Preparation process of dalteparin sodium

A technology for the preparation of dalteparin sodium, applied to medical preparations containing active ingredients, metabolic diseases, blood diseases, etc., can solve the problems of manganese dioxide difficult to filter out, quality control, and product recovery rate reduction, etc. Achieve the effects of easy control of the production process, prevention of unstable coronary heart disease, and convenient operation

Active Publication Date: 2012-07-11
HEBEI CHANGSHAN BIOCHEM PHARMA
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  • Abstract
  • Description
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  • Application Information

AI Technical Summary

Problems solved by technology

However, the degradation of hydrogen peroxide may introduce foreign matter, and the quality is not easy to control; the end of the enzymatic degradation product has unsaturated groups, which has poor stability and high cost; in terms of impurity removal and decolorization methods, at present, potassium permanganate under different pH conditions is mainly used in China. and hydrogen peroxide secondary oxidation method or hydrogen peroxide oxidation method
The disadvantage of the secondary oxidatio

Method used

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  • Preparation process of dalteparin sodium
  • Preparation process of dalteparin sodium
  • Preparation process of dalteparin sodium

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Embodiment 1: as figure 1 As shown, first:

[0029] ①. Weigh 3Kg sodium heparin, 45g sodium nitrite and 30g sodium borohydride respectively for later use;

[0030] ②. After adding 3Kg of heparin sodium into a 15-24L purified water reaction tank, stir at room temperature for 4-6 hours and dissolve to obtain a heparin sodium solution;

[0031] ③. After adjusting the pH of the above sodium heparin solution to 2~3 with hydrochloric acid, add 45g of sodium nitrite under stirring, then keep warm at 10~30°C and react for 2~5h under stirring, then let stand for 20 After ~24h, the heparin degradation solution was obtained;

[0032] ④. After adjusting the pH value of the above-mentioned heparin degradation solution to 9-11 with sodium hydroxide solution, add 30 g of sodium borohydride for reduction for 10-16 hours. After the reaction is completed, adjust the pH value to 6.5-7.0 with sodium hydroxide solution to obtain the reduction solution ;

[0033] ⑤. Add 2 to 4 times the ...

Embodiment 2

[0037] Example 2: The difference between this example and Example 1 is that the heparin sodium is 10Kg, the sodium nitrite is 150g, and the sodium borohydride is 100g. After freeze-drying, 9Kg of the finished product of dalteparin sodium is obtained.

Embodiment 3

[0038] Example 3: The difference between this example and Example 1 is that the heparin sodium is 30Kg, the sodium nitrite is 450g, and the sodium borohydride is 300g, and 27Kg of the finished product of dalteparin sodium is obtained after freeze-drying.

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Abstract

The invention discloses a preparation process of dalteparin sodium. The preparation process comprises the following steps: preparing a heparin sodium solution, a heparin degradation fluid, a reducing solution and a crude product, refining, freeze-drying and the like. The average molecular weight of the obtained product is 5,500 to 6,500, the peak molecular weight is 3,500 to 6,000, a component with the molecular weight of less than 3,000 is not greater than 13% , a component with the molecular weight of greater than 8,000 is not greater than 15%, anti-Xa activity is more than or equal to 130IU/mg. The invention has the advantages of rich source of raw materials, high yield, stable and reliable quality, high purity, low cost, simple process, easiness in operation and no waste discharge. The dalteparin sodium has the anticoagulant, antithrombotic, anti-tumor, anti-inflammatory, anti-allergy and blood lipid regulating effects, thereby having a significant curative effect. The dalteparin sodium can be used for preventing preoperative and postoperative thrombosis of general surgery, orthopedic surgery and neurosurgery, effectively preventing venous thromboembolism of ischemic stroke patients, greatly reducing the risk of stroke, effectively preventing the solidification caused by extracorporeal circulation of blood, effectively preventing the instable coronary heart disease, and having a wide usable range.

Description

technical field [0001] The invention relates to a production process of dalteparin sodium. Background technique [0002] Dalteparin sodium is a low-molecular sodium salt, which is mainly used for the prevention of coagulation and deep vein thrombosis in hemodialysis, the treatment of unstable coronary artery disease and the prevention of thrombosis related to surgery. Heparin is a kind of glycosaminoglycan widely present in animal organs, small intestinal mucosa, lung and other tissues. [0003] In addition to having all the pharmacological effects of unfractionated heparin, low-molecular-weight heparin is used as an anticoagulant, usually for short-term use, and has a high therapeutic index. The US FDA has approved dalteparin sodium as a prophylactic drug after low limb replacement. [0004] At present, the degradation methods of low molecular weight heparins produced in China mainly include sodium nitrite degradation method, hydrogen peroxide degradation method, enzymati...

Claims

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Application Information

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IPC IPC(8): C08B37/10A61K31/727A61P7/02A61P35/00A61P29/00A61P37/08A61P3/06
Inventor 姬胜利高树华李文茂
Owner HEBEI CHANGSHAN BIOCHEM PHARMA
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