Berberis Aristata Extract 89957-84-6 Manufacturer Exporter MEDIOCON INC

 

Berberis Aristata Extract Manufactured by MEDIOCON INC     

 

·   Name: Berberis Aristata Extract

 

·   CAS No : 89957-84-6

 

·   Molecular Weight: 336.4g/mol

 

 

·   Molecular formula:  C₂₀H₁₈O₄N.Cl.H₂O

 

·   Synonyms :    Daruharidra

 

 

·   Appearance :    a fine, yellowish powder with a characteristic odor.

 

·   Solubility:   partially soluble in water and soluble in ethanol.

 

 

·   Use :

 

Berberis aristata extract, also known as Indian barberry or tree turmeric, has various uses:

 

1. Medicinal properties: It's used in Ayurvedic medicine for its antimicrobial, anti-inflammatory, and antioxidant properties.

2. Digestive issues: It may help with digestive problems like diarrhea, dysentery, and stomach ulcers.

3. Antimicrobial agent: Berberine, a compound in Berberis aristata, has shown antimicrobial activity against various pathogens.

4. Antidiabetic potential: Some studies suggest it may help manage blood sugar levels.

5. Skin and wound healing: It's used in traditional medicine for skin issues and wound healing.

 

How is  Berberis Aristata Extract manufactured by MEDIOCON INC Synthesized?

 

- Soxhlet Extraction: This involves exhaustively extracting the plant material in a solvent like 95% ethanol using a Soxhlet apparatus.

- Microwave-Assisted Extraction (MAE): This method is used to isolate berberine from Berberis aristata, which is then characterized using spectroscopic techniques.

- Column Chromatography: This process isolates various phytoconstituents using solvents of increasing polarity.

- Freeze-Dried Extract: An optimized freeze-dried extract can be used to develop solid lipid nanoparticles (SLNs) as an effective drug-delivery system.

 

The extraction process typically involves³:

- Solvents: Ethanol, methanol, petroleum ether, and other solvents are used to extract specific compounds from Berberis aristata.

- Characterization: The isolated compounds are structurally elucidated using spectral data analysis, such as IR, 1HNMR, 13CNMR, and positive ion FAB MS.

 

Some studies have also explored the use of⁴:

- Nanoparticles: Gelatin-lipid nanocarriers incorporating Berberis aristata extract have been developed for cancer therapy, showing promising results in physical characterization, pharmacological, and molecular modeling analysis.

 

 

·         What are the different dosage forms of Berberis Aristata Extract Manufactured by MEDIOCON INC?

 

1. Tablets: Oral tablets containing standardized extracts of Berberis aristata.

2. Capsules: Capsules containing dried extracts or powders of Berberis aristata.

3. Liquid extracts: Liquid extracts or tinctures of Berberis aristata.

4. Solid lipid nanoparticles (SLNs): A delivery system using SLNs to enhance bioavailability and efficacy.

5. Topical formulations: Creams, ointments, or gels containing Berberis aristata extract for skin applications.

 

These dosage forms may vary depending on the intended use, such as digestive health, antimicrobial, or anti-inflammatory applications.

 

·         How Berberis Aristata Extract Manufactured by MEDIOCON INC   Dosage Forms are prepared?

 

The preparation of Berberis aristata extract dosage forms involves various steps:

 

Tablets/Capsules:

 

1. Extraction: Berberis aristata plant material is extracted using solvents like ethanol or water.

2. Concentration: The extract is concentrated through evaporation or lyophilization.

3. Standardization: The extract is standardized for berberine content.

4. Formulation: The extract is mixed with excipients and filled into capsules or compressed into tablets.

Liquid Extracts:

1. Extraction: Plant material is extracted using solvents like ethanol or glycerin.

2. Filtration: The extract is filtered to remove impurities.

3. Concentration: The extract may be concentrated through evaporation.

Solid Lipid Nanoparticles (SLNs):

1. Extraction: Berberis aristata extract is prepared.

2. Nanoparticle formulation: The extract is incorporated into SLNs using techniques like hot homogenization.

Topical Formulations:

1. Extraction: Berberis aristata extract is prepared.

2. Formulation: The extract is mixed with topical bases like creams, ointments, or gels.

The specific preparation method may vary depending on the manufacturer and intended use.

 

·         What are the appropriate Dosage forms of Berberis Aristata Extract Manufactured  by  MEDIOCON   INC?

 

The appropriate dosage forms of Berberis aristata extract depend on the intended use and desired benefits. Here are some common dosage forms and their potential uses:

 

Oral Dosage Forms:

 

1. Tablets/Capsules: Suitable for digestive issues, antimicrobial, and anti-inflammatory benefits.

2. Liquid Extracts: May be used for digestive issues, antimicrobial, and anti-inflammatory benefits.

 

Topical Dosage Forms:

 

1. Creams/Ointments: May be used for skin issues like wounds, acne, or eczema.

2. Gels: May be used for skin issues like acne or minor cuts and scrapes.

 

Other Dosage Forms:

 

1. Solid Lipid Nanoparticles (SLNs): May be used to enhance bioavailability and efficacy for specific applications.

 

The choice of dosage form depends on factors like:

 

1. Intended use: Digestive issues, skin problems, or other health benefits.

2. Desired onset of action: Quick relief or sustained release.

3. Patient preference: Ease of use, convenience, and palatability.

 

It's essential to consult with a healthcare professional to determine the most suitable dosage form and dosage for specific needs.

 

·         What are the effects And Side effects of Berberis Aristata Extract Manufactured by MEDIOCON INC?

 

Berberis aristata extract has various effects and potential side effects:

 

Effects:

 

1. Antimicrobial: Effective against various bacteria, fungi, and viruses.

2. Anti-inflammatory: May help reduce inflammation and alleviate symptoms.

3. Antidiabetic: May help manage blood sugar levels.

4. Digestive health: May help with digestive issues like diarrhea, dysentery, and stomach ulcers.

5. Antioxidant: May help protect against oxidative stress.

 

Side Effects:

 

1. Gastrointestinal issues: Nausea, vomiting, diarrhea, or stomach upset.

2. Allergic reactions: Rash, itching, or difficulty breathing.

3. Interactions with medications: May interact with blood thinners, diabetes medications, or other prescription drugs.

4. Hypoglycemia: May lower blood sugar levels, requiring monitoring.

5. Pregnancy and breastfeeding: Consult a healthcare professional before using Berberis aristata extract.

 

Precautions:

 

1. Consult a healthcare professional: Before using Berberis aristata extract, especially if pregnant, breastfeeding, or taking medications.

2. Monitor blood sugar levels: If diabetic, monitor blood sugar levels closely.

3. Start with low doses: Gradually increase dosage as needed and under medical supervision.

 

Contraindications:

 

1. Pregnancy: May stimulate uterine contractions.

2. Breastfeeding: May affect milk production or infant health.

3. Severe gastrointestinal issues: May exacerbate conditions like ulcers or inflammatory bowel disease.

 

Individual results may vary, and potential side effects should be discussed with a healthcare professional.

 

·         How is Berberis Aristata Extract Manufactured by MEDIOCON INC Tested Qualitatively?

 

Berberis aristata extract is tested qualitatively using various methods, including:

 

Phytochemical Screening:

 

1. High-Performance Liquid Chromatography (HPLC): To identify and quantify berberine and other alkaloids.

2. Thin-Layer Chromatography (TLC): To detect the presence of specific compounds.

3. Gas Chromatography-Mass Spectrometry (GC-MS): To identify and quantify volatile compounds.

 

Spectroscopic Analysis:

 

1. Ultraviolet-Visible Spectroscopy (UV-Vis): To detect the presence of specific compounds.

2. Infrared Spectroscopy (IR): To identify functional groups.

 

Other Methods:

 

1. Pharmacopoeial Testing: To ensure compliance with standards.

2. Microbial Contamination Testing: To ensure the extract is free from microbial contaminants.

 

           These tests help ensure the quality, purity, and potency of Berberis aristata      

            extract.

·         Which tests are performed on Berberis Aristata Extract Manufactured by MEDIOCON INC?

Berberis aristata extract undergoes various tests to ensure its quality, purity, and potency. Some common tests include:

 

Physicochemical Tests:

 

1. Appearance: Visual examination of color, texture, and consistency.

2. Solubility: Testing solubility in various solvents.

3. pH: Measuring the pH value of the extract.

 

Phytochemical Tests:

 

1. Berberine Content: Quantification of berberine using HPLC or other methods.

2. Alkaloid Profile: Identification and quantification of other alkaloids.

3. Flavonoid Content: Detection and quantification of flavonoids.

 

Microbial Contamination Tests:

 

1. Total Plate Count: Testing for total microbial load.

2. Pathogen Testing: Screening for specific pathogens like E. coli, Salmonella, etc.

 

Heavy Metal Testing:

 

1. Lead, Mercury, Arsenic: Testing for heavy metal contaminants.

 

Other Tests:

 

1. Moisture Content: Measuring the moisture level in the extract.

2. Ash Value: Determining the ash content to assess purity.

These tests help ensure the extract's quality, safety, and efficacy.

 

·         What are the challenges in Manufacturing of Berberis Aristata Extract Manufactured by MEDIOCON   INC API?

 

The manufacturing of Berberis aristata extract API (Active Pharmaceutical Ingredient) faces several challenges, including:

 

Raw Material Sourcing:

 

1. Quality and Consistency: Ensuring consistent quality of Berberis aristata plant material.

2. Sustainability: Sourcing plant material sustainably to avoid over-harvesting.

 

Extraction and Purification:

 

1. Efficient Extraction Methods: Developing efficient extraction methods to maximize yield.

2. Purification Challenges: Removing impurities and achieving high purity levels.

 

Standardization:

 

1. Berberine Content: Standardizing the extract for berberine content.

2. Batch-to-Batch Consistency: Ensuring consistency across batches.

 

Regulatory Compliance:

 

1. GMP Compliance: Adhering to Good Manufacturing Practices (GMP) regulations.

2. Regulatory Approvals: Obtaining necessary regulatory approvals.

 

Quality Control:

 

1. Testing and Analysis: Conducting thorough testing and analysis to ensure quality.

2. Stability Studies: Conducting stability studies to ensure shelf-life.

 

Scalability:

 

1. Scaling Up Production: Scaling up production while maintaining quality and consistency.

 

           Addressing these challenges is crucial to ensure the quality, efficacy, and safety  of Berberis Aristata extract API.

 

·         What are the challenges in manufacturing of Berberis Aristata Extract Manufactured by MEDIOCON  INC ’s Dosage forms?

 

The manufacturing of Berberis aristata extract dosage forms faces several challenges, including:

 

Formulation Challenges:

 

1. Stability Issues: Ensuring the stability of the extract in various dosage forms.

2. Compatibility: Ensuring compatibility between the extract and excipients.

 

Bioavailability Challenges:

 

1. Poor Bioavailability: Overcoming poor bioavailability of berberine.

2. Enhancing Absorption: Enhancing absorption through formulation strategies.

 

Manufacturing Challenges:

 

1. Scaling Up: Scaling up production while maintaining quality and consistency.

2. Process Optimization: Optimizing manufacturing processes for efficiency and cost-effectiveness.

 

Quality Control Challenges:

 

1. Standardization: Standardizing the extract and dosage forms for berberine content.

2. Testing and Analysis: Conducting thorough testing and analysis to ensure quality.

Regulatory Challenges:

1. Compliance with Regulations: Complying with regulatory requirements and guidelines.

2. Documentation and Validation: Maintaining documentation and validation records.

Other Challenges:

1. Raw Material Variability: Managing variability in raw material quality.

2. Cost-Effective Production: Ensuring cost-effective production while maintaining quality.

Addressing these challenges is crucial to ensure the quality, efficacy, and safety of Berberis aristata extract dosage forms.

·         What is the Packing for Berberis Aristata Extract Manufactured by MEDIOCON INC?

 

Berberis aristata extract packaging varies depending on the dosage form and intended use. Common packaging options include:

 

For Powders/Extracts:

 

1. Air-tight containers: Glass or plastic containers with tight-fitting lids.

2. Sealed pouches: Foil or plastic pouches sealed to maintain freshness.

 

For Tablets/Capsules:

 

1. Bottles: Glass or plastic bottles with child-resistant caps.

2. Blister packs: Individual tablets/capsules packaged in blister strips.

 

For Liquid Extracts:

 

1. Glass bottles: Dark glass bottles with dropper lids.

2. Plastic bottles: PET or HDPE bottles with screw caps.

 

Labeling:

 

1. Product name and description

2. Ingredients and dosage instructions

3. Storage conditions and shelf-life

 

Packaging should ensure product stability, safety, and compliance with regulatory requirements.

·         What is shelf life Of Berberis Aristata Extract Manufactured by MEDIOCON INC? 

 

The shelf life of Berberis aristata extract varies depending on factors like:

 

Storage Conditions:

 

1. Temperature: Cool, dry place or refrigerated.

2. Humidity: Low humidity to prevent degradation.

3. Light: Protection from direct sunlight.

Packaging:

1. Air-tight containers: Protects from moisture and air.

2. Light-resistant packaging: Protects from UV light.

Typical Shelf Life:

1. Powder extracts: 2-5 years.

2. Liquid extracts: 1-3 years.

3. Tablets/Capsules: 2-5 years.

Manufacturer's Guidelines:

Always follow the manufacturer's recommended storage conditions and shelf life.

 

·         What should the label claim for Berberis Aristata Extract Manufactured by MEDIOCON INC Include?

 

The label claim for Berberis aristata extract should include:

 

Required Information:

 

1. Product name and description

2. Ingredients: List of ingredients, including Berberis aristata extract

3. Berberine content: Quantification of berberine content (if applicable)

4. Dosage instructions: Recommended dosage and usage guidelines

5. Storage conditions: Instructions for storage, such as temperature and humidity

6. Shelf life: Expiration date or shelf life

7. Cautionary statements: Warnings or cautions for specific populations (e.g., pregnant women, children)

8. Manufacturer's information: Name and contact details of the manufacturer or distributor

Optional Claims:

1. Standardization: Statement of standardization for berberine content

2. Vegetarian/Vegan certification: Certification logo (if applicable)

3. Allergen warnings: Warnings for potential allergens (if applicable)

Regulatory Compliance:

Ensure compliance with relevant regulatory requirements, such as those set by food and drug authorities.

Where can Berberis Aristata Extract Manufactured by MEDIOCON INC are procured?

Berberis Aristata Extract Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

1.      FOR API

 MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/Whatsapp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

 GST No: 27DHUPM2366D1ZZ

 

 

2.      For Dosage Forms :

     - Online Marketplaces: You can find Berberis Aristata Extract Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

 - Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Berberis Aristata Extract Manufactured by MEDIOCON INC products.

 Remember to ensure the quality and authenticity of the Berberis Aristata Extract Manufactured by MEDIOCON INC product, regardless of the procurement source.