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Dexamethasone sodium phosphate freeze-dried powder injection and preparation method thereof

A technology of dexamethasone sodium phosphate and freeze-dried powder injection, which is applied in the field of medicine and can solve problems such as opalescence and low clarity of dexamethasone sodium phosphate freeze-dried powder injection

Active Publication Date: 2011-12-28
HAINAN XIANTONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007]Currently, the dexamethasone sodium phosphate freeze-dried powder sold on the market has low clarity and is prone to opalescence

Method used

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  • Dexamethasone sodium phosphate freeze-dried powder injection and preparation method thereof
  • Dexamethasone sodium phosphate freeze-dried powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Example 1: Preparation of dexamethasone sodium phosphate freeze-dried powder injection

[0036] Dexamethasone sodium phosphate: 5g

[0037] Mannitol: 40g

[0038] Add water for injection to: 1000ml

[0039] Weigh dexamethasone sodium phosphate and mannitol according to the formula, add 800 parts by volume of water for injection, heat and stir to dissolve, add 0.2% activated carbon for needles, mix well, stir, and keep warm at 40°C to 100°C for 10 minutes to 30 minutes , coarse filtration and decarbonization, add water for injection to the filtrate to 1000 parts by volume, after passing the intermediate inspection, fine filter with a 0.22μm filter membrane, quantitatively fill in 2ml vials, press the rubber stopper halfway, and put it in a freeze-drying box Inside, freeze-dried, fully pressed rubber stopper, out of the box, locked aluminum cover, packaged, and obtained dexamethasone sodium phosphate freeze-dried powder injection.

Embodiment 2

[0040] Embodiment 2: Preparation of dexamethasone sodium phosphate freeze-dried powder injection

[0041] Dexamethasone sodium phosphate: 5g

[0042] Mannitol: 40g

[0043] Add water for injection to: 800ml

[0044] Weigh dexamethasone sodium phosphate and mannitol according to the formula, add 750 parts by volume of water for injection, heat and stir to dissolve, add 0.05% activated carbon for needles, mix well, stir, and keep warm at 40°C to 100°C for 10 minutes to 30 minutes ,, coarse filtration and decarbonization, add water for injection to the filtrate to 800 parts by volume, after passing the intermediate inspection, fine filter with a 0.22 μm filter membrane, quantitatively fill in 2ml vials, half-press the rubber stopper, and freeze-dry Inside the box, freeze-dry, fully press the rubber stopper, lock the aluminum cover when out of the box, and pack it to get dexamethasone sodium phosphate freeze-dried powder injection.

Embodiment 3

[0045] Example 3: Preparation of dexamethasone sodium phosphate freeze-dried powder injection

[0046] Dexamethasone sodium phosphate: 2g

[0047] Mannitol: 10g

[0048] Add water for injection to: 800ml

[0049] Weigh dexamethasone sodium phosphate and mannitol according to the formula, add 750 parts by volume of water for injection, heat and stir to dissolve, add 0.02% activated carbon for needles, mix well, stir, and keep warm at 40°C to 100°C for 10 minutes to 30 minutes , coarse filtration and decarbonization, add water for injection to the filtrate to 800 parts by volume, after passing the intermediate inspection, fine filter with a 0.22 μm filter membrane, quantitatively fill in 2ml vials, half-press the rubber stopper, and put it in a freeze-drying box Inside, freeze-dried, fully pressed rubber stopper, out of the box, locked aluminum cover, packaged, and obtained dexamethasone sodium phosphate freeze-dried powder injection.

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Abstract

The invention discloses a Dexamethasone Sodium Phosphate freeze-dried powder injection composition, The invention is characterized in that a composition before freeze-drying comprises Dexamethasone Sodium Phosphate, mannitol and water according to the proportion of 2-5 weight parts : 10-40 weight parts : 0.5-1.2 volume parts. The invention has the advantages of simple preparation technology, easy control of product quality, convenient storage and transport, and is suitable for large-scale production. Compared with the injection products, the freeze-dried powder injection of the invention has merits of good stability, high quality and long storage period.

Description

technical field [0001] The invention relates to a preparation method of dexamethasone sodium phosphate freeze-dried powder injection, which belongs to the technical field of medicine. Background technique [0002] Dexamethasone is an adrenocortical hormone drug with anti-inflammatory, anti-allergic, anti-rheumatic, and immunosuppressive effects. Its main mechanism of action is to reduce the manifestations of inflammation by reducing and preventing the tissue response to inflammation. It plays an anti-inflammatory effect by inhibiting the accumulation of inflammatory cells, including macrophages and leukocytes, at the site of inflammation, and inhibiting phagocytosis, release of lysosomal enzymes, and synthesis and release of inflammatory chemical mediators. At the same time, dexamethasone can prevent or inhibit cell-mediated immune response, delay allergic reaction, reduce the number of T lymphocytes, monocytes, and eosinophils, reduce the binding ability of immunoglobulins...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/573A61K31/661A61P29/00A61P37/06A61P37/08
Inventor 齐慧
Owner HAINAN XIANTONG PHARMA CO LTD
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