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Polysaccharide iron complex separating and purifying method

A separation method and technology for separation and purification, which is applied in the field of separation and purification of polysaccharide-iron complexes, can solve the problems of high purification cost, long cycle, and poor purification effect, and achieve the effects of improving safety, reducing content, and improving quality

Active Publication Date: 2014-12-03
CHONGQING SHENGHUAXI PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The technical problem to be solved by the present invention is to provide a method for separating and purifying polysaccharide-iron complexes with low cost, simple process and easy industrial production, so as to overcome the problems of poor purification effect or high purification cost and long cycle in the prior art

Method used

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Examples

Experimental program
Comparison scheme
Effect test

reference example 1

[0022] Reference example 1 Preparation of polysaccharide-iron complex (refer to US3821192)

[0023] Add 244.5 g of corn syrup into 455.5 mL of water, and stir to form an aqueous solution. Add 535 mL of 75% ferric chloride hexahydrate aqueous solution. After the addition, 40% sodium hydroxide aqueous solution was added dropwise until the pH reached 11.5, the addition was stopped, the temperature was controlled to be less than 80°C and stirring was continued for 15 minutes, and then the temperature was raised to 80°C until the reaction was completed. Add an equal volume of methanol to precipitate a precipitate, collect the precipitate by centrifugation, wash and purify the precipitate repeatedly with 50% aqueous methanol solution, collect the precipitate by centrifugation, and dry at 60°C to obtain the polysaccharide-iron complex. After determination: chloride> 8%, heavy metal> 20ppm.

reference example 2

[0024] Reference example 2 Separation and Purification of Polysaccharide Iron Complex by Alcohol Precipitation and Centrifugation

[0025] Add 10 g of the above-mentioned crude polysaccharide-iron complex into 1000 mL of purified water, and stir to dissolve at room temperature. Add 1000mL of coagulant methanol to precipitate out the precipitate, and centrifuge to dry 9.0g of polysaccharide-iron complex. After determination: chloride> 6%, heavy metal> 20ppm.

Embodiment 1

[0027] Add 10 g of the crude polysaccharide-iron complex into 200 mL of purified water, and stir to dissolve at room temperature. Use hydrochloric acid aqueous solution to adjust the pH to its isoelectric point between 4.0-4.6, and precipitate out. Suction filtration, add the filter cake into 400mL of water, adjust the pH to 10-11 with aqueous sodium hydroxide solution, stir and dissolve at room temperature. Add coagulant ethanol dropwise until the precipitation is complete, filter with suction, and dry the filter cake with 9.5 g of polysaccharide-iron complex. After determination: chloride <1%, heavy metal <10ppm.

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Abstract

The invention relates to a polysaccharide iron complex separating and purifying method. The method can effectively purify a polysaccharide iron complex, effectively remove impurities of chloride and heavy metals in the polysaccharide iron complex to improve the purity and drug use safety of the polysaccharide iron complex; and the method is low in cost, simple in process and easy in industrialization production.

Description

technical field [0001] The present invention relates to a method for separating and purifying polysaccharide-iron complex, which can make the limit of chloride and heavy metal in the polysaccharide-iron complex easy to meet the requirements of national drug quality standards, and the method is low in cost, simple in process and easy to industrialize Production. Background technique [0002] Polysaccharide-iron complex is a complex of starch oligosaccharides and ferric iron, which is used to treat iron deficiency anemia. It is currently imported and marketed by Schwarz pharma manufacturing inc. and Kremers Urban Pharmaceuticals Inc. in the United States. The trade name is Niferex. . The iron content in the polysaccharide-iron complex is as high as 46%, which is completely absorbed in the form of molecules, and has a good iron supplement effect; it does not contain free iron ions, has little side effects on the gastrointestinal tract, and has no side effects such as nausea, a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08B31/00
Inventor 刘军姜维平
Owner CHONGQING SHENGHUAXI PHARMA CO LTD
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