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Preparation method of cerebrolysin vial with high and stable nitrogen content

A technology of cerebroprotein hydrolyzate and nitrogen content, applied to medical preparations containing active ingredients, pharmaceutical formulas, powder delivery, etc., can solve the problems of low nitrogen content and instability of natural cerebroprotein hydrolyzate

Inactive Publication Date: 2014-07-16
云南盟生药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the problems of low nitrogen content and instability of the natural cerebroprotein hydrolyzate currently produced, the present invention provides a method for preparing a cerebroprotein hydrolyzate with high nitrogen content and stability

Method used

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  • Preparation method of cerebrolysin vial with high and stable nitrogen content
  • Preparation method of cerebrolysin vial with high and stable nitrogen content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] (1) Take 2 kg of frozen fresh pig brain, soak it in water to thaw naturally, wash it with water, grind it into a slurry, add 8 kg of water 4 times, heat it to 80 ° C, keep it warm for 20 minutes, then cool it to 32 ° C, and then turn it at 3500 rpm Centrifuge for 3 minutes per minute to collect the lower layer of sediment to obtain 1.216 kg of degreased brain pulp;

[0020] (2) Add 3.00 kg of water 1.5 times the mass of fresh pig brain to the degreased brain pulp obtained in step (1) and stir well, then add 20.0 g of pepsin at 1% of the mass of fresh pig brain, and use 50% (w / w ) Dilute hydrochloric acid to adjust the pH value to 3.0, then heat up to 40°C for hydrolysis for 7 hours, adjust the pH value to 8.0 with 50% (w / w) sodium hydroxide solution, and then filter through a 300-mesh nylon sieve to obtain enzymatic hydrolysis liquid;

[0021] (3) Heat the enzymolysis solution obtained in step (2) to 50°C, adjust the pH value to 8.0, then add 30.0 g of 1.5% trypsin in ...

Embodiment 2

[0024] (1) Take 2kg of fresh pig brain, wash it with water, grind it into a slurry, add 6kg of water with 3 times the mass, heat it to 100°C, keep it warm for 10 minutes, then cool it to 40°C, and then perform centrifugation at 3200 rpm for 5 Minutes, collect the sediment in the lower layer to obtain the degreased brain pulp;

[0025] (2) Add 3 kg of water 1.5 times the mass of fresh pig brain to the degreased brain pulp obtained in step (1) and stir evenly, then add 10 g of pepsin 0.5% of the mass of fresh pig brain, adjust the pH value to 2.0, and then heat up to Perform hydrolysis at 50°C for 8 hours, adjust the pH value to 9.0, and then filter through a 300-mesh nylon sieve to obtain the enzymatic hydrolysis solution;

[0026] (3) Heat the enzymolysis solution obtained in step (2) to 40°C, adjust the pH value to 9.0, then add 100 g of 5% trypsin of fresh pig brain mass to carry out hydrolysis for 3 hours, and then circulate and filter the solution through a ceramic membran...

Embodiment 3

[0029] (1) Take 2kg of fresh pig brain, wash it with water, grind it into a slurry, add 4kg of water twice the mass, heat it to 90°C, keep it warm for 15 minutes, then cool it down to 30°C, and then perform centrifugation at 3700 rpm for 1 Minutes, collect the sediment in the lower layer to obtain the degreased brain pulp;

[0030] (2) Add water 1.5 times the mass of fresh pig brain to the degreased brain pulp obtained in step (1), stir well, then add 3% pepsin of fresh pig brain mass, adjust the pH value to 5.0, and then heat up to 50°C Perform hydrolysis for 5 hours, adjust the pH value to 7.0, and then filter through a 300-mesh nylon sieve to obtain the enzymatic solution;

[0031] (3) Heat the enzymolysis solution obtained in step (2) to 60°C, adjust the pH value to 7.0, then add 2.5% fresh pig brain mass trypsin to hydrolyze for 6 hours, and then circulate and filter the solution through a ceramic membrane to clarify the solution. After ultrafiltration by a 10,000 Dalton...

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Abstract

The invention discloses a preparation method of cerebrolysin vial with high and stable nitrogen content. The preparation method comprises the following steps: preparing degreased brains; carrying out enzymolysis with pepsase; carrying out enzymolysis with pancreatin; and concentrating the prepared solutions to obtain a cerebrolysin vial composition. The composition has the advantages that any exogenous amino acid is not added, the nitrogen content is up to 6 to 20mg / mL, proper auxiliary materials are also contained, and thus the natural cerebrolysin vial solution can be prevented from producing any undissolved substance on the premise that the high nitrogen content is ensured, and the similarity is more than 0.9. The method and composition provided by the invention are in accordance with the national standard and meet the requirements on producing a freeze-dried powder injection preparation.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of a high nitrogen content natural cerebroprotein hydrolyzate composition. Background technique [0002] Brain protein hydrolyzate is a specific amino acid mixture obtained by enzymatic hydrolysis of pig brain protein. It is protein-free and contains a variety of essential amino acids, non-essential amino acids, active polypeptides, sialic acid, etc. Additions. [0003] In the 1970s, brain protein hydrolyzate was first sold by the Austrian EBEWE pharmaceutical company under the trade name of Cerebrolysin (Shi Pushan). In 1995, the National Ministry of Health approved the domestic production of cerebroprotein hydrolyzate injection, but the nitrogen content in the cerebroprotein hydrolyzate obtained by the existing domestic preparation methods was low and could not reach the national standard. Many cerebroprotein hydrolyzate products need to meet...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/30A61K9/19
Inventor 马维波陈雪江
Owner 云南盟生药业有限公司
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