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A kind of dexamethasone sodium phosphate injection

A technology of dexamethasone sodium phosphate and injections, which is applied in the direction of inorganic non-active ingredients, drug combinations, sensory diseases, etc., can solve the problems of many side effects of systemic application and short residence time of local application, so as to avoid side effects, change cell shape, The effect of prolonged residence time

Active Publication Date: 2021-01-08
和舆(苏州)医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to provide a kind of injection with certain viscosity that takes dexamethasone as active component, effectively solved the problems such as systemic application side effect of dexamethasone drug in the treatment of deafness, local application residence time is few etc.

Method used

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  • A kind of dexamethasone sodium phosphate injection
  • A kind of dexamethasone sodium phosphate injection
  • A kind of dexamethasone sodium phosphate injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068]

[0069] Preparation:

[0070] (1) Take 80% of the prescription water for injection and dissolve NaHSO in turn 3 , EDTA-2NaCa, glycerol and dexamethasone sodium phosphate;

[0071] (2) adjust the pH to 8.0 with 30% sodium hydroxide, and dilute to full volume with water for injection;

[0072] (3) After filtering the medicinal liquid, pack it in 2ml ampoules, ventilate it with nitrogen, and seal it;

[0073] (4) Sterilization: Sterilize with circulating steam at 100°C for 15 minutes.

[0074] The resulting injection viscosity is: 1.32cP

Embodiment 2

[0076]

[0077] Preparation:

[0078] (1) Take 80% of the full amount of water for injection and dissolve NaHSO in turn 3 , EDTA-2Na, dexamethasone sodium phosphate, and hyaluronic acid, and adjust the pH to 8.0, and dilute to full volume;

[0079] (2) After filtering the medicinal liquid, pack it in 2ml ampoules, ventilate it with nitrogen, and seal it;

[0080] (3) Sterilization: Sterilize with circulating steam at 100°C for 15 minutes.

[0081] The resulting injection viscosity is: 5.37cP

Embodiment 3

[0083]

[0084] Preparation:

[0085] (1) Dissolve the prescribed amount of sodium dihydrogen phosphate and disodium hydrogen phosphate with water for injection.

[0086] (2) Dissolve the raw and auxiliary materials in the prescribed amount with the above-mentioned solvent, adjust to 8.0 with 30% sodium hydroxide solution, and dilute to full volume with water for injection;

[0087] (3) Filter and sterilize the medicinal liquid, then pack it into 2ml ampoules, ventilate it with nitrogen, and seal it;

[0088] (4) Sterilization: Sterilize with circulating steam at 100°C for 15 minutes.

[0089] The resulting injection viscosity is: 0.70cP

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Abstract

The invention relates to a dexamethasone sodium phosphate injection and a preparation method thereof. The injection is prepared from dexamethasone sodium phosphate, a stabilizer, an antioxidant, a metal ion chelant, a pH regulator, a viscosity regulator, a solubilizer, an osmotic pressure regulator and water for injection by dissolving and high-temperature sterilization, and has certain viscosity.The dexamethasone sodium phosphate injection is applied to intratympanic injection, and has the effects of enhancing intratympanic medicine absorption and improving sudden deafness.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to an injection containing dexamethasone with a certain viscosity and a preparation method thereof. Background technique [0002] In recent years, glucocorticoids have been widely used to treat a variety of inner ear diseases, such as deafness, Meniere's disease, and acute postmeningitis labyrinthitis. Sudden deafness is a kind of non-fluctuating sensorineural deafness that occurs suddenly. Its onset is acute and progresses rapidly, and it can lead to sudden hearing loss within minutes, hours, or 3 days. Common accompanying symptoms are mainly tinnitus and vertigo. At present, the etiology of sudden deafness has not been fully clarified. The main causes are: inner ear microcirculation lesions, specific infections, immune factors, and psychological factors. The causes of acute deafness are similar to those of sudden deafness, but they are different. Acute deafness is acco...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K31/661A61K47/02A61K47/10A61K47/18A61K47/36A61P27/16
CPCA61K9/0046A61K9/08A61K31/661A61K47/02A61K47/10A61K47/18A61K47/36A61P27/16
Inventor 王玺玫
Owner 和舆(苏州)医药科技有限公司
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