Cerebrolysin 60mg

Cerebrolysin is not a single compound. It is a peptide preparation made by enzymatic digestion of purified porcine brain proteins, leaving short peptides, mostly under 10 kDa, together with free amino acids. This listing is a 60 mg vial of the freeze-dried hydrolysate, identified by LC-MS peptide mapping. The research literature on Cerebrolysin, nearly all of it on the licensed medicinal solution, covers neurotrophic-like effects in cell and animal models and randomised trials after ischaemic stroke.

Specifications

What a certificate can show for a mixture

A synthetic peptide is identified by one sequence and one mass. A hydrolysate has neither, so its certificate works differently. For this material, identity is established by LC-MS peptide mapping against PrymaLab’s in-house reference: the certificate records more than 638 peptides and confirms fingerprint peptides from tubulin, actin and myelin basic protein. It also describes the size range, a peptide fraction below 10 kDa and mostly between 1 and 5 kDa, with free L-amino acids accounting for about 75% of the nitrogen.

The certificate also reports an RP-HPLC result. For a mixture of hundreds of peptides that figure describes a chromatographic profile, not the purity of one molecule, so it is best read alongside the peptide map and compared lot to lot. Water content, endotoxin and sterility are reported as for any other lot. The sealed vial is kept at 2 to 8 °C and dark, not frozen like most freeze-dried peptides in the catalogue. How to read certificates in general is covered in peptide purity testing.

Not the licensed medicine

The name Cerebrolysin also belongs to a licensed medicine: a sterile solution made by EVER Neuro Pharma in Austria and described in the trial literature as a neuropeptide preparation for parenteral use, approved for stroke¹. It is widely used for acute ischaemic stroke in Russia, Eastern Europe, China and other Asian and post-Soviet countries², and it is not approved by the FDA. This vial is different material: a freeze-dried hydrolysate characterised against PrymaLab’s own reference, not the medicinal solution in another form.

Because a hydrolysate is defined by its starting tissue and its process, results obtained with one preparation cannot be assumed to hold for another. The trials and most of the animal work below describe the manufacturer’s product; none of them tested this vial.

What the research covers

What the preparation is

The Cochrane review describes Cerebrolysin as a mixture of low-molecular-weight peptides and amino acids derived from porcine brain, with potential neuroprotective properties². A 2012 review described it as a neuropeptide preparation that mimics the action of endogenous neurotrophic factors on brain protection and repair³. No single component has been identified as responsible.

Cell and animal models

The 2012 review summarised the preclinical record. In dementia models Cerebrolysin decreased β-amyloid deposition and tau phosphorylation by regulating glycogen synthase kinase-3β and cyclin-dependent kinase 5, increased synaptic density and increased neurogenesis in the dentate gyrus³. In stroke models it inhibited calpain, reduced the number of apoptotic cells, infarct volume and oedema, and promoted subventricular zone neurogenesis and functional recovery; in experimental spinal cord injury it prevented apoptosis of lesioned motoneurons³. Zhang, Chopp and colleagues studied rats after embolic middle cerebral artery occlusion and found more BrdU-positive progenitor cells and doublecortin-positive neuroblasts in the subventricular zone at 28 days, with TUNEL-positive cells at the ischaemic boundary cut by about half⁴. In one arm infarct volume did not fall significantly, yet behavioural outcomes improved, and in cultured progenitors the rise in proliferation disappeared when the PI3K/Akt pathway was blocked⁴.

Randomised trials of the licensed solution

CARS was a prospective, randomised, double-blind, placebo-controlled multicentre trial in people beginning rehabilitation after stroke, with upper-limb function on the Action Research Arm Test at day 90 as its primary endpoint⁵. It reported a difference in favour of Cerebrolysin on that endpoint and on a combined measure of 12 outcome scales, and its authors called it exploratory and said the results should be confirmed in a large trial⁵. A 2018 meta-analysis pooled nine randomised, placebo-controlled trials in acute ischaemic stroke, 1,879 participants in all, and reported an early difference on the NIH Stroke Scale favouring Cerebrolysin¹. The 2020 Cochrane review, limited to trials starting within 48 hours of onset, included seven trials and 1,601 participants. It found moderate-quality evidence of little or no effect on all-cause death and a possible increase in non-fatal serious adverse events, and noted that the manufacturer had supported four of the multicentre studies².

What is not established

The trial evidence points in different directions depending on the outcome and the analysis, and much of it was manufacturer supported². None of these references reports human pharmacokinetics for any component, and the animal findings describe pathways engaged by the whole mixture, not which peptides are active. All of the work concerns the manufacturer’s preparation. Whether a different porcine brain hydrolysate behaves the same way has not been tested.

The Cerebrolysin Peptide guide covers the literature in more depth.

How each lot is tested

Every lot is tested in PrymaLab’s own laboratory in Ashland, Kentucky before release: RP-HPLC for purity, LC-MS for identity, Karl Fischer titration for water, LAL for endotoxin and USP <71> for sterility. The results for the lot now shipping are in the certificate panel on this page, and the certificate number, key and QR code can be checked on the verify page. These are in-house results from PrymaLab Analytical, not an independent test, and the lab is not accredited to ISO 17025. The third-party testing guarantee on this page still applies: if any independent laboratory finds the wrong compound, or less than the stated purity or amount, the order is refunded and the cost of the test is reimbursed.

Frequently asked questions

References

1. Bornstein NM, Guekht A, Vester J, et al. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials. Neurol Sci. 2018;39(4):629-640. DOI · PubMed
2. Ziganshina LE, Abakumova T, Hoyle CH. Cerebrolysin for acute ischaemic stroke. Cochrane Database Syst Rev. 2020;7(7):CD007026. DOI · PubMed
3. Masliah E, Díez-Tejedor E. The pharmacology of neurotrophic treatment with Cerebrolysin: brain protection and repair to counteract pathologies of acute and chronic neurological disorders. Drugs Today (Barc). 2012;48 Suppl A:3-24. DOI · PubMed
4. Zhang C, Chopp M, Cui Y, et al. Cerebrolysin enhances neurogenesis in the ischemic brain and improves functional outcome after stroke. J Neurosci Res. 2010;88(15):3275-81. DOI · PubMed
5. Muresanu DF, Heiss WD, Hoemberg V, et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-9. DOI · PubMed