Refining method for heparin sodium

A refining method and heparin sodium technology, applied in the field of medicine, can solve problems such as the problem of the clarity of finished heparin sodium products, etc., and achieve the effects of easy product collection and simple production process.

Inactive Publication Date: 2016-03-16
QINGDAO JIULONG BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

(3) For the preparation of heparin sodium products, methods such as alcohol precipitation and freeze-drying have been used in relevant literature reports, but the above methods cannot well solve the problem of the clarity of heparin sodium products

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Add 20g of crude heparin sodium and 400ml of purified water to a dry 1L reaction flask, stir and dissolve at 10°C to 30°C to form a medicinal solution with a concentration of 5%, adjust the pH to 7.8 with 1mol / L sodium hydroxide, and add according to the volume of the medicinal solution. 1% hydrogen peroxide, the concentration of hydrogen peroxide is 30%, the concentration here is the mass volume concentration in the usual sense, continue to stir for 12 hours, gradually add 40g of sodium chloride to the liquid, stir and dissolve, add the liquid 2.5 times the volume of methanol, precipitation, and filtration to obtain the intermediate product of heparin sodium. Repeat this step once. Add 15g of heparin sodium intermediate and 75ml of purified water to a dry 250ml reaction flask, stir and dissolve at 20°C to 30°C to form a medicinal solution with a concentration of 20%. The inlet temperature of the dried medicinal liquid is 180°C, the outlet temperature is 90°C, and the ...

Embodiment 2

[0016] Add 20g of crude heparin sodium and 400ml of purified water to a dry 1L reaction flask, stir and dissolve at 10°C to 30°C to form a medicinal solution with a concentration of 5%, adjust the pH to 8.8 with 1 mol / L sodium hydroxide, and add according to the volume of the medicinal solution. 0.5% times hydrogen peroxide, the concentration of hydrogen peroxide is 30%, continue stirring for 20 hours, gradually add 40g sodium chloride to the medicinal solution, stir to dissolve, add 2.5 times the volume of medicinal solution methanol, precipitate and filter to obtain the intermediate of heparin sodium. . Repeat this step once. Add 15g of crude heparin sodium and 50ml of purified water to a dry 250ml reaction flask, stir and dissolve at 20°C to 30°C to form a medicinal solution with a concentration of 30%, and the medicinal solution is filtered through a 0.1 micron filter membrane and spray-dried. The inlet temperature of the medicinal liquid is 140 DEG C, the outlet temperat...

Embodiment 3

[0018] Add 20g of crude heparin sodium and 400ml of purified water to a dry 1L reaction flask, stir and dissolve at 10°C to 30°C to form a medicinal solution with a concentration of 5%, adjust the pH to 6.8 with 1mol / L sodium hydroxide, and add according to the volume of the medicinal solution. 0.3% hydrogen peroxide, the concentration of hydrogen peroxide is 30%, continue stirring for 18 hours, gradually add 40 g of sodium chloride to the liquid and stir to dissolve, add 5 times the volume of methanol, precipitate and filter to obtain the intermediate of heparin sodium. Taste. Repeat this step once. Add 15g of crude heparin sodium and 50ml of purified water to a dry 250ml reaction flask, stir and dissolve at 20°C to 30°C to form a medicinal solution with a concentration of 30%, and the medicinal solution is filtered through a 0.1 micron filter membrane and spray-dried. The inlet temperature of the medicinal liquid is 120°C, the outlet temperature is 60°C, the spray rate of t...

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PUM

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Abstract

The invention provides a refining method for heparin sodium. Crude heparin sodium is used as a raw material, hydrogen peroxide oxidative decoloration and methyl alcohol grading-alcoholic precipitation are organically combined, a two-time decoloration and methyl alcohol grading-alcoholic precipitation method is adopted, liquid medicine decolorized through the method is almost colorless, colored impurities can be effectively removed, the finished heparin sodium meeting EP7.0 requirements is successfully synthesized through a method for preparing finished heparin sodium through spray drying, the product clarity is not smaller than that of No. 0.5 turbidimetric liquid, the requirements of European Pharmacopoeia EP7.0 are met, meanwhile, the production process is simple, product collection is easily conducted, and the method is provided for industrial production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a purification method of heparin sodium. Background technique [0002] Regarding the production process of heparin sodium, there have been many reports in literature at home and abroad, such as: US5389618, CN100436483, CN101165071A and so on. However, one of the important production processes, namely the refining of heparin sodium, has been reported in different domestic and foreign literatures. (1) Decolorization of crude heparin sodium, related literatures include the use of macroporous adsorption resin, activated carbon adsorption decolorization, hydrogen peroxide oxidation decolorization, etc. (2) The molecular weight and molecular weight distribution of crude heparin sodium, as one of the most important indicators of low molecular weight heparin, are quite different from the requirements of EP7.0 and Kesai, and the relevant literature reports are less, and main...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 刘冠男尚明彩迟培升
Owner QINGDAO JIULONG BIO PHARMA
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