Combined preparation method of dalteparin sodium and nadroparin calcium

A technology of nadroparin calcium and dalteparin sodium, applied in the field of chemical pharmacy

Active Publication Date: 2017-07-28
YANTAI DONGCHENG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method of joint production of two low molecular weight heparins will make more effective use of raw materials and reduce production costs, but has not yet been reported

Method used

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  • Combined preparation method of dalteparin sodium and nadroparin calcium
  • Combined preparation method of dalteparin sodium and nadroparin calcium

Examples

Experimental program
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Effect test

Embodiment 1

[0016] Example 1, weigh 2 kg of heparin sodium, dissolve it, adjust the pH to 2.0-3.5, then add sodium nitrite, stir and react for 6 hours to obtain a degradation feed solution, in which the weight-average molecular weight of low-molecular-weight heparin is 2818.

[0017] Adjust the pH of the degradation feed solution to neutral, add sodium borohydride, stir and react at 10°C-30°C for 6 hours, adjust the pH of the feed solution to 4.0-4.5, and stir for 1 hour to obtain a reduction feed solution.

[0018] Add the reducing material solution to ethanol for fractional precipitation, and control the degree of ethanol to 35°. Collect the precipitate, dissolve it with 5 times the weight of water, add 3% sodium chloride, and then grade the precipitate with ethanol. The degree of ethanol is controlled at 35°, collect the precipitate, and detect the weight average molecular weight of low molecular weight heparin in the precipitate to be 5967. After the precipitation was dried, daltepari...

Embodiment 2

[0020] Example 2, weigh 2 kg of heparin sodium, dissolve it, adjust the pH to 2.0-3.5, then add sodium nitrite, stir and react for 5 hours to obtain a degradation feed solution, in which the weight-average molecular weight of low-molecular-weight heparin is 3591.

[0021] Adjust the pH of the degradation feed solution to neutral, add sodium borohydride, stir and react at 10°C-30°C for 6 hours, adjust the pH of the feed solution to 4.0-4.5, and stir for 1 hour to obtain a reduction feed solution.

[0022] Add the reduced raw material solution to ethanol for fractional precipitation, control the degree of ethanol to 45°, collect the precipitate and detect the weight average molecular weight of low molecular weight heparin in the precipitate to be 6055. After the precipitation was dried, dalteparin sodium was obtained, with a weight of 0.69 kg and a yield of 34.5%.

[0023] Add 2 times the volume of ethanol to the upper layer feed solution in the ethanol fractionation precipitati...

Embodiment 3

[0024] Example 3, weigh 2 kg of heparin sodium, dissolve it, adjust the pH to 2.0-3.5, then add sodium nitrite, stir and react for 6 hours to obtain a degradation feed solution, in which the weight-average molecular weight of low molecular weight heparin is 3346.

[0025] Adjust the pH of the degradation feed solution to neutral, add sodium borohydride, stir and react at 10°C-30°C for 6 hours, adjust the pH of the feed solution to 4.0-4.5, and stir for 1 hour to obtain a reduction feed solution.

[0026] Add the reduced raw material solution to ethanol for fractional precipitation, control the degree of ethanol to 40°, collect the precipitate and detect the weight average molecular weight of low molecular weight heparin in the precipitate to be 5755. After the precipitation was dried, dalteparin sodium was obtained, with a weight of 0.60 kg and a yield of 30%.

[0027] Add 2 times the volume of ethanol to the upper layer feed solution in the ethanol fractionation precipitation...

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Abstract

Common sodium heparin is taken as a raw material to be fed once, and low molecular heparin obtained after degradation of the common sodium heparin is utilized for preparing two products including dalteparin sodium and nadroparin calcium by virtue of an ethanol fractional precipitation method.

Description

[0001] 1. Technical field [0002] The invention relates to the field of chemical pharmacy, in particular to a combined preparation method of dalteparin sodium and nadroparin calcium. [0003] 2. Technical Background [0004] Both dalteparin sodium and nadroparin calcium are low-molecular-weight heparins, which are obtained by cleavage of heparin sodium under acidic conditions by sodium nitrite. [0005] Dalteparin sodium can be used in the treatment of acute deep vein thrombosis, prevention of anticoagulation in the extracorporeal circulation system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency, treatment of unstable coronary artery disease, and prevention related to surgery of thrombosis. According to the quality standards stipulated in the European Pharmacopoeia, the anti-Xa potency is 110-210 IU / mg, the anti-Xa / anti-IIa potency ratio is 1.9-3.2, and the weight-average molecular weight is 5600-6400. [0006] Nadr...

Claims

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Application Information

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IPC IPC(8): C08B37/10
CPCC08B37/0003C08B37/0075
Inventor 王建强曹红光张美由单懿祁静
Owner YANTAI DONGCHENG PHARMA GRP
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