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Preparation method of high-titer heparin sodium crude product and production apparatus therefor

A production device and technology of heparin sodium, applied in the biological field, can solve problems such as low biological activity, waste of salt, environmental pollution, etc., and achieve the effects of high product quality, energy saving, and investment reduction

Active Publication Date: 2017-04-26
重庆伊诺生化制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Conventional production methods use saturated brine to cause a large amount of waste of salt and environmental pollution, and the crude heparin sodium obtained contains a large amount of protein nucleic acid impurities, organic impurities such as dermatan sulfate and chondroitin sulfate, and has low biological activity.

Method used

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  • Preparation method of high-titer heparin sodium crude product and production apparatus therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0066] Embodiment 1 is used to improve the reagent composition of crude product heparin sodium purity

[0067] A reagent composition for increasing the potency of heparin sodium, comprising the following reagents:

[0068] Reagent A: a 2% sodium chloride aqueous solution by mass volume percentage;

[0069] Reagent B: 3% sodium chloride aqueous solution by mass volume percentage;

[0070] Reagent C: 4% sodium chloride aqueous solution in mass volume percentage;

[0071] Reagent D: an aqueous solution of 8% sodium chloride by mass volume percentage;

[0072] Reagent E: an aqueous solution of heparin sodium alcohol, where the concentration of ethanol in the aqueous solution of heparin sodium alcohol is 20°.

Embodiment 2

[0073] Embodiment 2 is used to improve the reagent composition of crude product heparin sodium purity

[0074] A reagent composition for increasing the potency of heparin sodium, comprising the following reagents:

[0075] Reagent A: a 5% sodium chloride aqueous solution by mass volume percentage;

[0076] Reagent B: 6% sodium chloride aqueous solution in mass volume percentage;

[0077] Reagent C: a 7% sodium chloride aqueous solution by mass volume percentage;

[0078] Reagent D: a 20% sodium chloride aqueous solution by mass volume percentage;

[0079] Reagent E: an aqueous solution of heparin sodium alcohol, where the concentration of ethanol in the aqueous solution of heparin sodium alcohol is 40°.

Embodiment 3

[0080] Embodiment 3 is used to improve the reagent composition of crude product heparin sodium purity

[0081] A reagent composition for increasing the potency of heparin sodium, comprising the following reagents:

[0082] Reagent A: 4% sodium chloride aqueous solution by mass volume percentage;

[0083] Reagent B: 5% sodium chloride aqueous solution by mass volume percentage;

[0084] Reagent C: a 6% sodium chloride aqueous solution by mass volume percentage;

[0085] Reagent D: a 14.5% sodium chloride aqueous solution by mass volume percentage;

[0086] Reagent E: an aqueous solution of heparin sodium alcohol, where the concentration of ethanol in the aqueous solution of heparin sodium alcohol is 30°.

[0087] The mass volume percentage in the following examples is represented by w / v.

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Abstract

The invention belongs to the technical field of biology and particularly relates to a preparation method of a high-titer heparin sodium crude product and a production apparatus therefor. The invention provides a reagent composition for preparing the heparin sodium crude product. The reagent composition includes: a low-salt washing reagent A: a NaCl water solution being 2-5% in mass volume percentage; a medium-salt washing reagent B: a NaCl water solution being 3-6% in mass volume percentage; a high-salt washing reagent C: a NaCl water solution being 4-7% in mass volume percentage; an elution reagent D: a NaCl water solution being 8-20% in mass volume percentage; and a precipitation reagent E: a heparin sodium ethanol water solution in 20-40 degrees. In the invention, gradient washing is carried out with the washing reagents in different salinity. The heparin sodium crude product prepared through the method of low-salinity elution and low-ethanol-degree precipitation is low in impurity content and has complete heparin sodium molecular structure. The bioactivity of the heparin sodium crude product is approximate to or reaches injection grade of heparin sodium.

Description

technical field [0001] The invention belongs to the field of biotechnology, and in particular relates to a method for preparing high-potency crude heparin sodium and a production device thereof. Background technique [0002] Heparin Sodium (Heparin Sodium) Heparin Sodium is a mucopolysaccharide sulfate anticoagulant. Heparin sodium is the sodium salt of aminodextran sulfate extracted from the intestinal mucosa of pigs or cattle, and belongs to mucopolysaccharides. In animals, it mostly exists in the form of heparin sodium-protein complex. In medicine, heparin sodium has an anticoagulant effect both in vivo and in vitro, and can prolong the coagulation time, prothrombin time and thrombin time. Clinically, it has the effects of anticoagulation, lowering blood fat, protecting endothelial cells, anti-platelet accumulation and release, promoting fibrinolysis, inhibiting the proliferation of arterial smooth muscle cells, reducing blood viscosity, lowering blood lipids and anti-i...

Claims

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Application Information

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IPC IPC(8): C08B37/10
CPCC08B37/0075
Inventor 尹怀君
Owner 重庆伊诺生化制品有限公司
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