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A kind of preparation method of low molecular weight heparin sodium with ultra-low free sulfate group

A low-molecular-weight, heparin sodium technology is applied in the field of preparation of low-molecular-weight heparin sodium, which can solve the problems of inability to separate low-molecular-weight heparin, and achieve the effects of good clarity, low impurity content, and simple and easy-to-operate process.

Active Publication Date: 2016-08-17
山东万邦赛诺康生化制药股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The production process of above-mentioned a kind of ultra-low molecular weight heparin sodium (calcium) is when high concentration sodium chloride (calcium) washes off ion exchange resin, while low molecular weight heparin (sodium) calcium is eluted, the polarity such as sulfate group is relatively high. Strong substances may also be eluted together, and the separation of low molecular weight heparin (sodium) calcium and free sulfate can not be achieved

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A preparation method of low molecular weight heparin sodium with ultra-low free sulfate groups, comprising the following steps:

[0025] (1) Weigh 100g of heparin sodium, dissolve it in purified water, prepare a 5% to 15% (w / v) heparin sodium solution, and control the solution temperature below 30°C, stir; wherein, heparin sodium is purchased from Zaozhuang Pig mucosal heparin sodium product sold by Sinokang Biochemical Co., Ltd.

[0026] (2) adjust the pH value of the solution prepared in step (1) to 2.3 to 3.0 with 6mol / L hydrochloric acid, and stir;

[0027] (3) Add 2.3 to 3.5 g of sodium nitrite into the solution of step (2), stir and keep the pH value stable, and the reaction time is 1.5 hours;

[0028] (4) After the reaction is completed, quickly adjust the pH value of the solution to 8.0-10.0 with 1 mol / L sodium hydroxide; add sodium borohydride with a weight of 1-3% (w / w) of heparin sodium weighed in advance, and keep it for 12 hours , use 6mol / L hydrochloric ...

Embodiment 2

[0036] Different from Example 1, step (6) replaced the anion resin with Amberlite IRA-400.

Embodiment 3

[0038] Unlike Example 1, step (6) replaced the anion resin with Diaion SA-10A.

[0039] After testing, although different anion resins are used in Examples 1-3, they can all achieve selective adsorption of free sulfate radicals and some impurities, and the final results are basically the same; the preparation process is changed, which not only makes the process simple It is easy to operate, and the obtained low molecular weight heparin sodium has good quality, low impurity content, good clarity and higher yield.

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PUM

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Abstract

The invention discloses a preparation method for low molecular weight heparin sodium with ultralow free sulfate group content. According to the method, heparin sodium is taken as the starting raw material, sodium nitrite is added to depolymerize heparin sodium, and low molecular weight heparin sodium and impurities are generated; and ion exchange resin is used for performing ion exchange on free sulfate radical and the impurities to remove the free sulfate radical and the impurities, and the safety of low molecular weight heparin calcium is improved. Different from the prior art, the preparation method has the benefits that the preparation process is changed to be simpler and easier to operate, and further, obtained low molecular weight heparin sodium is good in quality, low in impurity content, good in clarity and higher in yield.

Description

technical field [0001] The invention relates to the technical field of pharmacy, in particular to a preparation method of low-molecular-weight heparin sodium with ultra-low free sulfate groups. Background technique [0002] Enoxaparin sodium is a low-molecular-weight heparin sodium salt, mainly used for the prevention of venous thromboembolic diseases (prevention of venous thrombosis), especially for the prevention of thrombosis related to orthopedic or general surgery; "Stipulates that Heparin Sodium (Heparin Sodium) is the sodium salt of aminodextran sulfate extracted from the intestinal mucosa of pigs or cattle. Calculation of heparin sodium as a dry product, the titer per 1mg shall not be less than 170 units. [0003] Low-molecular-weight heparin is a low-molecular-weight heparin sodium salt or calcium salt. It is a new type of antithrombin Ⅲ (ATⅢ)-dependent antithrombotic drug, and its pharmacological effects are basically similar to unfractionated heparin sodium. [...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10
Inventor 郑会武石滨丛义国刘清凉
Owner 山东万邦赛诺康生化制药股份有限公司