Dexamethasone sodium phosphate freeze-dried powder injection

A technology of dexamethasone sodium phosphate and freeze-dried powder injection, which is applied in the direction of freeze-dried delivery, anti-inflammatory agent, powder delivery, etc., and can solve the problems of yellowish appearance, low pass rate and hazard of powder injection

Active Publication Date: 2013-10-30
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the freeze-dried powder injection prepared by the application produced higher levels of related substances in the high-temperature accelerated test.
[0004] Chinese patent application 200910250340.9 also discloses a freeze-dried powder injection of dexamethasone sodium phosphate. However, we found that according to the process disclosed in the application specification, the temperature of 4-6°C during the first freeze-drying of the powder injection cannot guarantee the stability of the drug. The solidified state of the liquid, so the preparation of freeze-dried powder injection cannot be carried out
Even if the temperature of the part is lowered, the appearance of the prepared powder injection is also yellowish when other process conditions remain unchanged, and the related substances produced in the accelerated test of the high temperature accelerated test are also relatively high.
[0005] In addition, we also found that the dexamethasone sodium phosphate freeze-dried powder injection produced in the prior art, after reconstitution, found that the insoluble particles in the injection were significantly increased after testing, and the pass rate was low. It is extremely important but easily overlooked. Excessive insoluble particles are likely to cause many potential hazards, such as thrombosis, granuloma, and similar pyrogen reactions. Since most insoluble particles cannot be metabolized by the human body, once they are infused into the body, The resulting risk will be accompanied by lifelong, so reducing the insoluble particles of injections has become an important issue in injection preparations

Method used

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  • Dexamethasone sodium phosphate freeze-dried powder injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment 1 prepares injection

[0026] Dexamethasone Sodium Phosphate 50g

[0027] Mannitol 1000g Ethanol 500ml

[0028] 1) Dissolve the prescribed amount of mannitol and ethanol in 7000ml of water for injection, add 20g of activated carbon, keep warm at 40-60°C for 20-30 minutes, pass through a 0.22μm filter membrane to remove the activated carbon; add dexamethasone sodium phosphate, stir to dissolve completely , add water for injection to 10,000ml, adjust the pH value to 8.0-8.5 with phosphate buffer solution, filter and sterilize the liquid medicine through a 0.22μm filter element, divide it into control glass bottles, and half-tighten the stopper

[0029] 2) Pre-freezing, after controlling the product temperature to -40°C, keep it warm for 2 hours.

[0030] 3) Sublimation drying, turn on the vacuum pump, control the vacuum degree below 40pa, gradually raise the temperature to control the product temperature at -10°C to -8°C, keep it for 2h, then raise the temper...

Embodiment 2

[0034] Dexamethasone Sodium Phosphate 20g

[0035] Mannitol 500g Ethanol 1000ml

[0036] 1) Dissolve the prescribed amount of mannitol and ethanol in 7000ml of water for injection, add 20g of activated carbon, keep warm at 40-60°C for 20-30 minutes, pass through a 0.22μm filter membrane to remove the activated carbon; add dexamethasone sodium phosphate, stir to dissolve completely , add water for injection to 10,000ml, adjust the pH value to 8.0-8.5 with sodium hydroxide solution, filter and sterilize the liquid medicine through a 0.22μm filter element, divide it into control glass bottles, and half-tighten the stopper

[0037] 2) Pre-freezing, after controlling the product temperature below -40°C, keep it warm for 1 hour.

[0038] 3) Sublimation drying, turn on the vacuum pump, control the vacuum degree below 40pa, gradually raise the temperature to control the product temperature at -10°C to -8°C, keep it for 2h, then raise the temperature to -5°C, and keep it for 6h.

[0...

Embodiment 3

[0042]Dexamethasone Sodium Phosphate 20g

[0043] Mannitol 1200g Ethanol 1000ml

[0044] 1) 1) Dissolve the prescribed amount of mannitol and ethanol in 7000ml of water for injection, add 20g of activated carbon, keep warm at 40-60 degrees for 20-30 minutes, pass through a 0.22μm filter membrane to remove the activated carbon; add dexamethasone sodium phosphate, stir to make it Completely dissolve, add water for injection to 15000ml, adjust the pH value to 8.0-8.5 with sodium hydroxide solution, filter and sterilize the drug solution through a 0.22μm filter element, divide it into control glass bottles, and half stopper

[0045] 2) Pre-freezing, after controlling the product temperature to -40°C, keep it warm for 2 hours;

[0046] 3) Sublimation drying, turn on the vacuum pump, control the vacuum degree below 40pa, gradually raise the temperature to control the product temperature at -10°C to -8°C, keep it for 4 hours, then raise the temperature to -5°C, and keep it for 8 hou...

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PUM

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Abstract

The invention relates to a dexamethasone sodium phosphate freeze-dried powder injection. Every bottle contains 1-20mg of dexamethasone sodium phosphate, 20-150mg of excipient and pH regulator. The components in the formula are dissolved in a solvent and freeze-dried to obtain the powder injection. The invention is characterized in that the solvent is ethanol-containing water for injection, and the liquor prepared by dissolving the components in the formula in the solvent contains 5-10 vol% of ethanol.

Description

Technical field: [0001] The invention relates to a corticosteroid preparation, in particular to a freeze-dried powder injection containing dexamethasone sodium phosphate. Background technique: [0002] Dexamethasone sodium phosphate (DEXAMETHASONE SODIUM PHOSPHATE, referred to as "de sodium") is an adrenocortical hormone drug. It has anti-inflammatory, anti-allergic, anti-rheumatic and immunosuppressive effects, and is widely used in the treatment of allergic and autoimmune inflammatory diseases. Such as connective tissue disease, active rheumatism, rheumatoid arthritis, lupus erythematosus, severe bronchial asthma, severe dermatitis, ulcerative colitis, acute leukemia, etc. It is also used for some serious infections, poisoning, and malignant lymphoma. treat. The common dosage form is sodium desalination injection. However, the injection dosage form needs to be sterilized by high temperature after filling, and the high temperature is likely to cause a decrease in the yie...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/573A61K47/10A61K47/26A61P37/08A61P37/06A61P29/00A61P35/00A61P35/02A61P31/00
Inventor 孙亮赵琳陈松
Owner TIANJIN JINYAO GRP
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