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Dexamethasone acetate injection and preparation method

A technology of dexamethasone acetate and injection, which is applied in the field of medicine and can solve problems such as insufficiency

Active Publication Date: 2020-05-22
CHENGDU TIANTAISHAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing technology is still insufficient in the preparation technology of dexamethasone acetate injection, especially the chemical stability of the active ingredient and the physical stability of particles in the aqueous dexamethasone acetate injection, which are still expected to be improved in this field.

Method used

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  • Dexamethasone acetate injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0096] Embodiment 1: preparation dexamethasone acetate injection

[0097] prescription:

[0098] Dexamethasone acetate 5mg,

[0099] Sodium chloride 8mg,

[0100] 1.5mg Polysorbate 80,

[0101] Thimerosal 10μg,

[0102] Carmellose Sodium 5mg,

[0103] Add water for injection to 1ml.

[0104] Preparation method:

[0105] (1) Add sodium chloride to the water for injection (the temperature is 55 ℃) of formula volume 75% to dissolve;

[0106] (2) Add thimerosal to the sodium chloride solution, stir to dissolve, then slowly add carmellose sodium and stir to disperse, continue stirring to fully dissolve, filter (pass through a 30-mesh filter screen), heat up and boil;

[0107] (3) Add polysorbate 80 and dexamethasone acetate to the above-mentioned boiled solution, continue to boil for 30 minutes to fully dissolve the medicinal solution, cool to room temperature, add water for injection to 85-90% of the formula volume;

[0108] (4) Carry out the shear cycle 45min with the me...

Embodiment 2

[0110] Embodiment 2: preparation dexamethasone acetate injection

[0111] prescription:

[0112] Dexamethasone acetate 4.5mg,

[0113] Sodium chloride 7.5mg,

[0114] 1.6mg polysorbate 80,

[0115] Thimerosal 9μg,

[0116] Carmellose Sodium 5.5mg,

[0117] Add water for injection to 1ml.

[0118] Preparation method:

[0119] (1) Add sodium chloride to the water for injection (the temperature is 50 ℃) of formula volume 80% to dissolve;

[0120] (2) Add thimerosal to the sodium chloride solution, stir to dissolve, then slowly add carmellose sodium and stir to disperse, continue stirring to fully dissolve, filter (pass through a 30-mesh filter screen), heat up and boil;

[0121] (3) Add polysorbate 80 and dexamethasone acetate to the above boiled solution, continue to boil for 35 minutes to fully dissolve the medicinal solution, cool to room temperature, add water for injection to 85-90% of the formula volume;

[0122] (4) Use a high-shear homogeneous emulsifier to shea...

Embodiment 3

[0124] Embodiment 3: preparation dexamethasone acetate injection

[0125] prescription:

[0126] Dexamethasone acetate 5.5mg,

[0127] Sodium chloride 8.5mg,

[0128] 1.4mg polysorbate 80,

[0129] Thimerosal 11μg,

[0130] Carmellose Sodium 4.5mg,

[0131] Add water for injection to 1ml.

[0132] Preparation method:

[0133] (1) Add sodium chloride to the water for injection (the temperature is 60° C.) of 70% of the formula volume to dissolve;

[0134] (2) Add thimerosal to the sodium chloride solution, stir to dissolve, then slowly add carmellose sodium and stir to disperse, continue stirring to fully dissolve, filter (pass through a 30-mesh filter screen), heat up and boil;

[0135] (3) Add polysorbate 80 and dexamethasone acetate to the above-mentioned boiled solution, continue to boil for 25 minutes to fully dissolve the medicinal solution, cool to room temperature, and add water for injection to 85-90% of the formula volume;

[0136] (4) Use a high-shear homogene...

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Abstract

The invention relates to a dexamethasone acetate injection and a preparation method. specifically, the dexamethasone acetate injection contains an active ingredient, namely, dexamethasone acetate, sodium chloride, water for injection and the like. The dexamethasone acetate injection is prepared with a conventional method. the dexamethasone acetate injection has good technical effects in the specification.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an injection and a preparation method thereof, in particular to an injection with dexamethasone acetate as an active ingredient and a preparation method thereof. Since dexamethasone acetate cannot be dissolved in water, the present invention The dexamethasone acetate injection provided by the invention is a suspension type injection. Background technique [0002] Dexamethasone (DXMS) was synthesized for the first time in 1957. In 1960, Merck & Co. produced dexamethasone sodium phosphate. So far, more than 12 kinds of dexamethasone derivatives have been listed on the World Health Organization. In the standard list of drugs, it is one of the essential drugs for the basic public health system. [0003] The chemical structure of dexamethasone is that a fluorine atom is introduced into the 9α position of the B ring of prednisolone, and a methyl group is introduced into the 16α ​​posit...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/26A61K47/38A61K47/24A61K47/02A61K31/573A61P29/00A61P37/08A61P11/06
CPCA61K9/08A61K9/0019A61K47/26A61K47/38A61K47/24A61K47/02A61K31/573A61P29/00A61P37/08A61P11/06
Inventor 李玉红何玉祥李伟胡军陈先祥冷振华
Owner CHENGDU TIANTAISHAN PHARMA
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