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High-purity nadroparin calcium

A nadroparin calcium, high-purity technology, applied in the field of heparin drugs, can solve the problems of less impurities, low quality standard of low molecular weight heparin calcium, high anti-Xa factor/anti-IIa factor titer ratio, and achieve the effect of reducing the burden

Active Publication Date: 2015-07-29
SHENZHEN SCIPROGEN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The present invention aims at the problem that the existing low-molecular-weight heparin calcium has a low quality standard and it is difficult to obtain high-purity nadroparin calcium, and provides a low-molecular-weight heparin calcium with less impurities, high purity, narrow molecular weight distribution range, and anti-Xa factor / anti-IIa factor potency nadroparin calcium

Method used

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Examples

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Embodiment 1

[0035] This embodiment provides a kind of high-purity nadroparin calcium, and the specific steps for preparing the high-purity nadroparin calcium are as follows:

[0036] (1) Desalination

[0037] Dissolve 1 kg of heparin sodium with 8 kg of water to form a heparin sodium solution with a mass percent concentration of 11%, then add a strong acid cation exchange resin to the heparin sodium solution, adjust the pH of the heparin sodium solution to 2.03 by the strong acid cation exchange resin, and then Filtration was performed using a 800-mesh filter cloth to obtain a filtrate.

[0038] (2) cracking

[0039] Add a sodium nitrite solution with a mass percentage concentration of 21.2% to the above filtrate (21.5 g of sodium nitrite is dissolved in 80 mL of water, and all the prepared sodium nitrite solution is put into the filtrate), and then stirred at room temperature for 4 h to obtain a reaction liquid.

[0040] (3) reduction-calcification

[0041] Calcium oxide was added to...

Embodiment 2

[0055] This embodiment provides a kind of high-purity nadroparin calcium, and the specific steps for preparing the high-purity nadroparin calcium are as follows:

[0056] (1) Desalination

[0057] Dissolve 1 kg of heparin sodium with 10 kg of water to form a heparin sodium solution with a mass percent concentration of 9%, then add a strong acid cation exchange resin to the heparin sodium solution, adjust the pH of the heparin sodium solution to 2.5 by the strong acid cation exchange resin, and then Filtration was performed using a 800-mesh filter cloth to obtain a filtrate.

[0058] (2) cracking

[0059] Add a sodium nitrite solution with a mass percent concentration of 22.6% to the above filtrate (29.2 g of sodium nitrite is dissolved in 100 mL of water, and all the prepared sodium nitrite solution is put into the filtrate), and then stirred at room temperature for 1 h to obtain a reaction liquid.

[0060] (3) reduction-calcification

[0061] Calcium oxide was added to th...

Embodiment 3

[0075] This embodiment provides a kind of high-purity nadroparin calcium, and the specific steps for preparing the high-purity nadroparin calcium are as follows:

[0076] (1) Desalination

[0077] Dissolve 3kg heparin sodium with 27kg water to form a heparin sodium solution with a mass percentage concentration of 10%, then add a strong acid type cation exchange resin to the heparin sodium solution, adjust the pH of the heparin sodium solution to 2.4 by the strong acid type cation exchange resin, and then Filtration was performed using a 800-mesh filter cloth to obtain a filtrate.

[0078] (2) cracking

[0079] Add a sodium nitrite solution with a mass percent concentration of 20.2% to the above filtrate (75.8 g of sodium nitrite is dissolved in 300 mL of water, and all the prepared sodium nitrite solution is put into the filtrate), and then stirred at room temperature for 2 h to obtain a reaction liquid.

[0080] (3) reduction-calcification

[0081] Calcium oxide was added...

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Abstract

The invention relates to the technical field of heparin medicines, in particular to high-purity nadroparin calcium. The high-purity nadroparin calcium is prepared by the steps of sodium removal, splitting, restoration-calcium-conversion, ultraviolet light irradiation, extraction-ultra-filtration, alcohol precipitation-pulping and centrifugation-drying; strong acid cation exchange resin is added into a heparin sodium solution to enable the heparin sodium solution to reach a certain pH range as well as to remove about 1 / 3 sodium ions from the heparin sodium solution through ion exchange and filtration so as to reduce the load of calcium-conversion in the late period; calcium oxide is used to replace the sodium hydroxide for neutralizing the reaction liquid to reduce the intake amount of the sodium ions in the reaction liquid; sodium borohydride and excessive calcium chloride are both added into the reaction liquid and are stirred for a proper duration for achieving a better calcium-conversion effect; the primary feed liquid is irradiated by the ultraviolet light, so that the vast majority of N-NO foreign matters are removed to enable the content of the N-NO to meet the most strict EP (European pharmacopoeia) demand.

Description

technical field [0001] The invention relates to the technical field of heparin drugs, in particular to nadroparin calcium with high purity and narrow molecular weight distribution range. Background technique [0002] Heparin is a sulfated glycosaminoglycan compound extracted from mammalian tissues (such as small intestinal mucosa, lung, liver). It is extremely complex and cannot be synthesized artificially for a long time, and currently only heparin derived from pig small intestinal mucosa can be used for clinical treatment. [0003] Heparin series drugs are mainly used for the prevention and treatment of deep vein thrombosis, hemodialysis anticoagulation, anticoagulation after surgery, etc., and are also used for the prevention and treatment of acute coronary syndrome and ischemic cerebral thrombosis. In addition, they are also widely used in obstetrics and gynecology. Department of Medicine, Pediatrics, Respiratory Medicine, Oncology and Burns, etc. [0004] In the mid-1...

Claims

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Application Information

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IPC IPC(8): C08B37/10A61P7/02
Inventor 郑华淦吴园园顾申勇张涤平盛光阳
Owner SHENZHEN SCIPROGEN BIO PHARMA
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