064] Twelve water phosphate di sodium 0.15g,

[0065] 0.4g of glycine,

[0066] 0.2g of uncleol,

[0067] 0.3m phosphate regulation pH between 8.15 and 8.25,

[0068] Injecting water to the total volume of the total volume of the liquid distribution is 40ml.

[0069] Preparation:

[0070] (1) First use 90%of injection of water to dissolve the glycine and uncopyl alcohol, and then add sodium di -sodium water phosphate, so that the pH is between 8.9 and 9.1, and then maintains the temperature of 35-40 ℃.The amount of Parimetu sodium is quickly dissolved. Use a 0.3m phosphate solution to adjust the pH to 8.15 to 8.25, and replenish the water to the full amount.

[0071] (2) Pre-frozen stage: Cool the above-mentioned Pariecabin sodium frozen dry preparation intermediate solution at 20 ° C / h to reduce the temperature of the sample to -40 ° C ~ -50 ° C, 4h thermal insulation, r...

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Abstract

The invention relates to a stable parecoxib sodium pharmaceutical composition for injection. The stable parecoxib sodium pharmaceutical composition for injection concretely comprises a main drug parecoxib sodium, a lyophilized protective agent glycine, a lyophilized additive tertiary butanol and pH regulators disodium hydrogen phosphate and phosphoric acid. The stable parecoxib sodium pharmaceutical composition for injection has the advantages that a production technology is feasible, quality is stable and controllable, skin irritation is less, multiple key parameters of time, temperature, vacuum degree, heating rate, cooling rate and the like are smartly controlled in a lyophilization process, a reasonable and effective preparation prescription and preparation technology scheme is provided for clinical medication, and industrialization can be easily realized.

Description

Technical field [0001] The present invention is a drug preparation technology field, which involves a sodium frozen dry preparation and preparation method of Parryciebu. Background technique [0002] Pariecosi sodium, chemical name n- [4- (5-methyl-3-benzyl-4-isopenzol) phenyl] Sulfamyl] sodium sodium salt, molecular C19H17N2O4SNA, molecular weight 392.41.Indications are short -term treatment for pain after surgery. The specifications are 20 mg or 40mg (with Parisiebu). [0003] [0004] Parryqiban sodium is a high-selective epoxyase -2 inhibitor, which belongs to the cicbab analgesic drugs in the anthart arthritis, which can be used for short-term treatment of pain after surgery.Parisseb's sodium is fast and the analgesic effect is lasting.The effect of Parimob's 40mg is similar to that of muscle injection 60mg or 30mg of removal of 30 mg.Pariscob has a high degree of selectivity for COX-2, and has only weak selectivity for COX-1. Therefore, it has good safety. The incidence o...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/42A61K47/18A61P29/00A61P19/02
Inventor 柏丹丹徐丽阮攀刘婷婷
Owner NANJING HERON PHARMA SCI & TECH CO LTD
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