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A kind of dexamethasone sodium phosphate freeze-dried powder injection

A technology of dexamethasone sodium phosphate and freeze-dried powder injection, applied in the field of biomedicine, can solve the problems of drug refractory concentration, obvious systemic side effects, etc., and achieve the effects of obvious curative effect, protection and promotion of recovery, and rapid progress.

Active Publication Date: 2022-03-29
HEYU (SUZHOU) PHARM TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, for the treatment of inner ear diseases, the main problems in the traditional systemic administration mode (oral, intravenous): firstly, the existence of the blood-labyrinth barrier makes it difficult for the drug to reach the therapeutic concentration in the inner ear; secondly, the systemic side effects are obvious

Method used

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  • A kind of dexamethasone sodium phosphate freeze-dried powder injection
  • A kind of dexamethasone sodium phosphate freeze-dried powder injection
  • A kind of dexamethasone sodium phosphate freeze-dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0112] The formula and preparation method of embodiment 1 dexamethasone sodium phosphate injection

[0113] Table 2

[0114]

[0115] Preparation:

[0116] (1) dissolving disodium hydrogen phosphate and sodium dihydrogen phosphate of prescription quantity into phosphate buffer saline solution of pH8.0 with water for injection cooled to room temperature of 90% of prescription quantity;

[0117] (2) Add the dexamethasone sodium phosphate and EDTA-2NaCa of the prescription amount to the solution in (1) and stir to dissolve, measure the pH, and adjust the pH to 8.0±.005;

[0118] (3) Dilute to a 50mL measuring bottle and shake well;

[0119] (4) Sterilize and filter the medicinal solution, pack in 3mL vials, 1mL per bottle, and use freeze-drying technology to make the medicinal solution into sterile powder, to obtain final product;

[0120] (5) Gained sterile powder is a white loose lump;

[0121] (6) The temperature is controlled at room temperature throughout the preparat...

Embodiment 2

[0122] The formula and preparation method of embodiment 2 dexamethasone sodium phosphate injection

[0123] table 3

[0124]

[0125] Preparation:

[0126] (1) the water for injection is cooled to room temperature;

[0127] (2) Dissolve the prescribed amount of dexamethasone sodium phosphate and EDTA-2NaCa with the above-mentioned water for injection, and adjust the pH to 8.0 ± 0.05 with a pH regulator;

[0128] (3) Dilute to full volume and shake well;

[0129] (4) The medicinal liquid is sterilized and filtered, and the medicinal liquid is made into sterile powder by using freeze-drying technology, and then packed in 3mL vials, 1mL per bottle, to obtain the product;

[0130] (5) Gained sterile powder is a white loose lump;

[0131] (6) The temperature is controlled at room temperature throughout the preparation process.

Embodiment 3

[0132] The formula and preparation method of embodiment 3 dexamethasone sodium phosphate injection

[0133] Table 4

[0134]

[0135] Preparation:

[0136] (1) Dissolving the dexamethasone sodium phosphate and auxiliary materials of the prescription amount with water for injection at room temperature;

[0137] (2) Adjust the pH of the medicinal solution to 8.0±0.05 with 0.1M HCl;

[0138] (3) Sterile filtration, subpackage in 3mL vials, 1mL per bottle, apply freeze-drying technology to make the medicinal liquid into sterile powder, to get final product;

[0139] (4) Gained sterile powder is a white loose lump;

[0140] (5) The temperature is controlled at room temperature throughout the preparation process.

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Abstract

The invention belongs to the field of biomedicine and relates to a freeze-dried powder injection containing dexamethasone. The freeze-dried powder injection preparation provided by the present invention is a freeze-dried powder injection preparation of dexamethasone drugs without freeze-dry support agent or excipient or scaffolding agent. Administration of the freeze-dried powder preparation through the tympanic cavity, on the one hand, can reduce the systemic toxic and side effects of oral administration, and play a role in the lesion; on the other hand, compared with ordinary water injection, the preparation can effectively prevent drug hydrolysis and improve the biological activity of the drug Utilization. The freeze-dried powder injection involved in the present invention does not require a scaffolding agent, and has a more suitable osmotic pressure than the commercially available dexamethasone sodium phosphate injection, and avoids excessive deposition of auxiliary materials in the middle ear and damage to local tissues caused by hypertonic fluid. Can increase the safety of intratympanic administration. In addition, the freeze-dried powder preparation prepared by the invention has fewer types and dosages of auxiliary materials, reduces the interaction between drugs, and has good safety for industrial production and clinical medication.

Description

[0001] The parent filing date of this divisional application is June 15, 2020, the application number is 202010543814.5, and the title of the invention is "a dexamethasone sodium phosphate freeze-dried powder injection". technical field [0002] The invention belongs to the field of biomedicine and relates to a freeze-dried powder injection containing dexamethasone. Background technique [0003] 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 infecti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/573A61K9/08A61K47/02A61K47/10A61K47/18A61K47/36A61P27/16
CPCA61K9/19A61K47/183A61K31/573A61P27/16A61K9/0019A61K9/0043A61K47/02A61K47/10A61K47/36A61K9/08
Inventor 王玺玫
Owner HEYU (SUZHOU) PHARM TECH CO LTD
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