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Low-impurity and high-stability torasemide injection and preparation method

A technology of torasemide and high stability, applied in the field of torasemide injection and preparation of low impurity and high stability, can solve the problems of thermal instability, increase in impurities, loss of torasemide raw materials, etc. The effect of batching time, reducing impurities and optimizing the feeding sequence

Active Publication Date: 2021-01-05
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Torsemide is unstable to heat, and after being adsorbed by activated carbon at high temperature for 30 minutes, it is easy to produce degraded impurities, resulting in increased impurities
In addition, the adsorption of activated carbon can easily lead to the loss of torasemide raw materials, and the adsorption can easily produce elemental impurities, which poses a safety risk.

Method used

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  • Low-impurity and high-stability torasemide injection and preparation method
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  • Low-impurity and high-stability torasemide injection and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] The preparation method of embodiment 1 torasemide injection

[0026]

[0027] The preparation method is:

[0028] (1) Measure a certain amount of water for injection, and control the water temperature at 30°C;

[0029] (2) add polyethylene glycol 400, tromethamine, sodium hydroxide successively (the amount of sodium hydroxide is 95% of the total amount of sodium hydroxide), and stir evenly;

[0030] (3) Add torasemide and stir until completely dissolved;

[0031] (4) Use sodium hydroxide solution to adjust the pH value to 8.5-9.5, add water to make up to full volume, and take a sample to detect the intermediate product.

[0032] (5) Filtrate through 0.45um and 0.22um microporous membranes, carry out nitrogen-filled potting, leak detection, and light inspection.

Embodiment 2

[0033] The preparation method of embodiment 2 torasemide injection

[0034]

[0035] The preparation method is:

[0036] (1) Measure a certain amount of water for injection, and control the water temperature at 45°C;

[0037] (2) add polyethylene glycol 400, tromethamine, sodium hydroxide successively (the amount of sodium hydroxide is 95% of the total amount of sodium hydroxide), and stir evenly;

[0038] (3) Add torasemide and stir until completely dissolved;

[0039] (4) Use sodium hydroxide solution to adjust the pH value to 8.5-9.5, add water to make up to full volume, and take a sample to detect the intermediate product.

[0040] (5) Filtrate through 0.45um and 0.22um microporous membranes, carry out nitrogen-filled potting, leak detection, and light inspection.

Embodiment 3

[0041] The preparation method of embodiment 3 torasemide injection

[0042]

[0043] The preparation method is:

[0044] (1) Measure a certain amount of water for injection, and control the water temperature at 65°C;

[0045] (2) add polyethylene glycol 400, tromethamine, sodium hydroxide successively (the amount of sodium hydroxide is 95% of the total amount of sodium hydroxide), and stir evenly;

[0046] (3) Add torasemide and stir until completely dissolved;

[0047] (4) Use sodium hydroxide solution to adjust the pH value to 8.5-9.5, add water to make up to full volume, and take a sample to detect the intermediate product.

[0048] (5) Filtrate through 0.45um and 0.22um microporous membranes, carry out nitrogen-filled potting, leak detection, and light inspection.

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Abstract

The invention relates to a low-impurity and high-stability torasemide injection and a preparation method. The low-impurity and high-stability torasemide injection is prepared from the following components of torasemide, polyethylene glycol 400, tromethamine, sodium hydroxide and water for injection with the weight ratio of (20-80):(100-2000):(0.5-10):(1-10):(5000-15000), and the preparation methodcomprises the following steps: (1) measuring water for injection and controlling water temperature at 30-65 DEG C; (2) sequentially adding polyethylene glycol 400, tromethamine and sodium hydroxide,and uniformly stirring; (3) adding torasemide, and stirring; (4) adjusting the pH value to 8.5-9.5 by using a sodium hydroxide solution, and adding water to a constant volume; and (5) filtering to obtain the torasemide injection. The preparation method aims to shorten the batching time by optimizing the feeding sequence; an activated carbon adsorption procedure is not adopted, so that the drug safety risk is reduced; and medium-low temperature is adopted in all procedures, and generation of degradation impurities is controlled.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a low-impurity and highly stable torasemide injection and a preparation method. Background technique [0002] Torsemide is a pyridine-sulfonylurea loop diuretic, its chemical name is 1-isopropyl-3-[(4-m-tolylamino-3-pyridyl)sulfonyl]urea, molecular formula: C 16 h 20 N 4 o 3 S, molecular weight: 348.43, [0003] The structural formula is: [0004] [0005] Hypertension is one of the clinical frequently-occurring diseases, often accompanied by a variety of cardiovascular risk factors. Diuretics reduce the amount of sodium and water circulating in the body through urination, reducing blood volume and lowering blood pressure. As a new generation of high-efficiency loop diuretic, torasemide has the characteristics of rapid onset, long-lasting effect, stable dose-effect relationship, wide indications, and good tolerance compared with other diur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/44A61K47/02A61K47/18A61L2/02A61P7/10
CPCA61K31/44A61K9/0019A61K9/08A61K47/18A61K47/02A61P7/10A61L2/0017
Inventor 曾文洁贺莲杨世平张静刘娟刘爱霞
Owner KAMP PHARMA
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