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Preparation process of nadroparin calcium

A technology of heparin calcium and heparin sodium, which is applied in the field of high-quality nadroparin calcium, can solve the problems of cumbersome operation in the calcium transfer process, restrictions on industrialized large-scale production, and large product losses, and achieve abundant raw material sources, stable and controllable product quality, and low cost. low effect

Inactive Publication Date: 2020-04-17
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the preparation process of low-molecular-weight heparin calcium, the general process is to add calcium chloride and stir for a long time to transfer calcium, and it needs to go through more than 2 calcium transfer processes, and the operation of calcium transfer process is cumbersome and takes a long time, which is easy to cause Incomplete calcium transfer
Moreover, it is often necessary to control the molecular weight of small molecule heparin calcium by means of fractional alcohol precipitation, ultrafiltration membrane separation, molecular sieve and gel adsorption separation. These methods have disadvantages such as backward technology, large product loss, low yield, and high cost. Limit its application in industrialized large-scale production and increase production capacity

Method used

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  • Preparation process of nadroparin calcium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] 1 oxidation

[0021] Weigh 100g of refined heparin sodium and dissolve it in 1.25L of purified water to prepare an 8% aqueous solution, and adjust the pH value of the solution to 10-10.5 with 20% NaOH; h was added; after oxidation, filter with a 0.45 μm filter membrane, and wash the filter membrane with a small amount of purified water; slowly add 1 L of ethanol to the filtrate at 37°C, stir for 30 minutes, and then let it stand for 4 hours; after the precipitation, Discard the supernatant, add 2L of 3% saline to the insoluble oil, adjust the pH of the solution to 6.5-7 with 4mol / L HCl, filter through a 0.22μm membrane, and slowly add 1.8 to the filtrate at 37°C L of ethanol, stirred for 30 min, then stood still for 4 h, discarded the supernatant, and the insoluble matter was directly used for the next step of sodium removal.

[0022] 2 Sodium removal, degradation and reduction

[0023] Dissolve the precipitate obtained in step 1 in 1.25 L of purified water to prepare...

Embodiment 2

[0027] 1 oxidation

[0028] Weigh 100g of refined heparin sodium and dissolve it in 1.1L of purified water to prepare a 9% aqueous solution, and adjust the pH value of the solution to 10-10.5 with 20% NaOH; h is added; after oxidation, filter with a 0.45μm filter membrane, and wash the filter membrane with a small amount of purified water; at 37°C, slowly add 0.9L of 95% ethanol to the filtrate, stir for 30min, and then stand for 6h; precipitate After the end, discard the supernatant, add 1.25 L of 3% saline to the insoluble oil, adjust the pH of the solution to 6.5-7 with 4 mol / L HCl, filter with a 0.22 μm filter membrane, and pour into the filtrate at 37°C Slowly add 1.35L of ethanol, stir for 30min, then let it stand for 6h, discard the supernatant, and the insoluble matter is directly used for the next step of desalination.

[0029] 2 Sodium removal, degradation and reduction

[0030] Dissolve the precipitate obtained in step 1 in 1.11L of purified water to prepare a 9% ...

Embodiment 3

[0034] 1 oxidation

[0035]Weigh 100g of refined heparin sodium and dissolve it in 1L of purified water to prepare a 10% aqueous solution. Use 20% NaOH to adjust the pH value of the solution to 10-10.5; After the oxidation is completed, filter with a 0.45 μm filter membrane, and wash the filter membrane with a small amount of purified water; slowly add 1 L of ethanol to the filtrate at 37°C, stir for 30 minutes, and then let it stand for 8 hours; after the precipitation is completed, discard Remove the supernatant, add 1L of 3% saline to the insoluble oil, adjust the pH of the solution to 6.5-7 with 4mol / L HCl, filter through a 0.22μm filter membrane, and slowly add 1L of ethanol, stirred for 30min, and then stood still for 8h, discarded the supernatant, and the insoluble matter was directly used for the next step of desalination.

[0036] 2 Sodium removal, degradation and reduction

[0037] Dissolve the precipitate obtained in step 1 in 1L of purified water to prepare a 10%...

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Abstract

The invention discloses a preparation process of nadroparin calcium. High-quality heparin used as a starting raw material undergoes the processes of oxidation, sodium removal, degradation, reduction,ultraviolet irradiation, calcium replacement and the like to prepare the high-quality nadroparin calcium. By optimizing parameters, the calcium replacement frequency is reduced, and the molecular weight is effectively controlled. The technical content is improved, the material loss is reduced, the product yield is improved, and the production cost is reduced.

Description

technical field [0001] The invention relates to the preparation of high-quality nadroparin calcium by using high-quality heparin sodium as a raw material through processes such as oxidation, degradation, reduction, ultraviolet irradiation, and calcium replacement. Background technique [0002] Heparin is a kind of glycosaminoglycan, which is a linear natural acidic mucopolysaccharide containing sulfuric acid groups composed of two kinds of uronic acids, one kind of glucosamine and their derivatives. It mainly exists in the small intestinal mucosa, liver and lung of pigs in tissue cells. Heparin can not only anticoagulant and antithrombotic, but also regulate other functions in the human body, such as lowering blood fat, anti-inflammation, anti-allergy, lowering blood pressure and anti-cancer. Heparin has the effect of prolonging blood clotting time, and its molecule has a linear chain structure composed of hexasaccharide or octasaccharide repeating units, and exists in the ...

Claims

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Application Information

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IPC IPC(8): C08B37/10
CPCC08B37/0078
Inventor 张立冬周裕林刘志孙迎基
Owner SUZHOU ERYE PHARMA CO LTD