Torasemide raw material and preparation method

A technology of torasemide and raw materials, which is applied in the field of pharmaceutical preparations, can solve the problems of low product purity and easy decomposition of torasemide into related substances, and achieve the effect of improving quality stability and reducing requirements

Inactive Publication Date: 2020-01-21
NANJING CHENGONG PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The main problem with the currently commercially available torasemide raw materials is that torasemide is easily decomposed into related substances, resulting in low product purity

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Embodiment 1: the preparation of torasemide raw material comprises the following steps:

[0020] S1: Add 200g of sodium bicarbonate to 1000mL of deionized water, keep stirring and dissolving at above 70°C;

[0021] S2: Add 1000mL of ethanol, then add 400g of torasemide crude product, raise the temperature to 90°C, stir to dissolve, prepare a saturated solution, use medicinal activated carbon to absorb and remove color, and first pass through a 0.5μm filter element for coarse filtration, and then pass through 0.2 Fine filter with μm filter element;

[0022] S3: Add 15g of citric acid, add 2000g of sodium acetate, adjust the pH to acidic, rapidly lower the solution temperature to 4°C, wait for torasemide crystals to precipitate, filter after 4h, take the filtered crystals, and dry them in vacuum at low temperature.

[0023] S4: Grind the dried crystals, pass through a 100-mesh sieve, add 15 g of citric acid passed through a 100-mesh sieve, and mix well to obtain.

Embodiment 2

[0024] Embodiment 2: the preparation of torasemide raw material comprises the following steps:

[0025] S1: Add 200g of sodium bicarbonate to 1000mL of deionized water, keep stirring and dissolving at above 70°C;

[0026] S2: Add 1000mL of ethanol, then add 600g of torasemide crude product, heat up to 90°C, stir to dissolve, prepare a saturated solution, use medicinal activated carbon to absorb and remove color, and first pass through a 0.5μm filter element for coarse filtration, and then pass through 0.2 Fine filter with μm filter element;

[0027] S3: Add 50 g of citric acid, add 2000 g of sodium acetate, adjust the pH to acidity, rapidly lower the temperature of the solution to 4°C, wait for torasemide crystals to precipitate, filter after 4 hours, take the filtered crystals, and dry them in vacuum at low temperature.

[0028] S4: Grind the dried crystals, pass through a 100-mesh sieve, add 50 g of citric acid passed through a 100-mesh sieve, and mix well to obtain.

Embodiment 3

[0029] Embodiment 3: the preparation of torasemide raw material comprises the following steps:

[0030] S1: Add 200g of sodium bicarbonate to 1000mL of deionized water, keep stirring and dissolving at above 70°C;

[0031] S2: Add 1000mL of ethanol, then add: 500g of torasemide crude product, heat up to 90°C, stir to dissolve, make a saturated solution, use medicinal activated carbon to absorb and remove color, and first pass through a 0.5μm filter element for coarse filtration, and then pass through 0.2μm filter fine filter;

[0032] S3: Add 30 g of citric acid, add 2000 g of sodium acetate, adjust the pH to acidity, rapidly lower the temperature of the solution to 4°C, wait for torasemide crystals to precipitate, filter after 4 hours, take the filtered crystals, and dry them in vacuum at low temperature.

[0033] S4: Grind the dried crystals, pass through a 100-mesh sieve, add 30 g of citric acid passed through a 100-mesh sieve, and mix well to obtain.

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PUM

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Abstract

The invention discloses a torasemide raw material. The torasemide raw material is prepared from the following components in parts by weight: 40-60 parts of torasemide and 3-10 parts of citric acid. According to the torasemide raw material, the requirements for the preparation process can be reduced, the production of too many related substances can be avoided, and the quality stability of productsis improved. The invention further provides a preparation method of the torasemide raw material.

Description

technical field [0001] The invention relates to a raw material of torasemide, which belongs to the technical field of pharmaceutical preparations. Background technique [0002] Hypertension is a common clinical multiple chronic disease, often accompanied by a variety of cardiovascular risk factors, is one of the most common chronic diseases in my country, and poses a huge threat to the health of the people. Diuretics reduce the content of sodium and water in the body's circulation through natriuresis and diuresis, reducing blood volume and lowering blood pressure. Torsemide is a long-acting diuretic that acts on the loop of Henle of the renal tubules. It was first launched in Belgium in 1993 and entered my country in 2003. Compared with traditional diuretics, torasemide has strong diuretic effect, high bioavailability, long-lasting effect, fewer adverse reactions, and good patient tolerance. Not only can it treat edema caused by congestive heart failure, but it can also ha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/12A61K31/44A61P9/12
CPCA61K47/12A61K31/44A61P9/12
Inventor 史志迅
Owner NANJING CHENGONG PHARM CO LTD
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