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Production method of enoxaparin sodium

A technology of enoxaparin sodium and production method, applied in the production field of enoxaparin sodium, can solve the problems of non-standard structure, unfavorable production and economy, waste of time, manpower and material resources and the like

Active Publication Date: 2014-12-10
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the production of dalteparin sodium, the structure of this batch of dalteparin sodium products did not meet the standards due to the inappropriate structure of heparin sodium, which not only wastes time, manpower and material resources, but also is not conducive to production and economy.

Method used

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  • Production method of enoxaparin sodium
  • Production method of enoxaparin sodium
  • Production method of enoxaparin sodium

Examples

Experimental program
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Effect test

Embodiment 1

[0031] 1) Preparation of heparin sodium solution: Accurately weigh 20mg of heparin sodium, put it in a 2mL centrifuge tube, add 1mL of ultrapure water, vortex to dissolve, and shake well to obtain a 20mg / mL heparin sodium solution;

[0032] 2) Preparation of phosphate buffer solution: Accurately weigh 68 mg of potassium dihydrogen phosphate, add 10 mg of bovine serum albumin, put it in a 50 mL volumetric flask, add 30 mL of ultrapure water to dissolve, measure pH, and adjust pH7 with 1M potassium hydroxide if necessary .0, dilute to the mark with ultrapure water, and shake well. Use a syringe to draw a certain volume before each use, and use it after filtering with a 0.45μm filter membrane;

[0033] 3) Mixture of heparanase I, II, and III: Calculate the volume required for each according to the labeled amounts of the three heparinases, absorb the volume and dissolve it in a certain amount of phosphate buffer solution to prepare a heparinase-containing solution. I, II, III con...

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Abstract

The invention discloses a production method of enoxaparin sodium, which comprises the following steps: carrying out enzymolysis on heparin sodium, carrying out HPLC (high performance liquid chromatography) analysis, calculating the contents of various peaks by a peak area normalization process, determining the varieties of disaccharides and tetrasaccharides of the heparin sodium subjected to enzymolysis according to a standard spectrum of disaccharides and tetrasaccharides after heparin sodium enzymolysis, comparing with the contents of disaccharides and tetrasaccharides of the standard spectrum, and selecting the satisfactory heparin sodium raw material to produce the enoxaparin sodium. The method is simple and effective, can ensure the safety and effectiveness of the product, controls the quality of the enoxaparin sodium from the source, can avoid the waste of the active pharmaceutical ingredient heparin sodium, greatly saves the cost and enhances the production efficiency.

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a production method of enoxaparin sodium. Background technique [0002] Heparin is a highly sulfated linear polysaccharide composed of repeated disaccharide units formed by L-iduronic acid (or glucuronic acid) and N-acetylglucosamine (or D-glucosamine), with anticoagulant properties Blood effect, is widely used in the treatment of venous thrombosis and prevention of blood coagulation. Low molecular weight heparin is a component or fragment with lower molecular weight in unfractionated heparin, and it is a new generation of heparin antithrombotic drugs. Low molecular weight heparin can be obtained by partially degrading heparin enzymatically or chemically. Due to the small molecular weight of low-molecular-weight heparin products, it is not easy to be neutralized by factor IV, and the anticoagulant and fibrinolytic effects are enhanced, while the effects of anti-platelet, affecting pl...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 唐咏群黄锡伟段艳冰
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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