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Torasemide tablet

A technology of torasemide tablets and torasemide, which is applied in the field of medicine, can solve the problems of complex liposome process of torasemide, unsteady drug development, large fluctuations in blood drug concentration, etc., and achieve good quality stability , The preparation method is simple and feasible, and the release effect is uniform

Inactive Publication Date: 2016-10-26
NANJING ZENKOM PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN101007003A discloses a torasemide injection. The stability of the injection is greatly improved, but the drug cannot be played stably, and it is easy to cause sudden release, large fluctuations in blood drug concentration, and excessive metabolism. It is necessary to increase the dosage of the drug to maintain the drug. effect, with greater side effects
Patent CN2102078300B discloses a liposome solid preparation of torasemide, which uses liposome as the carrier of the drug to control the release of the drug, which improves the targeting of the drug, but the stability of the liposome, encapsulation efficiency, and in vivo There is a great relationship between the effective time and toxic and side effects of liposome composition and preparation method, and the process of preparing good-quality torasemide liposome is complicated
Patent CN1919196A discloses a slow-release tablet containing active ingredients of torasemide, which realizes the steady release of the drug and is beneficial to reduce the fluctuation of the drug, but the drug absorption part is mainly in the stomach and small intestine, and is suitable for making a slow-release tablet that is taken once every 24 hours. Release preparations, and the sustained release preparations cannot be released completely within 24 hours, affecting drug compliance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Preparation of torasemide tablets each containing 50 mg of the new crystal form:

[0030]

[0031] Pass torasemide through a 100-mesh sieve, starch, lactose, and sodium carboxymethylcellulose through a 80-mesh sieve, mix evenly, add 45ml of binder solution, granulate with 30 mesh, dry at 60°C for 80min, and obtain dry material, add Magnesium stearate, mixed for 10 minutes, granulated with 24 mesh, compressed into tablets, ready to be obtained.

Embodiment 2

[0033] Preparation of torasemide tablets containing 10 mg of the new crystal form per tablet:

[0034]

[0035] Pass torasemide through a 100-mesh sieve, starch, lactose, and sodium carboxymethylcellulose through a 80-mesh sieve, mix evenly, add 65ml of binder solution, granulate with 30 mesh, dry at 60°C for 90min, and obtain dry material, add Magnesium stearate, mixed for 10 minutes, granulated with 24 mesh, compressed into tablets, ready to be obtained.

Embodiment 3

[0037] Preparation of torasemide tablets containing 2.5 mg of the new crystal form per tablet:

[0038]

[0039] Pass torasemide through a 100-mesh sieve, starch, lactose, and sodium carboxymethylcellulose through a 80-mesh sieve, mix evenly, add 50ml of binder solution, granulate with 30 mesh, dry at 60°C for 70min, and obtain dry material, add Magnesium stearate, mixed for 10 minutes, granulated with 24 mesh, compressed into tablets, ready to be obtained.

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Abstract

The divisional application of the invention provides torasemide with a novel crystal form and with an application number of 201610363797.0, and discloses a torasemide tablet. The torasemide tablet is a preparation mainly prepared from the torasemide with the novel crystal form. According to the crystal form, the aspects of the stability, dissolution rate, water solubility and the like of the preparation are greatly improved. The torasemide tablet can play a role of slow release without a retardant, so that the use of the retardant is reduced, toxic and side effects are reduced, and the preparation is very applicable to clinical application. According to the torasemide tablet, the zero-level release, smooth dissolution and stable decompression are realized, the awkwardness of urgent urination of a patient is avoided, the toxic and side effects are reduced, and the torasemide tablet can be adequately absorbed after being orally taken. The torasemide tablet is good in stability and medication compliance, simple in production process, relatively low in cost and easy to industrialize.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a torasemide tablet and a preparation method thereof. This application is a divisional application of an invention patent application with the application number 201610363797.0 and the application date of May 26, 2016, named "A New Crystal Form of Torsemide". Background technique [0002] Torasemide is a sulfonylurea pyridine diuretic with the chemical name 1-isopropyl-3-[(4-m-tolylamino-3-pyridyl)sulfonyl]urea. It was first launched in Belgium in 1993 and entered my country in 2003. It has definite curative effect and is mainly used for the treatment of congestive heart failure, hypertension, renal edema, renal insufficiency, cirrhotic ascites and cerebral edema and other diseases. Torsemide acts on the thick ascending limb of the Henle's loop to inhibit Na + 、K + , Cl - Carrier system that makes urine Na + 、K + , Cl - And water excretion increased, no signif...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/44A61K47/38A61K47/36A61K47/26A61P9/04A61P9/12A61P13/12A61P1/16A61P7/10
CPCA61K31/44A61K9/2018A61K9/2054A61K9/2059
Inventor 单飞徐卓业
Owner NANJING ZENKOM PHARMA
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