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Production process for dexamethasone sodium phosphate bulk medicament

A technology of dexamethasone sodium phosphate and production process, which is applied in directions such as drug delivery, drug combination, and pharmaceutical formulation, can solve problems such as harm and small amount of propylene glycol, and achieves the advantages of simplifying production process steps, reducing propylene glycol and improving stability. Effect

Active Publication Date: 2010-01-13
TIANJIN JINYAO GRP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] It can be seen from this that although the amount of propylene glycol used in each dexamethasone sodium phosphate injection is not large, there are still certain risks, especially when used for a long time or in large quantities, the potential harm to the human body is relatively large

Method used

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  • Production process for dexamethasone sodium phosphate bulk medicament

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Dexamethasone Sodium Phosphate 10g

[0036] Water for injection 100g

[0037] (1) Dissolve the prescribed amount of dexamethasone sodium phosphate in the prescribed amount of water for injection, and stir until completely dissolved to obtain the medicinal solution (1).

[0038] (2) Spray-drying the medicinal solution (1) to obtain the bulk drug of dexamethasone sodium phosphate. The spray drying conditions are as follows:

[0039] Hot air flow: 0.55m 3 / min

[0040] Hot air inlet temperature: 110°C

[0041] Outlet temperature: 85°C

[0042] Hot air pressure (gauge pressure): 120kpa

[0043] Liquid flow rate: 5ml / min

[0044] (3) Subpackaging the dexamethasone sodium phosphate bulk drug obtained in step (2) through the inspection of the bulk drug of dexamethasone sodium phosphate.

Embodiment 2

[0046] Dexamethasone Sodium Phosphate 10g

[0047] Water for injection 150g

[0048] (1) Dissolve the prescribed amount of dexamethasone sodium phosphate in the prescribed amount of water for injection, and stir until completely dissolved to obtain the medicinal solution (1).

[0049] (2) Spray-drying the medicinal solution (1) to obtain the bulk drug of dexamethasone sodium phosphate. The spray drying conditions are as follows:

[0050] Hot air flow: 0.65m 3 / min

[0051] Hot air inlet temperature: 115°C

[0052] Outlet temperature: 90°C

[0053] Liquid flow rate: 5ml / min

[0054] Hot air pressure (gauge pressure): 130kpa

[0055] (3) Subpackaging the dexamethasone sodium phosphate bulk drug obtained in step (2).

Embodiment 3

[0057] Dexamethasone Sodium Phosphate 10g

[0058] Water for injection 150g

[0059] (1) Dissolve the prescribed amount of dexamethasone sodium phosphate in the prescribed amount of water for injection, and stir until completely dissolved to obtain the medicinal solution (1).

[0060] (2) The liquid medicine (1) is filtered and sterilized with a G6 glass vertical melting funnel, and treated for depyrogenation.

[0061] (3) Spray-dry the medicinal solution (1) to obtain dexamethasone sodium phosphate bulk drug powder. The spray drying conditions are as follows:

[0062] Hot air flow: 0.75m 3 / min

[0063] Hot air inlet temperature: 120°C

[0064] Outlet temperature: 90°C

[0065] Liquid flow rate: 10min / L

[0066] Hot air pressure (gauge pressure): 140kpa

[0067] (4) The dexamethasone bulk drug powder obtained in step (3) is aseptically subpackaged.

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Abstract

The invention provides a production process for a dexamethasone sodium phosphate bulk medicament, which dissolves certain amount of dexamethasone sodium phosphate into proper amount of water for injection and performs spray drying to obtain the dexamethasone sodium phosphate bulk medicament. The dexamethasone sodium phosphate bulk medicament can be used for preparing medicaments for treating human or mammal diseases, and is preferably prepared into injection or eye drop.

Description

Technical field: [0001] The invention relates to a production process of a corticosteroid bulk drug, in particular to a production process of 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. Due to the different production processes of desalination, the excipients used in the formulations of domestic and foreign desalination injections are also...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/661A61K31/573A61K9/08A61P37/00
Inventor 王淑丽郑彤
Owner TIANJIN JINYAO GRP
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