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Freeze-dried powder injection containing dexamethasone sodium phosphate

A technology of dexamethasone sodium phosphate and freeze-dried powder injection, which is applied in the field of biomedicine, can solve the problems of difficult-to-treat drug concentration and obvious systemic side effects, achieve good therapeutic effect, reduce the interaction between drugs, and relieve pain. Effect

Active Publication Date: 2020-10-16
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

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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  • Freeze-dried powder injection containing dexamethasone sodium phosphate
  • Freeze-dried powder injection containing dexamethasone sodium phosphate
  • Freeze-dried powder injection containing dexamethasone sodium phosphate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0111] The formula and preparation method of embodiment 1 dexamethasone sodium phosphate injection

[0112] Table 2

[0113]

[0114] Preparation:

[0115] (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;

[0116] (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;

[0117] (3) Dilute to a 50mL measuring bottle and shake well;

[0118] (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;

[0119] (5) Gained sterile powder is a white loose lump;

[0120] (6) The temperature is controlled at room temperature throughout the preparat...

Embodiment 2

[0121] The formula and preparation method of embodiment 2 dexamethasone sodium phosphate injection

[0122] table 3

[0123]

[0124] Preparation:

[0125] (1) the water for injection is cooled to room temperature;

[0126] (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;

[0127] (3) Dilute to full volume and shake well;

[0128] (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;

[0129] (5) Gained sterile powder is a white loose lump;

[0130] (6) The temperature is controlled at room temperature throughout the preparation process.

Embodiment 3

[0131] The formula and preparation method of embodiment 3 dexamethasone sodium phosphate injection

[0132] Table 4

[0133]

[0134] Preparation:

[0135] (1) Dissolving the dexamethasone sodium phosphate and auxiliary materials of the prescription amount with water for injection at room temperature;

[0136] (2) Adjust the pH of the medicinal solution to 8.0±0.05 with 0.1M HCl;

[0137] (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;

[0138] (4) Gained sterile powder is a white loose lump;

[0139] (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 a dexamethasone medicine. The freeze-dried powder injection preparation provided by the present invention is a dexamethasone-type drug freeze-dried powder injection preparation without a freeze-dried support agent or excipient or stent. By tympanum administration, on one hand, the freeze-dried powder injection preparation can reduce the whole-body toxic and side effects of oral administration and play a role in lesion parts; on the other hand, the preparation can effectively prevent hydrolysis of the medicine and improve the bioavailability of the medicine compared with common aqueous injections. The freeze-dried powder injection does not require a stent, and at the same time has amore suitable osmotic pressure than commercially available dexamethasone sodium phosphate injection solutions, avoids the deposition of excessive auxiliary materials in the middle ear and the damage of hypertonic fluid to local tissues, and can increase the safety of tympanum administration. In addition, the prepared freeze-dried powder preparation has fewer types and small dosages of auxiliary materials, reduces the interaction between medicines, and has good safety for industrial production and clinical medication.

Description

technical field [0001] The invention belongs to the field of biomedicine and relates to a freeze-dried powder injection containing dexamethasone. 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 accompanied by tinnitus but not vertigo. Some scholars believe...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/18A61K31/573A61P27/16
CPCA61K9/19A61K47/183A61K31/573A61P27/16A61K9/0019A61K9/0043A61K47/02A61K47/10A61K47/36A61K9/08
Inventor 王玺玫
Owner 和舆(苏州)医药科技有限公司
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