Cerebrolysin

 Cerebrolysin is a small molecular polypeptide with high content in mammalian brain tissue, which is also extremely important in various functional activities of human brain. 

It is an extract of pig brain and an aqueous solution of various amino acids, which can pass through the blood-brain barrier. Its main function is to enter brain cells, improve cell metabolism, increase cell nutrition, and enhance the vitality and function of brain cells under ischemia and hypoxia. Therefore, it has the effects of anti-ischemia, anti-aging and anti-dysfunction caused by ischemia and hypoxia. Cerebrolysin is mainly used to treat early dementia, early cognitive dysfunction, and cerebral vascular cell dysfunction caused by early cerebral ischemia and hypoxia. It also has sedative effect. It can be used for insomnia, mobility inconvenience and amnesia caused by depression, anxiety and schizophrenia. It has certain auxiliary effect on cerebral edema and cerebral hemorrhage caused by hypertensive cerebral hemorrhage.

Cerebrolysin has the functions as following:

Keep brain cell mitochondria in normal state and enhance memory.

Activating the central nervous system is helpful for the vitality of brain cells and the response of limbs.

It can help patients recover from brain injury, improve speech disorder and increase brain growth.

It can nourish brain cells, improve the activity of mitochondria, and maintain the integrity of cell structure and normal function.

Our production follows strict GMP guidelines to ensure viral safety and purity:

1.Raw Material Collection: Sourcing from certified, disease-free porcine brains (Veterinary certified).

2.Defatting: Removal of lipids (cholesterol, myelin) using acetone/ethanol.

3.Enzymatic Hydrolysis: Controlled proteolysis to generate specific low-molecular-weight peptides.

4.Purification: Multi-step filtration including Ultrafiltration (<10 kDa cutoff) to remove high molecular weight proteins (prion safety).

5.Viral Inactivation: Heat treatment and nanofiltration.

6.Lyophilization (Freeze-Drying): Converting to stable powder form (or sterile filtration for liquid).

Product: Cerebrolysin

CAS No.: 12656-61-0

1.Kjeldahl method

1.1 Sample treatment: Weigh well mixed0.2g~2g of solid sample , 2g~5g of semi-solid sample or 10g~25g of liquid sample(about 30mg~40mg nitrogen), accurate to 0.001g, transferred to a dry 100mL, 250mL or 500mL nitrogen bottle, add 0.4g of copper sulfate, 6g of potassium sulfate and 20mL of sulfuric acid, after gently shaking, put a small funnel in the mouth of the bottle, and tilt the bottle at a 45 °C angle to the asbestosed wire gauze with small holes. Heat carefully, until the contents are completely carbonized, after the foam is completely stopped, strengthen the firepower, and keep the liquid in the bottle slightly boiling until the liquid is blue-green,clear and transparent, continue heating for 0.5h~1h. Remove and cool, add 20mL of water, cool, transfer to 100mL bottle, wash the nitrogen bottle with water, add the washing solution to the volumetric flask, add water to the mark, mix and set aside. At the same time, do the reagent blank test.

1.2 Determination: Install the nitrogen-distillation unit according to Figure 1. Add water to the steam generator to 2/3, add several glass beads, add a few drops of methyl red alcohol solution and milliliters of sulfuric acid to keep the water acidic, heat the water in the steam generator till boiling and keep it boiling.
1.3 Add 10.0mL boric acid solution and 1~2 drops of A mixed indicator or B mixed indicator to the receiving bottle, and make the lower end of condenser inserted under the liquid surface. Based on the nitrogen content in the sample, accurately absorb 2.0mL~10.0mL of the sample treatment liquid into the reaction chamber from the small glass cup. Wash the small glass with 10 mL water and let it flow into the reaction chamber, plugged with the rod-shaped stopper. Add 10.0mL of sodium hydroxide solution into the small glass cup, lift the glass stopper and let it flow into the reaction chamber, immediately close the glass stopper and water seal. Tighten the screw clamp and start the distillation. After 10 minutes of distillation, Move the distillate receiving bottle, the liquid surface leaves the lower end of the condenser and distill for 1 min. Then rinse the outside of the lower end of the condenser with a small amount of water and remove the steam distillate receiving bottle. Titrate the solution with sulfuric acid or hydrochloric acid to the end point. The end point color is gray-blue with A mixed indicator solution ;Mix with B, the end point is light gray red. At the same time do reagent blanks.

2.Automatic Kjeldah Analyzer

Weigh well-mixed 0.2g~2g solid sample, 2g~5g of semi-solid sample or 10g~25g of liquid sample (about 30mg~40mg nitrogen), accurate to 0.001g, into the digestive tube, then add 0.4g copper sulfate, 6g potassium sulfate and 20mL sulfuric acid in the digestion furnace to digest. After the temperature of the digestion furnace reaches 420 C, continue to digest for 1h, and when the liquid in the digestive tube is green and transparent, taken out and cooled and then add 50mL water. The processes of automatic dosing, distillation, titration and recording of titration data are on the automatic Kjeldahl analyzer (add sodium hydroxide solution, hydrochloric acid or sulfuric acid standard solution and boric acid solution containing mixed indicator A or B before use).

Stability Studies

• Shelf Life: Supports a 24-month shelf life when stored in sealed vials.

• Long-term Data: Samples stored at 25°C/60% RH showed stable nitrogen content and pH levels over 2 years.

• Sterility Maintenance: Container Closure Integrity Testing (CCIT) confirms sterility is maintained throughout the valid period.

Safety & Handling (MSDS Summary)

• Classification: Non-hazardous substance for transport.

• Viral Safety: Source material is screened for porcine viruses; manufacturing process includes dedicated viral inactivation steps.

• Storage: Store in a cool, dry place (2-8°C recommended for long-term storage of API). Protect from light.

1.Gschanes, A., et al. (2000). "The drug Cerebrolysin prevents neuronal degeneration..." Journal of Neural Transmission.

2.Rockenstein, E., et al. (2003). "Effects of Cerebrolysin on amyloid-beta deposition..." Journal of Neuroscience Research.

3.Alvarez, X.A., et al. (2011). "Cerebrolysin in Alzheimer's disease." Drugs of Today.

4.Chen, N., et al. (2013). "Cerebrolysin for vascular dementia." Cochrane Database of Systematic Reviews.

5.Sharma, H.S., et al. (2010). "Neuroprotective effects of Cerebrolysin in heat stress." Annals of the New York Academy of Sciences.