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Method for removing organic residue in heparin sodium through vacuum drying

A vacuum drying, heparin sodium technology, applied in metabolic diseases, extracellular fluid diseases, blood diseases, etc., can solve problems such as excessive organic residues of heparin sodium products

Active Publication Date: 2012-07-04
NANJING KING FRIEND BIOCHEM PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The purpose of the present invention is to provide a method for removing organic residues in heparin sodium by vacuum drying in order to overcome the problem that the organic residues (especially ethanol residues) of the heparin sodium fine product in the existing refining process exceed the standard

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] 1. Get about 100 kilograms of ethanol precipitate wet solid obtained after aseptic filtration in the refining process of heparin sodium crude product (enzymolysis-resin adsorption method).

[0019] 2. Add about 80-100L of 99% ethanol to the heparin sodium precipitate, stir the precipitate for 20-30 minutes until it becomes wet solid fine particles, and then let it stand for dehydration for ≥2 hours. The waste ethanol in the upper layer of heparin sodium precipitation is pumped into the ethanol recovery tank.

[0020] 3. Add about 80-100L of 85% ethanol to the precipitate, stir and precipitate for 20-30 minutes until wet solid fine particles, and then let it stand for dehydration for more than 4 hours. The waste ethanol in the upper layer of heparin sodium precipitation is pumped into the ethanol recovery tank. Repeat this step 3 times.

[0021] 4. Centrifuge the heparin sodium precipitate for 5-10 minutes to dehydrate, evenly divide it into 28 stainless steel plates, ...

Embodiment 2

[0027] 1. Get about 110 kilograms of ethanol precipitate wet solids obtained after sterilizing and filtering the heparin sodium crude product (enzymolysis-resin adsorption method) in the refining process.

[0028] 2. Add about 80-100L of 99% ethanol to the heparin sodium precipitate, stir and precipitate for 20-30 minutes until it becomes wet solid fine particles, then let it stand for dehydration for ≥2 hours. The waste ethanol in the upper layer of heparin sodium precipitation is pumped into the ethanol recovery tank.

[0029] 3. Add about 80-100L of 85% ethanol to the precipitate, stir and precipitate for 20-30 minutes until wet solid fine particles, and then let it stand for dehydration for more than 4 hours. The waste ethanol in the upper layer of heparin sodium precipitation is pumped into the ethanol recovery tank. Repeat this step 3 times.

[0030] 4. Centrifuge the heparin sodium precipitate for 5-10 minutes to dehydrate, evenly divide it into 28 stainless steel pla...

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PUM

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Abstract

The invention discloses a method for removing organic residue in heparin sodium through vacuum drying. The method comprises the following steps of: adding a wet solid ethanol precipitate obtained after aseptic filtration in the process of the refinement of a crude product of the heparin sodium into ethanol at the concentration of between 90 and 99 percent for dehydration treatment; repeatedly performing dehydration treatment on the precipitate treated in the previous step by adopting ethanol at the concentration of between 80 and 90 percent for 1 to 4 times; and performing vacuum drying on the precipitate for over 20 hours at the temperature of between 30 and 75 DEG C under the relative vacuum degree of less than or equal to -0.09MPa to obtain a refined product of the heparin sodium, wherein the temperature is not more than 50 DEG C within early 5 to 10 hours of vacuum drying. The refined product of the heparin sodium prepared by the method ensures that the content of the ethanol is less than 0.5 percent and can further reach below 0.1 percent on the basis of ensuring the quality of the heparin sodium. The method also has the advantages that: the energy consumption is low, the cost is low, small area is occupied in clean area, the product batch is easy to enlarge and the performance is steady.

Description

technical field [0001] The invention belongs to the production field of heparin sodium, and in particular relates to a method for removing organic residues in the process of refining crude heparin sodium. Background technique [0002] Heparin sodium is a mucopolysaccharide sulfate anticoagulant. Heparin sodium is the sodium salt of aminodextran sulfate extracted from the intestinal mucosa of pigs or cattle, and belongs to mucopolysaccharides. Studies in recent years have proved that heparin sodium also has the effect of lowering blood lipids. [0003] Heparin is the compound with the most complex molecular structure known in the world so far, and it cannot be artificially chemically synthesized in the short term. Currently, only heparin derived from pig small intestinal mucosa can be used for clinical treatment. The raw material of heparin API is crude heparin, which can only be extracted from the small intestinal mucosa of healthy pigs. Because it contains a large amount ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C08B37/10A61P7/02A61P3/06
Inventor 唐咏群
Owner NANJING KING FRIEND BIOCHEM PHARMA CO LTD