Nadroparin calcium preparation technology

A technology of nadroparin calcium and preparation process, applied in the field of nadroparin calcium production technology, can solve the problems of incomplete calcium transfer, cumbersome operation of calcium transfer process, long time, etc., and achieve complete calcium transfer, wide range of use, cost low effect

Inactive Publication Date: 2013-11-27
HEBEI CHANGSHAN BIOCHEM PHARMA
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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 times of calcium transfer, and the operation of calcium transfer is cumbersome and takes a long time. completely

Method used

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  • Nadroparin calcium preparation technology
  • Nadroparin calcium preparation technology

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] a. Preparation of degradation solution

[0034] Add 3Kg of heparin sodium into 15L~24L of pure water and stir to dissolve, then adjust the pH of the solution to 2~3 with hydrochloric acid, then add 60g of sodium nitrite, stir and react at 10~30°C for 2~5h, then cool at 2~10°C Stand still for 20-24 hours;

[0035] b. Preparation of reducing solution

[0036] In the degradation solution prepared in step ②, use sodium hydroxide solution to adjust the pH of the solution to 9-11, add 18g of sodium borohydride for reduction for 10-16 hours, and use sodium hydroxide to adjust the pH of the solution to 6.5-7.0 after the reaction get the reducing solution;

[0037] c. Collect the sediment

[0038] Add 95% volume concentration of ethanol to the reducing solution for precipitation and collect the precipitate;

[0039] d. Oxidation

[0040] After adding pure water to the collected precipitate and stirring to dissolve, add 0.2% to 1.0% mass concentration of hydrogen peroxide to...

Embodiment 2

[0049] Example 2: The difference between this example and Example 1 is that the sodium heparin is 2Kg, the sodium nitrite is 40g, and the sodium borohydride is 20g.

Embodiment 3

[0050] Example 3: The difference between this example and Example 1 is that the sodium heparin is 4Kg, the sodium nitrite is 80g, and the sodium borohydride is 40g.

[0051] Instance detection results

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PUM

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Abstract

The invention discloses a nadroparin calcium preparation technology. The technology comprises the steps of degradation liquid preparation, reducing liquid preparation, precipitation, oxidation, ion exchange, crude nadroparin calcium preparation, refining, and lyophilization. The technology which adopts a chemical degradation method to produce nadroparin calcium allows the highest nadroparin calcium yield to reach 75%, and has the advantages of simplicity, abundant sources of raw materials, convenient operation, no discharge of three wastes, low cost, and stable and controllable product quality. Heparin fragments having different molecular weights are separated through membrane separation to prepare the nadroparin calcium product having an anti-Xa titer of 95-130IU / mg, an activity ratio of 2.5-4.0 and a molecular weight of 3600-5000D, and the product can reach the quality standard prescribed in European Pharmacopoeia. The product can reduce the local hematoma phenomena and obviously improve the ache condition during hypodermic injection, has the efficacies of venous thromboembolism prevention, coronary heart disease treatment, anticoagulation, antithrombotic property, antitumor, anti-inflammation, anti-allergy and blood fat adjustment, and has the advantages of substantial curative effects, wide application range and convenience for the large scale production.

Description

technical field [0001] The invention relates to a production process of nadroparin calcium. Background technique [0002] Nadroparin calcium is the calcium salt of low molecular weight heparin, which is obtained by depolymerizing heparin extracted from the small intestinal mucosa of pigs. Heparin is a glycosaminoglycan widely present in animal organs and tissues such as small intestinal mucosa and lungs. Heparin has various pharmacological activities such as anticoagulation, anti-inflammation, anti-allergy, anti-virus, anti-cancer, and regulation of blood lipids, but long-term use may cause some adverse reactions, such as bleeding and induction of thrombocytopenia. [0003] Low molecular weight heparin (LMWH) is a fragment with a smaller molecular weight obtained by fractionating or degrading heparin. nearly 10 years. Studies on low-molecular-weight heparin have found that its antithrombotic effect is superior to heparin, and has the characteristics of high bioavailabilit...

Claims

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Application Information

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IPC IPC(8): C08B37/10A61P7/02A61P9/10A61P35/00A61P29/00A61P37/08A61P3/00
Inventor 姬胜利高树华李文茂崔洁白文举
Owner HEBEI CHANGSHAN BIOCHEM PHARMA
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