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A torasemide for injection and preparation process thereof

A torasemide preparation technology, applied in the field of torasemide preparations for injection and its preparation process, can solve the problem of poor solubility and stability of torasemide freeze-drying, poor stability, long reconstitution time, etc. problems, achieve excellent resolubilization performance, considerable economic and social benefits, and complete moisture drying

Active Publication Date: 2019-01-15
NANJING YOUKE BIOLOGICAL MEDICAL RES +3
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the inventors have found through research that the lyophilized solubility and stability of torasemide are poor when no cosolvent is added such as sodium bicarbonate
[0007] Experiments by the inventors have confirmed that the freeze-dried preparations of the above prior art either have the problem of long reconstitution time, or poor stability, and all have certain deficiencies.

Method used

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  • A torasemide for injection and preparation process thereof
  • A torasemide for injection and preparation process thereof
  • A torasemide for injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Embodiment 1 prescription 1 and preparation technology

[0034] Prescription 1:

[0035] prescription

Specification 20mg

torsemide

20g

sodium bicarbonate

20g

10% sodium hydroxide solution

Appropriate amount

10% hydrochloric acid solution

Appropriate amount

Mannitol

160g

water for injection

up to 2kg

[0036] Preparation Process:

[0037] (1) Take the raw and auxiliary materials according to the prescription, prepare a pH regulator (10% sodium hydroxide solution, 10% hydrochloric acid solution), and set aside;

[0038] (2) Weigh 70% water for injection, add sodium bicarbonate and stir to dissolve, then add torasemide and stir to make it fully suspended;

[0039] (3) Stir and slowly add an appropriate amount of 10% sodium hydroxide solution until the main ingredient is completely dissolved, and measure the pH value of the solution;

[0040] (4) Stir and slowly add an appropriate amount of...

Embodiment 2

[0044] Embodiment 2 prescription 2 and preparation technology

[0045] Prescription 2:

[0046] prescription

[0047] Preparation process: According to the above prescription amount, it is prepared by the same process as in Example 1, named 20141008 (10 mg).

Embodiment 3

[0048] Embodiment 3 prescription 3 and preparation technology

[0049] Prescription 3:

[0050] prescription

Specification 20mg

torsemide

100g

sodium bicarbonate

100g

10% sodium hydroxide solution

Appropriate amount

10% hydrochloric acid solution

Appropriate amount

Mannitol

800g

water for injection

up to 10kg

[0051] Preparation Process:

[0052] (1) cooling the water for injection to below 45°C for subsequent use; weighing torasemide, sodium bicarbonate, and mannitol successively according to the prescription amount for subsequent use; preparing 10% sodium hydroxide solution and 10% hydrochloric acid solution for subsequent use;

[0053] (2) Weigh 70% of the prescribed amount of water for injection (below 45°C), add the prescribed amount of sodium bicarbonate, and stir until completely dissolved;

[0054](3) Add the prescribed amount of torasemide and stir until fully suspended;

[0055] (4...

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PUM

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Abstract

The invention relates to a torasemide freeze-dried powder injection and a preparation process thereof. The freeze-dried powder injection comprises 1 part by weight of torasemide, 1 part by weight of sodium bicarbonate, 8 to 17 parts by weight of mannitol, an appropriate amount of a pH regulator, and the pH value of the freeze-dried composition aqueous solution is adjusted to be 8.5 to 9.5. The torasemide freeze-dried powder injection prepare by that method according to the prescription of the invention has the advantages of short redissolution time, low moisture content, good appearance and high stability, and is very suitable for clinical use.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a torasemide preparation for injection and a preparation process thereof. Background technique [0002] Torasemide is a sulfonylurea loop diuretic developed by Boehringer Mannheim, Germany, with a chemical name of 1-isopropyl-3-[(4-m-tolylamino-3-pyridyl) Sulfonyl]urea. It was listed in Belgium for the first time in 1993, and was subsequently approved to be listed in Italy, Belgium, the United States, the United Kingdom and other countries, and entered my country in 2003. Torsemide is a long-acting diuretic that acts on the loop of Henle of the renal tubules. It is mainly used clinically to treat various edema and various types of hypertension caused by congestive heart failure, kidney or liver diseases, etc. Torsemide is superior to other diuretics in that it has strong diuretic effect, long duration, high bioavailability, less adverse reactions, no diuretic resistan...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/44A61K47/10A61P7/10
CPCA61K9/19A61K31/44A61K47/10
Inventor 张峰钟元元薛峪泉朱素华刘春猛
Owner NANJING YOUKE BIOLOGICAL MEDICAL RES
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