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Preparation method for heparin sodium

A technology of heparin sodium and heparinase, which is applied in the biological field, can solve the problems of large investment in hardware facilities for the production of heparin sodium, high requirements for material and environmental temperature control, and large hardware investment. The effect of low environmental temperature requirements and small investment in hardware facilities

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

[0003] The preparation of heparin sodium has high requirements for material and environmental temperature control, and a large investment in hardware facilities; this method adopts strong acidic conditions (pH1. Very unstable under the pH value environment, very easy to degrade and inactivate), affect the final activity yield and titer, and the operability is not strong; this method adopts ultrafiltration concentration and separation technology, ultrafiltration equipment is expensive, and hardware investment is relatively large; The ion balance exchange method adopted by the method is to realize the conversion of heparin sodium to heparin sodium by the continuous intervention of high-concentration sodium ions, which cannot guarantee the adequacy and continuous stability of the dynamic ion balance conversion.
The preparation of heparin sodium in foreign countries all adopts the ion exchange method. This method needs to use high-quality heparin sodium as a raw material. Carried out under low-temperature extraction conditions, resulting in a large investment in hardware facilities for the production of heparin sodium, and high production costs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Step 1: Stir and dissolve the crude sodium heparin raw material (commercially available raw material, potency 65-105IU / mg) with 1%-3% NaCl solution, the concentration of crude sodium heparin is 8%-16% (mass percentage concentration ), adjust the pH to 7.5-9.0 with 5M NaOH solution, heat up to 50-55°C, add heparin enzymolysis trypsin according to 0.1-0.3% of the mass of the crude product heparin sodium solution, keep warm for 4-5 hours, and use 5M NaOH Adjust the pH value of the solution to 9.0-11, heat up to 85°C-90°C, cool to room temperature, filter to remove the precipitate, and precipitate the filtrate with 0.8-1.5 times the volume of 95% ethanol for more than 4 hours, and collect the precipitate A;

[0021] Step 2: Stir and dissolve the precipitate A with pure water, the dissolved concentration is 10%-20% (mass percentage), adjust the pH to 8.5-11 with 5M NaOH solution, and press 0.1%-5% of the mass of the precipitate A aqueous solution Add protein flocculation and...

Embodiment 2

[0026] The heparin enzymolysis trypsin in step 1 is selected as compound trypsin containing trypsin;

[0027] The protein flocculation precipitant in step 2 is selected polyaluminum chloride for use;

[0028] The other steps were the same as in Example 1 to obtain the refined heparin sodium.

Embodiment 3

[0030] The heparin enzymolysis trypsin in step 1 is selected as neutral trypsin;

[0031] The protein flocculation precipitant in step 2 is selected sodium polyacrylate for use;

[0032] The other steps were the same as in Example 1 to obtain the refined heparin sodium.

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PUM

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Abstract

The invention discloses a preparation method for heparin sodium. After crude heparin is enzymatically degraded, protein removal treatment is conducted, a heparin sodium solution is obtained through resin exchange after oxidative decoloration is completed, the oxidative decoloration solution is precipitated, dehydrated and dried, and then fine heparin sodium is obtained. The raw material source is wide, universality is high, the activity yield is high, the technological quality is stable, production cost is low, the preparation method of heparin sodium is high in operability under the normal temperature condition, and then low-investment, low-cost, high-recovery, high-operability, stable-technological-quality and large-batch preparation of heparin sodium is conveniently achieved.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a preparation method of heparin sodium. Background technique [0002] Heparin, sodium salt and sodium salt are common in clinical blood tests, has a unique application value, heparin has low chelating power, has little effect on the movement of water molecules, has little interference with blood components, does not affect the volume of red blood cells, and does not cause hemolysis. Therefore, heparin is recommended as an anticoagulant in various tests using whole blood or plasma as specimens. It is suitable for red blood cell fragility test, blood gas analysis, hematocrit test, hemorheology and emergency biochemical determination. In the detection of pH value, blood gas, electrolyte and calcium ion, heparin is the only anticoagulant that can be used, so heparin sodium is recommended as the anticoagulant. [0003] The preparation of heparin sodium has high requirements ...

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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