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A kind of extraction method of middle grade heparin sodium

An extraction method and technology of heparin sodium, applied in the field of extraction of medium-grade heparin sodium, to achieve the effect of increasing yield, increasing potency and yield

Active Publication Date: 2016-08-17
山东绅联药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although heparin has a history of more than 60 years in clinical use, so far, there is no product that can completely replace it, so it is still one of the most important biochemical drugs and one of the main export drugs in my country

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] (1) Dissolution: crude heparin sodium 2Kg, potency 95 USP u / mg, equivalent to 190 million units of crude heparin sodium. Dissolve with 22.8L of 3% saline saline, heat up to 38°C with stirring, and react for 2 hours.

[0028] (2) Enzymolysis: After step (1), adjust the pH of the solution to 7.5 with 20% NaOH, add 30.4 g of trypsin, control the temperature at 40°C, and react for 4 hours.

[0029] (3) Protein removal: After step (2), adjust the pH to 8.5, raise the temperature to 60°C, add 500g of calcium chloride, react for 0.5 hours, continue to raise the temperature to 90°C, and stop heating. Then cool down to about 40°C and perform centrifugation.

[0030] (4) Calcium ion removal: After step (3), keep the solution temperature at 40°C, add 500g of anhydrous sodium carbonate, react for 0.5 hours, filter, and collect the filtrate.

[0031] (5) Precipitation: Adjust the pH of the filtrate obtained in step (4) to 7.0 with 6mol / L hydrochloric acid, and precipitate with foo...

Embodiment 2

[0043] (1) Dissolution: crude heparin sodium 1.5Kg, potency 88 USP u / mg, equivalent to 132 million units of crude heparin sodium. Dissolve with 14.52L of 3% saline saline, stir and heat up to 40°C, and react for 2.5 hours.

[0044] (2) Enzymatic hydrolysis: After step (1), adjust the pH of the solution to 8.0 with 20% NaOH, add 21.12 g of trypsin, control the temperature at 41°C, and react for 4.5 hours.

[0045] (3) Protein removal: After step (2), adjust the pH to 8.5, raise the temperature to 60°C, add 300g of calcium chloride, react for 0.5 hours, continue to raise the temperature to 93°C, and stop heating. Then cool down to about 40°C and perform centrifugation.

[0046] (4) Calcium ion removal: After step (3), keep the solution temperature at 40°C, add 300g of anhydrous sodium carbonate, react for 0.5 hours, filter, and collect the filtrate.

[0047] (5) Precipitation: Adjust the pH of the filtrate obtained in step (4) to 7.5 with 6mol / L hydrochloric acid, and precipit...

Embodiment 3

[0059] (1) Dissolution: crude heparin sodium 2.5Kg, potency 98 USP u / mg, equivalent to 245 million units of crude heparin sodium. Dissolve with 31.85L of 3% saline saline, stir and heat up to 36°C, and react for 3 hours.

[0060] (2) Enzymolysis: After step (1), adjust the pH of the solution to 7.5 with 20% NaOH, add 39.2 g of trypsin, control the temperature at 41°C, and react for 4.5 hours.

[0061] (3) Protein removal: After step (2), adjust the pH to 8.5, raise the temperature to 60°C, add 700g of calcium chloride, react for 0.5 hours, continue to raise the temperature to 92°C, and stop heating. Then cool down to about 40°C and perform centrifugation.

[0062] (4) Calcium ion removal: After step (3), keep the solution temperature at 40°C, add 700g of anhydrous sodium carbonate, react for 0.5 hours, filter, and collect the filtrate.

[0063] (5) Precipitation: Adjust the pH of the filtrate obtained in step (4) to 7.5 with 6mol / L hydrochloric acid, and precipitate with foo...

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Abstract

The invention in particular relates to a method for extracting a heparin sodium medium-grade drug. The method for extracting the heparin sodium medium-grade drug comprises the following steps: dissolving, carrying out enzymolysis, removing protein, removing calcium ion, carrying out sedimentation, carrying out resin adsorption, eluting, carrying out primary oxidation, filtering, carrying out sedimentation, carrying out secondary oxidation, filtering, carrying out sedimentation, dehydrating, drying, weighing and packaging. The method for extracting the heparin sodium medium-grade drug has the advantages that a hydrogen peroxide secondary oxidation method is adopted for preparing the heparin sodium medium-grade drug, a new heparin sodium preparation process is defined by combining enzymolysis with resin adsorption and an oxidation method, and the defect that residual protein is difficult to remove in a heparin sodium medium-grade drug purifying process is overcome; besides, trypsin is added into heparin sodium medium-grade drug solution for dissolving impurity protein, then resin adsorption and oxidation are combined for removing impurities, and titer and yield of the heparin sodium medium-grade drug are improved.

Description

(1) Technical field [0001] The invention belongs to the field of biochemical industry, and in particular relates to a method for extracting medium-grade heparin sodium. (2) Background technology [0002] Heparin is an acidic mucopolysaccharide found in liver tissue when Mclean studied the mechanism of coagulation in 1916. In 1939, Brinkhousflj et al. proved that heparin has anticoagulant activity. Since then, heparin has been valued by countries all over the world as a natural anticoagulant substance. Although heparin has been used clinically for more than 60 years, so far, there is no product that can completely replace it, so it is still one of the most important biochemical drugs and one of the main export drugs in my country. Heparin has a strong anticoagulant effect and is the drug of choice for the prevention and treatment of deep venous thrombosis and other thromboembolic diseases. Anti-allergy, anti-virus, anti-cancer and other biological functions. (3) Contents ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 李鑫谢成君王慧陈露刘建洋甄爱华
Owner 山东绅联药业股份有限公司
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