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Freeze-drying process preparation method of dalteparin sodium

A technology of dalteparin sodium and dalteparin, which is applied in the field of preparing dalteparin sodium by freeze-drying, can solve the problems of excessive organic solvent residues, unqualified product properties and clarity, and unclear language, so as to improve quality and facilitate product collection Effect

Inactive Publication Date: 2021-04-06
JIANGSU WANBANG BIOPHARMLS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In the synthetic route that has been reported in the patent literature of dalteparin sodium, compared with the traditional refining and drying process of dalteparin sodium, organic solvents such as ethanol, acetone and other solvents are used in the refining process for precipitation, and then vacuum drying to obtain dalteparin sodium. For heparin sodium, excessive residual organic solvents are a problem that often plagues commercial production, and direct drying in traditional drying methods has a greater impact on the activity of dalteparin sodium
Although the freeze-drying of heparin sodium is involved in the existing literature reports (application publication number: CN104045744A, etc.), the discussion is not comprehensive enough, or the language is unclear, and there are quality risks and defects such as unqualified properties and clarity of the product

Method used

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  • Freeze-drying process preparation method of dalteparin sodium
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  • Freeze-drying process preparation method of dalteparin sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Add 1 gram of dalteparin sodium into purified water, stir, dissolve and clarify at 30°C, then continue to add water to the feed solution and adjust the volume to 10ml, filter to form a 10% dalteparin sodium aqueous solution to obtain the first dalteparin sodium aqueous solution ; transfer and place in a lyophilizer, and freeze at -40°C for 5 hours to obtain the solid matter of dalteparin sodium and water. Raise the temperature to -35°C, maintain at this temperature for 10 hours, and turn on the vacuum, set the vacuum control below 0.25mbar, raise the temperature to -25°C, maintain at this temperature for 7 hours, raise the temperature to -10°C, in This temperature was maintained for 3 hours. After the first drying, enter into analytical drying, raise the temperature to 0°C and maintain this temperature for 3 hours. Raise the temperature to 40°C, maintain at this temperature for 4-5 hours, turn off the lyophilizer, and obtain dalteparin sodium refined product A.

[002...

Embodiment 2

[0027] Add 1 gram of dalteparin sodium into purified water, stir, dissolve and clarify at 30°C, then continue to add water to the feed solution and adjust the volume to 10ml, filter to form a 10% dalteparin sodium aqueous solution to obtain the first dalteparin sodium aqueous solution ; transfer to a freeze dryer, set the freeze dryer to cool from 20°C to -40°C for 5 hours, and freeze at -40°C for 5 hours to obtain solids of dalteparin sodium and water. Raise the temperature to -35°C, maintain at this temperature for 10 hours, and turn on the vacuum, set the vacuum control below 0.25mbar, raise the temperature to -25°C, maintain at this temperature for 7 hours, raise the temperature to -10°C, in This temperature was maintained for 3 hours. After the first drying, enter into analytical drying, raise the temperature to 0°C and maintain this temperature for 3 hours. Raise the temperature to 20°C, maintain at this temperature for 4-5 hours, turn off the lyophilizer, and obtain da...

Embodiment 3

[0029] Add 1.8 g of dalteparin sodium into purified water, stir, dissolve and clarify at 30°C, continue to add water to the feed solution and adjust the volume to 10 ml, filter to form 18% dalteparin sodium aqueous solution, and obtain the first dalteparin sodium aqueous solution ; transfer and place in a lyophilizer, the lyophilizer is pre-cooled to -40°C, and frozen at -40°C for 5 hours to obtain solids of dalteparin sodium and water. Raise the temperature to -35°C, maintain at this temperature for 10 hours, and turn on the vacuum, set the vacuum control below 0.25mbar, raise the temperature to -25°C, maintain at this temperature for 7 hours, raise the temperature to -10°C, in This temperature was maintained for 3 hours. After the first drying, enter into analytical drying, raise the temperature to 0°C and maintain this temperature for 3 hours. Raise the temperature to 20°C, maintain at this temperature for 4-5 hours, turn off the lyophilizer, and obtain dalteparin sodium r...

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Abstract

The invention discloses a freeze-drying preparation process method of dalteparin sodium, by adjusting parameters of a dalteparin sodium aqueous solution in the freeze-drying process and controlling the processes of different freeze-drying stages, on the basis of not damaging the quality of the original dalteparin sodium structure and potency, the problem that after a low-molecular-weight heparin sodium raw material is freeze-dried, the clarity after redissolution in water is unqualified in the prior art can be solved, the method improves the quality of the product, successfully synthesizes the high purity dalteparin sodium bulk drug finished product, and has the advantages of easy product collection and suitableness for industrial expanded production compared with traditional low molecular weight heparin sodium preparation technologies through alcohol precipitation and vacuum drying.

Description

technical field [0001] The invention belongs to the field of biomedicine, and relates to a preparation method of dalteparin sodium through a freeze-drying process, in particular to a preparation method of dalteparin sodium by a freeze-drying method. Background technique [0002] Dalteparin sodium, its English name: Dalteparin Sodium, trade name: Fragmin, its structural formula is: [0003] [0004] Dalteparin sodium is a kind of low molecular weight heparin, developed by Pfizer, it is suitable for the prevention of coagulation during hemodialysis, the treatment of deep vein thrombosis, and it is also used in combination with aspirin to treat unstable coronary artery disease, such as: no Stable angina and non-Q-wave myocardial infarction. [0005] In the synthetic route that has been reported in the patent literature of dalteparin sodium, compared with the traditional refining and drying process of dalteparin sodium, organic solvents such as ethanol, acetone and other sol...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/727A61P7/02C08B37/10
CPCA61K9/19A61K31/727A61P7/02C08B37/0075
Inventor 王振李春雷王克艳
Owner JIANGSU WANBANG BIOPHARMLS
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