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Torasemide freeze-drying preparation and prepn. method

A technology of torasemide and freeze-drying, which is used in freeze-dried delivery, active ingredients of heterocyclic compounds, powder delivery, etc., and can solve the problems of unsuitability for long-term storage, increase of related substances, and unstable injections.

Active Publication Date: 2006-09-20
南京海辰药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are also people who increase the water solubility of torasemide by adding polyethylene glycol-400 and prepare it into injections. Since torasemide has an amide bond in its molecular structure, it is easily hydrolyzed after being prepared into a liquid preparation, resulting in a decrease in drug content. The increase of related substances will affect the curative effect, and it is not suitable for long-term storage
In addition, injections with polyethylene glycol-400 added are less stable
Moreover, polyethylene glycol-400 has a stimulating effect on blood vessels, which is not conducive to long-term large-scale use

Method used

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  • Torasemide freeze-drying preparation and prepn. method
  • Torasemide freeze-drying preparation and prepn. method

Examples

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Embodiment 1

[0027] Torsemide 10g

[0028] Sodium bicarbonate 20g

[0029] Mannitol 100g

[0030] Makes 1000 bottles

[0031] Take by weighing prescription amount torasemide, sodium bicarbonate respectively in aseptic weighing room, add the water for injection of 75% prescription amount (1500ml) in the liquid mixing barrel, slowly add torasemide and sodium bicarbonate, Stir, add an appropriate amount of 10% NaOH solution, adjust the pH to 9.0, stir to fully dissolve the main ingredient, then add the prescribed amount of mannitol, stir to dissolve, add water for injection to 2000ml, add 0.05% activated carbon for needles, and stir at room temperature For 10 minutes, use a sterile sand core to filter and decarbonize, and filter with a microporous membrane (0.22 μm). After passing the quality inspection, the filtrate is divided into 2ml vials, freeze-dried, aseptically sealed, and packaged. Instantly.

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Abstract

A freeze-dried composition of torasemide features that it contains sodium hydrogen carbonate for higher solubility. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a torasemide freeze-dried preparation and a preparation method. Background technique [0002] Torsemide, the English name is Torsaemide, [0003] The chemical structural formula is as follows: [0004] [0005] Molecular formula: C 16 h 20 N 4 o 3 S [0006] Molecular weight: 348.43 [0007] It is white or off-white loose lumps. It is a new generation of sulfonylurea loop diuretics researched and developed by Boehringer Mannheim in Germany. It was first launched in Germany in 1993 and approved by the US FDA in 1994. The drug is sold in many countries and regions such as the United States, Canada, Switzerland, and Hong Kong. This drug is the fourth loop diuretic on the market today. It is mainly used clinically to treat various edemas caused by congestive heart failure, kidney or liver diseases, etc. And various types of hypertension, it is a milestone drug i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/44A61K9/19
Inventor 曹于平蒋金元冒宜兰
Owner 南京海辰药业股份有限公司
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