Acetazolamide sodium freeze-dried powder injection as well as preparation method and application thereof

A technology of acetazolamide sodium and freeze-dried powder injection, which is applied in the field of biomedicine, can solve problems such as the effectiveness and safety of clinical medication, certain risks in clinical application, and residual organic solvents in the final product, so as to achieve stable product quality, The effect of convenient preparation and low cost

Active Publication Date: 2021-12-07
OCUMENSION THERAPEUTICS SUZHOU CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Acetazolamide Sodium for Injection is unstable in the liquid state and will degrade. Therefore, the existing marketed products are freeze-dried powder injections, but even so, a large amount of hydrolysis will still occur during the freeze-drying preparation process. Impurities, so that the impurity content in the final product is at a high level, and it will increase significantly with the prolongation of storage time, which will have a certain impact on the effectiveness and safety of clinical medication
[0005] The prior related art discloses a freeze-dried preparation of injection-grade acetazolamide sodium. When preparing injection-grade acetazolamide sodium bulk drug before freeze-drying, an organic solvent such as ethanol or methanol or isopropanol or Acetone or methyl ethyl ketone, etc., this method is likely to cause residual organic solvents in the final product, which poses a certain risk to clinical application

Method used

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  • Acetazolamide sodium freeze-dried powder injection as well as preparation method and application thereof
  • Acetazolamide sodium freeze-dried powder injection as well as preparation method and application thereof
  • Acetazolamide sodium freeze-dried powder injection as well as preparation method and application thereof

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Effect test

Embodiment 1

[0031] The prescription of this embodiment acetazolamide sodium freeze-dried powder injection is shown in Table 1.

[0032] Table 1

[0033] Acetazolamide 10.066kg sodium hydroxide 3.5kg Water for Injection Add to 106.6kg

[0034] A preparation method of acetazolamide sodium freeze-dried powder injection, comprising the following steps:

[0035] (1) Dosing: Inject 25kg of water for injection into a 200L dosing tank, cool down to 20°C, add 51kg of 5% sodium hydroxide solution, stir evenly, keep the temperature at 8°C, and then add 10.066kg of acetazolamide , stir and dissolve completely, measure the pH value, continue to add 5% sodium hydroxide solution to make the amount of sodium hydroxide reach the amount designed in the prescription, and adjust the pH value to 9.6±0.2, if the pH value is too high, you can add an appropriate amount Adjust with 0.1mol / L HCl, and continue to add water for injection to the prescribed amount to obtain a medicinal ...

Embodiment 2

[0041] The prescription of this embodiment acetazolamide sodium freeze-dried powder injection is shown in Table 2.

[0042] Table 2

[0043] Acetazolamide 10.072kg sodium hydroxide 3.5kg Water for Injection Add to 106.76kg

[0044] A preparation method of acetazolamide sodium freeze-dried powder injection, comprising the following steps:

[0045](1) Dosing: Inject 25kg of water for injection into a 200L dosing tank, cool down to 10°C, add 51kg of 5% sodium hydroxide solution, stir evenly, keep the temperature at 5°C, and then add 10.072kg of acetazolamide , stir and dissolve completely, measure the pH value, continue to add 5% sodium hydroxide solution to make the amount of sodium hydroxide reach the amount designed in the prescription, and adjust the pH value to 9.6±0.2, if the pH value is too high, you can add an appropriate amount Adjust with 0.1mol / L HCl, and continue to add water for injection to the prescribed amount to obtain a medicinal ...

Embodiment 3

[0051] The prescription of this embodiment acetazolamide sodium freeze-dried powder injection is shown in Table 3.

[0052] table 3

[0053] Acetazolamide 10.069kg sodium hydroxide 3.5kg Water for Injection Add to 106.8kg

[0054] A preparation method of acetazolamide sodium freeze-dried powder injection, comprising the following steps:

[0055] (1) Dosing: Inject 25kg of water for injection into a 200L dosing tank, cool down to 30°C, add 51kg of 5% sodium hydroxide solution, stir evenly, keep the temperature at 10°C, and then add 10.069kg of acetazolamide , stir and dissolve completely, measure the pH value, continue to add 5% sodium hydroxide solution to make the amount of sodium hydroxide reach the amount designed in the prescription, and adjust the pH value to 9.6±0.2, if the pH value is too high, you can add an appropriate amount Adjust with 0.1mol / L HCl, and continue to add water for injection to the prescribed amount to obtain a medicinal...

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Abstract

The invention discloses an acetazolamide sodium freeze-dried powder injection as well as a preparation method and application thereof. The preparation method comprises the following steps of (1) mixing acetazolamide and water for injection, keeping the temperature at 5-10 DEG C, adding acetazolamide, and stirring to obtain a liquid medicine; and (2) sterilizing and filtering the liquid medicine, pre-freezing and drying to obtain the acetazolamide sodium freeze-dried powder injection, wherein the pre-freezing process specifically comprises the following steps of cooling to -40 to -50 DEG C, preserving heat for 2-3 hours, heating to -15 to -25 DEG C, preserving heat for 2-3 hours, cooling to -40 to -50 DEG C, and preserving heat for 4-5 hours. The prepared product is more stable in quality, low in total impurity content, free of addition of organic reagents and higher in safety, and the preparation method is simple.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to acetazolamide sodium freeze-dried powder injection and its preparation method and application. Background technique [0002] The chemical name of acetazolamide sodium is N-(5-sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide monosodium salt, and the molecular formula is C 4 h 5 N 4 NaO 3 S 2 , the molecular weight is 244.23. The structural formula is: [0003] [0004] Acetazolamide Sodium for Injection was first developed by TEVA WOMENS HEALTH INC and launched in the United States in December 1990. Acetazolamide Sodium for Injection is unstable in the liquid state and will degrade. Therefore, the existing marketed products are freeze-dried powder injections, but even so, a large amount of hydrolysis will still occur during the freeze-drying preparation process. Impurities make the impurity content in the final product at a relatively high level and increase sig...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/433A61K47/02A61P27/06
CPCA61K9/19A61K9/0019A61K31/433A61K47/02A61P27/06
Inventor 彭贵子汪祥戴赫
Owner OCUMENSION THERAPEUTICS SUZHOU CO LTD
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