Heparanase composition capable of complete specific enzymolysis of enoxaparin sodium and application of heparanase composition

A technology of enoxaparin sodium and heparinase, which is applied in the field of medicine and biology, can solve the problems of inability to judge the performance of samples, instability of heparinase I, poor selectivity, etc., and achieve high practical value and significance, and the effect of reliable methods

Inactive Publication Date: 2015-07-22
SUZHOU RONGXI BIOTECH CO LTD
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AI Technical Summary

Problems solved by technology

However, in practical applications, the results often fail to meet the standards when this method is used. The main reason is that the enzymatic hydrolysis process cannot be completed completely due to the special nature of heparinase, so that the performance of the sample cannot be judged.
In particular, heparanase I is unstable, high ...

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  • Heparanase composition capable of complete specific enzymolysis of enoxaparin sodium and application of heparanase composition
  • Heparanase composition capable of complete specific enzymolysis of enoxaparin sodium and application of heparanase composition
  • Heparanase composition capable of complete specific enzymolysis of enoxaparin sodium and application of heparanase composition

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Embodiment Construction

[0030] The invention provides a heparanase composition, the heparanase composition is a mixture of heparanase II and heparanase III, the enzyme amount ratio of the heparanase II: heparanase III is 3: 1. The heparinase composition of the present invention can completely and specifically enzymolyze enoxaparin sodium, and the content of 1,6 anhydride in the enzymolysis reduction product can be controlled within 15-25%.

[0031] The specific application of the heparanase composition in the present invention is described in detail below:

[0032] Step (1): Complete enzymatic hydrolysis of enoxaparin sodium

[0033] a. Solution preparation in the complete enzymatic hydrolysis step of enoxaparin sodium:

[0034] Solution A: 10mM potassium dihydrogen phosphate solution, the specific configuration is to weigh 136mg of potassium dihydrogen phosphate, use about 40mL of ultrapure aqueous solution, adjust the pH to 7.0 with 2mol / L sodium hydroxide solution, add 20mg of small Bovine albu...

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Abstract

The invention provides a heparanase composition capable of complete specific enzymolysis of enoxaparin sodium. The heparanase composition is a mixture of heparanase II and heparanase III, wherein the enzyme activity ratio of heparanase II to heparanase III is 3: 1. According to the invention, the heparanase composition can realize the complete specific enzymolysis of enoxaparin sodium and is reduced to obtain 1, 6-anhydride derivatives, and the contents are in an acceptable range; the heparanase composition is free from heparanase I to reduce the introduction of enzyme impurities, so that the method is more reliable, is an important supplement for several pharmacopoeia methods, has high practical use value and significance.

Description

technical field [0001] The invention relates to a heparanase composition without heparanase I for detecting the content of 1,6 anhydride in enoxaparin sodium and its application and detection method, belonging to the technical field of medicine and biology. Background technique [0002] Enoxaparin Sodium (Enoxaparin Sodium, ES) is a low-molecular-weight heparin sodium salt obtained by alkaline depolymerization of pig intestinal mucosal heparin benzyl ester derivatives. US Patent US005389618A describes the preparation process of this enoxaparin sodium in detail . The United States Pharmacopoeia and European Pharmacopoeia have many requirements for the quality control of enoxaparin sodium. In addition to the detection of physical and chemical items such as potency, molecular weight distribution, heavy metal content and reagent residue content, the determination of 1,6-anhydride content is also required. Since the percentage of oligosaccharide chains with 1,6-anhydride ring st...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N3/06
Inventor 金永生姚亦明王宁霞王林林闫倩倩
Owner SUZHOU RONGXI BIOTECH CO LTD
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