Torasemide freeze-drying preparation and prepn. method

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...

Examples

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.

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...

Examples

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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