In the field of neurodegenerative diseases and brain injury treatment, Cerebrolysin Capsule, as a drug with a unique mechanism of action, is attracting widespread attention from the global medical community. Its core component is a mixture of bioactive peptides derived from pig brain tissue, which demonstrates significant potential in promoting nerve repair, protecting neurons, and improving cognitive function by simulating the function of natural neurotrophic factors. The various neurotrophic factors in this substance form a neuroprotective network through multi-target synergistic effects: BDNF and NGF jointly promote hippocampal neurogenesis and enhance learning and memory abilities; The combination of GDNF and CNTF inhibits oxidative stress response and reduces neuronal mortality; Free amino acids act as neurotransmitter precursors, supporting energy metabolism and synaptic transmission. This substance scavenges free radicals, reduces lipid peroxidation levels, protects mitochondrial function, regulates glutamate receptor expression, and reduces neuronal damage caused by calcium influx. Downregulate the expression of pro-inflammatory factors such as TNF - α and IL-1 β to alleviate neuroinflammation.
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Cerebrolysin COA
Cerebrolysin Capsule, as a neuropeptide complex derived from pig brain tissue, has demonstrated unique value in the treatment of Alzheimer's disease, vascular dementia, and post-stroke cognitive impairment due to its multi-target neuroprotective and reparative effects. Its core components are prepared through standardized enzymatic hydrolysis process, comprising a complex of 80% low molecular weight peptides (molecular weight<10kDa) and 20% free amino acids. This combination simulates the function of natural neurotrophic factors and can penetrate the blood-brain barrier to directly act on neurons. Compared to traditional injectable formulations, capsule formulations have achieved a breakthrough in oral bioavailability through nanoencapsulation technology, significantly improving patient medication adherence. The manufacturing information of this substance will be elaborated from four dimensions: raw material selection, extraction process, formulation technology, and quality control：
Raw material selection: from pig brain tissue to standardized extracts
Raw material sources and quality control
Animal source: Select healthy pig brain tissue that has passed quarantine inspection as raw material, and exclude the risk of animal diseases such as mad cow disease and pseudorabies.
Pre treatment process:
Remove impurities such as blood vessels, fat, and connective tissue, and reduce immunogenic substances.
After cleaning, perform low-temperature freezing (below -20 ℃) to inhibit endogenous enzyme activity.
Cut into small pieces (about 1cm ³) to improve enzymatic hydrolysis efficiency.
Optimization of enzymatic hydrolysis process
Dual enzyme stepwise hydrolysis:
Step 1: Hydrolysis by gastric protease
Conditions: pH 1.8-2.0, temperature 42 ℃, time 3-4 hours
Function: Break hydrophobic peptide bonds and release neurotrophic active fragments.
Step 2: Trypsin hydrolysis
Conditions: pH 7.6-7.8, temperature 42 ℃, time 2 hours
Function: Further cleave into low molecular weight peptides (<10kDa) to enhance blood-brain barrier penetration.
Key parameter control:
Enzyme to substrate ratio: pepsin 1:50 (w/w), trypsin 1:100 (w/w).
Enzyme inactivation treatment: After hydrolysis is complete, heat up to 95 ℃ and maintain for 10 minutes to terminate enzyme activity.
Purification and concentration
Centrifugal separation: Centrifuge at 4000 × g for 30 minutes to remove insoluble residue.
Ultrafiltration membrane separation: Using a 10kDa molecular weight cut-off membrane, the target low molecular weight peptide is separated.
Ion exchange chromatography: further removes large molecular proteins and endotoxins, with a purity of over 95%.
Vacuum concentration: Concentrate the filtrate to 1/10 of its original volume to obtain a concentrated solution of brain protein hydrolysate.
Formulation Technology: Transformation from Liquid to Solid Form
Nano embedding technology
Technical principle:Using the hydrophobic cavity of β - cyclodextrin (β - CD) to encapsulate active peptides, a host guest complex is formed.
The particle size of the composite is controlled between 200-500nm to improve gastrointestinal stability.
Preparation process:Dissolve β - CD in deionized water (concentration 10%), heat to 60 ℃ and stir to dissolve.
Slowly add concentrated brain protein hydrolysate solution (β - CD: peptide=5:1, w/w), Stir continuously for 4 hours.
Freeze drying yields nano encapsulated powder with a moisture content of less than 3%.
Capsule filling process
Empty Capsule Selection:
Specification: No. 0 hard capsule (capacity 0.68ml), suitable for filling 200-400mg powder.
Material: Hydroxypropyl methylcellulose (HPMC), in compliance with USP standards.
Filling equipment:
Adopting a fully automatic capsule filling machine (such as Bosch GKF 700 model) with an accuracy of ± 2%.
Filling process: Arrange empty capsules → Separate cap body → Fill powder → Close capsules → Remove waste.
Process parameters:
Filling speed: 6000 particles/hour to ensure even distribution of powder.
Environmental control: temperature 20-25 ℃, humidity<40%, reduce the risk of moisture absorption.
Coating technology (optional)
Enteric coating:
Material: Hydroxypropyl methylcellulose phthalate (HPMCP), resistant to gastric acid (insoluble at pH<5.5).
Process: Fluidized bed coating, coating weight increases by 10% -15%, ensuring release in the intestine (pH>6.0).
Extended release coating:
Material: A mixture of ethyl cellulose (EC) and polyethylene glycol (PEG).
Process: spray coating, control the drug release rate (t50%>6 hours).
Quality control: full chain supervision from raw materials to finished products
Raw material inspection
Microbial limit:
The total number of aerobic bacteria is less than 100 CFU/g, and mold and yeast are less than 10 CFU/g.
No pathogenic bacteria such as Escherichia coli and Salmonella shall be detected.
Heavy metal detection:
Lead (Pb)<0.5ppm, arsenic (As)<0.3ppm, mercury (Hg)<0.1ppm.
Quantification of active ingredients:
The content of brain-derived neurotrophic factor (BDNF) was determined by HPLC method, with a standard range of 20-50 μ g/g.
Intermediate control
Enzymatic hydrolysate detection:
Peptide content: Total nitrogen is determined by Kjeldahl method with a conversion factor of 6.25.
Molecular weight distribution: SDS-PAGE gel electrophoresis, the proportion of target peptide is>80%.
Purified liquid detection:
Endotoxin content: detected by horseshoe crab reagent method,<0.5EU/mg.
Residual enzyme activity: determined by Folin phenol method, pepsin residue<0.1%, trypsin residue<0.05%.
Finished product inspection
Content uniformity:
The BDNF content of each capsule should be between 85% and 115% of the labeled amount.
Dissolution test:
Enteric coated capsules: Dissolve<10% in artificial gastric juice (pH 1.2) within 2 hours, and dissolve>80% in artificial intestinal juice (pH 6.8) within 45 minutes.
Ordinary capsules: Dissolve>75% in water medium within 30 minutes.
Stability assessment:
Accelerated test: After being placed under 40 ℃± 2 ℃/75% ± 5% RH conditions for 6 months, the degradation of active ingredients is less than 5%.
Long term test: After being placed under 25 ℃± 2 ℃/60% ± 10% RH conditions for 24 months, the dissolution rate meets the standard.
Process optimization and innovation direction
Green enzymatic hydrolysis technology
Fixed enzyme reactor:Covalent binding of pepsin and trypsin to the surface of magnetic nanoparticles enables the reuse of enzymes.
The reaction time has been shortened to one-third of the traditional process, and the enzyme dosage has been reduced by 50%.
Low temperature enzymatic hydrolysis:
Using low-temperature resistant mutant enzymes (such as Psychotropic protease), hydrolysis is carried out at 10-15 ℃.
Reduce the loss of thermosensitive components and retain more biological activity.
Intelligent formulation technology
3D printed capsules:Using fused deposition modeling (FDM) technology to prepare personalized dosage capsules.
Accurate control of the drug layer and sustained-release layer can be achieved to meet the needs of different patients.
Micro needle array capsule:Prepare biodegradable microneedles (500 μ m in length) on the surface of the capsule to promote drug absorption through intestinal mechanical stimulation.
Animal experiments have shown a 2.3-fold increase in bioavailability.
Intelligent Quality Control
Near infrared spectroscopy (NIR) online detection:Install NIR probes in the filling process to monitor the uniformity of capsule content in real-time.
Detection time<1 second, accuracy>99%.
Blockchain traceability system:The entire process data from raw material procurement to finished product delivery is on chain to ensure traceability.
Patients can check the production batch and quality inspection report of drugs by scanning the code.
Regulatory and ethical considerations
Drug registration requirements
Clinical trial design:Phase I-III clinical trials need to be completed to demonstrate safety and efficacy.
Key endpoint: Changes in Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS Cog) scores.
Production standards:Compliant with GMP standards, the air cleanliness reaches Class C (local Class A).
Key equipment such as filling machines and coating machines need to be regularly validated.
Ethical review
Animal experiment ethics:The optimization of enzymatic hydrolysis process should follow the "3R principle" (substitution, reduction, optimization).
The use of experimental animals requires approval from the institutional ethics committee.
Patient data protection:Clinical trial data needs to be anonymized and comply with HIPAA or GDPR standards.
The patient informed consent form should clearly state the potential risks and benefits of the drug.
The production of Cerebrolysin Capsule integrates multidisciplinary wisdom from biotechnology, formulation engineering, and quality control. From standardized enzymatic hydrolysis of pig brain tissue, to breakthroughs in nanoencapsulation technology, to innovative applications of intelligent formulations, every step reflects the modern pharmaceutical industry's pursuit of precision medicine. In the future, with the maturity of green enzymatic hydrolysis, 3D printing and other technologies, the production of Cerebrolysin Capsule will be more efficient, environmentally friendly and personalized, providing better treatment options for patients with neurological diseases worldwide.
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