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Betamethasone sodium phosphate and betamethasone acetate suspension injection and preparation method thereof

A technology of betamethasone acetate and metasone sodium phosphate, which is applied in the field of medicine, can solve the problems of poor thermal stability of betamethasone sodium phosphate, unstable thermodynamics and dynamics of the suspension, etc., and achieve good drug efficacy, easy storage, Ease of filling

Pending Publication Date: 2021-12-31
莱默(北京)药业科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But because of its two active ingredients, the thermal stability of betamethasone sodium phosphate is poor, and betamethasone acetate needs a long time to be in the state of suspended particles in the preparation, and the two need to overcome the suspension for being prepared into suspension injection. thermodynamic and kinetic instability problems

Method used

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  • Betamethasone sodium phosphate and betamethasone acetate suspension injection and preparation method thereof
  • Betamethasone sodium phosphate and betamethasone acetate suspension injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] This example provides suspension injections of betamethasone sodium phosphate and betamethasone acetate and their preparation methods.

[0040] Specific steps are as follows:

[0041] (1) Get 12g of betamethasone acetate and pulverize it until 90% of the particle size of betamethasone acetate is less than or equal to 10um, and sterilize to obtain a sterile bulk drug;

[0042] (2) Take a total of 1600mL of sterilized water for injection and add the prescribed amount of sodium dihydrogen phosphate, disodium hydrogen phosphate, disodium edetate, benzalkonium chloride, betamethasone sodium phosphate to dissolve, add inorganic acid or Adjust the pH to 6.8-7.2 with an inorganic base, and filter with a 0.2um filter membrane to obtain a sterile solution of betamethasone sodium phosphate;

[0043] (3) Mix the sterile bulk drug with the sterile solution, shear and stir at 15000 rpm for 20 minutes, add water for injection to 4000 mL, and obtain a suspension;

[0044] (4) In the ...

Embodiment 2

[0047] This example provides suspension injections of betamethasone sodium phosphate and betamethasone acetate and their preparation methods.

[0048] Specific steps are as follows:

[0049] (6) Get 12 g of betamethasone acetate and pulverize it until 99% of the betamethasone acetate particle size≤10um, and sterilize to obtain a sterile bulk drug;

[0050] (7) Take a total of 2000mL of sterilized water for injection and add the prescribed amount of sodium dihydrogen phosphate, disodium hydrogen phosphate, disodium edetate, benzalkonium chloride, betamethasone sodium phosphate to dissolve, add inorganic acid or Adjust the pH to 6.8-7.2 with an inorganic base, and filter with a 0.2um filter membrane to obtain a sterile solution of betamethasone sodium phosphate;

[0051] (8) Mix the sterile bulk drug with the sterile solution, shear and stir at 18,000 rpm for 10 minutes, add water for injection to 4,000 mL, and obtain a suspension;

[0052] (9) In the step (3), the suspension ...

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Abstract

The invention discloses a betamethasone sodium phosphate and betamethasone acetate suspension injection composition. The suspension composition adopts a high-pressure homogenization process, can obtain a preparation with excellent stability, and is suitable for industrial production.

Description

technical field [0001] The invention relates to a betamethasone sodium phosphate & betamethasone acetate suspension injection and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Glucocorticoid (GC) is an extremely important class of regulatory molecules in the body. It plays an important role in regulating the development, growth, metabolism and immune function of the body. It is the most important regulatory hormone for the body's stress response. The most widely used and effective anti-inflammatory and immunosuppressant. In urgent or critical situations, glucocorticoids are often the first choice. Common clinical glucocorticoids include prednisone, methylprednisone, betamethasone, beclomethasone dipropionate, prednisolone, hydrocortisone, dexamethasone, etc. It has anti-inflammatory, anti-toxic, anti-allergic, anti-shock, non-specific immune suppression and antipyretic effects, etc. It can prevent and prevent the ...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K31/661A61K31/573A61P29/00A61P37/08A61P7/08A61P37/06
CPCA61K9/10A61K9/0019A61K31/661A61K31/573A61K47/183A61P29/00A61P37/08A61P7/08A61P37/06A61K2300/00
Inventor 廖锦沁王清慧孙照英提雨晴张寒刘艳平周晓宇高莹王君盼
Owner 莱默(北京)药业科技有限公司
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