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Enzymolysis-HPLC method for detecting enoxaparin

A technology of enoxaparin and enoxaparan enzyme, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., and can solve problems that are difficult to involve in the detailed structure of molecules

Active Publication Date: 2013-10-16
SHENZHEN TECHDOW PHARM CO LTD
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Problems solved by technology

[0005] In view of the high complexity of the enoxaparin structure, and the current routine is still difficult to relate to its detailed molecular structure, the present invention proposes a method by specifically degrading the enoxaparin molecule with heparanase and then analyzing the disaccharide content of its main constituents by HPLC. , and thus determine whether the drug is qualified

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  • Enzymolysis-HPLC method for detecting enoxaparin
  • Enzymolysis-HPLC method for detecting enoxaparin
  • Enzymolysis-HPLC method for detecting enoxaparin

Examples

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Embodiment 1

[0023] a. Solution preparation in the complete enzymatic hydrolysis step of enoxaparin:

[0024] Preparation of buffer solution A: Weigh 136mg of potassium dihydrogen phosphate, dissolve it with about 40ml of ultrapure water, add 50ml of glycerol, neutralize it with 1mol / Ld sodium hydroxide solution to pH 7, add 200mg The bovine albumin was transferred to a 100ml volumetric flask, made up to volume with ultrapure water, and shaken up. A 10 mM potassium dihydrogen phosphate solution was obtained.

[0025] Preparation of buffer B: pipette 0.57ml of glacial acetic acid into a beaker, add about 80ml of ultrapure water, add 35mg of calcium acetate, and dissolve it. Neutralize to pH 7 with 1 mol / L sodium hydroxide solution, and add 100 mg of bovine albumin. Transfer to a 100ml volumetric flask, dilute to the mark with ultrapure water, and shake well. A 100 mM sodium acetate solution was obtained.

[0026] Preparation of heparinase solution: Dilute heparinase to 1.5 IU / ml with bu...

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Abstract

The invention discloses an enzymolysis-HPLC method for detecting enoxaparin. The method comprises steps of: a. complete enzymolysis of enoxaparin: adding a mixed enzyme solution with enzyme I, enzyme II and enzyme III in a ratio of 8:1:2 to an enoxaparin solution with a concentration of 10-200mg / ml and carrying out an enzymolysis at room temperature for 48 h. b. HPLC analysis: carrying out a SAX-HPLC analysis on the degradation products; c. calculation of variety and content of disaccharide and tetrose units: determining variety and content of disaccharide and tetrose units according to a wash out time of prior standard disaccharide and tetrose and calculating percentage content of each of the eight disaccharides and one tetrasaccharide.

Description

technical field [0001] The invention relates to a method for detecting the di- and tetrasaccharide unit fingerprints of completely enzymolyzed enoxaparin by HPLC and judging whether the product is qualified or not. Background technique [0002] Enoxaparin is a kind of low molecular weight heparin, which is degraded by heparin phenylalanine. It is a mixture of many small heparin molecules with different chain lengths, and its structure is very complex. It is clinically used to prevent deep vein thrombosis and pulmonary embolism; treat existing venous thrombosis; prevent thrombosis in extracorporeal circulation during hemodialysis; treat unstable angina and non-Q wave myocardial infarction. [0003] Enoxaparin was originally produced by Sanofi Aventis of France, and its commercial product in the United States is named "Lovenox", and its commercial product in mainland China is named "Kesai". In recent years, a number of generic drugs of this drug have emerged at home and abro...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 李建科
Owner SHENZHEN TECHDOW PHARM CO LTD
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