Preparation method of fine heparin sodium

A technology of heparin sodium and high-quality products, applied in the field of preparation of high-quality heparin sodium, can solve the problems of manganese dioxide reducing product yield, large product activity loss, low titer, etc., to reduce product activity loss, improve titer and effect. Valence recovery rate, the effect of avoiding by-products

Inactive Publication Date: 2016-11-09
郭舒洋
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The technical problem mainly solved by the present invention is to produce high-quality heparin sodium by the two-step oxidation method of potassium permanganate and hydrogen peroxide commonly used at present or the secondary oxidation method in which hydrogen peroxide is added in stages, and the resulting product has a large loss of activity and a poor color. Poor, by-product manganese dioxide reduces product yield and low potency, provides a self-made enzyme preparation obtained by loading expanded perlite with compound enzymes, uses it to pretreat crude heparin sodium, and then oxidizes it once with hydrogen peroxide Prepare high-quality heparin sodium

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

[0018] First, 40 g of expanded perlite were weighed and soaked in 0.5 mol / L sulfuric acid solution and 0.3 mol / L sodium hydroxide solution for 3 hours, and then moved into a Buchner funnel for suction filtration and washing for 20 minutes to obtain surface-modified expanded perlite; The ratio is 5:3:1. After mixing trypsin, alkaline protease and lipase, add deionized water with 3 times the total volume of the three, stir evenly, transfer to the vacuum concentration tank, and concentrate to its original volume under 900Pa pressure. 1 / 2 of the composite enzyme solution was obtained, the above-mentioned surface-modified expanded perlite was immersed in the composite enzyme solution according to the solid-liquid ratio of 1:3, put into an ultrasonic oscillator and immersed overnight with a power of 200W; After freeze-drying at -40 °C with a vacuum freeze dryer, a self-made immobilized composite enzyme preparation was obtained; next, 1 kg of crude heparin sodium was weighed and disso...

example 2

[0021] First, 45g of expanded perlite were weighed and soaked in 0.5mol / L sulfuric acid solution and 0.3mol / L sodium hydroxide solution for 4 hours, and then moved into a Buchner funnel for suction filtration and washing for 25min to obtain surface-modified expanded perlite; The ratio is 5:3:1. After mixing trypsin, alkaline protease and lipase, add deionized water with 4 times the total volume of the three, stir evenly, transfer to the vacuum concentration tank, and concentrate to its original volume under 950Pa pressure. 1 / 2 of the composite enzyme solution was obtained, and the above-mentioned surface-modified expanded perlite was immersed in the composite enzyme solution at a solid-liquid ratio of 1:3, put into an ultrasonic oscillator, and immersed overnight with a power of 250W; After freeze-drying at -35 °C with a vacuum freeze dryer, a self-made immobilized composite enzyme preparation was obtained; next, 1.5 kg of crude heparin sodium was weighed and dissolved in a 3% ...

example 3

[0024] Firstly, 50g of expanded perlite was weighed and soaked in 0.5mol / L sulfuric acid solution and 0.3mol / L sodium hydroxide solution for 5 hours, and then moved into a Buchner funnel for suction filtration and washing for 30min to obtain surface-modified expanded perlite; then by mass The ratio is 5:3:1. Mix trypsin, alkaline protease and lipase, add deionized water with 5 times the total volume of the three, stir evenly, transfer to the vacuum concentration tank, and concentrate to its original volume under 1000Pa pressure. 1 / 2 of the composite enzyme solution was obtained, and the surface-modified expanded perlite was immersed in the composite enzyme solution at a solid-to-liquid ratio of 1:3, placed in an ultrasonic oscillator, and immersed overnight with a power of 300W; After freeze-drying at -30 °C with a vacuum freeze dryer, a self-made immobilized composite enzyme preparation was obtained; next, 2 kg of crude heparin sodium was weighed and dissolved in a 3% sodium c...

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Abstract

The invention discloses a preparation method of fine heparin sodium, and belongs to the technical field of preparation of heparin sodium. Expanded perlite is loaded with compound enzyme to obtain a home-made enzyme preparation, the home-made enzyme preparation is used for pretreating crude heparin sodium, and the crude heparin sodium is subjected to primary oxidation by hydrogen oxide to obtain the fine heparin sodium. Examples prove that the preparation method is unique and novel, by-products generated in the traditional refining method are avoided, loss of activity of the product is reduced to a maximum extent, refining steps are simplified, valence and valence recovery of the fine heparin sodium are improved effectively, the valence can reach 160-170 u / mg, and the recovery reaches 98% or above.

Description

technical field [0001] The invention discloses a preparation method of fine heparin sodium, and belongs to the technical field of heparin sodium preparation. Background technique [0002] 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, which is a mucopolysaccharide. It has anticoagulant effect both in vitro and in vivo, and is currently the mainstream anticoagulant drug. However, the bioavailability of unfractionated heparin sodium is low and the side effects are large. Later, it was found that the sodium salt of aminodextran sulfate fragments obtained by the cracking of heparin sodium has an average molecular weight of 4000-6000 Daltons, which is called low molecular weight heparin sodium. Like heparin sodium injection, low molecular weight heparin sodium injection is an antithrombin III (AT III)-dependent thrombin inhibitor. However, compared w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10A61K31/727A61K9/08A61P7/02
CPCC08B37/0075A61K9/0019A61K9/08A61K31/727C08B37/0003
Inventor 郭舒洋张明林茂平
Owner 郭舒洋
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