Cerebrolysin hydrolysate injection and preparation method thereof

Abstract

The invention provides a cerebrolysin hydrolysate injection and a preparation method thereof. The preparation method comprises the following steps: taking pig brain, removing impurities, and adding purified water for homogenizing; hydrolyzing homogenate through pepsin and pancreatin, and collecting a clear liquid; regulating the pH of the clear liquid to be 1.7-3, heating to 100-110 DEG C, insulating for 15-45min, then regulating pH to 8.0-9.0; conducting ultrafiltration through a 8-10kd membrane, and collecting filtrate; conducting column chromatography to the filtrate, collecting an eluent, regulating ph to 8.0-9.0, concentrating through an anion-exchange membrane, filtering through a 0.2mu m membrane to obtain a stock liquid; and freezing the stock liquid, then defreezing, adding an antioxidant, regulating the pH to be 6.9-7.5, and filtering respectively through a 8-10kd membrane and a 0.2mu m membrane. The polypeptide in the obtained cerebrolysin hydrolysate injection is similar to that of a control drug being more than or equal to 0.90, and the obtained cerebrolysin hydrolysate injection contains 16 amino acids, the nitrogen amount of total amino acids accounts for more than or equal to 85% of total nitrogen content, additional amino acids are not required, and the amino acids can be prepared completely by means of pig brain, thus being stable and safe.

Description

technical field

[0001] The invention relates to the field of biological preparations, in particular to a cerebroprotein hydrolyzate injection and a preparation method thereof. Background technique

[0002] Cerebroprotein hydrolyzate injection 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 enzymes, in...

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