Dexamethasone sodium phosphate injection and preparation method thereof

A technology of dexamethasone sodium phosphate and injection, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problems of user product scrapping and waste of resources, and achieve storage time Longevity, prevention of precipitation of crystals, and stable pH

Inactive Publication Date: 2019-04-12
湖北久安医药集团有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, there are many problems in the existing dexamethasone sodium phosphate injection products, which lead to repeated returns by users and scrapped products, resulting in a waste of resources

Method used

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  • Dexamethasone sodium phosphate injection and preparation method thereof
  • Dexamethasone sodium phosphate injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] A dexamethasone sodium phosphate injection, which is made of the following raw materials: dexamethasone sodium phosphate 2g, propylene glycol 22g, edetate disodium 0.3g, disodium hydrogen phosphate 6g, anhydrous sodium sulfite 1g, injection Dilute to 1000ml with water.

[0023] The preparation method of the present invention is as follows:

[0024] Take an appropriate amount of water for injection, add disodium hydrogen phosphate, stir to dissolve, add anhydrous sodium sulfite and disodium edetate, stir to dissolve, fill with nitrogen for 10 minutes, add dexamethasone sodium phosphate and propylene glycol, stir to dissolve, and then use 10% hydrogen Adjust the pH value to 8.0-8.2 with sodium oxide, add water for injection to 1000ml, then add 0.1% activated carbon, fill with nitrogen, let it stand for 20 minutes, decarbonize, fine filter with microporous membrane, potting, and sterilize with fluid steam at 100°C 20 minutes, and finally use 50 ℃ red water to check for le...

Embodiment 2

[0027] A dexamethasone sodium phosphate injection, which is made of the following raw materials: dexamethasone sodium phosphate 5g, propylene glycol 35g, edetate disodium 0.8g, disodium hydrogen phosphate 9g, anhydrous sodium sulfite 3g, injection Dilute to 1000ml with water.

[0028] The preparation method of the present invention is as follows:

[0029] Take an appropriate amount of water for injection, add disodium hydrogen phosphate, stir to dissolve, add anhydrous sodium sulfite and disodium edetate, stir to dissolve, fill with nitrogen for 10 minutes, add dexamethasone sodium phosphate and propylene glycol, stir to dissolve, and then use 10% hydrogen Adjust the pH value to 8.0-8.2 with sodium oxide, add water for injection to 1000ml, then add 0.1% activated carbon, fill with nitrogen, let it stand for 20 minutes, decarbonize, fine filter with microporous membrane, potting, and sterilize with fluid steam at 100°C 20 minutes, and finally use 50 ℃ red water to check for le...

Embodiment 3

[0032] A dexamethasone sodium phosphate injection, which is made of the following raw materials: dexamethasone sodium phosphate 2g, propylene glycol 25g, edetate disodium 0.4g, disodium hydrogen phosphate 6.5g, anhydrous sodium sulfite 1.5g , dilute to 1000ml with water for injection.

[0033] The preparation method of the present invention is as follows:

[0034] Take an appropriate amount of water for injection, add disodium hydrogen phosphate, stir to dissolve, add anhydrous sodium sulfite and disodium edetate, stir to dissolve, fill with nitrogen for 10 minutes, add dexamethasone sodium phosphate and propylene glycol, stir to dissolve, and then use 10% hydrogen Adjust the pH value to 8.0-8.2 with sodium oxide, add water for injection to 1000ml, then add 0.1% activated carbon, fill with nitrogen, let it stand for 20 minutes, decarbonize, fine filter with microporous membrane, potting, and sterilize with fluid steam at 100°C 20 minutes, and finally use 50 ℃ red water to che...

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Abstract

The invention discloses a dexamethasone sodium phosphate injection and a preparation method thereof. The injection of the present invention is prepared from the following raw materials by weight percentages: 0.1-0.5% of dexamethasone sodium phosphate, 2.2-3.5% of propylene glycol, 0.03-0.08% of ethylenediaminetetraacetic acid disodium salt, 0.6-0.9% of disodium hydrogen phosphate, 0.1%-0.3% of anhydrous sodium sulfite, and the balance of water for injection. The invention also discloses a preparation method of the injection. The dexamethasone sodium phosphate injection prepared by the invention has stable pH value and long storage time, and all the indexes are qualified during a product validity period; and the method adopts the ethylenediaminetetraacetic acid disodium salt to effectivelyresist oxidation, and adopts hot red water for leak detection to effectively prevent crystals from being quenched by the liquid.

Description

technical field [0001] The invention specifically relates to a dexamethasone sodium phosphate injection and a preparation method thereof. Background technique [0002] Dexamethasone sodium phosphate, chemical name 16α-methyl-11β,17α,21 trihydroxy-9α-flupregna-1,4-diene-3,20-dione-21-phosphate disodium salt, It is an adrenocortical hormone drug with anti-inflammatory, anti-allergic, anti-rheumatic and immunosuppressive effects. The mechanism of action is: (1) Anti-inflammatory effect: it can reduce and prevent the response of tissues to inflammation, thereby reducing the manifestation of inflammation. It can inhibit the accumulation of inflammatory cells, including macrophages and leukocytes at the site of inflammation, and inhibit phagocytosis, the release of lysosomes, and the synthesis and release of inflammatory chemical mediators. (2) Immunosuppressive effect: including preventing or inhibiting cell-mediated immune response, delayed allergic reaction, reducing the numb...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K47/02A61K31/661A61P37/08A61P37/02A61P29/00
CPCA61K9/0019A61K9/08A61K31/661A61K47/02A61K47/183A61P29/00A61P37/02A61P37/08
Inventor 何凯峰田贞东吴中
Owner 湖北久安医药集团有限公司
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