Drying method of nadroparin calcium

A drying method, heparin calcium technology, applied in the field of biomedicine, can solve the problems of large amount of drying organic solvent, high energy consumption of freeze-drying, low product recovery rate, etc., and achieve the advantages of reduced production process, rapid drying and low energy consumption Effect

Inactive Publication Date: 2017-05-24
YANTAI DONGCHENG PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the production process, most of nadroparin calcium currently adopts freeze-drying and drying methods. These two methods have different disadvantages: freeze-drying consumes a lot of energy, needs to be pulverized after drying, and the product recovery rate is low; drying organic solvents The dosage is large, the drying time is long, and it needs to be crushed after drying, and the product recovery rate is low

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Take 40 g of nadroparin calcium intermediate, dissolve it in 200 ml of purified water, the concentration is 20% (w / v), and adjust the pH to 5.9. The resulting feed liquid is filtered with a 0.22um microporous membrane. Open the spray drying tower (maximum drying capacity: 1.5 liters of water / hour), set the inlet temperature as 180° C., and the feed rate as 10 ml / min to obtain 39.5 g of finished product of nadrixarparin calcium, with a yield of 98.75%.

[0017] The product quality indicators are shown in the table below.

[0018] Embodiment: nadroparin calcium European standard Weight average molecular weight 4288Da 3600~5000Da Molecular weight 9.8％ ≤15％ The content of molecular weight in 2000~4000Da 40.3％ 35％～55％ The content of molecular weight in 2000~8000Da 82.6％ 75％～95％ Anti-Xa factor titer (IU / mg) 106.5 95～130 Anti-Xa titer / anti-IIa titer 3.6 2.5～4.0 calcium content 10.4％ 9.5～11.5％ N-NO group 0....

Embodiment 2

[0020] Take 40 g of nadroparin calcium intermediate, dissolve it in 100 ml of purified water, the concentration is 40% (w / v), and adjust the pH to 7.8. The resulting feed liquid is filtered with a 0.22um microporous membrane. Open the spray drying tower (maximum drying capacity: 1.5 liters of water / hour), the inlet temperature is set to 150°C, and the feed rate is 15ml / min to obtain 39.6g of Nadroparin calcium finished product with a yield of 99%.

[0021] The product quality indicators are shown in the table below.

[0022] Embodiment: nadroparin calcium European standard Weight average molecular weight 4302Da 3600~5000Da Molecular weight 9.6％ ≤15％ The content of molecular weight in 2000~4000Da 40.5％ 35％～55％ The content of molecular weight in 2000~8000Da 82.5％ 75％～95％ Anti-Xa factor titer (IU / mg) 108.1 95～130 Anti-Xa titer / anti-IIa titer 3.6 2.5～4.0 calcium content 10.5％ 9.5～11.5％ N-NO group 0.17ppm ≤0....

Embodiment 3

[0024] Take 1 kg of nadroparin calcium intermediate, dissolve it in 3300 ml of purified water, the concentration is 30% (w / v), and adjust the pH to 7.0. The resulting feed liquid is filtered with a 0.22um microporous membrane. Open the spray drying tower, set the inlet temperature to 160° C., and the feed rate to 15 ml / min to obtain 995 g of finished product of nadrixarparin calcium with a yield of 99.5%.

[0025] The product quality indicators are shown in the table below.

[0026] Embodiment: nadroparin calcium European standard Weight average molecular weight 4489Da 3600~5000Da Molecular weight 10.5％ ≤15％ The content of molecular weight in 2000~4000Da 42.3％ 35％～55％ The content of molecular weight in 2000~8000Da 85.7％ 75％～95％ Anti-Xa factor titer (IU / mg) 110.6 95～130 Anti-Xa titer / anti-IIa titer 3.7 2.5～4.0 calcium content 11.0％ 9.5～11.5％ N-NO group 0.15ppm ≤0.25ppm Loss on drying 2.0％ ≤10％

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PUM

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Abstract

The invention belongs to the field of biological medicine, in particular, relates to a spray drying process of glycosaminoglycans, and particularly, relates to a spray drying process of nadroparin calcium. The spray drying method is adopted; spray drying is a drying technology comprising the steps of dispersing a raw material into fog droplets by a liquid atomizer, making hot air (or other gases) direct contact with the fog droplets, carrying out heat exchange, and rapidly evaporating a solvent in the fog droplets, to obtain a powder or fine granular finished product or semi-finished product. The technology has the advantages of short drying time, less damage to active ingredients, uniform texture and good solubility. The invention aims to search the preparation method suitable for industrial production of nadroparin calcium under conditions of different drying ways of nadroparin calcium, and the high-quality nadroparin calcium product can be simply and efficiently obtained with low cost.

Description

technical field [0001] The invention belongs to the field of biomedicine, in particular to a spray-drying process of glycosaminoglycans, in particular to a spray-drying process of natroparin calcium Background technique [0002] Nadroparin calcium is a low molecular weight heparin calcium salt obtained from heparin sodium extracted from pig intestinal mucosa through nitrous acid cleavage and selective fractionation. Its weight average molecular weight is about 4300Da, has anti-Xa factor activity, antithrombotic effect is better than unfractionated heparin, and has higher bioavailability. Clinically, it can be used to prevent and treat diseases such as thromboembolism, angina pectoris and myocardial infarction. In the production process, most of nadroparin calcium currently adopts freeze-drying and drying methods. These two methods have different disadvantages: freeze-drying consumes a lot of energy, needs to be pulverized after drying, and the product recovery rate is low; ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B37/10
Inventor 杨清宝王建强张美由祁静仰振球吕慧忠由守谊
Owner YANTAI DONGCHENG PHARMA GRP
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