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Cerebroprotein hydrolysate freeze-dried powder injection and preparation method thereof

A technology of cerebroprotein hydrolyzate and freeze-dried powder injection, which is applied in the direction of freeze-drying transportation, hydrolyzed protein components, powder transportation, etc., to achieve the effects of not being difficult for the substance, reducing the incidence of adverse reactions, and stabilizing the quality during the storage period

Active Publication Date: 2014-10-15
GUANGZHOU YIPINHONG PHARMA +4
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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 overcome the defect that additional corresponding amino acids need to be added in the existing cerebroprotein hydrolyzate preparation technology, and to provide a cerebroprotein hydrolyzate freeze-dried powder injection and a preparation method thereof. The cerebroprotein hydrolyzate frozen powder prepared by the preparation method The similarity between the small molecular peptides in the dry powder injection and the reverse phase peptide map chromatographic identification is ≥0.90, no need to add exogenous amino acids, and it is completely prepared by hydrolysis of pig brain

Method used

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  • Cerebroprotein hydrolysate freeze-dried powder injection and preparation method thereof
  • Cerebroprotein hydrolysate freeze-dried powder injection and preparation method thereof
  • Cerebroprotein hydrolysate freeze-dried powder injection and preparation method thereof

Examples

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Embodiment 1

[0065] Brain tissue (quarantine qualified) remove blood vessels, fat and other impurities, take 100kg, add 1.5 times volume of purified water to homogenate, keep warm at 80°C for 25 minutes, cool, adjust pH to 1.7 with hydrochloric acid, hydrolyze with pepsin, keep warm at 42°C for 3 hours , adjust the pH to 7.6 with sodium hydroxide, hydrolyze with trypsin, incubate at 42°C for 2 hours, collect the supernatant by centrifugation; adjust the pH to 2 with hydrochloric acid, incubate at 105°C for 30 minutes, adjust the pH to 8.5 with sodium hydroxide; cool down, extract the supernatant, 10kd Remove macromolecules by membrane ultrafiltration, collect 150L of filtrate; apply column chromatography, wash the column with purified water, analyze, collect eluate, adjust pH to 8.0-9.0, concentrate 50L with DUS-8040C ion membrane, and sterilize with 0.2μm membrane Filtrate to obtain the stock solution, freeze and store below -15°C; thaw the stock solution, add 5% excipients, adjust the pH ...

Embodiment 2

[0080] Brain tissue (quarantine qualified) removes blood vessels, fat and other impurities and takes 100kg, add 2 times the volume of purified water to homogenate, keep warm at 85°C for 30 minutes, cool, adjust pH to 2.0 with hydrochloric acid, hydrolyze with pepsin, keep warm at 42°C for 4 hours, Adjust the pH to 7.8 with sodium hydroxide, hydrolyze with trypsin, incubate at 42°C for 2 hours, collect the supernatant by centrifugation; Remove macromolecules by filtration, collect 150L of filtrate; apply column chromatography, wash the column with purified water, analyze, collect the eluate, adjust the pH to 8.0-9.0, concentrate 50L with DUS-040C ion membrane, and sterilize and filter with 0.2μm membrane. The stock solution was obtained and stored frozen below -5°C; the stock solution was thawed, added 6% of excipients, adjusted to pH 6.9-7.5, 8-10 kd membrane ultrafiltration, 0.2 μm membrane sterilization filtration, filling; set freeze-drying curve (refer to Figure 9 : When ...

Embodiment 3

[0087] Brain tissue (qualified for inspection and quarantine) removes impurities such as blood vessels and takes 100kg, add 2 times the volume of purified water to homogenate, keep warm at 85°C for 30 minutes, cool, adjust pH to 3.0 with hydrochloric acid, hydrolyze with pepsin, keep warm at 35°C for 5 hours, Adjust the pH to 7.2 with sodium hydroxide, hydrolyze with trypsin, incubate at 45°C for 3 hours, and centrifuge to collect the supernatant; 10kd membrane ultrafiltration to remove macromolecules, collect 150L of filtrate; apply column chromatography, wash the column with purified water, analyze, collect eluate, adjust pH to 8.0-9.0, concentrate 50L with DUS-040C ion membrane, and filter with 0.2μm membrane , to obtain the stock solution, frozen and stored below -15°C; the stock solution was thawed, added 8% of excipients, adjusted to pH 6.9-7.5, 8-10kd membrane ultrafiltration, 0.2 μm membrane filtration, filling; set freeze-drying curve (filling When the temperature of ...

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Abstract

The invention provides a cerebroprotein hydrolysate freeze-dried powder injection and a preparation method thereof. The preparation method includes: taking a pig brain, removing impurities, adding purified water to conduct homogenization; subjecting the obtained homogenate to hydrolysis by pepsin and pancreatin successively, and collecting the clear liquid; adjusting the pH of the clear liquid to 1.7-3, conducting heating to 100-110DEG C and performing heat preservation for 15-45min, and then adjusting the pH to 8.0-9.0; carrying out ultrafiltration by a 8-10kd membrane, and collecting the filtrate; subjecting the filtrate to column chromatography, adjusting the pH of the eluent to 8.0-9.0, performing concentration by an anion exchange membrane, and conducting filtering by a membrane of 0.2 micrometer to obtain a stock solution; freezing the stock solution, then performing thawing, adding an excipient, adjusting the pH to 6.9-7.5, carrying out 8-10kd membrane ultrafiltration, and performing filtration by a 0.2 micrometer membrane; and carrying out filling and freeze-drying. In the obtained freeze-dried powder injection, the similarity of polypeptide and a reference substance is greater than or equal to 0.90, and the freeze-dried powder injection contains 16 amino acids, the nitrogen content of total amino acids accounts for greater than or equal to 85% of the total nitrogen content, and no additional amino acids are needed. The cerebroprotein hydrolysate freeze-dried powder injection is prepared entirely by pig brain hydrolysis, and is stable and safe.

Description

technical field [0001] The invention relates to the field of biological preparations, in particular to a cerebroprotein hydrolyzate freeze-dried powder injection and a preparation method thereof. Background technique [0002] Cerebroprotein hydrolyzate products are prepared from raw materials that have been inspected, quarantined, extracted, refined, sterilized and other production processes; the main components of cerebroprotein hydrolyzate are low-molecular-weight peptides and free amino acids. It is easy to enter the brain nerve cells through the blood-brain barrier. Low-molecular-weight peptides have the same effect as naturally occurring neurotrophic factors, which can induce neuron differentiation, maintain normal nerve cell functions, increase neurotransmitter production and synaptic transmission, and protect Nerve cells can be protected from various damages, regulate human brain metabolism, neurotransmission and nerve growth; can increase the activity of glucolytic e...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/01A61K35/30A61K9/19A61K47/34A61P3/02A61P25/00A61P9/10
Inventor 张莉李捍雄
Owner GUANGZHOU YIPINHONG PHARMA
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