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Method for purifying crude product heparin sodium

A purification method and heparin sodium technology, applied in the purification field of heparin sodium, can solve the problems of wasting resources, long production cycle, flocculant residue, etc., and achieve the effects of ensuring product yield, low production cost, and short production cycle

Active Publication Date: 2010-09-08
江苏麦德森制药有限公司
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  • Abstract
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  • Application Information

AI Technical Summary

Problems solved by technology

The ion exchange resin method has a long production cycle and produces a large amount of waste water, which is not only costly but also a waste of resources
In the traditional method of removing impurities under different pH conditions, the impurities are not easy to flocculate. Generally, the separation problem is solved by high-speed centrifugation or adding a flocculant. The product quality is unstable and the yield is low. The added flocculant is prone to residue

Method used

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Examples

Experimental program
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Effect test

Embodiment Construction

[0020] (1) Dissolving the crude heparin sodium product (100 titer / mg) in 1000 kilograms of 5% sodium chloride solution with a total titer of 7 billion, then adding alcohol with a weight concentration of 95% to make the solution alcohol concentration reach 10% ;

[0021] (2) The solution is warmed up to 50-60°C, adjusted to pH 11-12 with 20% sodium hydroxide by weight, kept warm for 2 hours, filtered, and the insoluble matter is washed with 5% salt water and discarded;

[0022] (3) Add 1 times of alcohol of filtrate weight in gained filtrate, precipitate more than 8 hours, discard supernatant alcohol and obtain precipitate;

[0023] (4) the precipitate is dissolved in 800 liters of 5% sodium chloride solution, and then adding weight concentration is 95% alcohol, so that the solution alcohol concentration reaches 10%;

[0024] (5) Cool the solution in step (4) to 0°C, adjust the pH to 3.0 with hydrochloric acid, filter after precipitation, discard the insoluble matter, and coll...

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Abstract

The invention discloses a method for purifying a crude product heparin sodium. The method comprises the following steps of: adjusting the pH value of the heparin sodium solution containing alcohol to remove most impurities; oxidizing the heparin sodium solution containing alcohol by using hydrogen peroxide for decoloring and impurity removing; and performing fractional precipitation of organic solvent to obtain the heparin sodium meeting pharmacopoeia standard. In the method, the heparin sodium solution containing low concentrate alcohol is selected in the steps of pH adjustment, impurity removal, oxidization and the like for operation, so that the method can not only effectively improve the product quality (ensuring impurities can be better separated from the heparin sodium and can be easily flocculated), but also ensure the product yield, the structure of the heparin sodium cannot be changed in the whole process, and the alcohol can be recycled. Therefore, the method has the advantages of low production cost, short production period, stable quality, suitability for mass production, and product quality in accordance with the quality requirement of injection heparin sodium raw material.

Description

Technical field: [0001] The invention relates to a purification method of heparin sodium, in particular to a method for purifying crude heparin sodium to meet the quality requirements of injection-grade heparin sodium raw materials. Background technique: [0002] Heparin sodium is derived from the small intestinal mucosa of pigs. It is an acidic mucopolysaccharide containing sulfate groups. It is a typical anticoagulant drug, which can prevent the coagulation process of blood and prevent the formation of thrombus. It is widely used clinically to prevent thrombosis and embolism before and after surgery, to prevent blood coagulation during blood transfusion and as an anticoagulant for preserving fresh blood. Eliminate uremia caused by nephropathy in children. Heparin ointment is also widely used in the treatment of skin diseases and cosmetics. my country is the country with the largest output of heparin sodium, and more than 70% of the raw materials of heparin sodium product...

Claims

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Application Information

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IPC IPC(8): C08B37/10
Inventor 刘榜惠张志斌袁红英
Owner 江苏麦德森制药有限公司
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