Method for quickly detecting heparin disaccharide content in heparin and/or low-molecular heparin

A technology of low molecular weight heparin and heparin disaccharide, applied in the field of drug detection, can solve problems such as long detection time, and achieve the effect of long service life and rapid analysis

Inactive Publication Date: 2018-07-24
DONGYING TIANDONG PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The Chinese patent with the publication number CN104792896A discloses a heparinase composition and its application that can completely and specifically enzymatically hydrolyze enoxaparin sodium. The heparinase composition provided by it is heparinase II and heparinase III The mixture can th

Method used

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  • Method for quickly detecting heparin disaccharide content in heparin and/or low-molecular heparin
  • Method for quickly detecting heparin disaccharide content in heparin and/or low-molecular heparin
  • Method for quickly detecting heparin disaccharide content in heparin and/or low-molecular heparin

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Experimental program
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Effect test

Embodiment 1

[0064] instrument:

[0065] High-performance liquid chromatography (Waters e2695-2489), BSA224S electronic balance (Mettler), low-temperature circulating water tank, FE20pH meter (Mettler).

[0066] Reagent:

[0067] Heparin Sodium (Dongying Tiandong Pharmaceutical Co., Ltd.), Enoxaparin Sodium (Dongying Tiandong Pharmaceutical Co., Ltd.), Heparinase I / II / III (Iduron), Calcium Acetate, Potassium Hydroxide, Sodium Hydroxide, Dihydrogen Phosphate Potassium, bovine serum albumin, purified water, tetrabutylammonium bisulfate, acetonitrile, sodium chloride.

[0068] Preparation of reagents:

[0069] Mobile phase A: prepare 2L of aqueous solution containing 3.3954g tetrabutylammonium hydrogensulfate and 170ml of acetonitrile, that is, 5mmol / L tetrabutylammonium hydrogensulfate and 8.5% aqueous acetonitrile.

[0070] Mobile phase B: prepare 2L of aqueous solution containing 3.3954g tetrabutylammonium hydrogensulfate, 170ml acetonitrile, 35.10g NaCl, that is, 5mmol / L tetrabutylammo...

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Abstract

The invention provides a method for quickly detecting a heparin disaccharide content in heparin and/or low-molecular heparin. The method comprises S1) mixing heparin and/or low-molecular heparin solution with heparinase to react to obtain an enzymolysis product; S2) utilizing reversed-phase ion pair chromatography to detect the enzymolysis product and recording an HPLC spectrogram, wherein a mobile phase of the reversed-phase ion pair chromatography includes a mobile phase A and a mobile phase B, the mobile phase A is an organic solvent and water mixed solution containing reversed-phase ion pairs, the mobile phase B is an organic solvent and water mixed solution containing reversed-phase ion pairs and alkali metal chlorine salt, and the reversed-phase ion pairs are quaternary ammonium salt. Compared with the prior art, the method disclosed by the invention can obtain main heparin disaccharide composition and/or small fragments like trisaccharide and tetrasaccharide units by completelydegrading the heparin and/or the low-molecular heparin through the heparinase; a reversed-phased ion pair reagent and a reversed-phase chromatography are combined to quickly separate and quantitatively analyze the main heparin disaccharide composition and the small fragments; furthermore, the method has very good durability and repeatability.

Description

technical field [0001] The invention belongs to the technical field of drug detection, in particular to a method for rapidly detecting the content of heparin disaccharide in heparin and / or low molecular weight heparin. Background technique [0002] Enoxaparin sodium belongs to low-molecular-weight heparin. With the increase of generic drug manufacturers, the diversity of low-molecular-weight heparin products emerges endlessly. FDA has strengthened the monitoring of low-molecular-weight heparin generics entering the US market. [0003] On July 23, 2010, the FDA formulated a systematic and rigorous method based on five criteria, the so-called generic drug consistency guidelines, including the following five points: 1. Physical and chemical properties; 2. Heparin source and degradation method ; 3. Sequence identity of disaccharide and oligosaccharide fragments; 4. Biochemical equivalence; 5. Pharmacodynamic equivalence in vivo. In addition to this, the FDA used in vivo, in vit...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张在忠郭林陈少鹏马向明王秀萍
Owner DONGYING TIANDONG PHARM CO LTD
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